{
  "FullStudy":{
    "Rank":218278,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01510392",
          "OrgStudyIdInfo":{
            "OrgStudyId":"OHSU IRB#00008034-Outreach"
          },
          "Organization":{
            "OrgFullName":"Oregon Health and Science University",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"CEI Van Outreach Screening Study",
          "OfficialTitle":"Prospective Evaluation of Optical Coherence Tomography Usage in the Screening of Eye Diseases"
        },
        "StatusModule":{
          "StatusVerifiedDate":"April 2018",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"January 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"February 2, 2017",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"February 2, 2017",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 3, 2012",
          "StudyFirstSubmitQCDate":"January 11, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 16, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"April 10, 2018",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"April 12, 2018",
            "LastUpdatePostDateType":"Actual"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"David Huang",
            "ResponsiblePartyInvestigatorTitle":"Michael Chiang, MD, Professor, Provisional, Department of Ophthalmology and Medical Informatics & Clinical Epidemiology",
            "ResponsiblePartyInvestigatorAffiliation":"Oregon Health and Science University"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Oregon Health and Science University",
            "LeadSponsorClass":"OTHER"
          },
          "CollaboratorList":{
            "Collaborator":[
              {
                "CollaboratorName":"National Eye Institute (NEI)",
                "CollaboratorClass":"NIH"
              }
            ]
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes"
        },
        "DescriptionModule":{
          "BriefSummary":"The primary goal of the trial is to show that optical coherence tomography (OCT) technology can be used to effectively screen for diseases of the eye including glaucoma, macular diseases and keratoconus. Glaucoma is a disease that causes permanent vision loss and is usually accompanied by increased eye pressure. Macular diseases affect sharp, central vision. Keratoconus is a disease that affects the cornea (clear surface covering the colored part of the eye).",
          "DetailedDescription":"The identification of many eye diseases would significantly benefit from earlier detection than is available with typical eye exams. Optical coherence tomography (OCT) is an imaging technology that can perform non-contact cross-sectional imaging of tissue structure in real time. It is similar to ultrasound B-mode imaging, except that OCT measures the intensity of reflected light rather than sound waves."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Glaucoma",
              "Macular Disease",
              "Keratoconus"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Optical coherence tomography",
              "Glaucoma",
              "Macula",
              "Keratoconus",
              "Screening"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Observational",
          "DesignInfo":{
            "DesignObservationalModelList":{
              "DesignObservationalModel":[
                "Other"
              ]
            },
            "DesignTimePerspectiveList":{
              "DesignTimePerspective":[
                "Prospective"
              ]
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"118",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Device",
                "InterventionName":"OCT imaging, the FDA Cleared iVue",
                "InterventionDescription":"The OCT system scans a beam of light across the eye to take a picture. OCT imaging does not touch the eye. This is a test that is performed using an FDA approved system, and is regularly used to take pictures of the back of the eye."
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"OCT screening efficacy for detection of early stage eye diseases in comparison to the current standard of care methods",
                "PrimaryOutcomeDescription":"The primary goal of the trial is to show that OCT technology, specifically the FDA cleared iVue, can be used to effectively screen for glaucoma, macular diseases and keratoconus. The rate of detection of these diseases detected using OCT will be compared to the rate of detection by the physician's exam.",
                "PrimaryOutcomeTimeFrame":"1 year"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nParticipant undergoing a screening examination at the Casey Eye Institute Outreach Van.\nParticipants must be between the ages of 18 and 89 years old.\n\nExclusion Criteria:\n\nInability to give informed consent.\nInability to maintain stable fixation for OCT imaging",
          "HealthyVolunteers":"Accepts Healthy Volunteers",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "MaximumAge":"89 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          },
          "StudyPopulation":"This study will be performed enrolling participants from the Casey Eye Institute outreach van.",
          "SamplingMethod":"Non-Probability Sample"
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Michael Chiang, MD",
                "OverallOfficialAffiliation":"Oregon Health and Science University",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Casey Eye Institute Outreach Screening Van",
                "LocationCity":"Portland",
                "LocationState":"Oregon",
                "LocationZip":"97239",
                "LocationCountry":"United States"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000005901",
                "ConditionMeshTerm":"Glaucoma"
              },{
                "ConditionMeshId":"D000007640",
                "ConditionMeshTerm":"Keratoconus"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000009798",
                "ConditionAncestorTerm":"Ocular Hypertension"
              },{
                "ConditionAncestorId":"D000005128",
                "ConditionAncestorTerm":"Eye Diseases"
              },{
                "ConditionAncestorId":"D000003316",
                "ConditionAncestorTerm":"Corneal Diseases"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M6854",
                "ConditionBrowseLeafName":"Eye Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M7596",
                "ConditionBrowseLeafName":"Glaucoma",
                "ConditionBrowseLeafAsFound":"Glaucoma",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M9249",
                "ConditionBrowseLeafName":"Keratoconus",
                "ConditionBrowseLeafAsFound":"Keratoconus",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M8607",
                "ConditionBrowseLeafName":"Hypertension",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M11314",
                "ConditionBrowseLeafName":"Ocular Hypertension",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M5122",
                "ConditionBrowseLeafName":"Corneal Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"T3231",
                "ConditionBrowseLeafName":"Keratoconus",
                "ConditionBrowseLeafAsFound":"Keratoconus",
                "ConditionBrowseLeafRelevance":"high"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC11",
                "ConditionBrowseBranchName":"Eye Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"BC14",
                "ConditionBrowseBranchName":"Heart and Blood Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"Rare",
                "ConditionBrowseBranchName":"Rare Diseases"
              }
            ]
          }
        }
      }
    }
  }
}