{
  "FullStudy":{
    "Rank":217646,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01518686",
          "OrgStudyIdInfo":{
            "OrgStudyId":"217/2006 local review board"
          },
          "Organization":{
            "OrgFullName":"University Hospital Tuebingen",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Age-related Normative Values for the Octopus 900 Perimeter",
          "OfficialTitle":"Normal Values for the Full Visual Field, Corrected for Age- and Reaction Time, Using Semi-automated Kinetic Testing on the Octopus 900 Perimeter",
          "Acronym":"Norm-Oct900"
        },
        "StatusModule":{
          "StatusVerifiedDate":"December 2013",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"June 2006"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"March 2008",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"September 2008",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 12, 2012",
          "StudyFirstSubmitQCDate":"January 25, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 26, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"December 10, 2013",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"December 11, 2013",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Ulrich Schiefer",
            "ResponsiblePartyInvestigatorTitle":"Prof. Dr. med Ulrich Schiefer",
            "ResponsiblePartyInvestigatorAffiliation":"University Hospital Tuebingen"
          },
          "LeadSponsor":{
            "LeadSponsorName":"University Hospital Tuebingen",
            "LeadSponsorClass":"OTHER"
          },
          "CollaboratorList":{
            "Collaborator":[
              {
                "CollaboratorName":"Haag-Streit AG",
                "CollaboratorClass":"INDUSTRY"
              }
            ]
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"The purpose of this study is to determine normal values of the visual field (VF), corrected for age- and reaction time (RT) using the Octopus 900 perimeter and semi-automated kinetic perimetry (SKP)."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Healthy"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Norm values",
              "semi-automated kinetic perimetry",
              "isopters",
              "mathematical model",
              "luminance",
              "test-retest reliability",
              "deviation",
              "age dependance",
              "different age groups",
              "Healthy subjects"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Not Applicable"
            ]
          },
          "DesignInfo":{
            "DesignInterventionModel":"Single Group Assignment",
            "DesignPrimaryPurpose":"Diagnostic",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"86",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"one arm",
                "ArmGroupType":"No Intervention",
                "ArmGroupDescription":"observational study, no cohort, single group of different ages",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Device: Octopus 900 perimeter (Haag Streit AG, Koeniz, Switzerland)"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Device",
                "InterventionName":"Octopus 900 perimeter (Haag Streit AG, Koeniz, Switzerland)",
                "InterventionDescription":"We used the following six combinations of Goldmann8,1 stimulus size, stimulus luminance and angular velocity: V4e (64mm², 103', 320cd/m²) at 5°/s, III4e (4mm², 25.7', 320cd/m²) at 5°/s, I4e (0.25mm², 6.45', 320cd/m²) at 2°/s (for the assessment of the blind spot), I3e (0.25mm², 6.45', 100cd/m²) at 5°/s, I2e (0.25mm², 6.45', 32cd/m²) at 3°/s, I1e (0.25mm², 6.45', 10cd/m²) at 3°/s, I1a (0.25mm², 6.45', 4cd/m²) at 2°/s .\n\nThe peripheral five isopters, consisting of 24 vectors (every 15° meridian), were presented in random order, while the innermost isopter (I1a) consisted of 12 vectors (every 30° meridian)",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "one arm"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Measurement of the full Visual Field using semi-automated kinetic perimetry.",
                "PrimaryOutcomeDescription":"additional a subgroup of 14 participants were tested at 3 separate sessions within 4 weeks.",
                "PrimaryOutcomeTimeFrame":"one day"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nmaximum spherical ametropia ± 6 Diopters (D)\nmaximum cylindrical ametropia ± 2 D\ndistant visual acuity ≥ 1.0 logMAR [20/20] for subjects up to 60 years, ≥ 0.8 logMAR [20/25] for subjects from 61-70 years, ≥ 0.63 logMAR [20/30] for subjects older than 70 years\nisocoria, pupil diameter > 3mm\nintraocular pressure (air pulse tonometer) ≤ 21mmHg\nnormal anterior segments\nocular fundus: normal appearance of the cup to disc ratio (CDR) ≤ 0.5, interocular difference of CDR < 0.3\nnormal macular region, vessels, and peripheral retinal examination (with undilated pupils).\n\nExclusion Criteria:\n\namblyopia\nstrabismus\nocular motility disorder\ndiseases of the retina\nglaucoma, glaucoma suspect\nmacular degeneration\nIOP > 21 mmHg\nabnormal color vision test (ISPP - Ishihara and Standard Pseudoisochromatic Plates = SPP)\nhistory or findings of other neuro-ophthalmological disease\nrelevant opacities of the central refractive media (cornea, lens, vitreous body)\nuse of miotic drugs\nintraocular surgery (except uncomplicated cataract surgery, more than three months previous to testing)\nkerato-refractive surgery (LASIK)\ndrugs influencing reaction time\ndrugs indicating severe general diseases (anti-diabetic pharmaceuticals and anti-hypertensive medication were allowed for subjects older than 70 years)\nmental diseases (for example psychosis)\npregnancy, nursing\nacute infections\nheavy smoking (>10 cigarettes /day)\nalcohol abuse\ndiabetic retinopathy\ncoronary heart disease\nstroke\nmigraine\nRaynaud's syndrome\nsuspected lack of compliance",
          "HealthyVolunteers":"Accepts Healthy Volunteers",
          "Gender":"All",
          "MinimumAge":"11 Years",
          "MaximumAge":"79 Years",
          "StdAgeList":{
            "StdAge":[
              "Child",
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Ulrich Schiefer, Prof. Dr. med.",
                "OverallOfficialAffiliation":"Centre for Ophthalmology / Institute for Ophthalmic Research, University of Tübingen, Germany",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Centre for Ophthalmology / Institute for Ophthalmic Research, University of Tübingen",
                "LocationCity":"Tübingen",
                "LocationState":"Baden-Württemberg",
                "LocationZip":"72076",
                "LocationCountry":"Germany"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        }
      }
    }
  }
}