Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2025-12-25 @ 5:27 PM
Study NCT ID:
NCT03887104
Status:
COMPLETED
Last Update Posted:
2019-09-03
First Post:
2019-03-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Data Collection of OCT and OCTA-based Ocular Measurements
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 482}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-30', 'studyFirstSubmitDate': '2019-03-11', 'studyFirstSubmitQcDate': '2019-03-20', 'lastUpdatePostDateStruct': {'date': '2019-09-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retinal thickness', 'timeFrame': 'Day 1', 'description': 'micrometers'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Eyes Without Ocular Pathology']}, 'descriptionModule': {'briefSummary': 'Data Collection of OCT and OCTA-based Ocular Measurements', 'detailedDescription': 'The purpose of this study is to collect measurements of anatomical structures of the posterior pole of the eye based on OCT scans in subjects without clinical signs of pathology.'}, 'eligibilityModule': {'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Persons having eyes without ocular pathology', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* No glaucoma\n* No retinal pathology\n* No systemic disorders impacting the eye\n* No ocular surgery or medical treatment of ocular condition\n\nExclusion Criteria:\n\n* High IOP\n* Poor vision\n* Clinical findings consistent with pathology\n* Unable to complete the study'}, 'identificationModule': {'nctId': 'NCT03887104', 'briefTitle': 'Data Collection of OCT and OCTA-based Ocular Measurements', 'organization': {'class': 'INDUSTRY', 'fullName': 'Optovue'}, 'officialTitle': 'Data Collection of OCT and OCTA-based Ocular Measurements', 'orgStudyIdInfo': {'id': '200-53771'}}, 'armsInterventionsModule': {'interventions': [{'name': 'SD-OCT', 'type': 'DEVICE', 'description': 'Spectral Domain Optical Coherence Tomography for non-invasive, light-based, cross-sectional imaging of ocular structures'}]}, 'contactsLocationsModule': {'locations': [{'zip': '91766', 'city': 'Pomona', 'state': 'California', 'country': 'United States', 'facility': 'Eye Care Center', 'geoPoint': {'lat': 34.05529, 'lon': -117.75228}}, {'zip': '33312', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Eye Care Institute', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '07103', 'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'facility': 'IOVS', 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}, {'zip': '43040', 'city': 'Marysville', 'state': 'Ohio', 'country': 'United States', 'facility': 'AMA Eye Physicians & Surgeons', 'geoPoint': {'lat': 40.23645, 'lon': -83.36714}}, {'zip': '74464', 'city': 'Tahlequah', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'College of Optometry', 'geoPoint': {'lat': 35.91537, 'lon': -94.96996}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Optovue', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}