{ "FullStudy":{ "Rank":218254, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01510717", "OrgStudyIdInfo":{ "OrgStudyId":"C-10-016" }, "Organization":{ "OrgFullName":"Alcon Research", "OrgClass":"INDUSTRY" }, "BriefTitle":"Clinical Investigation of AcrySof® IQ ReSTOR® +2.5 D Multifocal Intraocular Lens (IOL) Model SN6AD2 [SV25T0]", "OfficialTitle":"Clinical Investigation of AcrySof® IQ ReSTOR® +2.5 D Multifocal Intraocular Lens (IOL) Model SN6AD2" }, "StatusModule":{ "StatusVerifiedDate":"May 2015", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"February 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"December 2012", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"December 2012", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 12, 2012", "StudyFirstSubmitQCDate":"January 12, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 16, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"May 8, 2015", "ResultsFirstSubmitQCDate":"May 8, 2015", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"May 27, 2015", "ResultsFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"May 8, 2015", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"May 27, 2015", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Alcon Research", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"The purpose of this study is to compare the safety and efficacy of an investigational multifocal intraocular lens (IOL) to an FDA-approved monofocal IOL.", "DetailedDescription":"Participants 21 years and older in need of cataract extraction were consented and randomized in a 1:1 ratio at each investigative site to receive either the AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0] or the AcrySof® IQ Monofocal IOL Model SN60WF in both eyes. Each participant completed a preoperative examination of both eyes, implantation of IOL at the operative visit for each eye, and up to 7 postoperative visits, with monocular testing at Day 1-2, Day 7-14, and Day 30-60, and monocular and binocular testing at Day 120-180 following the second implantation. The first eye to be implanted was considered the primary eye. The second eye was implanted 7 and 30 days of the first. If the first eye was not implanted during surgery, the second eye was not eligible. If the second eye was not implanted during surgery, only the first eye was followed." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Cataracts" ] }, "KeywordList":{ "Keyword":[ "Intraocular Lens", "Monofocal", "Multifocal" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Not Applicable" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"Double", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Outcomes Assessor" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"409", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Multifocal IOL", "ArmGroupType":"Experimental", "ArmGroupDescription":"AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0], bilateral implantation", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Device: AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]" ] } },{ "ArmGroupLabel":"Monofocal IOL", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"AcrySof® IQ Monofocal IOL Model SN60WF, bilateral implantation", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Device: AcrySof® IQ Monofocal IOL Model SN60WF" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Device", "InterventionName":"AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]", "InterventionDescription":"Multifocal IOL with extended secondary focal point implanted for long-term use over the lifetime of the cataract patient", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Multifocal IOL" ] } },{ "InterventionType":"Device", "InterventionName":"AcrySof® IQ Monofocal IOL Model SN60WF", "InterventionDescription":"Monofocal IOL implanted for long-term use over the lifetime of the cataract patient", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Monofocal IOL" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Mean Photopic Monocular Distance Corrected VA (53 cm) at Day 120-180", "PrimaryOutcomeDescription":"Visual acuity (VA) was tested monocularly (each eye separately) using the manifest refraction adjusted for optical infinity and the hand-held, 100% contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart set at 53 centimeters (cm) on the nearpoint rod. VA was measured in logMAR (logarithm of the minimum angle of resolution), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the primary eye.", "PrimaryOutcomeTimeFrame":"Day 120-180 from second eye implantation" },{ "PrimaryOutcomeMeasure":"Number of Cumulative and Persistent Adverse Events as Defined in IS EN ISO 11979-7:2006, up to Day 120-180", "PrimaryOutcomeDescription":"Cumulative and persistent adverse events were collected. This outcome measure was prespecified for the multifocal IOL.", "PrimaryOutcomeTimeFrame":"Day 0 first operative eye visit, up to Day 120-180 from second eye implantation" },{ "PrimaryOutcomeMeasure":"Photopic Contrast Sensitivity Without Glare at Day 120-180", "PrimaryOutcomeDescription":"Contrast sensitivity (ie, the ability to detect objects by distinguishing them from their background) was assessed binocularly with the participant's best spectacle correction under photopic (bright) conditions at a distance of 8 feet at spatial frequencies of 3, 6, 12, and 18 cycles per degree (cpd) using the Vector Vision CSV 1000 without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Scores of (-1) were set to missing; hence, the mean measures may be overestimated and the variability measures may be underestimated. A higher numeric value represents better contrast sensitivity.", "PrimaryOutcomeTimeFrame":"Day 120-180 from second eye implantation" },{ "PrimaryOutcomeMeasure":"Photopic Contrast Sensitivity With Glare at Day 120-180", "PrimaryOutcomeDescription":"Contrast sensitivity was assessed binocularly with the participant's best spectacle correction under photopic (bright) conditions at a distance of 8 feet at spatial frequencies of 3, 6, 12, and 18 cycles per degree (cpd) using the Vector Vision CSV 1000 with a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Scores of (-1) were set to missing; hence, the mean measures may be overestimated and the variability measures may be underestimated. A higher numeric value represents better contrast sensitivity.", "PrimaryOutcomeTimeFrame":"Day 120-180 from second eye implantation" },{ "PrimaryOutcomeMeasure":"Mesopic Contrast Sensitivity Without Glare at Day 120-180", "PrimaryOutcomeDescription":"Contrast sensitivity was assessed binocularly with the participant's best spectacle correction under mesopic (dim lighting) conditions at a distance of 8 feet at spatial frequencies of 1.5, 3, 6, and 12 cycles per degree (cpd) using the Vector Vision CSV 1000 without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Scores of (-1) were set to missing; hence, the mean measures may be overestimated and the variability measures may be underestimated. A higher numeric value represents better contrast sensitivity.", "PrimaryOutcomeTimeFrame":"Day 120-180 from second eye implantation" },{ "PrimaryOutcomeMeasure":"Mesopic Contrast Sensitivity With Glare at Day 120-180", "PrimaryOutcomeDescription":"Contrast sensitivity was assessed binocularly with the participant's best spectacle correction under mesopic conditions at a distance of 8 feet at spatial frequencies of 1.5, 3, 6, and 12 cpd using the Vector Vision CSV 1000 with a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Scores of (-1) were set to missing; hence, the mean measures may be overestimated and the variability measures may be underestimated. A higher numeric value represents better contrast sensitivity.", "PrimaryOutcomeTimeFrame":"Day 120-180 from second eye implantation" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Mean Photopic Monocular Best Corrected Distance VA (4 m) at Day 120-180", "SecondaryOutcomeDescription":"VA was tested monocularly (each eye separately) using the correction obtained from the manifest refraction and 100% contrast, ETDRS charts at a distance of 4 meters. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the primary eye.", "SecondaryOutcomeTimeFrame":"Day 120-180 from second eye implantation" },{ "SecondaryOutcomeMeasure":"Mean Photopic Monocular Distance Corrected Near VA at Standard Distance (40 cm) at Day 120-180", "SecondaryOutcomeDescription":"VA was tested monocularly (each eye separately) using the manifest refraction adjusted for optical infinity and the hand-held, 100% contrast, ETDRS chart set at 40 cm on the nearpoint rod. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the primary eye.", "SecondaryOutcomeTimeFrame":"Day 120-180 from second eye implantation" },{ "SecondaryOutcomeMeasure":"Overall Spectacle Independence Using SILVER Patient Reported Outcome (PRO) Questionnaire at Day 120-180", "SecondaryOutcomeDescription":"Overall Spectacle Independence was rated using SILVER (Spectacle Independence Lens Vision Evaluation and Repurchase), a new patient reported outcome questionnaire. The participant was asked, \"How often do you wear eyeglasses or contact lenses overall?\"", "SecondaryOutcomeTimeFrame":"Day 120-180 from second eye implantation" },{ "SecondaryOutcomeMeasure":"Near Spectacle Independence Using SILVER Patient Reported Outcome (PRO) Questionnaire at Day 120-180", "SecondaryOutcomeDescription":"Near Spectacle Independence was rated using SILVER, a new patient reported outcome questionnaire. The participant was asked, \"How often do you wear eyeglasses or contact lenses for seeing objects up close?\"", "SecondaryOutcomeTimeFrame":"Day 120-180 from second eye implantation" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nDiagnosis of bilateral cataracts\nWilling and able to complete all required postoperative visits\nCalculated lens power within the available supply range\nPlanned cataract removal by phacoemulsification\nPotential postoperative visual acuity of 0.2 logMAR or better in both eyes\nPreoperative astigmatism less than 1.0 diopter\nClear intraocular media other than cataract in study eyes\nPreoperative Best Corrected Distance Visual Acuity (BCDVA) worse than 0.2 logMAR\nAble to undergo second eye surgery between 7 days and 30 days of the first eye surgery\nOther protocol-defined inclusion criteria may apply\n\nExclusion Criteria:\n\nPrevious refractive surgery\nInflammation or edema of the cornea\nOptic nerve atrophy\nPregnancy\nCurrent participation in another investigational drug or device study\nOther protocol-defined exclusion criteria may apply", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"21 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Magda Michna, PhD", "OverallOfficialAffiliation":"Alcon Research", "OverallOfficialRole":"Study Director" } ] } } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowPreAssignmentDetails":"Of the 409 participants enrolled, 80 were discontinued prior to randomization as screen failures and 9 were discontinued after randomization prior to implantation. This reporting group includes all participants with successful IOL implantation in at least 1 eye (320).", "FlowRecruitmentDetails":"Participants were recruited and enrolled from 15 investigative sites located in the United States.", "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"Multifocal IOL", "FlowGroupDescription":"AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]" },{ "FlowGroupId":"FG001", "FlowGroupTitle":"Monofocal IOL", "FlowGroupDescription":"AcrySof® IQ Monofocal IOL Model SN60WF" } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Overall Study", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"155" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"165" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"153" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"160" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"2" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"5" } ] } } ] }, "FlowDropWithdrawList":{ "FlowDropWithdraw":[ { "FlowDropWithdrawType":"Adverse Event", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"2" } ] } },{ "FlowDropWithdrawType":"Death", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" } ] } },{ "FlowDropWithdrawType":"Lost to Follow-up", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"1" } ] } },{ "FlowDropWithdrawType":"Withdrawal by Subject", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"2" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselinePopulationDescription":"This analysis population includes all participants with successful IOL implantation in at least 1 eye.", "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"Multifocal IOL", "BaselineGroupDescription":"AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]" },{ "BaselineGroupId":"BG001", "BaselineGroupTitle":"Monofocal IOL", "BaselineGroupDescription":"AcrySof® IQ Monofocal IOL Model SN60WF" },{ "BaselineGroupId":"BG002", "BaselineGroupTitle":"Total", "BaselineGroupDescription":"Total of all reporting groups" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"155" },{ "BaselineDenomCountGroupId":"BG001", "BaselineDenomCountValue":"165" },{ "BaselineDenomCountGroupId":"BG002", "BaselineDenomCountValue":"320" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Continuous", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"years", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"68.7", "BaselineMeasurementSpread":"9.64" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"69.4", "BaselineMeasurementSpread":"8.27" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"69.0", "BaselineMeasurementSpread":"8.95" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Age, Customized", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"20-29 years", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"1" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"1" } ] } } ] } },{ "BaselineClassTitle":"30-39 years", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"2" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"2" } ] } } ] } },{ "BaselineClassTitle":"40-49 years", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"2" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"3" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"5" } ] } } ] } },{ "BaselineClassTitle":"50-59 years", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"18" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"12" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"30" } ] } } ] } },{ "BaselineClassTitle":"60-69 years", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"53" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"62" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"115" } ] } } ] } },{ "BaselineClassTitle":"70-79 years", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"65" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"71" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"136" } ] } } ] } },{ "BaselineClassTitle":"≥80 years", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"14" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"17" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"31" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"96" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"97" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"193" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"59" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"68" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"127" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Region of Enrollment", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"United States", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"155" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"165" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"320" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Mean Photopic Monocular Distance Corrected VA (53 cm) at Day 120-180", "OutcomeMeasureDescription":"Visual acuity (VA) was tested monocularly (each eye separately) using the manifest refraction adjusted for optical infinity and the hand-held, 100% contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart set at 53 centimeters (cm) on the nearpoint rod. VA was measured in logMAR (logarithm of the minimum angle of resolution), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the primary eye.", "OutcomeMeasurePopulationDescription":"This analysis population includes all participants with successful IOL implantation in the primary eye.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Error", "OutcomeMeasureUnitOfMeasure":"logMAR", "OutcomeMeasureTimeFrame":"Day 120-180 from second eye implantation", "OutcomeMeasureTypeUnitsAnalyzed":"eyes", "OutcomeMeasureDenomUnitsSelected":"Participants", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Multifocal IOL", "OutcomeGroupDescription":"AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Monofocal IOL", "OutcomeGroupDescription":"AcrySof® IQ Monofocal IOL Model SN60WF" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"155" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"165" } ] } },{ "OutcomeDenomUnits":"eyes", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"155" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"165" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.322", "OutcomeMeasurementSpread":"0.014" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.512", "OutcomeMeasurementSpread":"0.013" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Number of Cumulative and Persistent Adverse Events as Defined in IS EN ISO 11979-7:2006, up to Day 120-180", "OutcomeMeasureDescription":"Cumulative and persistent adverse events were collected. This outcome measure was prespecified for the multifocal IOL.", "OutcomeMeasurePopulationDescription":"This analysis population includes all participants with attempted IOL implantation in at least one eye (successful or aborted after contact with the eye).", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"adverse events", "OutcomeMeasureTimeFrame":"Day 0 first operative eye visit, up to Day 120-180 from second eye implantation", "OutcomeMeasureTypeUnitsAnalyzed":"eyes", "OutcomeMeasureDenomUnitsSelected":"Participants", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Multifocal IOL", "OutcomeGroupDescription":"AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"155" } ] } },{ "OutcomeDenomUnits":"eyes", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"310" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Cystoid macular oedema (cumulative)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"4" } ] } } ] } },{ "OutcomeClassTitle":"Endophthalmitis (cumulative)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Hypopyon (cumulative)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Lens dislocated from posterior (cumulative)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Pupillary block (cumulative)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Retinal detachment (cumulative)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Secondary surgical intervention (cumulative)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Corneal stroma oedema (persistent)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Cystoid macular oedema (persistent", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2" } ] } } ] } },{ "OutcomeClassTitle":"Iritis (persistent", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2" } ] } } ] } },{ "OutcomeClassTitle":"Raised IOP requiring treatment (persistent)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Photopic Contrast Sensitivity Without Glare at Day 120-180", "OutcomeMeasureDescription":"Contrast sensitivity (ie, the ability to detect objects by distinguishing them from their background) was assessed binocularly with the participant's best spectacle correction under photopic (bright) conditions at a distance of 8 feet at spatial frequencies of 3, 6, 12, and 18 cycles per degree (cpd) using the Vector Vision CSV 1000 without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Scores of (-1) were set to missing; hence, the mean measures may be overestimated and the variability measures may be underestimated. A higher numeric value represents better contrast sensitivity.", "OutcomeMeasurePopulationDescription":"The analysis population includes all participants with successful IOL implantation that had at least 1 postoperative visit, had no preoperative pathology or macular degeneration, and had no major protocol deviations at any time. Here n=number of participants with data for analysis.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"logMAR", "OutcomeMeasureTimeFrame":"Day 120-180 from second eye implantation", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Multifocal IOL", "OutcomeGroupDescription":"AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Monofocal IOL", "OutcomeGroupDescription":"AcrySof® IQ Monofocal IOL Model SN60WF" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"133" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"137" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"3 cpd (n=131,133)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.676", "OutcomeMeasurementSpread":"0.259" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1.743", "OutcomeMeasurementSpread":"0.203" } ] } } ] } },{ "OutcomeClassTitle":"6 cpd (n=130,133)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.816", "OutcomeMeasurementSpread":"0.256" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1.938", "OutcomeMeasurementSpread":"0.251" } ] } } ] } },{ "OutcomeClassTitle":"12 cpd (n=129,132)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.460", "OutcomeMeasurementSpread":"0.312" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1.555", "OutcomeMeasurementSpread":"0.312" } ] } } ] } },{ "OutcomeClassTitle":"18 cpd (n=130,131)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.970", "OutcomeMeasurementSpread":"0.348" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1.109", "OutcomeMeasurementSpread":"0.325" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Mean Photopic Monocular Best Corrected Distance VA (4 m) at Day 120-180", "OutcomeMeasureDescription":"VA was tested monocularly (each eye separately) using the correction obtained from the manifest refraction and 100% contrast, ETDRS charts at a distance of 4 meters. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the primary eye.", "OutcomeMeasurePopulationDescription":"This analysis population includes all participants with successful IOL implantation in the primary eye.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Error", "OutcomeMeasureUnitOfMeasure":"logMAR", "OutcomeMeasureTimeFrame":"Day 120-180 from second eye implantation", "OutcomeMeasureTypeUnitsAnalyzed":"eyes", "OutcomeMeasureDenomUnitsSelected":"Participants", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Multifocal IOL", "OutcomeGroupDescription":"AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Monofocal IOL", "OutcomeGroupDescription":"AcrySof® IQ Monofocal IOL Model SN60WF" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"155" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"165" } ] } },{ "OutcomeDenomUnits":"eyes", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"155" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"165" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.025", "OutcomeMeasurementSpread":"0.009" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.003", "OutcomeMeasurementSpread":"0.009" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Mean Photopic Monocular Distance Corrected Near VA at Standard Distance (40 cm) at Day 120-180", "OutcomeMeasureDescription":"VA was tested monocularly (each eye separately) using the manifest refraction adjusted for optical infinity and the hand-held, 100% contrast, ETDRS chart set at 40 cm on the nearpoint rod. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the primary eye.", "OutcomeMeasurePopulationDescription":"This analysis population includes all participants with successful IOL implantation in the primary eye.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Error", "OutcomeMeasureUnitOfMeasure":"logMAR", "OutcomeMeasureTimeFrame":"Day 120-180 from second eye implantation", "OutcomeMeasureTypeUnitsAnalyzed":"eyes", "OutcomeMeasureDenomUnitsSelected":"Participants", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Multifocal IOL", "OutcomeGroupDescription":"AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Monofocal IOL", "OutcomeGroupDescription":"AcrySof® IQ Monofocal IOL Model SN60WF" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"155" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"165" } ] } },{ "OutcomeDenomUnits":"eyes", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"155" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"165" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.426", "OutcomeMeasurementSpread":"0.014" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.632", "OutcomeMeasurementSpread":"0.013" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Overall Spectacle Independence Using SILVER Patient Reported Outcome (PRO) Questionnaire at Day 120-180", "OutcomeMeasureDescription":"Overall Spectacle Independence was rated using SILVER (Spectacle Independence Lens Vision Evaluation and Repurchase), a new patient reported outcome questionnaire. The participant was asked, \"How often do you wear eyeglasses or contact lenses overall?\"", "OutcomeMeasurePopulationDescription":"This analysis population includes all participants with successful IOL implantation in at least 1 eye with data present.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"participants", "OutcomeMeasureTimeFrame":"Day 120-180 from second eye implantation", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Multifocal IOL", "OutcomeGroupDescription":"AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Monofocal IOL", "OutcomeGroupDescription":"AcrySof® IQ Monofocal IOL Model SN60WF" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"153" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"160" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"None of the time", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"35" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"33" } ] } } ] } },{ "OutcomeClassTitle":"Some of the time", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"104" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"109" } ] } } ] } },{ "OutcomeClassTitle":"Most of the time", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"12" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"13" } ] } } ] } },{ "OutcomeClassTitle":"All of the time", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"5" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Near Spectacle Independence Using SILVER Patient Reported Outcome (PRO) Questionnaire at Day 120-180", "OutcomeMeasureDescription":"Near Spectacle Independence was rated using SILVER, a new patient reported outcome questionnaire. The participant was asked, \"How often do you wear eyeglasses or contact lenses for seeing objects up close?\"", "OutcomeMeasurePopulationDescription":"This analysis population includes all participants with successful IOL implantation in at least 1 eye with data present.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"participants", "OutcomeMeasureTimeFrame":"Day 120-180 from second eye implantation", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Multifocal IOL", "OutcomeGroupDescription":"AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Monofocal IOL", "OutcomeGroupDescription":"AcrySof® IQ Monofocal IOL Model SN60WF" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"153" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"160" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"None of the time", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"25" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"19" } ] } } ] } },{ "OutcomeClassTitle":"Some of the time", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"70" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"53" } ] } } ] } },{ "OutcomeClassTitle":"Most of the time", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"34" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"40" } ] } } ] } },{ "OutcomeClassTitle":"All of the time", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"24" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"48" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Photopic Contrast Sensitivity With Glare at Day 120-180", "OutcomeMeasureDescription":"Contrast sensitivity was assessed binocularly with the participant's best spectacle correction under photopic (bright) conditions at a distance of 8 feet at spatial frequencies of 3, 6, 12, and 18 cycles per degree (cpd) using the Vector Vision CSV 1000 with a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Scores of (-1) were set to missing; hence, the mean measures may be overestimated and the variability measures may be underestimated. A higher numeric value represents better contrast sensitivity.", "OutcomeMeasurePopulationDescription":"The analysis population includes all participants with successful IOL implantation that had at least 1 postoperative visit, had no preoperative pathology or macular degeneration, and had no major protocol deviations at any time. Here n=number of participants with data for analysis.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"logMAR", "OutcomeMeasureTimeFrame":"Day 120-180 from second eye implantation", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Multifocal IOL", "OutcomeGroupDescription":"AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Monofocal IOL", "OutcomeGroupDescription":"AcrySof® IQ Monofocal IOL Model SN60WF" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"133" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"137" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"3 cpd (n=130,131)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.608", "OutcomeMeasurementSpread":"0.307" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1.692", "OutcomeMeasurementSpread":"0.274" } ] } } ] } },{ "OutcomeClassTitle":"6 cpd (n=117,125)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.684", "OutcomeMeasurementSpread":"0.316" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1.844", "OutcomeMeasurementSpread":"0.309" } ] } } ] } },{ "OutcomeClassTitle":"12 cpd (n=117,127)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.334", "OutcomeMeasurementSpread":"0.321" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1.475", "OutcomeMeasurementSpread":"0.336" } ] } } ] } },{ "OutcomeClassTitle":"18 cpd (n=119,128)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.914", "OutcomeMeasurementSpread":"0.333" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1.043", "OutcomeMeasurementSpread":"0.361" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Mesopic Contrast Sensitivity Without Glare at Day 120-180", "OutcomeMeasureDescription":"Contrast sensitivity was assessed binocularly with the participant's best spectacle correction under mesopic (dim lighting) conditions at a distance of 8 feet at spatial frequencies of 1.5, 3, 6, and 12 cycles per degree (cpd) using the Vector Vision CSV 1000 without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Scores of (-1) were set to missing; hence, the mean measures may be overestimated and the variability measures may be underestimated. A higher numeric value represents better contrast sensitivity.", "OutcomeMeasurePopulationDescription":"The analysis population includes all participants with successful IOL implantation that had at least 1 postoperative visit, had no preoperative pathology or macular degeneration, and had no major protocol deviations at any time. Here n=number of participants with data for analysis.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"logMAR", "OutcomeMeasureTimeFrame":"Day 120-180 from second eye implantation", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Multifocal IOL", "OutcomeGroupDescription":"AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Monofocal IOL", "OutcomeGroupDescription":"AcrySof® IQ Monofocal IOL Model SN60WF" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"133" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"137" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"1.5 cpd (n=128,131)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.594", "OutcomeMeasurementSpread":"0.224" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1.622", "OutcomeMeasurementSpread":"0.204" } ] } } ] } },{ "OutcomeClassTitle":"3 cpd (n=131,132)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.563", "OutcomeMeasurementSpread":"0.267" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1.618", "OutcomeMeasurementSpread":"0.226" } ] } } ] } },{ "OutcomeClassTitle":"6 cpd (n=122,130)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.581", "OutcomeMeasurementSpread":"0.296" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1.673", "OutcomeMeasurementSpread":"0.275" } ] } } ] } },{ "OutcomeClassTitle":"12 cpd (n=102,112)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.077", "OutcomeMeasurementSpread":"0.363" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1.208", "OutcomeMeasurementSpread":"0.345" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Mesopic Contrast Sensitivity With Glare at Day 120-180", "OutcomeMeasureDescription":"Contrast sensitivity was assessed binocularly with the participant's best spectacle correction under mesopic conditions at a distance of 8 feet at spatial frequencies of 1.5, 3, 6, and 12 cpd using the Vector Vision CSV 1000 with a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Scores of (-1) were set to missing; hence, the mean measures may be overestimated and the variability measures may be underestimated. A higher numeric value represents better contrast sensitivity.", "OutcomeMeasurePopulationDescription":"The analysis population includes all participants with successful IOL implantation that had at least 1 postoperative visit, had no preoperative pathology or macular degeneration, and had no major protocol deviations at any time. Here n=number of participants with data for analysis.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"logMAR", "OutcomeMeasureTimeFrame":"Day 120-180 from second eye implantation", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Multifocal IOL", "OutcomeGroupDescription":"AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Monofocal IOL", "OutcomeGroupDescription":"AcrySof® IQ Monofocal IOL Model SN60WF" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"133" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"137" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"1.5 cpd (n=127,129)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.536", "OutcomeMeasurementSpread":"0.237" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1.596", "OutcomeMeasurementSpread":"0.238" } ] } } ] } },{ "OutcomeClassTitle":"3 cpd (n=128,130)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.542", "OutcomeMeasurementSpread":"0.292" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1.600", "OutcomeMeasurementSpread":"0.296" } ] } } ] } },{ "OutcomeClassTitle":"6 cpd (n=114,126)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.543", "OutcomeMeasurementSpread":"0.329" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1.617", "OutcomeMeasurementSpread":"0.277" } ] } } ] } },{ "OutcomeClassTitle":"12 cpd (n=90,105)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.043", "OutcomeMeasurementSpread":"0.385" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1.153", "OutcomeMeasurementSpread":"0.375" } ] } } ] } } ] } } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"5", "EventsTimeFrame":"Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012).", "EventsDescription":"An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. \"At Risk\" population for ocular AEs is included with unit of \"eyes.\"", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"Pre-Treatment", "EventGroupDescription":"All enrolled participants", "EventGroupSeriousNumAffected":"1", "EventGroupSeriousNumAtRisk":"409", "EventGroupOtherNumAffected":"0", "EventGroupOtherNumAtRisk":"409" },{ "EventGroupId":"EG001", "EventGroupTitle":"Multifocal IOL", "EventGroupDescription":"All participants with attempted IOL implantation in at least one eye (successful or aborted after contact with the eye), AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]", "EventGroupSeriousNumAffected":"10", "EventGroupSeriousNumAtRisk":"155", "EventGroupOtherNumAffected":"0", "EventGroupOtherNumAtRisk":"155" },{ "EventGroupId":"EG002", "EventGroupTitle":"Monofocal IOL", "EventGroupDescription":"All participants with 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