Ignite Creation Date:
2025-12-24 @ 2:50 PM
Ignite Modification Date:
2025-12-26 @ 1:49 PM
Study NCT ID:
NCT00792259
Status:
COMPLETED
Last Update Posted:
2022-06-28
First Post:
2008-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Topcon 3D OCT-1000 Optical Coherence Tomography System
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005901', 'term': 'Glaucoma'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'RGIBSON@TOPCON.COM', 'phone': '(201) 599-5121', 'title': 'Bob Gibson', 'organization': 'Topcon Medical Systems'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 hour', 'eventGroups': [{'id': 'EG000', 'title': 'Retinal Disease Eyes', 'description': 'Retinal Disease subjects with ocular pathology', 'otherNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Normal Subjects', 'description': 'Normal subjects with no known ocular pathology', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Glaucoma Subjects', 'description': 'Subjects presented with glaucoma', 'otherNumAtRisk': 13, 'otherNumAffected': 0, 'seriousNumAtRisk': 13, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Precision and Agreement Between the Topcon 3D OCT 1000 and the Identified Predicate Device', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal Subjects', 'description': 'Normal subjects with no known ocular pathology'}, {'id': 'OG001', 'title': 'Retinal Disease Eyes', 'description': 'Retinal Disease subjects with ocular pathology'}, {'id': 'OG002', 'title': 'Glaucoma Subjects', 'description': 'Subjects presented with glaucoma'}], 'classes': [{'title': 'Retinal Thickness ILM-IS/OS 3D OCT-1000', 'categories': [{'measurements': [{'value': '235.0', 'spread': '9.03', 'groupId': 'OG000'}, {'value': '236.1', 'spread': '48.06', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Subject group not observed for this measurement', 'groupId': 'OG002'}]}]}, {'title': 'Retinal Thickness ILM-IS/OS Stratus', 'categories': [{'measurements': [{'value': '236.0', 'spread': '12.54', 'groupId': 'OG000'}, {'value': '263.1', 'spread': '48.66', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Subject group not observed for this measurement', 'groupId': 'OG002'}]}]}, {'title': 'Retinal Thickness ILM-RPE 3D OCT-1000', 'categories': [{'measurements': [{'value': '252.8', 'spread': '7.68', 'groupId': 'OG000'}, {'value': '279.5', 'spread': '45.36', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Subject group not observed for this measurement', 'groupId': 'OG002'}]}]}, {'title': 'Retinal Thickness ILM-BM 3D OCT-1000', 'categories': [{'measurements': [{'value': '296.0', 'spread': '8.97', 'groupId': 'OG000'}, {'value': '318.5', 'spread': '41.90', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Subject group not observed for this measurement', 'groupId': 'OG002'}]}]}, {'title': 'RNFL Thickness 3D OCT-1000', 'categories': [{'measurements': [{'value': '107.4', 'spread': '10.50', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Subject group not observed for this measurement', 'groupId': 'OG001'}, {'value': '70.7', 'spread': '19.87', 'groupId': 'OG002'}]}]}, {'title': 'RNFL Thickness Stratus', 'categories': [{'measurements': [{'value': '105.9', 'spread': '9.98', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Subject group not observed for this measurement', 'groupId': 'OG001'}, {'value': '72.1', 'spread': '20.25', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 Minutes', 'description': 'The precision and agreement measures the thickness of RNFL and Full Retinal Thickness of the study device and is compared to the predicate device to show agreement.\n\nKeywords, ILM - Internal Limiting Membrane RPE - Retinal Pigment Epithelium RNFL - Retinal Nerve Fiber Layer', 'unitOfMeasure': 'µm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Retinal Disease Eyes', 'description': 'Retinal Disease subjects with ocular pathology'}, {'id': 'FG001', 'title': 'Normal Subjects', 'description': 'Normal subjects with no known ocular pathology'}, {'id': 'FG002', 'title': 'Glaucoma Subjects', 'description': 'Subjects presented with Glaucoma'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Poor Quality Scans', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '48', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Normal Subjects', 'description': 'Normal Subjects with no known ocular pathology'}, {'id': 'BG001', 'title': 'Retinal Disease Subjects', 'description': 'Retinal Disease subjects with ocular pathology'}, {'id': 'BG002', 'title': 'Glaucoma Subjects', 'description': 'Glaucoma subjects presented with pathology'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '33.45', 'spread': '10.36', 'groupId': 'BG000'}, {'value': '66.6', 'spread': '13.92', 'groupId': 'BG001'}, {'value': '59.1', 'spread': '17.63', 'groupId': 'BG002'}, {'value': '50.52', 'spread': '20.05', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '48', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': '20 Normal Subjects 15 Retinal Disease subjects 13 Glaucoma Subjects'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-06', 'studyFirstSubmitDate': '2008-11-14', 'resultsFirstSubmitDate': '2013-12-12', 'studyFirstSubmitQcDate': '2008-11-14', 'lastUpdatePostDateStruct': {'date': '2022-06-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-06-15', 'studyFirstPostDateStruct': {'date': '2008-11-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-06-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Precision and Agreement Between the Topcon 3D OCT 1000 and the Identified Predicate Device', 'timeFrame': '30 Minutes', 'description': 'The precision and agreement measures the thickness of RNFL and Full Retinal Thickness of the study device and is compared to the predicate device to show agreement.\n\nKeywords, ILM - Internal Limiting Membrane RPE - Retinal Pigment Epithelium RNFL - Retinal Nerve Fiber Layer'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Retinal Disease', 'Glaucoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical protocol is to perform a comparison of Retinal and Retinal Nerve Fiber Layer (RNFL) thickness measurements between the Topcon 3D-1000 and the identified predicate device. In addition, this protocol performs a comparison of the thickness measurement results from images collected and analyzed with the Zeiss Stratus OCT to images collected with the Zeiss Stratus OCT and imported into the Topcon 3D OCT-1000 StratusViewer for analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'ophthalmology practice', 'healthyVolunteers': True, 'eligibilityCriteria': 'Retinal Disease Study\n\nNo Retinal Disease:\n\nInclusion Criteria:\n\n* Male or female\n* Between 18 and 80 years of age\n* Either eye, but only one eye per subject will be enrolled\n* Topcon image quality factor ≥ 45 or Stratus signal strength ≥ 5.\n\nExclusion Criteria:\n\n* Any known ocular disease\n* Any systemic disease that could result in ocular manifestations such as hypertension, diabetes, heart disease, etc.\n* Topcon image quality factor ≤ 44 or Stratus signal strength \\< 5.\n\nRetinal Disease\n\nInclusion Criteria:\n\n* Male or female\n* Between 18 and 80 years of age\n* Either eye, but only one eye per subject will be enrolled\n* Symptoms consistent with one of the following retinal diseases: diabetic macular edema, cystoid macular edema, epiretinal membrane, macular hole, wet AMD and dry AMD for which OCT imaging is warranted. At lease one (1) case each of these diseases will be included in the study\n* A range of retinal thickness will be included\n* Topcon image quality factor ≥ 45 or Stratus signal strength ≥ 5.\n\nExclusion Criteria:\n\n* Presence of glaucoma\n* Topcon image quality factor ≤ 44 or Stratus signal strength \\< 5.'}, 'identificationModule': {'nctId': 'NCT00792259', 'briefTitle': 'Topcon 3D OCT-1000 Optical Coherence Tomography System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Topcon Corporation'}, 'officialTitle': 'Topcon 3D OCT-1000 Optical Coherence Tomography System for Measurements of Retinal and RNFL Thicknesses: Precision and Agreement Study', 'orgStudyIdInfo': {'id': 'Topcon 01'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Patients with Retinal Disease'}, {'label': '2', 'description': 'Patients without Retinal Disease'}, {'label': '3', 'description': 'Normal Subjects'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10708', 'city': 'Bronxville', 'state': 'New York', 'country': 'United States', 'facility': 'Retina Consultations', 'geoPoint': {'lat': 40.93815, 'lon': -73.83208}}, {'zip': '10003', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York Eye and Ear-Glaucoma Associates of New York', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10022', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Vitreous-Retina-Macula Consultants of NY', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10036', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'SUNY', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Topcon Medical Systems, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}