Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2026-02-03 @ 1:41 AM
Study NCT ID:
NCT03107104
Status:
COMPLETED
Last Update Posted:
2022-06-08
First Post:
2017-03-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Triton Fundus Autofluorescence and Fluorescein Angiography
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': 47}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2017-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-06', 'studyFirstSubmitDate': '2017-03-30', 'studyFirstSubmitQcDate': '2017-04-04', 'lastUpdatePostDateStruct': {'date': '2022-06-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fundus autofluorescence image quality', 'timeFrame': '1 Minute', 'description': 'Comparison of DRI OCT Triton (plus) and TRC-50DX photographs'}, {'measure': 'Fluorescein angiography image quality at 120 seconds to 300 seconds after dye injection', 'timeFrame': '120 seconds to 300 seconds', 'description': 'Comparison of DRI OCT Triton (plus) and TRC-50DX photographs'}, {'measure': 'Fluorescein angiography image quality at greater than 300 seconds after dye injection', 'timeFrame': 'greater than 300 seconds', 'description': 'Comparison of DRI OCT Triton (plus) and TRC-50DX photographs'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Medical Need for Fluorescein Angiography Imaging']}, 'descriptionModule': {'briefSummary': 'Compare the image quality of the fundus autofluorescence and fluorescein angiography', 'detailedDescription': 'The objectives of this study are to:\n\n1. Compare the image quality of the fundus autofluorescence (FAF) photographs between DRI OCT Triton (plus) and TRC-50DX retinal camera.\n2. Compare the image quality of the fluorescein angiography (FA) photographs between DRI OCT Triton (plus) and TRC-50DX retinal camera.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects with medical need for FA imaging', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria\n\n1. Subjects must be at least 18 years of age\n2. Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent\n3. Subjects who consent to, via clinic's standard FA consent form, and will undergo dye injection for FA imaging at the clinic visit based on medical need\n\nExclusion Criteria\n\n1. Subjects unable to tolerate ophthalmic imaging\n2. Subjects with ocular media not sufficiently clear to obtain acceptable fundus images\n3. Patients with ocular motility dysfunction"}, 'identificationModule': {'nctId': 'NCT03107104', 'briefTitle': 'Triton Fundus Autofluorescence and Fluorescein Angiography', 'organization': {'class': 'INDUSTRY', 'fullName': 'Topcon Corporation'}, 'officialTitle': 'Topcon DRI OCT Triton (Plus) Fundus Autofluorescence and Fluorescein Angiography Image Quality Evaluation Study', 'orgStudyIdInfo': {'id': 'Triton FA FAF'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Medical need for FA imaging', 'description': 'Subjects deemed to have a medical need for FA imaging will be imaged on the Topcon DRI OCT Triton (plus) and TRC-50DX retinal camera', 'interventionNames': ['Device: Topcon DRI OCT Triton (plus)', 'Device: TRC-50DX retinal camera']}], 'interventions': [{'name': 'Topcon DRI OCT Triton (plus)', 'type': 'DEVICE', 'description': 'The Topcon DRI OCT Triton (plus) is an OCT with a fundus camera used for diagnostic purposes', 'armGroupLabels': ['Medical need for FA imaging']}, {'name': 'TRC-50DX retinal camera', 'type': 'DEVICE', 'description': 'The TRC-50DX retinal camera is a fundus camera used for diagnostic purposes', 'armGroupLabels': ['Medical need for FA imaging']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10022', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Vitreous Retina Macula Consultants of New York', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Charles Riesman, MS', 'role': 'STUDY_CHAIR', 'affiliation': 'Topcon Corporation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Topcon Medical Systems, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}