{ "FullStudy":{ "Rank":217892, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01515475", "OrgStudyIdInfo":{ "OrgStudyId":"HTS1" }, "SecondaryIdInfoList":{ "SecondaryIdInfo":[ { "SecondaryId":"2U10EY011751", "SecondaryIdType":"U.S. NIH Grant/Contract", "SecondaryIdLink":"https://projectreporter.nih.gov/reporterapi.cfm?PROJECTNUM=2U10EY011751&Fy=all" } ] }, "Organization":{ "OrgFullName":"Jaeb Center for Health Research", "OrgClass":"OTHER" }, "BriefTitle":"Hyperopia Treatment Study 1 (HTS1) - Glasses vs Observation", "OfficialTitle":"Glasses Versus Observation for Moderate Hyperopia in Young Children (HTS1)", "Acronym":"HTS1" }, "StatusModule":{ "StatusVerifiedDate":"July 2019", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"February 23, 2012", "StartDateType":"Actual" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"February 2018", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"February 2018", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 11, 2012", "StudyFirstSubmitQCDate":"January 18, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 24, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"March 21, 2019", "ResultsFirstSubmitQCDate":"April 18, 2019", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"May 9, 2019", "ResultsFirstPostDateType":"Actual" }, "LastUpdateSubmitDate":"July 2, 2019", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"July 16, 2019", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Jaeb Center for Health Research", "LeadSponsorClass":"OTHER" }, "CollaboratorList":{ "Collaborator":[ { "CollaboratorName":"Pediatric Eye Disease Investigator Group", "CollaboratorClass":"NETWORK" },{ "CollaboratorName":"National Eye Institute (NEI)", "CollaboratorClass":"NIH" } ] } }, "OversightModule":{ "OversightHasDMC":"Yes" }, "DescriptionModule":{ "BriefSummary":"The purpose of this study is to compare visual acuity outcomes and development of strabismus after a 3-year follow-up period in children age 12 to <72 months with moderate hyperopia (spherical equivalent +3.00D to +6.00D) who are prescribed glasses either immediately or only after confirmation of pre-specified deterioration criteria.", "DetailedDescription":"Moderate and high hyperopia are associated with the development of strabismus and amblyopia. The primary aims of treatment for asymptomatic moderate and high hyperopia in preschool children are to facilitate the development of normal visual acuity and to prevent the development of esotropia and amblyopia. Treatment consists of optical correction, typically using glasses. For children with high hyperopia (>+5.00D) and without strabismus or amblyopia, there is general consensus that a correction should be prescribed. Nevertheless, for children with moderate hyperopia (+3.00D to +5.00D) without strabismus or amblyopia, there is less consensus among pediatric eye care professionals. A survey by Lyons et al found that for a 2-year-old child with hyperopia greater than +3.00D, 65% of optometrists would prescribe glasses compared to 25% of ophthalmologists; for a 4-year old with hyperopia greater than +3.00D, 67% of optometrists would prescribe compared with 42% of ophthalmologists. The American Association for Pediatric Ophthalmology and Strabismus (AAPOS) recommends correcting +4.00D or more in 2 to 7 year olds and the American Academy of Ophthalmology recommends a threshold of +4.50D for correction in 2-to 3-year olds. Unlike ophthalmology, optometry does not provide specific recommendations based on age and level of refractive error. Such variation in practice highlights the lack of rigorously collected scientific evidence for the management of this condition. Across all levels of hyperopia, most ophthalmologists and optometrists usually prescribe less than the full cycloplegic refraction (71% in the Lyons survey) when no strabismus or amblyopia is present.\n\nThe rationale for proactively correcting moderate hyperopia in an asymptomatic child is the prevention of esotropia, amblyopia, or asthenopia. The argument against correcting moderate hyperopia in an asymptomatic child is the expense and inconvenience of glasses that might be unnecessary and the potential disruption of emmetropization in infants and toddlers. At present, it remains uncertain whether correction of moderate hyperopia is beneficial in terms of visual acuity outcomes or strabismus development. There is some evidence that using partial correction of hyperopia allows emmetropization to take place.\n\nIf refractive correction of moderate hyperopia does not reduce the incidence of amblyopia and/or esotropia compared to no refractive correction, then glasses can be avoided. However, if correcting moderate hyperopia does reduce the development of amblyopia and/or esotropia, then the benefits of preemptive refractive correction will have been identified." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Hyperopia" ] }, "KeywordList":{ "Keyword":[ "Hyperopia", "Glasses" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Not Applicable" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"Single", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Outcomes Assessor" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"249", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Glasses", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Procedure: Glasses" ] } },{ "ArmGroupLabel":"Observation", "ArmGroupType":"Placebo Comparator", "ArmGroupDescription":"Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Procedure: Glasses" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Procedure", "InterventionName":"Glasses", "InterventionDescription":"Glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Glasses", "Observation" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Number of Participants With Confirmation of Failure Criteria", "PrimaryOutcomeDescription":"At the 36-month visit, each subject's condition will be classified as either failure or not a failure. The primary analytic approach will be a treatment group comparison of the proportion meeting failure criteria at 36-months using the Fisher's exact test.\n\nThe participant met failure criteria if ANY of the following criteria (except strabismus surgery prior to the 3-year outcome exam) were met during testing at the 3-year examination both with and without trial frames (without prism or bifocal), and the criteria was confirmed by a retest\n\nAny measurable manifest strabismus in primary gaze at distance or at near not correctable with distance refractive correction alone\nStrabismus surgery prior to the 36-month exam\nDistance VA below age norms in either eye\n≥2 logMAR lines of IOD if VA is 20/25 or worse in the better-seeing eye\n≥3 logMAR lines of IOD if VA is 20/20 or better in the better-seeing eye\nStereoacuity measured at near below age normal values", "PrimaryOutcomeTimeFrame":"36 months after randomization" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Subgroup Analysis - Race", "SecondaryOutcomeDescription":"Treatment effect in subgroups based on baseline factors will be assessed. Outcome failure status at 36 months will be tabulated by subgroup and reviewed for consistency. Total number of patients who experienced failure at 3 years are shown.", "SecondaryOutcomeTimeFrame":"36 months after randomization" },{ "SecondaryOutcomeMeasure":"Subgroup Analysis - Gender", "SecondaryOutcomeDescription":"Treatment effect in subgroups based on baseline factors will be assessed. Outcome failure status at 36 months will be tabulated by subgroup and reviewed for consistency. Total number of patients who experienced failure at 3 years are shown.", "SecondaryOutcomeTimeFrame":"36 months" },{ "SecondaryOutcomeMeasure":"Subgroup Analysis - Family History of Amblyopia", "SecondaryOutcomeDescription":"Treatment effect in subgroups based on baseline factors will be assessed. Outcome failure status at 36 months will be tabulated by subgroup and reviewed for consistency. Total number of patients who experienced failure at 3 years are shown.", "SecondaryOutcomeTimeFrame":"36 months" },{ "SecondaryOutcomeMeasure":"Subgroup Analysis - Family History of Strabismus", "SecondaryOutcomeDescription":"Treatment effect in subgroups based on baseline factors will be assessed. Outcome failure status at 36 months will be tabulated by subgroup and reviewed for consistency. Total number of patients who experienced failure at 3 years are shown.", "SecondaryOutcomeTimeFrame":"36 months" },{ "SecondaryOutcomeMeasure":"Subgroup Analysis - SE Anisometropia", "SecondaryOutcomeDescription":"Treatment effect in subgroups based on baseline factors will be assessed. Outcome failure status at 36 months will be tabulated by subgroup and reviewed for consistency. Total number of patients who experienced failure at 3 years are shown.", "SecondaryOutcomeTimeFrame":"36 months" },{ "SecondaryOutcomeMeasure":"Subgroup Analysis - Mean Refractive Error at Enrollment (Diopters)", "SecondaryOutcomeDescription":"Treatment effect in subgroups based on baseline factors will be assessed. Outcome failure status at 36 months will be tabulated by subgroup and reviewed for consistency. Total number of patients who experienced failure at 3 years are shown.", "SecondaryOutcomeTimeFrame":"36 months" },{ "SecondaryOutcomeMeasure":"Deterioration Criteria Met (Prior to 3 Years)", "SecondaryOutcomeDescription":"Estimate of Cumulative Deterioration Rate. Proportion of subjects who deteriorated during the course of the study were evaluated. Reasons for deterioration included stereoacuity, strabismus, treatment due to parental concern, and treatment that was prescribed against protocol.", "SecondaryOutcomeTimeFrame":"Enrollment to <36 months" },{ "SecondaryOutcomeMeasure":"Mean Change in Spherical Equivalent (SE) Refractive Error (Diopters)", "SecondaryOutcomeDescription":"Refractive error is the measurement of the power of the lenses needed to focus light on the retina. This is measured in diopters (D). Spherical Equivalent is a pair of numbers, one for each eye, that gives an estimate of the refractive error in the eyes. Hyperopia is farsightedness, or a type of refractive error in which things are seen more clearly at a distance than at near. Myopia is nearsightedness, or refractive error in which things are seen more clearly at near.\n\nMean change in SE refractive error is from baseline to 3 years, measured in diopters. Negative values indicate a shift in the myopic direction.", "SecondaryOutcomeTimeFrame":"Enrollment to 3 years" },{ "SecondaryOutcomeMeasure":"Percentage of Participants With Hyperopia Reduction", "SecondaryOutcomeDescription":"Percentage of Participants (%) in which hyperopia reduced by 1.00D (diopters) or more over 3 years", "SecondaryOutcomeTimeFrame":"Enrollment to 3 years" },{ "SecondaryOutcomeMeasure":"Best Visual Acuity", "SecondaryOutcomeDescription":"A treatment group comparison of the mean maximum visual acuity per subject at the masked 36-month visit (best visual acuity on any test with and without correction) will be performed using a t-test. Evaluated the best of the values reported with and without trial frames, during initial assessment and retest.\n\nSnellen visual acuity (VA) equivalents were converted to logarithm of minimum angle of resolution (logMAR) equivalents (in parentheses) as follows: 20/16 (-0.1), 20/20 (0), 20/25 (0.1), 20/32 (0.2), 20/40 (0.3), 20/50 (0.4)\n\nA logMAR value of less than 0 is associated with better than 20/20 vision, while a logMAR value greater than 0 is associated with worse than 20/20 vision.", "SecondaryOutcomeTimeFrame":"36 months after randomization" },{ "SecondaryOutcomeMeasure":"Failure to Meet Age-Normal VA at Distance", "SecondaryOutcomeDescription":"Proportion who failed to meet age-normal VA at distance at 3 years. Participants were classified as failing to meet age-normal visual acuity if, for either eye, distance visual acuity was below age-normal values both with and without trial frames, during initial assessment and re-test.", "SecondaryOutcomeTimeFrame":"36 months" },{ "SecondaryOutcomeMeasure":"Proportion With Amblyopia (at Distance)", "SecondaryOutcomeDescription":"A treatment group comparison of the proportion of subjects who developed amblyopia at distance during the course of the study will be performed using the Barnard's exact test.\n\nParticipants were classified as having amblyopia if any of the following criteria were met: 1) the interocular difference was ≥2 logMAR lines of IOD if VA is 20/25 or worse in the better-seeing eye, or 2) the interocular differences was ≥3 logMAR lines of IOD if VA is 20/20 or better in the better-seeing eye. 3) VA less than age normal in each eye (presumed bilateral amblyopia)", "SecondaryOutcomeTimeFrame":"36 months after randomization" },{ "SecondaryOutcomeMeasure":"Binocular Near Visual Acuity", "SecondaryOutcomeDescription":"A treatment group comparison of the mean binocular near visual acuity (logarithm of minimum angle of resolution, or logMAR) at the 36-month outcome exam will be performed. Assessment completed in randomized correction.\n\nSnellen visual acuity (VA) equivalents were converted to logarithm of minimum angle of resolution (logMAR) equivalents (in parentheses) as follows: 20/16 (-0.1), 20/20 (0), 20/25 (0.1), 20/32 (0.2), 20/40 (0.3), 20/50 (0.4) A logMAR value of less than 0 is associated with better than 20/20 vision, while a logMAR value greater than 0 is associated with worse than 20/20 vision.", "SecondaryOutcomeTimeFrame":"36 months after randomization" },{ "SecondaryOutcomeMeasure":"Number of Participants With Strabismus at 3 Years", "SecondaryOutcomeDescription":"The number of participants who developed measurable heterotropia was estimated for each treatment group and the proportions were compared using Barnard's exact test.", "SecondaryOutcomeTimeFrame":"36 months after randomization" },{ "SecondaryOutcomeMeasure":"Mean Stereoacuity", "SecondaryOutcomeDescription":"Mean stereoacuity at 3 years was measured in log seconds of arc (log arcsec) (see explanation below). Evaluated the best of the values reported with and without trial frames, during initial assessment and retest.\n\nStereoacuity scores (seconds of arc) were calculated based on the Randot Preschool stereoacuity test (scores: 800, 400, 200, 100, 60 and 40). Seconds of arc refers to the visual angle that is being measured in order to determine depth perception. Lower scores indicate better stereoacuity. A logarithm base 10 transformation was used to convert stereoacuity scores to the log scale to calculate descriptive statistics (reported as seconds of arc, or arcsec). Seconds of arc were converted to logarithm of seconds of arc, or log arcsec (in parentheses) as follows: 40 (1.60), 60(1.78), 100 (2.00), 200 (2.30), 400 (2.60), 800 (2.90), Nil (3.20)", "SecondaryOutcomeTimeFrame":"36 months" },{ "SecondaryOutcomeMeasure":"Failure to Meet Age-Normal Stereoacuity at 3 Years", "SecondaryOutcomeDescription":"Proportion who failed to meet age-normal stereoacuity. Participants were classified as failing to meet age-normal stereoacuity if near stereoacuity was below age-normal values both with and without trial frames, during initial assessment and re-test.", "SecondaryOutcomeTimeFrame":"36 months" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nAge 12 to < 72 months\nRefractive error between +3.00D and +6.00D SE (by cycloplegic refraction) in either eye\nAstigmatism < 1.50D in both eyes\nSpherical equivalent anisometropia ≤ +1.50D\n\nFor children 36 to <72 months of age:\n\nNo evidence of subnormal visual acuity - Uncorrected monocular visual acuity in both eyes of 20/50 or better for age 36 to <48 months,20/40 or better for age 48 to <60 months, and 20/32 or better for ages 60 to <72 months measured without cycloplegia using the ATS-HOTV© visual acuity testing protocol\nZero (0) or 1 logMAR line interocular difference (IOD) in uncorrected visual acuity measured without cycloplegia using the ATS-HOTV© visual acuity testing protocol\nAge-normal stereoacuity on the Randot Preschool Stereotest (see Table 2 of protocol)\nGestational age >32 weeks\nInvestigator is willing to prescribe glasses per protocol or observe the hyperopia untreated for 3 years unless specific criteria for deterioration outlined in section 3.3.3 are confirmed.\nParent understands the protocol and is willing to accept randomization to either glasses or no glasses initially, and is willing to wear glasses as prescribed or accept that glasses will not be prescribed by the investigator unless specific deterioration criteria outlined in section 3.3.3 are confirmed.\nParent has phone (or access to phone) and is willing to be contacted by Jaeb Center staff.\nRelocation outside of area of an active PEDIG site for this study within the next 36 months is not anticipated.\n\nExclusion Criteria:\n\nA patient is excluded for any of the following reasons:\n\nAny measurable heterotropia at distance (3 meters) or at near (1/3 meter) by cover/uncover testing. Note that patients with heterophoria are eligible.\nPrevious documented strabismus (parental report must be confirmed by investigator)\nManifest or latent nystagmus evident clinically\nPrevious treatment of refractive error with glasses or contacts unless duration of glasses or contacts wear was one week or less and occurred more than 2 months prior to enrollment.\nPrevious intraocular, refractive, or extraocular muscle surgery\nPrevious amblyopia treatment\nPrevious vergence/accommodative therapy\nParental concerns over learning or development\nOcular co-morbidity that may reduce visual acuity\nSymptoms of blur or asthenopia\nDevelopmental delay diagnosed by pediatrician or Individualized Education Program (IEP)\nKnown neurological anomalies (e.g. cerebral palsy, Down syndrome)\nInability to perform visual acuity ATS-HOTV testing if ≥ 36 months of age", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"12 Months", "MaximumAge":"71 Months", "StdAgeList":{ "StdAge":[ "Child" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Marjean Kulp, OD, MS", "OverallOfficialAffiliation":"Jaeb Center for Health Research", "OverallOfficialRole":"Study Chair" },{ "OverallOfficialName":"David Petersen, MD", "OverallOfficialAffiliation":"Jaeb Center for Health Research", "OverallOfficialRole":"Study Chair" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"The Ohio State University College of Optometry", "LocationCity":"Columbus", "LocationState":"Ohio", "LocationZip":"43210-1280", "LocationCountry":"United States" },{ "LocationFacility":"Rocky Mountain Eye Care Associates", "LocationCity":"Salt Lake City", "LocationState":"Utah", "LocationZip":"84107", "LocationCountry":"United States" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"27663627", "ReferenceType":"background", "ReferenceCitation":"Pediatric Eye Disease Investigator Group. Clinical factors associated with moderate hyperopia in preschool children with normal stereopsis and visual acuity. J AAPOS. 2016 Oct;20(5):455-457. doi: 10.1016/j.jaapos.2016.04.012. Epub 2016 Sep 20." },{ "ReferencePMID":"30615896", "ReferenceType":"result", "ReferenceCitation":"Pediatric Eye Disease Investigator Group, Kulp MT, Holmes JM, Dean TW, Suh DW, Kraker RT, Wallace DK, Petersen DB, Cotter SA, Manny RE, Superstein R, Roberts TL, Avallone JM, Fishman DR, Erzurum SA, Leske DA, Christoff A. A Randomized Clinical Trial of Immediate versus Delayed Glasses for Moderate Hyperopia in 1- and 2-Year-Olds. Ophthalmology. 2019 Jun;126(6):876-887. doi: 10.1016/j.ophtha.2018.12.049. Epub 2019 Jan 4." },{ "ReferencePMID":"31255587", "ReferenceType":"result", "ReferenceCitation":"Holmes JM, Kulp MT, Dean TW, Suh DW, Kraker RT, Wallace DK, Petersen DB, Cotter SA, Crouch ER, Lorenzana IJ, Ticho BH, Verderber LC, Weise KK; Pediatric Eye Disease Investigator Group. A Randomized Clinical Trial of Immediate Versus Delayed Glasses for Moderate Hyperopia in Children 3 to 5 Years of Age. Am J Ophthalmol. 2019 Dec;208:145-159. doi: 10.1016/j.ajo.2019.06.021. Epub 2019 Jun 28." } ] } }, "IPDSharingStatementModule":{ "IPDSharing":"Yes", "IPDSharingDescription":"In accordance with the NIH data sharing policy, a de-identified database is placed in the public domain on the PEDIG public website after the completion of each protocol and publication of the primary manuscript.", "IPDSharingTimeFrame":"Data will be made available after publication of each primary manuscript.", "IPDSharingAccessCriteria":"Users accessing the data must enter an email address." } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"Glasses- Older Cohort", "FlowGroupDescription":"Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study.\n\nGlasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion." },{ "FlowGroupId":"FG001", "FlowGroupTitle":"Observation- Older Cohort", "FlowGroupDescription":"Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol.\n\nGlasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion." },{ "FlowGroupId":"FG002", "FlowGroupTitle":"Glasses- Younger Cohort", "FlowGroupDescription":"Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study.\n\nGlasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion." },{ "FlowGroupId":"FG003", "FlowGroupTitle":"Observation- Younger Cohort", "FlowGroupDescription":"Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol.\n\nGlasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion." } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Overall Study", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"61" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"58" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"65" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"65" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"41" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"43" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"53" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"53" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"20" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"15" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"12" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"12" } ] } } ] }, "FlowDropWithdrawList":{ "FlowDropWithdraw":[ { "FlowDropWithdrawType":"Lost to Follow-up", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"20" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"15" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"12" },{ "FlowReasonGroupId":"FG003", "FlowReasonNumSubjects":"12" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"Glasses- Older Cohort", "BaselineGroupDescription":"Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study.\n\nGlasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion." },{ "BaselineGroupId":"BG001", "BaselineGroupTitle":"Observation- Older Cohort", "BaselineGroupDescription":"Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol.\n\nGlasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion." },{ "BaselineGroupId":"BG002", "BaselineGroupTitle":"Glasses- Younger Cohort", "BaselineGroupDescription":"Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study.\n\nGlasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion." },{ "BaselineGroupId":"BG003", "BaselineGroupTitle":"Observation- Younger Cohort", "BaselineGroupDescription":"Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol.\n\nGlasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion." },{ "BaselineGroupId":"BG004", "BaselineGroupTitle":"Total", "BaselineGroupDescription":"Total of all reporting groups" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"61" },{ "BaselineDenomCountGroupId":"BG001", "BaselineDenomCountValue":"58" },{ "BaselineDenomCountGroupId":"BG002", "BaselineDenomCountValue":"65" },{ "BaselineDenomCountGroupId":"BG003", "BaselineDenomCountValue":"65" },{ "BaselineDenomCountGroupId":"BG004", "BaselineDenomCountValue":"249" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Categorical", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"61" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"58" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"65" },{ "BaselineClassDenomCountGroupId":"BG003", "BaselineClassDenomCountValue":"65" },{ "BaselineClassDenomCountGroupId":"BG004", "BaselineClassDenomCountValue":"249" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"<=18 years", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"61" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"58" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"65" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"65" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"249" } ] } },{ "BaselineCategoryTitle":"Between 18 and 65 years", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"0" } ] } },{ "BaselineCategoryTitle":">=65 years", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"0" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Age, Customized", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"1 Year", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"61" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"58" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"65" },{ "BaselineClassDenomCountGroupId":"BG003", "BaselineClassDenomCountValue":"65" },{ "BaselineClassDenomCountGroupId":"BG004", "BaselineClassDenomCountValue":"249" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"42" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"42" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"84" } ] } } ] } },{ "BaselineClassTitle":"2 Years", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"61" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"58" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"65" },{ "BaselineClassDenomCountGroupId":"BG003", "BaselineClassDenomCountValue":"65" },{ "BaselineClassDenomCountGroupId":"BG004", "BaselineClassDenomCountValue":"249" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"23" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"23" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"46" } ] } } ] } },{ "BaselineClassTitle":"3 Years", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"61" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"58" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"65" },{ "BaselineClassDenomCountGroupId":"BG003", "BaselineClassDenomCountValue":"65" },{ "BaselineClassDenomCountGroupId":"BG004", "BaselineClassDenomCountValue":"249" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"19" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"20" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"39" } ] } } ] } },{ "BaselineClassTitle":"4 Years", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"61" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"58" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"65" },{ "BaselineClassDenomCountGroupId":"BG003", "BaselineClassDenomCountValue":"65" },{ "BaselineClassDenomCountGroupId":"BG004", "BaselineClassDenomCountValue":"249" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"31" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"30" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"61" } ] } } ] } },{ "BaselineClassTitle":"5 Years", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"61" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"58" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"65" },{ "BaselineClassDenomCountGroupId":"BG003", "BaselineClassDenomCountValue":"65" },{ "BaselineClassDenomCountGroupId":"BG004", "BaselineClassDenomCountValue":"249" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"11" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"8" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"19" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"61" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"58" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"65" },{ "BaselineClassDenomCountGroupId":"BG003", "BaselineClassDenomCountValue":"65" },{ "BaselineClassDenomCountGroupId":"BG004", "BaselineClassDenomCountValue":"249" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"38" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"32" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"33" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"35" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"138" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"23" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"26" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"32" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"30" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"111" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Race/Ethnicity, Customized", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"Asian", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"61" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"58" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"65" },{ "BaselineClassDenomCountGroupId":"BG003", "BaselineClassDenomCountValue":"65" },{ "BaselineClassDenomCountGroupId":"BG004", "BaselineClassDenomCountValue":"249" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"2" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"1" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"3" } ] } } ] } },{ "BaselineClassTitle":"Black/African American", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"61" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"58" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"65" },{ "BaselineClassDenomCountGroupId":"BG003", "BaselineClassDenomCountValue":"65" },{ "BaselineClassDenomCountGroupId":"BG004", "BaselineClassDenomCountValue":"249" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"12" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"14" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"2" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"3" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"31" } ] } } ] } },{ "BaselineClassTitle":"Hispanic", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"61" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"58" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"65" },{ "BaselineClassDenomCountGroupId":"BG003", "BaselineClassDenomCountValue":"65" },{ "BaselineClassDenomCountGroupId":"BG004", "BaselineClassDenomCountValue":"249" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"13" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"7" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"7" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"8" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"35" } ] } } ] } },{ "BaselineClassTitle":"White", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"61" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"58" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"65" },{ "BaselineClassDenomCountGroupId":"BG003", "BaselineClassDenomCountValue":"65" },{ "BaselineClassDenomCountGroupId":"BG004", "BaselineClassDenomCountValue":"249" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"34" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"35" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"53" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"52" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"174" } ] } } ] } },{ "BaselineClassTitle":"More than one race", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"61" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"58" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"65" },{ "BaselineClassDenomCountGroupId":"BG003", "BaselineClassDenomCountValue":"65" },{ "BaselineClassDenomCountGroupId":"BG004", "BaselineClassDenomCountValue":"249" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"1" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"2" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"2" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"5" } ] } } ] } },{ "BaselineClassTitle":"Unknown/Not reported", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"61" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"58" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"65" },{ "BaselineClassDenomCountGroupId":"BG003", "BaselineClassDenomCountValue":"65" },{ "BaselineClassDenomCountGroupId":"BG004", "BaselineClassDenomCountValue":"249" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"1" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"1" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Family History of Amblyopia", "BaselineMeasurePopulationDescription":"Family history of amblyopia was not available for 2 (3%) participants in glasses group and 3 (5%) in observation group in the Older Cohort.\n\nFamily history of amblyopia was not reported for 3 participants (5%) in glasses group and 2 participants (3%) in observation group in the Younger Cohort.", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"59" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"55" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"62" },{ "BaselineClassDenomCountGroupId":"BG003", "BaselineClassDenomCountValue":"63" },{ "BaselineClassDenomCountGroupId":"BG004", "BaselineClassDenomCountValue":"239" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"16" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"17" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"21" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"20" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"74" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Family History of Strabismus", "BaselineMeasurePopulationDescription":"Family history of strabismus was not available for 2 (3%) participants in glasses group and 1 (2%) in the observation group in the Older Cohort.\n\nFamily history of strabismus was not reported for 2 participants (3%) in glasses group in the Younger Cohort.", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"59" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"57" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"63" },{ "BaselineClassDenomCountGroupId":"BG003", "BaselineClassDenomCountValue":"65" },{ "BaselineClassDenomCountGroupId":"BG004", "BaselineClassDenomCountValue":"244" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"11" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"16" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"26" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"25" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"78" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Diagnosis Of ADHD", "BaselineMeasureDescription":"ADHD: Attention-Deficit/Hyperactivity Disorder", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"61" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"58" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"65" },{ "BaselineClassDenomCountGroupId":"BG003", "BaselineClassDenomCountValue":"65" },{ "BaselineClassDenomCountGroupId":"BG004", "BaselineClassDenomCountValue":"249" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"0" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"SE Refractive Error: More hyperopic eye", "BaselineMeasureDescription":"Refractive error is the measurement of the power of the lenses needed to focus light on the retina. This is measured in diopters (D). Spherical Equivalent is a pair of numbers, one for each eye, that gives an estimate of the refractive error in the eyes. Hyperopia is farsightedness, or a type of refractive error in which things are seen more clearly at a distance than at near. This measurement is in the more hyperopic eye, or the eye that sees worse at near than the other eye.", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"+2.00D to <+3.00D", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"61" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"58" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"65" },{ "BaselineClassDenomCountGroupId":"BG003", "BaselineClassDenomCountValue":"65" },{ "BaselineClassDenomCountGroupId":"BG004", "BaselineClassDenomCountValue":"249" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"0" } ] } } ] } },{ "BaselineClassTitle":"+3.00D to <+4.00D", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"61" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"58" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"65" },{ "BaselineClassDenomCountGroupId":"BG003", "BaselineClassDenomCountValue":"65" },{ "BaselineClassDenomCountGroupId":"BG004", "BaselineClassDenomCountValue":"249" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"37" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"32" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"25" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"20" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"114" } ] } } ] } },{ "BaselineClassTitle":"+4.00D to <+5.00D", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"61" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"58" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"65" },{ "BaselineClassDenomCountGroupId":"BG003", "BaselineClassDenomCountValue":"65" },{ "BaselineClassDenomCountGroupId":"BG004", "BaselineClassDenomCountValue":"249" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"16" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"19" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"19" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"27" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"81" } ] } } ] } },{ "BaselineClassTitle":"+5.00D to +6.00D", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"61" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"58" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"65" },{ "BaselineClassDenomCountGroupId":"BG003", "BaselineClassDenomCountValue":"65" },{ "BaselineClassDenomCountGroupId":"BG004", "BaselineClassDenomCountValue":"249" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"8" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"7" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"20" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"13" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"48" } ] } } ] } },{ "BaselineClassTitle":"+6.00 to +7.00 D", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"61" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"58" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"65" },{ "BaselineClassDenomCountGroupId":"BG003", "BaselineClassDenomCountValue":"65" },{ "BaselineClassDenomCountGroupId":"BG004", "BaselineClassDenomCountValue":"249" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"1" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"5" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"6" } ] } } ] } },{ "BaselineClassTitle":"+1.00 to <+2.00 D", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"61" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"58" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"65" },{ "BaselineClassDenomCountGroupId":"BG003", "BaselineClassDenomCountValue":"65" },{ "BaselineClassDenomCountGroupId":"BG004", "BaselineClassDenomCountValue":"249" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"0" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"SE Refractive Error: More hyperopic eye", "BaselineMeasureDescription":"Refractive error is the measurement of the power of the lenses needed to focus light on the retina. This is measured in diopters (D). Spherical Equivalent is a pair of numbers, one for each eye, that gives an estimate of the refractive error in the eyes. Hyperopia is farsightedness, or a type of refractive error in which things are seen more clearly at a distance than at near. This measurement is in the more hyperopic eye, or the eye that sees worse at near than the other eye.", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"diopters (D)", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"61" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"58" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"65" },{ "BaselineClassDenomCountGroupId":"BG003", "BaselineClassDenomCountValue":"65" },{ "BaselineClassDenomCountGroupId":"BG004", "BaselineClassDenomCountValue":"249" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"3.93", "BaselineMeasurementSpread":"0.71" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"3.94", "BaselineMeasurementSpread":"0.74" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"4.32", "BaselineMeasurementSpread":"0.85" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"4.37", "BaselineMeasurementSpread":"0.87" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"4.15", "BaselineMeasurementSpread":"0.82" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"SE Refractive Error: Less hyperopic eye", "BaselineMeasureDescription":"Refractive error is the measurement of the power of the lenses needed to focus light on the retina. This is measured in diopters (D). Spherical Equivalent is a pair of numbers, one for each eye, that gives an estimate of the refractive error in the eyes. Hyperopia is farsightedness, or a type of refractive error in which things are seen more clearly at a distance than at near. This measurement is in the less hyperopic eye, or the eye that sees better at near than the other eye.", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"+1.00 to <+2.00 D", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"61" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"58" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"65" },{ "BaselineClassDenomCountGroupId":"BG003", "BaselineClassDenomCountValue":"65" },{ "BaselineClassDenomCountGroupId":"BG004", "BaselineClassDenomCountValue":"249" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"1" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"1" } ] } } ] } },{ "BaselineClassTitle":"+2.00 to <+3.00D", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"61" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"58" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"65" },{ "BaselineClassDenomCountGroupId":"BG003", "BaselineClassDenomCountValue":"65" },{ "BaselineClassDenomCountGroupId":"BG004", "BaselineClassDenomCountValue":"249" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"10" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"10" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"4" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"2" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"26" } ] } } ] } },{ "BaselineClassTitle":"+3.00 to <+4.00D", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"61" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"58" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"65" },{ "BaselineClassDenomCountGroupId":"BG003", "BaselineClassDenomCountValue":"65" },{ "BaselineClassDenomCountGroupId":"BG004", "BaselineClassDenomCountValue":"249" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"34" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"30" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"26" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"27" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"117" } ] } } ] } },{ "BaselineClassTitle":"+4.00 to <+5.00D", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"61" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"58" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"65" },{ "BaselineClassDenomCountGroupId":"BG003", "BaselineClassDenomCountValue":"65" },{ "BaselineClassDenomCountGroupId":"BG004", "BaselineClassDenomCountValue":"249" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"12" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"13" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"22" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"21" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"68" } ] } } ] } },{ "BaselineClassTitle":"+5.00 to <+6.00D", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"61" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"58" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"65" },{ "BaselineClassDenomCountGroupId":"BG003", "BaselineClassDenomCountValue":"65" },{ "BaselineClassDenomCountGroupId":"BG004", "BaselineClassDenomCountValue":"249" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"5" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"5" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"13" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"11" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"34" } ] } } ] } },{ "BaselineClassTitle":"+6.00 to <+7.00D", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"61" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"58" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"65" },{ "BaselineClassDenomCountGroupId":"BG003", "BaselineClassDenomCountValue":"65" },{ "BaselineClassDenomCountGroupId":"BG004", "BaselineClassDenomCountValue":"249" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"3" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"3" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"SE Refractive Error: Less hyperopic eye", "BaselineMeasureDescription":"Refractive error is the measurement of the power of the lenses needed to focus light on the retina. This is measured in diopters (D). Spherical Equivalent is a pair of numbers, one for each eye, that gives an estimate of the refractive error in the eyes. Hyperopia is farsightedness, or a type of refractive error in which things are seen more clearly at a distance than at near. This measurement is in the less hyperopic eye, or the eye that sees better at near than the other eye.", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"diopters (D)", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"61" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"58" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"65" },{ "BaselineClassDenomCountGroupId":"BG003", "BaselineClassDenomCountValue":"65" },{ "BaselineClassDenomCountGroupId":"BG004", "BaselineClassDenomCountValue":"249" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"3.60", "BaselineMeasurementSpread":"0.78" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"3.59", "BaselineMeasurementSpread":"0.81" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"4.04", "BaselineMeasurementSpread":"0.85" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"4.07", "BaselineMeasurementSpread":"0.90" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"3.84", "BaselineMeasurementSpread":"0.86" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Anisometropia", "BaselineMeasureDescription":"Anisometropia is when the refractive error between two eyes is different. The difference in spherical equivalent refraction between the eyes is measured in diopters (D).", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"0.00 to <+0.50", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"61" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"58" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"65" },{ "BaselineClassDenomCountGroupId":"BG003", "BaselineClassDenomCountValue":"65" },{ "BaselineClassDenomCountGroupId":"BG004", "BaselineClassDenomCountValue":"249" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"42" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"39" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"47" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"46" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"174" } ] } } ] } },{ "BaselineClassTitle":"+0.50D to <+1.00D", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"61" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"58" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"65" },{ "BaselineClassDenomCountGroupId":"BG003", "BaselineClassDenomCountValue":"65" },{ "BaselineClassDenomCountGroupId":"BG004", "BaselineClassDenomCountValue":"249" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"16" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"14" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"13" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"12" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"55" } ] } } ] } },{ "BaselineClassTitle":"+1.00D to +1.50D", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"61" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"58" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"65" },{ "BaselineClassDenomCountGroupId":"BG003", "BaselineClassDenomCountValue":"65" },{ "BaselineClassDenomCountGroupId":"BG004", "BaselineClassDenomCountValue":"249" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"3" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"5" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"5" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"7" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"20" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Anisometropia", "BaselineMeasureDescription":"Anisometropia is when the refractive error between two eyes is different. The difference in spherical equivalent refraction between the eyes is measured in diopters (D).", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"diopters (D)", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"61" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"58" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"65" },{ "BaselineClassDenomCountGroupId":"BG003", "BaselineClassDenomCountValue":"65" },{ "BaselineClassDenomCountGroupId":"BG004", "BaselineClassDenomCountValue":"249" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0.33", "BaselineMeasurementSpread":"0.36" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0.34", "BaselineMeasurementSpread":"0.34" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0.28", "BaselineMeasurementSpread":"0.38" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"0.30", "BaselineMeasurementSpread":"0.39" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"0.31", "BaselineMeasurementSpread":"0.37" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Astigmatism: More astigmatic eye", "BaselineMeasureDescription":"Astigmatism is a condition in which the cornea or lens is irregular shaped/curved. The degree of astigmatism is measured in diopters (D). This measurement is in the more astigmatic eye, or the eye with a larger degree of astigmatism.", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"0.00D to <+0.50D", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"61" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"58" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"65" },{ "BaselineClassDenomCountGroupId":"BG003", "BaselineClassDenomCountValue":"65" },{ "BaselineClassDenomCountGroupId":"BG004", "BaselineClassDenomCountValue":"249" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"29" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"29" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"36" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"29" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"123" } ] } } ] } },{ "BaselineClassTitle":"+0.50D to <+1.00D", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"61" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"58" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"65" },{ "BaselineClassDenomCountGroupId":"BG003", "BaselineClassDenomCountValue":"65" },{ "BaselineClassDenomCountGroupId":"BG004", "BaselineClassDenomCountValue":"249" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"23" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"18" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"18" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"19" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"78" } ] } } ] } },{ "BaselineClassTitle":"+1.00D to +1.50D", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"61" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"58" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"65" },{ "BaselineClassDenomCountGroupId":"BG003", "BaselineClassDenomCountValue":"65" },{ "BaselineClassDenomCountGroupId":"BG004", "BaselineClassDenomCountValue":"249" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"9" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"11" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"11" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"17" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"48" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Astigmatism: More astigmatic eye", "BaselineMeasureDescription":"Astigmatism is a condition in which the cornea or lens is irregular shaped/curved. The degree of astigmatism is measured in diopters (D). This measurement is in the more astigmatic eye, or the eye with a larger degree of astigmatism.", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"diopters (D)", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"61" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"58" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"65" },{ "BaselineClassDenomCountGroupId":"BG003", "BaselineClassDenomCountValue":"65" },{ "BaselineClassDenomCountGroupId":"BG004", "BaselineClassDenomCountValue":"249" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0.45", "BaselineMeasurementSpread":"0.45" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0.44", "BaselineMeasurementSpread":"0.44" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0.40", "BaselineMeasurementSpread":"0.48" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"0.49", "BaselineMeasurementSpread":"0.48" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"0.45", "BaselineMeasurementSpread":"0.46" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Astigmatism: Less astigmatic eye", "BaselineMeasureDescription":"Astigmatism is a condition in which the cornea or lens is irregular shaped/curved. The degree of astigmatism is measured in diopters (D). This measurement is in the less astigmatic eye, or the eye with a smaller degree of astigmatism.", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"0.00D to <+0.50D", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"61" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"58" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"65" },{ "BaselineClassDenomCountGroupId":"BG003", "BaselineClassDenomCountValue":"65" },{ "BaselineClassDenomCountGroupId":"BG004", "BaselineClassDenomCountValue":"249" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"40" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"41" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"41" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"39" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"161" } ] } } ] } },{ "BaselineClassTitle":"+0.50D to <+1.00D", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"61" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"58" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"65" },{ "BaselineClassDenomCountGroupId":"BG003", "BaselineClassDenomCountValue":"65" },{ "BaselineClassDenomCountGroupId":"BG004", "BaselineClassDenomCountValue":"249" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"14" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"12" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"17" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"13" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"56" } ] } } ] } },{ "BaselineClassTitle":"+1.00D to +1.50D", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"61" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"58" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"65" },{ "BaselineClassDenomCountGroupId":"BG003", "BaselineClassDenomCountValue":"65" },{ "BaselineClassDenomCountGroupId":"BG004", "BaselineClassDenomCountValue":"249" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"7" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"5" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"7" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"13" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"32" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Astigmatism: Less astigmatic eye", "BaselineMeasureDescription":"Astigmatism is a condition in which the cornea or lens is irregular shaped/curved. The degree of astigmatism is measured in diopters (D). This measurement is in the less astigmatic eye, or the eye with a smaller degree of astigmatism.", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"diopters (D)", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"61" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"58" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"65" },{ "BaselineClassDenomCountGroupId":"BG003", "BaselineClassDenomCountValue":"65" },{ "BaselineClassDenomCountGroupId":"BG004", "BaselineClassDenomCountValue":"249" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0.32", "BaselineMeasurementSpread":"0.42" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0.25", "BaselineMeasurementSpread":"0.36" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0.27", "BaselineMeasurementSpread":"0.38" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"0.37", "BaselineMeasurementSpread":"0.47" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"0.31", "BaselineMeasurementSpread":"0.41" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Distance Visual Acuity: Better-seeing Eye", "BaselineMeasureDescription":"Distance visual acuity is typically measured by testing the smallest letter or object a patient can identify from 20 feet away. This measurement is recorded as a fraction. The numerator is the distance at which the patient is identifying the letter/object, while the denominator is the distance that a person with normal vision could identify that same object. For example, 20/20 vision is considered normal, where a patient can see at 20 feet what is normally seen at 20 feet. This measurement is for the better-seeing eye, or the eye with better visual acuity.", "BaselineMeasurePopulationDescription":"This measure was only used as a baseline characteristic for the Older cohort, no data for this characteristic was collected from the younger cohort.", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"20/16", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"61" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"58" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"0" },{ "BaselineClassDenomCountGroupId":"BG003", "BaselineClassDenomCountValue":"0" },{ "BaselineClassDenomCountGroupId":"BG004", "BaselineClassDenomCountValue":"119" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"5" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"3" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"8" } ] } } ] } },{ "BaselineClassTitle":"20/20", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"61" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"58" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"0" },{ "BaselineClassDenomCountGroupId":"BG003", "BaselineClassDenomCountValue":"0" },{ "BaselineClassDenomCountGroupId":"BG004", "BaselineClassDenomCountValue":"119" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"16" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"18" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"34" } ] } } ] } },{ "BaselineClassTitle":"20/25", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"61" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"58" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"0" },{ "BaselineClassDenomCountGroupId":"BG003", "BaselineClassDenomCountValue":"0" },{ "BaselineClassDenomCountGroupId":"BG004", "BaselineClassDenomCountValue":"119" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"25" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"18" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"43" } ] } } ] } },{ "BaselineClassTitle":"20/32", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"61" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"58" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"0" },{ "BaselineClassDenomCountGroupId":"BG003", "BaselineClassDenomCountValue":"0" },{ "BaselineClassDenomCountGroupId":"BG004", "BaselineClassDenomCountValue":"119" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"9" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"13" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"22" } ] } } ] } },{ "BaselineClassTitle":"20/40", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"61" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"58" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"0" },{ "BaselineClassDenomCountGroupId":"BG003", "BaselineClassDenomCountValue":"0" },{ "BaselineClassDenomCountGroupId":"BG004", "BaselineClassDenomCountValue":"119" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"6" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"6" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"12" } ] } } ] } },{ "BaselineClassTitle":"20/50", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"61" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"58" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"0" },{ "BaselineClassDenomCountGroupId":"BG003", "BaselineClassDenomCountValue":"0" },{ "BaselineClassDenomCountGroupId":"BG004", "BaselineClassDenomCountValue":"119" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"0" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Distance Visual Acuity: Better-seeing Eye", "BaselineMeasureDescription":"Each visual acuity (VA) measure was assigned a logarithm of minimum angle of resolution (logMAR) equivalent, with 20/20 VA equal to 0 logMAR, and each progressively worse VA equal to an additional 0.1 logMAR. For example:\n\n20/50 = 0.4 logMAR, 20/40 = 0.3 logMAR, 20/32 = 0.2 logMAR, 20/25 = 0.1 logMAR, 20/20 = 0 logMAR, 20/16 = -0.1 logMAR\n\nLarger logMAR indicates worse visual acuity.\n\nThis measurement is for the better-seeing eye, or the eye with smaller logMAR visual acuity.", "BaselineMeasurePopulationDescription":"This measure was only used as a baseline characteristic for the Older cohort, no data for this characteristic was collected from the younger cohort.", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"logMAR", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"61" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"58" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"0" },{ "BaselineClassDenomCountGroupId":"BG003", "BaselineClassDenomCountValue":"0" },{ "BaselineClassDenomCountGroupId":"BG004", "BaselineClassDenomCountValue":"119" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0.09", "BaselineMeasurementSpread":"0.11" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0.10", "BaselineMeasurementSpread":"0.11" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"0.10", "BaselineMeasurementSpread":"0.11" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Distance Visual Acuity: Worse-seeing Eye", "BaselineMeasureDescription":"Distance visual acuity is typically measured by testing the smallest letter or object a patient can identify from 20 feet away. This measurement is recorded as a fraction. The numerator is the distance at which the patient is identifying the letter/object, while the denominator is the distance that a person with normal vision could identify that same object. For example, 20/20 vision is considered normal, where a patient can see at 20 feet what is normally seen at 20 feet. This measurement is for the worse-seeing eye, or the eye with worse visual acuity.", "BaselineMeasurePopulationDescription":"This measure was only used as a baseline characteristic for the Older cohort, no data for this characteristic was collected from the younger cohort.", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"20/16", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"61" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"58" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"0" },{ "BaselineClassDenomCountGroupId":"BG003", "BaselineClassDenomCountValue":"0" },{ "BaselineClassDenomCountGroupId":"BG004", "BaselineClassDenomCountValue":"119" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"2" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"2" } ] } } ] } },{ "BaselineClassTitle":"20/20", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"61" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"58" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"0" },{ "BaselineClassDenomCountGroupId":"BG003", "BaselineClassDenomCountValue":"0" },{ "BaselineClassDenomCountGroupId":"BG004", "BaselineClassDenomCountValue":"119" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"7" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"7" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"14" } ] } } ] } },{ "BaselineClassTitle":"20/25", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"61" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"58" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"0" },{ "BaselineClassDenomCountGroupId":"BG003", "BaselineClassDenomCountValue":"0" },{ "BaselineClassDenomCountGroupId":"BG004", "BaselineClassDenomCountValue":"119" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"26" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"25" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"51" } ] } } ] } },{ "BaselineClassTitle":"20/32", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"61" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"58" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"0" },{ "BaselineClassDenomCountGroupId":"BG003", "BaselineClassDenomCountValue":"0" },{ "BaselineClassDenomCountGroupId":"BG004", "BaselineClassDenomCountValue":"119" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"15" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"15" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"30" } ] } } ] } },{ "BaselineClassTitle":"20/40", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"61" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"58" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"0" },{ "BaselineClassDenomCountGroupId":"BG003", "BaselineClassDenomCountValue":"0" },{ "BaselineClassDenomCountGroupId":"BG004", "BaselineClassDenomCountValue":"119" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"8" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"9" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"17" } ] } } ] } },{ "BaselineClassTitle":"20/50", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"61" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"58" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"0" },{ "BaselineClassDenomCountGroupId":"BG003", "BaselineClassDenomCountValue":"0" },{ "BaselineClassDenomCountGroupId":"BG004", "BaselineClassDenomCountValue":"119" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"3" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"2" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"5" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Distance Visual Acuity: Worse-seeing Eye", "BaselineMeasureDescription":"Each visual acuity (VA) measure was assigned a logarithm of minimum angle of resolution (logMAR) equivalent, with 20/20 VA equal to 0 logMAR, and each progressively worse VA equal to an additional 0.1 logMAR. For example:\n\n20/50 = 0.4 logMAR, 20/40 = 0.3 logMAR, 20/32 = 0.2 logMAR, 20/25 = 0.1 logMAR, 20/20 = 0 logMAR, 20/16 = -0.1 logMAR\n\nLarger logMAR indicates worse visual acuity.\n\nThis measurement is for the worse-seeing eye, or the eye with larger logMAR.", "BaselineMeasurePopulationDescription":"This measure was only used as a baseline characteristic for the Older cohort, no data for this characteristic was collected from the younger cohort.", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"logMAR", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"61" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"58" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"0" },{ "BaselineClassDenomCountGroupId":"BG003", "BaselineClassDenomCountValue":"0" },{ "BaselineClassDenomCountGroupId":"BG004", "BaselineClassDenomCountValue":"119" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0.15", "BaselineMeasurementSpread":"0.11" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0.16", "BaselineMeasurementSpread":"0.10" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"0.15", "BaselineMeasurementSpread":"0.11" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Stereoacuity at Near", "BaselineMeasureDescription":"Stereoacuity scores (seconds of arc) were calculated based on the Randot Preschool stereoacuity test (scores: 800, 400, 200, 100, 60 and 40). Seconds of arc refers to the visual angle that is being measured in order to determine depth perception. Lower scores indicate better stereoacuity.", "BaselineMeasurePopulationDescription":"This measure was only used as a baseline characteristic for the Older cohort, no data for this characteristic was collected from the younger cohort.", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"40", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"61" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"58" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"0" },{ "BaselineClassDenomCountGroupId":"BG003", "BaselineClassDenomCountValue":"0" },{ "BaselineClassDenomCountGroupId":"BG004", "BaselineClassDenomCountValue":"119" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"9" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"7" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"16" } ] } } ] } },{ "BaselineClassTitle":"60", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"61" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"58" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"0" },{ "BaselineClassDenomCountGroupId":"BG003", "BaselineClassDenomCountValue":"0" },{ "BaselineClassDenomCountGroupId":"BG004", "BaselineClassDenomCountValue":"119" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"21" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"12" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"33" } ] } } ] } },{ "BaselineClassTitle":"100", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"61" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"58" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"0" },{ "BaselineClassDenomCountGroupId":"BG003", "BaselineClassDenomCountValue":"0" },{ "BaselineClassDenomCountGroupId":"BG004", "BaselineClassDenomCountValue":"119" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"13" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"15" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"28" } ] } } ] } },{ "BaselineClassTitle":"200", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"61" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"58" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"0" },{ "BaselineClassDenomCountGroupId":"BG003", "BaselineClassDenomCountValue":"0" },{ "BaselineClassDenomCountGroupId":"BG004", "BaselineClassDenomCountValue":"119" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"12" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"16" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"28" } ] } } ] } },{ "BaselineClassTitle":"400", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"61" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"58" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"0" },{ "BaselineClassDenomCountGroupId":"BG003", "BaselineClassDenomCountValue":"0" },{ "BaselineClassDenomCountGroupId":"BG004", "BaselineClassDenomCountValue":"119" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"6" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"6" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"12" } ] } } ] } },{ "BaselineClassTitle":"Nil", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"61" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"58" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"0" },{ "BaselineClassDenomCountGroupId":"BG003", "BaselineClassDenomCountValue":"0" },{ "BaselineClassDenomCountGroupId":"BG004", "BaselineClassDenomCountValue":"119" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"1" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"1" } ] } } ] } },{ "BaselineClassTitle":"Failed pretest", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"61" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"58" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"0" },{ "BaselineClassDenomCountGroupId":"BG003", "BaselineClassDenomCountValue":"0" },{ "BaselineClassDenomCountGroupId":"BG004", "BaselineClassDenomCountValue":"119" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"1" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"1" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Stereoacuity at Near", "BaselineMeasureDescription":"Measure Description: Stereoacuity scores (seconds of arc) were calculated based on the Randot Preschool stereoacuity test (scores: 800, 400, 200, 100, 60 and 40). Seconds of arc refers to the visual angle that is being measured in order to determine depth perception. Lower scores indicate better stereoacuity.", "BaselineMeasurePopulationDescription":"This measure was only used as a baseline characteristic for the Older cohort, no data for this characteristic was collected from the younger cohort.", "BaselineMeasureParamType":"Median", "BaselineMeasureDispersionType":"Full Range", "BaselineMeasureUnitOfMeasure":"seconds of arc (arcsec)", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"61" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"58" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"0" },{ "BaselineClassDenomCountGroupId":"BG003", "BaselineClassDenomCountValue":"0" },{ "BaselineClassDenomCountGroupId":"BG004", "BaselineClassDenomCountValue":"119" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"100", "BaselineMeasurementLowerLimit":"40", "BaselineMeasurementUpperLimit":"400" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"100", "BaselineMeasurementLowerLimit":"40", "BaselineMeasurementUpperLimit":"400" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"100", "BaselineMeasurementLowerLimit":"40", "BaselineMeasurementUpperLimit":"400" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Number of Participants With Confirmation of Failure Criteria", "OutcomeMeasureDescription":"At the 36-month visit, each subject's condition will be classified as either failure or not a failure. The primary analytic approach will be a treatment group comparison of the proportion meeting failure criteria at 36-months using the Fisher's exact test.\n\nThe participant met failure criteria if ANY of the following criteria (except strabismus surgery prior to the 3-year outcome exam) were met during testing at the 3-year examination both with and without trial frames (without prism or bifocal), and the criteria was confirmed by a retest\n\nAny measurable manifest strabismus in primary gaze at distance or at near not correctable with distance refractive correction alone\nStrabismus surgery prior to the 36-month exam\nDistance VA below age norms in either eye\n≥2 logMAR lines of IOD if VA is 20/25 or worse in the better-seeing eye\n≥3 logMAR lines of IOD if VA is 20/20 or better in the better-seeing eye\nStereoacuity measured at near below age normal values", "OutcomeMeasurePopulationDescription":"Overall number is the number of patients who completed the entire study.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Count of Participants", "OutcomeMeasureUnitOfMeasure":"Participants", "OutcomeMeasureTimeFrame":"36 months after randomization", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Glasses- Older Cohort", "OutcomeGroupDescription":"Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study.\n\nGlasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Observation- Older Cohort", "OutcomeGroupDescription":"Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol.\n\nGlasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Glasses- Younger Cohort", "OutcomeGroupDescription":"Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study.\n\nGlasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Observation- Younger Cohort", "OutcomeGroupDescription":"Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol.\n\nGlasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"41" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"43" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"53" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"53" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"5" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"4" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"11" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"18" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisNonInferiorityType":"Other", "OutcomeAnalysisPValue":"0.72", "OutcomeAnalysisStatisticalMethod":"Barnard's Exact Test", "OutcomeAnalysisParamType":"Risk Difference (RD)", "OutcomeAnalysisParamValue":"3", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-12", "OutcomeAnalysisCIUpperLimit":"18" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG002", "OG003" ] }, "OutcomeAnalysisNonInferiorityType":"Other", "OutcomeAnalysisPValue":"0.14", "OutcomeAnalysisStatisticalMethod":"Barnard's Exact Test", "OutcomeAnalysisParamType":"Risk Difference (RD)", "OutcomeAnalysisParamValue":"-13", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-31", "OutcomeAnalysisCIUpperLimit":"4" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Subgroup Analysis - Race", "OutcomeMeasureDescription":"Treatment effect in subgroups based on baseline factors will be assessed. Outcome failure status at 36 months will be tabulated by subgroup and reviewed for consistency. Total number of patients who experienced failure at 3 years are shown.", "OutcomeMeasurePopulationDescription":"Total number that experienced failure, as reported in primary outcome", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Count of Participants", "OutcomeMeasureUnitOfMeasure":"Participants", "OutcomeMeasureTimeFrame":"36 months after randomization", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Glasses- Older Cohort", "OutcomeGroupDescription":"Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study.\n\nGlasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Observation- Older Cohort", "OutcomeGroupDescription":"Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol.\n\nGlasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Glasses- Younger Cohort", "OutcomeGroupDescription":"Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study.\n\nGlasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Observation- Younger Cohort", "OutcomeGroupDescription":"Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol.\n\nGlasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"5" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"4" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"11" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"18" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Race - Non-white", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"4" } ] } } ] } },{ "OutcomeClassTitle":"Race - White", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"11" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"14" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Subgroup Analysis - Gender", "OutcomeMeasureDescription":"Treatment effect in subgroups based on baseline factors will be assessed. Outcome failure status at 36 months will be tabulated by subgroup and reviewed for consistency. Total number of patients who experienced failure at 3 years are shown.", "OutcomeMeasurePopulationDescription":"Total number that experienced failure, as reported in primary outcome", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Count of Participants", "OutcomeMeasureUnitOfMeasure":"Participants", "OutcomeMeasureTimeFrame":"36 months", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Glasses- Older Cohort", "OutcomeGroupDescription":"Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study.\n\nGlasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Observation- Older Cohort", "OutcomeGroupDescription":"Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol.\n\nGlasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Glasses- Younger Cohort", "OutcomeGroupDescription":"Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study.\n\nGlasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Observation- Younger Cohort", "OutcomeGroupDescription":"Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol.\n\nGlasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"5" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"4" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"11" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"18" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Gender- Female", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"4" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"4" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"10" } ] } } ] } },{ "OutcomeClassTitle":"Gender - Male", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"7" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"8" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Subgroup Analysis - Family History of Amblyopia", "OutcomeMeasureDescription":"Treatment effect in subgroups based on baseline factors will be assessed. Outcome failure status at 36 months will be tabulated by subgroup and reviewed for consistency. Total number of patients who experienced failure at 3 years are shown.", "OutcomeMeasurePopulationDescription":"Total number that experienced failure, as reported in primary outcome", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Count of Participants", "OutcomeMeasureUnitOfMeasure":"Participants", "OutcomeMeasureTimeFrame":"36 months", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Glasses- Older Cohort", "OutcomeGroupDescription":"Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study.\n\nGlasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Observation- Older Cohort", "OutcomeGroupDescription":"Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol.\n\nGlasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Glasses- Younger Cohort", "OutcomeGroupDescription":"Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study.\n\nGlasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Observation- Younger Cohort", "OutcomeGroupDescription":"Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol.\n\nGlasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"5" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"4" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"11" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"18" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Family History of Amblyopia- Yes", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"4" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"6" } ] } } ] } },{ "OutcomeClassTitle":"Family History of Amblyopia- No", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"4" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"7" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"12" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Subgroup Analysis - Family History of Strabismus", "OutcomeMeasureDescription":"Treatment effect in subgroups based on baseline factors will be assessed. Outcome failure status at 36 months will be tabulated by subgroup and reviewed for consistency. Total number of patients who experienced failure at 3 years are shown.", "OutcomeMeasurePopulationDescription":"Total number that experienced failure, as reported in primary outcome", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Count of Participants", "OutcomeMeasureUnitOfMeasure":"Participants", "OutcomeMeasureTimeFrame":"36 months", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Glasses- Older Cohort", "OutcomeGroupDescription":"Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study.\n\nGlasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Observation- Older Cohort", "OutcomeGroupDescription":"Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol.\n\nGlasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Glasses- Younger Cohort", "OutcomeGroupDescription":"Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study.\n\nGlasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Observation- Younger Cohort", "OutcomeGroupDescription":"Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol.\n\nGlasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"5" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"4" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"11" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"18" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Family History of Strabismus- Yes", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"5" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"7" } ] } } ] } },{ "OutcomeClassTitle":"Family History of Strabismus- No", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"4" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"6" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"11" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Subgroup Analysis - SE Anisometropia", "OutcomeMeasureDescription":"Treatment effect in subgroups based on baseline factors will be assessed. Outcome failure status at 36 months will be tabulated by subgroup and reviewed for consistency. Total number of patients who experienced failure at 3 years are shown.", "OutcomeMeasurePopulationDescription":"Total number that experienced failure, as reported in primary outcome", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Count of Participants", "OutcomeMeasureUnitOfMeasure":"Participants", "OutcomeMeasureTimeFrame":"36 months", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Glasses- Older Cohort", "OutcomeGroupDescription":"Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study.\n\nGlasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Observation- Older Cohort", "OutcomeGroupDescription":"Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol.\n\nGlasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Glasses- Younger Cohort", "OutcomeGroupDescription":"Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study.\n\nGlasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Observation- Younger Cohort", "OutcomeGroupDescription":"Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol.\n\nGlasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"5" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"4" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"11" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"18" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"0.00D to <+0.50D", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"4" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"8" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"14" } ] } } ] } },{ "OutcomeClassTitle":"+0.50D to <+1.00D", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"1" } ] } } ] } },{ "OutcomeClassTitle":"+1.00D to +1.50D", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"3" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Subgroup Analysis - Mean Refractive Error at Enrollment (Diopters)", "OutcomeMeasureDescription":"Treatment effect in subgroups based on baseline factors will be assessed. Outcome failure status at 36 months will be tabulated by subgroup and reviewed for consistency. Total number of patients who experienced failure at 3 years are shown.", "OutcomeMeasurePopulationDescription":"Total number that experienced failure, as reported in primary outcome", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Count of Participants", "OutcomeMeasureUnitOfMeasure":"Participants", "OutcomeMeasureTimeFrame":"36 months", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Glasses- Older Cohort", "OutcomeGroupDescription":"Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study.\n\nGlasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Observation- Older Cohort", "OutcomeGroupDescription":"Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol.\n\nGlasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Glasses- Younger Cohort", "OutcomeGroupDescription":"Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study.\n\nGlasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Observation- Younger Cohort", "OutcomeGroupDescription":"Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol.\n\nGlasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"5" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"4" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"11" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"18" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"+2.50D to <+4.00D", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"6" } ] } } ] } },{ "OutcomeClassTitle":"+4.00D to <+5.00D", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"5" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"7" } ] } } ] } },{ "OutcomeClassTitle":"+5.00D to +6.00D", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"4" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"5" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Deterioration Criteria Met (Prior to 3 Years)", "OutcomeMeasureDescription":"Estimate of Cumulative Deterioration Rate. Proportion of subjects who deteriorated during the course of the study were evaluated. Reasons for deterioration included stereoacuity, strabismus, treatment due to parental concern, and treatment that was prescribed against protocol.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Count of Participants", "OutcomeMeasureUnitOfMeasure":"Participants", "OutcomeMeasureTimeFrame":"Enrollment to <36 months", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Glasses- Older Cohort", "OutcomeGroupDescription":"Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study.\n\nGlasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Observation- Older Cohort", "OutcomeGroupDescription":"Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol.\n\nGlasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Glasses- Younger Cohort", "OutcomeGroupDescription":"Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study.\n\nGlasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Observation- Younger Cohort", "OutcomeGroupDescription":"Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol.\n\nGlasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"61" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"58" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"65" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"65" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"16" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"14" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"20" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"36" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Mean Change in Spherical Equivalent (SE) Refractive Error (Diopters)", "OutcomeMeasureDescription":"Refractive error is the measurement of the power of the lenses needed to focus light on the retina. This is measured in diopters (D). Spherical Equivalent is a pair of numbers, one for each eye, that gives an estimate of the refractive error in the eyes. Hyperopia is farsightedness, or a type of refractive error in which things are seen more clearly at a distance than at near. Myopia is nearsightedness, or refractive error in which things are seen more clearly at near.\n\nMean change in SE refractive error is from baseline to 3 years, measured in diopters. Negative values indicate a shift in the myopic direction.", "OutcomeMeasurePopulationDescription":"Overall number is the total number of patients who completed the 3-year study.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"diopters", "OutcomeMeasureTimeFrame":"Enrollment to 3 years", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Glasses- Older Cohort", "OutcomeGroupDescription":"Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study.\n\nGlasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Observation- Older Cohort", "OutcomeGroupDescription":"Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol.\n\nGlasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Glasses- Younger Cohort", "OutcomeGroupDescription":"Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study.\n\nGlasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Observation- Younger Cohort", "OutcomeGroupDescription":"Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol.\n\nGlasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"41" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"43" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"53" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"53" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"More Hyperopic Eye", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.07", "OutcomeMeasurementLowerLimit":"-0.33", "OutcomeMeasurementUpperLimit":"0.19" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-0.67", "OutcomeMeasurementLowerLimit":"-0.92", "OutcomeMeasurementUpperLimit":"-0.41" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0.15", "OutcomeMeasurementLowerLimit":"-0.21", "OutcomeMeasurementUpperLimit":"0.51" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"-0.01", "OutcomeMeasurementLowerLimit":"-0.37", "OutcomeMeasurementUpperLimit":"0.35" } ] } } ] } },{ "OutcomeClassTitle":"Less Hyperopic Eye", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0", "OutcomeMeasurementLowerLimit":"-0.26", "OutcomeMeasurementUpperLimit":"0.26" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-0.58", "OutcomeMeasurementLowerLimit":"-0.84", "OutcomeMeasurementUpperLimit":"-0.33" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0.30", "OutcomeMeasurementLowerLimit":"-0.05", "OutcomeMeasurementUpperLimit":"0.64" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0.08", "OutcomeMeasurementLowerLimit":"-0.27", "OutcomeMeasurementUpperLimit":"0.42" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"Analysis for the more hyperopic eye, Older Cohort:\n\nAn analysis of covariance model adjusting for refractive error at enrollment was used to compare mean change in refractive error between treatment groups.", "OutcomeAnalysisNonInferiorityType":"Other", "OutcomeAnalysisPValue":"0.002", "OutcomeAnalysisPValueComment":"Results are considered statistically significant if p<0.01.", "OutcomeAnalysisStatisticalMethod":"ANCOVA", "OutcomeAnalysisParamType":"Mean Difference (Final Values)", "OutcomeAnalysisParamValue":"0.60", "OutcomeAnalysisCIPctValue":"99", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"0.11", "OutcomeAnalysisCIUpperLimit":"1.09" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"Analysis for the less hyperopic eye, Older Cohort:\n\nAn analysis of covariance model adjusting for refractive error at enrollment was used to compare mean change in refractive error between treatment groups.", "OutcomeAnalysisNonInferiorityType":"Other", "OutcomeAnalysisPValue":"0.002", "OutcomeAnalysisPValueComment":"Results are considered statistically significant if p<0.01.", "OutcomeAnalysisStatisticalMethod":"ANCOVA", "OutcomeAnalysisParamType":"Mean Difference (Final Values)", "OutcomeAnalysisParamValue":"0.58", "OutcomeAnalysisCIPctValue":"99", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"0.10", "OutcomeAnalysisCIUpperLimit":"1.06" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG002", "OG003" ] }, "OutcomeAnalysisGroupDescription":"Analysis for the more hyperopic eye, Younger Cohort:\n\nAn analysis of covariance model adjusting for refractive error at enrollment was used to compare mean change in refractive error between treatment groups.", "OutcomeAnalysisNonInferiorityType":"Other", "OutcomeAnalysisPValue":"0.53", "OutcomeAnalysisPValueComment":"Results are considered statistically significant if p≤0.01.", "OutcomeAnalysisStatisticalMethod":"ANCOVA", "OutcomeAnalysisParamType":"Mean Difference (Final Values)", "OutcomeAnalysisParamValue":"0.16", "OutcomeAnalysisCIPctValue":"99", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-0.51", "OutcomeAnalysisCIUpperLimit":"0.84" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG002", "OG003" ] }, "OutcomeAnalysisGroupDescription":"Analysis for the less hyperopic eye, Younger Cohort:\n\nAn analysis of covariance model adjusting for refractive error at enrollment was used to compare mean change in refractive error between treatment groups.", "OutcomeAnalysisNonInferiorityType":"Other", "OutcomeAnalysisPValue":"0.38", "OutcomeAnalysisPValueComment":"Results are considered statistically significant if p≤0.01.", "OutcomeAnalysisStatisticalMethod":"ANCOVA", "OutcomeAnalysisParamType":"Mean Difference (Final Values)", "OutcomeAnalysisParamValue":"0.22", "OutcomeAnalysisCIPctValue":"99", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-0.43", "OutcomeAnalysisCIUpperLimit":"0.86" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Participants With Hyperopia Reduction", "OutcomeMeasureDescription":"Percentage of Participants (%) in which hyperopia reduced by 1.00D (diopters) or more over 3 years", "OutcomeMeasurePopulationDescription":"Overall number is the number of patients that completed the 3-year study in the Older Cohort. This measure was not recorded for Younger Cohort.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"percentage of participants", "OutcomeMeasureTimeFrame":"Enrollment to 3 years", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Glasses- Older Cohort", "OutcomeGroupDescription":"Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study.\n\nGlasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Observation- Older Cohort", "OutcomeGroupDescription":"Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol.\n\nGlasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"41" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"43" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"More Hyperopic Eye", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"17" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"42" } ] } } ] } },{ "OutcomeClassTitle":"Less Hyperopic Eye", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"20" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"37" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"Analysis for the more hyperopic eye:\n\nBarnard’s exact test was used to compare proportions between treatment groups.", "OutcomeAnalysisNonInferiorityType":"Other", "OutcomeAnalysisPValue":"0.013", "OutcomeAnalysisPValueComment":"Results are considered statistically significant if p<0.01.", "OutcomeAnalysisStatisticalMethod":"Barnard's Exact Test", "OutcomeAnalysisParamType":"Mean Difference (Final Values)", "OutcomeAnalysisParamValue":"-25", "OutcomeAnalysisCIPctValue":"99", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-49", "OutcomeAnalysisCIUpperLimit":"1" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"Analysis for the less hyperopic eye:\n\nBarnard’s exact test was used to compare proportions between treatment groups.", "OutcomeAnalysisNonInferiorityType":"Other", "OutcomeAnalysisPValue":"0.08", "OutcomeAnalysisPValueComment":"Results are considered statistically significant if p<0.01.", "OutcomeAnalysisStatisticalMethod":"Barnard's Exact Test", "OutcomeAnalysisParamType":"Hazard Ratio, log", "OutcomeAnalysisParamValue":"-18", "OutcomeAnalysisCIPctValue":"99", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-42", "OutcomeAnalysisCIUpperLimit":"8" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Best Visual Acuity", "OutcomeMeasureDescription":"A treatment group comparison of the mean maximum visual acuity per subject at the masked 36-month visit (best visual acuity on any test with and without correction) will be performed using a t-test. Evaluated the best of the values reported with and without trial frames, during initial assessment and retest.\n\nSnellen visual acuity (VA) equivalents were converted to logarithm of minimum angle of resolution (logMAR) equivalents (in parentheses) as follows: 20/16 (-0.1), 20/20 (0), 20/25 (0.1), 20/32 (0.2), 20/40 (0.3), 20/50 (0.4)\n\nA logMAR value of less than 0 is associated with better than 20/20 vision, while a logMAR value greater than 0 is associated with worse than 20/20 vision.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"logMAR", "OutcomeMeasureTimeFrame":"36 months after randomization", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Glasses- Older Cohort", "OutcomeGroupDescription":"Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study.\n\nGlasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Observation- Older Cohort", "OutcomeGroupDescription":"Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol.\n\nGlasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Glasses- Younger Cohort", "OutcomeGroupDescription":"Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study.\n\nGlasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Observation- Younger Cohort", "OutcomeGroupDescription":"Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol.\n\nGlasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"41" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"43" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"53" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"53" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Better-seeing Eye", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.06", "OutcomeMeasurementSpread":"0.06" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-0.07", "OutcomeMeasurementSpread":"0.05" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0.06", "OutcomeMeasurementSpread":"0.12" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0.12", "OutcomeMeasurementSpread":"0.13" } ] } } ] } },{ "OutcomeClassTitle":"Worse-seeing Eye", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.03", "OutcomeMeasurementSpread":"0.08" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-0.01", "OutcomeMeasurementSpread":"0.10" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0.16", "OutcomeMeasurementSpread":"0.23" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0.23", "OutcomeMeasurementSpread":"0.26" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"Test for Difference in Means in Better-Seeing Eye: Older Cohort\n\nAn analysis of covariance model, adjusting for age at the 3-year visit and visual acuity at baseline, was used to compare mean visual acuity between treatment groups. Results are considered statistically significant if p<0.01.", "OutcomeAnalysisNonInferiorityType":"Other", "OutcomeAnalysisPValue":"0.22", "OutcomeAnalysisStatisticalMethod":"ANCOVA", "OutcomeAnalysisParamType":"Mean Difference (Final Values)", "OutcomeAnalysisParamValue":"0.01", "OutcomeAnalysisCIPctValue":"99", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-0.02", "OutcomeAnalysisCIUpperLimit":"0.04" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"Test for Difference in Means in Worse-Seeing Eye: Older Cohort\n\nAn analysis of covariance model, adjusting for age at the 3-year visit and visual acuity at baseline, was used to compare mean visual acuity between treatment groups. Results are considered statistically significant if p<0.01.", "OutcomeAnalysisNonInferiorityType":"Other", "OutcomeAnalysisPValue":"0.41", "OutcomeAnalysisStatisticalMethod":"ANCOVA", "OutcomeAnalysisParamType":"Mean Difference (Final Values)", "OutcomeAnalysisParamValue":"-0.02", "OutcomeAnalysisCIPctValue":"99", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-0.06", "OutcomeAnalysisCIUpperLimit":"0.03" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG002", "OG003" ] }, "OutcomeAnalysisGroupDescription":"Test for Difference in Means in Better-Seeing Eye: Younger Cohort\n\nAn analysis of covariance model, adjusting for age at the 3-year visit and visual acuity at baseline, was used to compare mean visual acuity between treatment groups. Results are considered statistically significant if p<0.01.", "OutcomeAnalysisNonInferiorityType":"Other", "OutcomeAnalysisPValue":"0.02", "OutcomeAnalysisStatisticalMethod":"ANCOVA", "OutcomeAnalysisParamType":"Mean Difference (Final Values)", "OutcomeAnalysisParamValue":"-0.05", "OutcomeAnalysisCIPctValue":"99", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-0.12", "OutcomeAnalysisCIUpperLimit":"0.01" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG002", "OG003" ] }, "OutcomeAnalysisGroupDescription":"Test for Difference in Means in Worse-Seeing Eye: Younger Cohort\n\nAn analysis of covariance model, adjusting for age at the 3-year visit and visual acuity at baseline, was used to compare mean visual acuity between treatment groups. Results are considered statistically significant if p<0.01.", "OutcomeAnalysisNonInferiorityType":"Other", "OutcomeAnalysisPValue":"0.15", "OutcomeAnalysisStatisticalMethod":"ANCOVA", "OutcomeAnalysisParamType":"Mean Difference (Final Values)", "OutcomeAnalysisParamValue":"-0.07", "OutcomeAnalysisCIPctValue":"99", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-0.19", "OutcomeAnalysisCIUpperLimit":"0.05" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Failure to Meet Age-Normal VA at Distance", "OutcomeMeasureDescription":"Proportion who failed to meet age-normal VA at distance at 3 years. Participants were classified as failing to meet age-normal visual acuity if, for either eye, distance visual acuity was below age-normal values both with and without trial frames, during initial assessment and re-test.", "OutcomeMeasurePopulationDescription":"Overall number is the total number of patients who completed the 3-year study.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Count of Participants", "OutcomeMeasureUnitOfMeasure":"Participants", "OutcomeMeasureTimeFrame":"36 months", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Glasses- Older Cohort", "OutcomeGroupDescription":"Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study.\n\nGlasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Observation- Older Cohort", "OutcomeGroupDescription":"Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol.\n\nGlasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Glasses- Younger Cohort", "OutcomeGroupDescription":"Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study.\n\nGlasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Observation- Younger Cohort", "OutcomeGroupDescription":"Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol.\n\nGlasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"41" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"43" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"53" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"53" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"4" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"Barnard’s exact test was used to compare proportions between treatment groups.", "OutcomeAnalysisNonInferiorityType":"Other", "OutcomeAnalysisPValue":"0.51", "OutcomeAnalysisPValueComment":"Results are considered statistically significant if p<0.01.", "OutcomeAnalysisStatisticalMethod":"Barnard's Exact Test", "OutcomeAnalysisParamType":"Mean Difference (Final Values)", "OutcomeAnalysisParamValue":"-2", "OutcomeAnalysisCIPctValue":"99", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-18", "OutcomeAnalysisCIUpperLimit":"13" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG002", "OG003" ] }, "OutcomeAnalysisGroupDescription":"Barnard’s exact test was used to compare proportions between treatment groups.", "OutcomeAnalysisNonInferiorityType":"Other", "OutcomeAnalysisPValue":"0.79", "OutcomeAnalysisPValueComment":"Results are considered statistically significant if p<0.01.", "OutcomeAnalysisStatisticalMethod":"Barnard's Exact Test", "OutcomeAnalysisParamType":"Mean Difference (Final Values)", "OutcomeAnalysisParamValue":"-2", "OutcomeAnalysisCIPctValue":"99", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-18", "OutcomeAnalysisCIUpperLimit":"14" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Proportion With Amblyopia (at Distance)", "OutcomeMeasureDescription":"A treatment group comparison of the proportion of subjects who developed amblyopia at distance during the course of the study will be performed using the Barnard's exact test.\n\nParticipants were classified as having amblyopia if any of the following criteria were met: 1) the interocular difference was ≥2 logMAR lines of IOD if VA is 20/25 or worse in the better-seeing eye, or 2) the interocular differences was ≥3 logMAR lines of IOD if VA is 20/20 or better in the better-seeing eye. 3) VA less than age normal in each eye (presumed bilateral amblyopia)", "OutcomeMeasurePopulationDescription":"Overall number is the total number of patients who completed the 3-year study.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Count of Participants", "OutcomeMeasureUnitOfMeasure":"Participants", "OutcomeMeasureTimeFrame":"36 months after randomization", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Glasses- Older Cohort", "OutcomeGroupDescription":"Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study.\n\nGlasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Observation- Older Cohort", "OutcomeGroupDescription":"Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol.\n\nGlasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Glasses- Younger Cohort", "OutcomeGroupDescription":"Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study.\n\nGlasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Observation- Younger Cohort", "OutcomeGroupDescription":"Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol.\n\nGlasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"41" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"43" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"53" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"53" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"7" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"9" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"Barnard’s exact test was used to compare proportions between treatment groups.", "OutcomeAnalysisNonInferiorityType":"Other", "OutcomeAnalysisPValue":"0.51", "OutcomeAnalysisPValueComment":"Results are considered statistically significant if p<0.01.", "OutcomeAnalysisStatisticalMethod":"Barnard's Exact Test", "OutcomeAnalysisParamType":"Mean Difference (Final Values)", "OutcomeAnalysisParamValue":"-2", "OutcomeAnalysisCIPctValue":"99", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-18", "OutcomeAnalysisCIUpperLimit":"13" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG002", "OG003" ] }, "OutcomeAnalysisGroupDescription":"Barnard’s exact test was used to compare proportions between treatment groups.", "OutcomeAnalysisNonInferiorityType":"Other", "OutcomeAnalysisPValue":"0.68", "OutcomeAnalysisPValueComment":"Results are considered statistically significant if p≤0.01.", "OutcomeAnalysisStatisticalMethod":"Barnard's Exact Test", "OutcomeAnalysisParamType":"Mean Difference (Final Values)", "OutcomeAnalysisParamValue":"-4", "OutcomeAnalysisCIPctValue":"99", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-24", "OutcomeAnalysisCIUpperLimit":"16" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Binocular Near Visual Acuity", "OutcomeMeasureDescription":"A treatment group comparison of the mean binocular near visual acuity (logarithm of minimum angle of resolution, or logMAR) at the 36-month outcome exam will be performed. Assessment completed in randomized correction.\n\nSnellen visual acuity (VA) equivalents were converted to logarithm of minimum angle of resolution (logMAR) equivalents (in parentheses) as follows: 20/16 (-0.1), 20/20 (0), 20/25 (0.1), 20/32 (0.2), 20/40 (0.3), 20/50 (0.4) A logMAR value of less than 0 is associated with better than 20/20 vision, while a logMAR value greater than 0 is associated with worse than 20/20 vision.", "OutcomeMeasurePopulationDescription":"Overall number is the total number of patients who completed the 3-year study.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"logMAR", "OutcomeMeasureTimeFrame":"36 months after randomization", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Glasses- Older Cohort", "OutcomeGroupDescription":"Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study.\n\nGlasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Observation- Older Cohort", "OutcomeGroupDescription":"Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol.\n\nGlasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Glasses- Younger Cohort", "OutcomeGroupDescription":"Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study.\n\nGlasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Observation- Younger Cohort", "OutcomeGroupDescription":"Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol.\n\nGlasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"41" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"43" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"53" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"53" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.01", "OutcomeMeasurementSpread":"0.04" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.04", "OutcomeMeasurementSpread":"0.14" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0.09", "OutcomeMeasurementSpread":"0.11" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0.12", "OutcomeMeasurementSpread":"0.12" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"An analysis of covariance model, adjusting for age at the 3-year visit and visual acuity at baseline, was used to compare mean visual acuity between treatment groups.", "OutcomeAnalysisNonInferiorityType":"Other", "OutcomeAnalysisPValue":"0.21", "OutcomeAnalysisPValueComment":"Results are considered statistically significant if p<0.01", "OutcomeAnalysisStatisticalMethod":"ANCOVA", "OutcomeAnalysisParamType":"Mean Difference (Final Values)", "OutcomeAnalysisParamValue":"-0.04", "OutcomeAnalysisCIPctValue":"99", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-0.12", "OutcomeAnalysisCIUpperLimit":"0.05" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG002", "OG003" ] }, "OutcomeAnalysisGroupDescription":"An analysis of covariance model, adjusting for age at the 3-year visit and visual acuity at baseline, was used to compare mean visual acuity between treatment groups.", "OutcomeAnalysisNonInferiorityType":"Other", "OutcomeAnalysisPValue":"0.25", "OutcomeAnalysisPValueComment":"Results are considered statistically significant if p≤0.01.", "OutcomeAnalysisStatisticalMethod":"ANCOVA", "OutcomeAnalysisParamType":"Mean Difference (Final Values)", "OutcomeAnalysisParamValue":"-0.03", "OutcomeAnalysisCIPctValue":"99", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-0.10", "OutcomeAnalysisCIUpperLimit":"0.04" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Number of Participants With Strabismus at 3 Years", "OutcomeMeasureDescription":"The number of participants who developed measurable heterotropia was estimated for each treatment group and the proportions were compared using Barnard's exact test.", "OutcomeMeasurePopulationDescription":"In the older cohort, one participant had esotropia. In the younger cohort, Three participants in the glasses group and two in the observation group received strabismus surgery prior to the 3-year visit. These participants are included in the table.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Count of Participants", "OutcomeMeasureUnitOfMeasure":"Participants", "OutcomeMeasureTimeFrame":"36 months after randomization", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Glasses- Older Cohort", "OutcomeGroupDescription":"Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study.\n\nGlasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Observation- Older Cohort", "OutcomeGroupDescription":"Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol.\n\nGlasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Glasses- Younger Cohort", "OutcomeGroupDescription":"Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study.\n\nGlasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Observation- Younger Cohort", "OutcomeGroupDescription":"Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol.\n\nGlasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"41" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"43" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"53" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"53" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"5" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"5" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"Barnard’s exact test used to compare proportions between treatment groups", "OutcomeAnalysisNonInferiorityType":"Other", "OutcomeAnalysisPValue":"0.51", "OutcomeAnalysisPValueComment":"Results are considered statistically significant if p<0.01.", "OutcomeAnalysisStatisticalMethod":"Barnard's Exact Test", "OutcomeAnalysisParamType":"Mean Difference (Final Values)", "OutcomeAnalysisParamValue":"-2", "OutcomeAnalysisCIPctValue":"99", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-18", "OutcomeAnalysisCIUpperLimit":"13" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG002", "OG003" ] }, "OutcomeAnalysisGroupDescription":"Barnard’s exact test used to compare proportions between treatment groups.", "OutcomeAnalysisNonInferiorityType":"Other", "OutcomeAnalysisPValueComment":"No p-value, because there was 0% difference", "OutcomeAnalysisParamType":"Mean Difference (Final Values)", "OutcomeAnalysisParamValue":"0", "OutcomeAnalysisCIPctValue":"99", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-17", "OutcomeAnalysisCIUpperLimit":"17" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Mean Stereoacuity", "OutcomeMeasureDescription":"Mean stereoacuity at 3 years was measured in log seconds of arc (log arcsec) (see explanation below). Evaluated the best of the values reported with and without trial frames, during initial assessment and retest.\n\nStereoacuity scores (seconds of arc) were calculated based on the Randot Preschool stereoacuity test (scores: 800, 400, 200, 100, 60 and 40). Seconds of arc refers to the visual angle that is being measured in order to determine depth perception. Lower scores indicate better stereoacuity. A logarithm base 10 transformation was used to convert stereoacuity scores to the log scale to calculate descriptive statistics (reported as seconds of arc, or arcsec). Seconds of arc were converted to logarithm of seconds of arc, or log arcsec (in parentheses) as follows: 40 (1.60), 60(1.78), 100 (2.00), 200 (2.30), 400 (2.60), 800 (2.90), Nil (3.20)", "OutcomeMeasurePopulationDescription":"Overall number is the total number of patients who completed the 3-year study.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"logarithm of seconds of arc (log arcsec)", "OutcomeMeasureTimeFrame":"36 months", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Glasses- Older Cohort", "OutcomeGroupDescription":"Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study.\n\nGlasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Observation- Older Cohort", "OutcomeGroupDescription":"Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol.\n\nGlasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Glasses- Younger Cohort", "OutcomeGroupDescription":"Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study.\n\nGlasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Observation- Younger Cohort", "OutcomeGroupDescription":"Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol.\n\nGlasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"41" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"43" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"53" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"53" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.76", "OutcomeMeasurementSpread":"0.20" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1.75", "OutcomeMeasurementSpread":"0.23" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"2.2", "OutcomeMeasurementSpread":"0.52" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"2.3", "OutcomeMeasurementSpread":"0.55" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"An analysis of covariance model was used to compare mean change in stereoacuity between treatment groups. The analysis controlled for age at the 3-year visit, anisometropia at the most recent visit, and stereoacuity at enrollment.", "OutcomeAnalysisNonInferiorityType":"Other", "OutcomeAnalysisPValue":"0.74", "OutcomeAnalysisPValueComment":"Results are considered statistically significant if p<0.01.", "OutcomeAnalysisStatisticalMethod":"ANCOVA", "OutcomeAnalysisParamType":"Mean Difference (Final Values)", "OutcomeAnalysisParamValue":"0.02", "OutcomeAnalysisCIPctValue":"99", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-0.11", "OutcomeAnalysisCIUpperLimit":"0.14" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG002", "OG003" ] }, "OutcomeAnalysisGroupDescription":"An analysis of covariance model was used to compare mean change in stereoacuity between treatment groups. The analysis controlled for age at the 3-year visit and anisometropia at the most recent visit.", "OutcomeAnalysisNonInferiorityType":"Other", "OutcomeAnalysisPValue":"0.15", "OutcomeAnalysisStatisticalMethod":"ANCOVA", "OutcomeAnalysisParamType":"Mean Difference (Final Values)", "OutcomeAnalysisParamValue":"-0.1", "OutcomeAnalysisCIPctValue":"99", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-0.4", "OutcomeAnalysisCIUpperLimit":"0.1" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Failure to Meet Age-Normal Stereoacuity at 3 Years", "OutcomeMeasureDescription":"Proportion who failed to meet age-normal stereoacuity. Participants were classified as failing to meet age-normal stereoacuity if near stereoacuity was below age-normal values both with and without trial frames, during initial assessment and re-test.", "OutcomeMeasurePopulationDescription":"Overall number is the total number of patients who completed the 3-year study.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Count of Participants", "OutcomeMeasureUnitOfMeasure":"Participants", "OutcomeMeasureTimeFrame":"36 months", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Glasses- Older Cohort", "OutcomeGroupDescription":"Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study.\n\nGlasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Observation- Older Cohort", "OutcomeGroupDescription":"Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol.\n\nGlasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Glasses- Younger Cohort", "OutcomeGroupDescription":"Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study.\n\nGlasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Observation- Younger Cohort", "OutcomeGroupDescription":"Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol.\n\nGlasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"41" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"43" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"53" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"53" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"5" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"6" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"16" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"Barnard’s exact test used to compare proportions between treatment groups", "OutcomeAnalysisNonInferiorityType":"Other", "OutcomeAnalysisPValue":"0.53", "OutcomeAnalysisPValueComment":"Results are considered statistically significant if p<0.01.", "OutcomeAnalysisStatisticalMethod":"Barnard's Exact Test", "OutcomeAnalysisParamType":"Mean Difference (Final Values)", "OutcomeAnalysisParamValue":"5", "OutcomeAnalysisCIPctValue":"99", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-14", "OutcomeAnalysisCIUpperLimit":"26" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG002", "OG003" ] }, "OutcomeAnalysisGroupDescription":"Barnard’s exact test used to compare proportions between treatment groups.", "OutcomeAnalysisNonInferiorityType":"Other", "OutcomeAnalysisPValue":"0.02", "OutcomeAnalysisPValueComment":"Results are considered statistically significant if p<0.01.", "OutcomeAnalysisStatisticalMethod":"Barnard's Exact Test", "OutcomeAnalysisParamType":"Mean Difference (Final Values)", "OutcomeAnalysisParamValue":"-19", "OutcomeAnalysisCIPctValue":"99", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-40", "OutcomeAnalysisCIUpperLimit":"2" } ] } } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"0", "EventsTimeFrame":"3 Years (36 months)", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"Glasses- Older Cohort", "EventGroupDescription":"Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study.\n\nGlasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.", "EventGroupDeathsNumAffected":"0", "EventGroupDeathsNumAtRisk":"41", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"41", "EventGroupOtherNumAffected":"0", "EventGroupOtherNumAtRisk":"41" },{ "EventGroupId":"EG001", "EventGroupTitle":"Observation- Older Cohort", "EventGroupDescription":"Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol.\n\nGlasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.", "EventGroupDeathsNumAffected":"0", "EventGroupDeathsNumAtRisk":"43", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"43", "EventGroupOtherNumAffected":"0", "EventGroupOtherNumAtRisk":"43" },{ "EventGroupId":"EG002", "EventGroupTitle":"Glasses- Younger Cohort", "EventGroupDescription":"Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study.\n\nGlasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.", "EventGroupDeathsNumAffected":"0", "EventGroupDeathsNumAtRisk":"53", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"53", "EventGroupOtherNumAffected":"0", "EventGroupOtherNumAtRisk":"53" },{ "EventGroupId":"EG003", "EventGroupTitle":"Observation- Younger Cohort", "EventGroupDescription":"Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol.\n\nGlasses: For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.", "EventGroupDeathsNumAffected":"0", "EventGroupDeathsNumAtRisk":"53", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"53", "EventGroupOtherNumAffected":"0", "EventGroupOtherNumAtRisk":"53" } ] } }, "MoreInfoModule":{ "CertainAgreement":{ "AgreementPISponsorEmployee":"No", "AgreementRestrictiveAgreement":"No" }, "PointOfContact":{ "PointOfContactTitle":"Ray Kraker M.S.P.H.", "PointOfContactOrganization":"Jaeb Center for Health Research", "PointOfContactEMail":"rkraker@jaeb.org", "PointOfContactPhone":"813-975-8690" } } }, "DocumentSection":{ "LargeDocumentModule":{ "LargeDocList":{ "LargeDoc":[ { "LargeDocTypeAbbrev":"ICF", "LargeDocHasProtocol":"No", "LargeDocHasSAP":"No", "LargeDocHasICF":"Yes", "LargeDocLabel":"Informed Consent Form", "LargeDocDate":"October 14, 2013", "LargeDocUploadDate":"03/12/2019 08:22", "LargeDocFilename":"ICF_000.pdf" },{ "LargeDocTypeAbbrev":"SAP", "LargeDocHasProtocol":"No", "LargeDocHasSAP":"Yes", "LargeDocHasICF":"No", "LargeDocLabel":"Statistical Analysis Plan", "LargeDocDate":"July 25, 2018", "LargeDocUploadDate":"03/12/2019 08:29", "LargeDocFilename":"SAP_001.pdf" },{ "LargeDocTypeAbbrev":"Prot", "LargeDocHasProtocol":"Yes", "LargeDocHasSAP":"No", "LargeDocHasICF":"No", "LargeDocLabel":"Study Protocol", "LargeDocDate":"January 28, 2015", "LargeDocUploadDate":"03/12/2019 08:31", "LargeDocFilename":"Prot_002.pdf" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000006956", "ConditionMeshTerm":"Hyperopia" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000012030", "ConditionAncestorTerm":"Refractive Errors" },{ "ConditionAncestorId":"D000005128", "ConditionAncestorTerm":"Eye Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M8590", "ConditionBrowseLeafName":"Hyperopia", "ConditionBrowseLeafAsFound":"Hyperopia", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M13455", "ConditionBrowseLeafName":"Refractive Errors", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M6854", "ConditionBrowseLeafName":"Eye Diseases", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC11", "ConditionBrowseBranchName":"Eye Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" } ] } } } } } }