Ignite Creation Date:
2025-12-25 @ 5:09 AM
Ignite Modification Date:
2026-03-26 @ 5:55 AM
Study NCT ID:
NCT02991027
Status:
WITHDRAWN
Last Update Posted:
2021-12-16
First Post:
2016-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
OCT Image Quality Performance Evaluation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'No subjects needed for enrollment anymore', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2016-12-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2017-07-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-10', 'studyFirstSubmitDate': '2016-12-09', 'studyFirstSubmitQcDate': '2016-12-09', 'lastUpdatePostDateStruct': {'date': '2021-12-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'OCT image quality', 'timeFrame': '5 minutes'}, {'measure': 'OCT angiography image quality', 'timeFrame': '5 minutes'}], 'secondaryOutcomes': [{'measure': 'Full Retinal Thickness', 'timeFrame': '5 minutes'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['no known ocular pathology'], 'conditions': ['Healthy Eyes']}, 'descriptionModule': {'briefSummary': "To evaluate the image qualities and segmentation performance of Topcon's DRI OCT Triton devices using two light sources.", 'detailedDescription': "To evaluate the image qualities and segmentation performance of Topcon's DRI OCT Triton devices using two light sources with equivalent specifications: the micro-electro-mechanical short cavity tunable laser and the micro-electro-mechanical tunable vertical cavity surface emitting laser."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria\n\n1. Participants must be at least 18 years of age\n2. They must be able to complete all testing (all OCT scans)\n3. They must volunteer to be in the study and sign the consent form\n\nExclusion Criteria\n\n1. Subject with history of ocular disease or ocular pathology\n2. Subjects unable to complete all OCT imaging modes'}, 'identificationModule': {'nctId': 'NCT02991027', 'briefTitle': 'OCT Image Quality Performance Evaluation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Topcon Corporation'}, 'officialTitle': 'OCT Image Quality Performance Evaluation', 'orgStudyIdInfo': {'id': 'Topcon Tabil-801-2016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Subjects Presenting With Normal Eyes', 'description': 'Subjects with no known ocular diseases will be imaged using 2 different light sources using the DRI Triton', 'interventionNames': ['Device: DRI OCT Triton']}], 'interventions': [{'name': 'DRI OCT Triton', 'type': 'DEVICE', 'description': 'DRI OCT Triton using micro-electro-mechanical short cavity tunable laser', 'armGroupLabels': ['Subjects Presenting With Normal Eyes']}, {'name': 'DRI OCT Triton', 'type': 'DEVICE', 'description': 'DRI OCT Triton using micro-electro-mechanical tunable vertical cavity surface emitting laser', 'armGroupLabels': ['Subjects Presenting With Normal Eyes']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07436', 'city': 'Oakland', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Topcon Medical Systems Inc.', 'geoPoint': {'lat': 41.01315, 'lon': -74.26431}}], 'overallOfficials': [{'name': 'Zhenguo Wang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Topcon Corporation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Topcon Medical Systems, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}