Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2026-03-06 @ 4:14 PM
Study NCT ID:
NCT02447133
Status:
COMPLETED
Last Update Posted:
2022-06-29
First Post:
2015-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
TopQ Cut-off Score Validation Study for 3D OCT-1 Maestro
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'CREISMAN@topcon.com', 'phone': '201-599-5283', 'title': 'Charles Reisman', 'organization': 'Topcon'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Subjects Presenting With Normal Eyes', 'description': 'Subjects with no known ocular diseases will be scanned on the Maestro device\n\n3D OCT-1 Maestro: OCT Machine used for diagnostic purposes', 'otherNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'TopQ Cut Off', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '12x9 Wide Scan', 'description': 'TopQ of 12x9 Wide Scan'}, {'id': 'OG001', 'title': '6x6 Macula Scan', 'description': 'TopQ of 6x6 Macular Scan'}, {'id': 'OG002', 'title': '6x6 Disc Scan', 'description': 'TopQ of 6x6 Disc Scan'}], 'classes': [{'title': 'Standard Deviation Above Threshold', 'categories': [{'measurements': [{'value': '2.94', 'groupId': 'OG000'}, {'value': '1.5', 'groupId': 'OG001'}, {'value': '2.14', 'groupId': 'OG002'}]}]}, {'title': 'Standard Deviation Below Threshold', 'categories': [{'measurements': [{'value': '17.54', 'groupId': 'OG000'}, {'value': '13.67', 'groupId': 'OG001'}, {'value': '13.67', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 hour', 'description': 'To validate the values of the predetermined TopQ score by showing the variability above and below the TopQ score of 25 for 12x9 Wide, 28 for 6x6 Macula, and 30 for 6x6 Disc scans.', 'unitOfMeasure': 'microns', 'reportingStatus': 'POSTED', 'populationDescription': 'use of 12 subjects for 3 different scan patterns'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Subjects Presenting With Normal Eyes', 'description': 'Subjects with no known ocular diseases will be scanned on the Maestro device\n\n3D OCT-1 Maestro: OCT Machine used for diagnostic purposes'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Subjects Presenting With Normal Eyes', 'description': 'Subjects with no known ocular diseases will be scanned on the Maestro device\n\n3D OCT-1 Maestro: OCT Machine used for diagnostic purposes'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.17', 'spread': '13.48', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Normal healthy eyes without any known eye conditions'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-06', 'studyFirstSubmitDate': '2015-05-11', 'resultsFirstSubmitDate': '2016-07-14', 'studyFirstSubmitQcDate': '2015-05-13', 'lastUpdatePostDateStruct': {'date': '2022-06-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-12-05', 'studyFirstPostDateStruct': {'date': '2015-05-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-01-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'TopQ Cut Off', 'timeFrame': '1 hour', 'description': 'To validate the values of the predetermined TopQ score by showing the variability above and below the TopQ score of 25 for 12x9 Wide, 28 for 6x6 Macula, and 30 for 6x6 Disc scans.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['no known ocular pathology'], 'conditions': ['Subjects Presenting With Normal Eyes']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to validate the TopQ cutoff scores, which have been previously determined.', 'detailedDescription': 'Scans with a TopQ score below the optimum cut-off should be considered to be poor or unacceptable quality, and scans with a TopQ score above the cut-off should be considered good or acceptable quality. The study will evaluate the predetermined cut-off values by investigating measurement variability of scans.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects with no known eye disease', '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. TopQ score from baseline OCT scan (i.e., without any ND filters) is below the cut-off value.'}, 'identificationModule': {'nctId': 'NCT02447133', 'briefTitle': 'TopQ Cut-off Score Validation Study for 3D OCT-1 Maestro', 'organization': {'class': 'INDUSTRY', 'fullName': 'Topcon Corporation'}, 'officialTitle': 'TopQ Cut-off Score Validation Study for 3D OCT-1 Maestro', 'orgStudyIdInfo': {'id': 'Topcon 001-2015'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Subjects Presenting With Normal Eyes', 'description': 'Subjects with no known ocular diseases will be scanned on the Maestro device', 'interventionNames': ['Device: 3D OCT-1 Maestro']}], 'interventions': [{'name': '3D OCT-1 Maestro', 'type': 'DEVICE', 'description': 'OCT Machine used for diagnostic purposes', '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': 'Randy Sun, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Topcon Corporation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Topcon Medical Systems, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}