Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2026-02-24 @ 5:02 PM
Study NCT ID:
NCT02447120
Status:
COMPLETED
Last Update Posted:
2022-06-08
First Post:
2015-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Topcon 3D OCT-1 Maestro Reference Database Study II
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': 504}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-06', 'studyFirstSubmitDate': '2015-05-12', 'studyFirstSubmitQcDate': '2015-05-13', 'lastUpdatePostDateStruct': {'date': '2022-06-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-05-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retinal Thickness', 'timeFrame': '1 minute'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Volunteers with Healthy Eyes'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to collect OCT measurement data on normal healthy eyes in order to determine the reference limits for Topcon 3D OCT-1 Maestro based on the percentile points for 1%, 5%, 95%, and 99%.', 'detailedDescription': 'The objective of this study is to collect OCT measurement data on normal healthy eyes in order to determine the reference limits for Topcon 3D OCT-1 Maestro based on the percentile points for 1%, 5%, 95%, and 99%.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects without eye disease', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria for Normal Group\n\n1. Subjects 18 years of age or older on the date of informed consent\n2. Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent\n3. Subjects presenting at the site with normal eyes (eyes without pathology)\n4. lOP \\<= 21 mmHg bilaterally\n5. BCVA 20/40 or better (each eye)\n6. Both eyes must be free of eye disease\n\nExclusion Criteria for Normal Group\n\n1. Subjects previously enrolled in either the Maestro AP study or the Maestro2 study\n2. Subjects unable to tolerate ophthalmic imaging\n3. Subject with ocular media not sufficiently clear to obtain acceptable OCT images\n4. HFA visual field (24-2 Sita Standard, white on white) result unreliable (based on manufacturer\'s recommendation), defined as fixation losses \\> 20% or false positives\\> 33%, or false negatives\\> 33%\n5. Visual field defects consistent with glaucomatous optic nerve damage based on with at least one of the following two findings:\n\n * On pattern deviation (PD), there exists a cluster of 3 or more points in an expected location of the visual field depressed below the 5% level, at least 1 of which is depressed below the 1% level;\n * Glaucoma hemi-field test "outside normal limits."\n6. Presence of any ocular pathology except for cataract\n7. Narrow angle\n8. History of leukemia, dementia or multiple sclerosis\n9. Concomitant use of hydroxychloroquine and chloroquine'}, 'identificationModule': {'nctId': 'NCT02447120', 'briefTitle': 'Topcon 3D OCT-1 Maestro Reference Database Study II', 'organization': {'class': 'INDUSTRY', 'fullName': 'Topcon Corporation'}, 'officialTitle': 'Topcon 3D OCT-1 Maestro Reference Database Study II', 'orgStudyIdInfo': {'id': 'Maestro_NDB_II'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Normal Eyes', 'description': 'Subjects with no known ocular diseases will be scanned with the Maestro device', 'interventionNames': ['Device: 3D OCT-1 Maestro']}], 'interventions': [{'name': '3D OCT-1 Maestro', 'type': 'DEVICE', 'description': 'OCT machines used for diagnostic purposes', 'armGroupLabels': ['Normal Eyes']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'UAB School of Optometry', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '92831', 'city': 'Fullerton', 'state': 'California', 'country': 'United States', 'facility': 'Southern California College of Optometry', 'geoPoint': {'lat': 33.87029, 'lon': -117.92534}}, {'zip': '94550', 'city': 'Livermore', 'state': 'California', 'country': 'United States', 'facility': 'Valley Eyecare Center', 'geoPoint': {'lat': 37.68187, 'lon': -121.76801}}, {'zip': '91716', 'city': 'Pomona', 'state': 'California', 'country': 'United States', 'facility': 'Western University of Health Sciences', 'geoPoint': {'lat': 34.05529, 'lon': -117.75228}}, {'zip': '60616', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Illinois College of Optometry', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '11425', 'city': 'Jamaica', 'state': 'New York', 'country': 'United States', 'facility': 'New York VA', 'geoPoint': {'lat': 40.69149, 'lon': -73.80569}}, {'zip': '10036', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'SUNY College of Optometry', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Charles Reisman, MS', 'role': 'STUDY_CHAIR', 'affiliation': 'Topcon Corporation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Topcon Medical Systems, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}