Ignite Creation Date:
2025-12-24 @ 5:31 PM
Ignite Modification Date:
2025-12-28 @ 3:57 PM
Study NCT ID:
NCT02921568
Status:
UNKNOWN
Last Update Posted:
2017-03-14
First Post:
2016-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Side-by-Side Comparison of P200TE and Spectral OCT/SLO on Diseased Eyes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'lastUpdateSubmitDate': '2017-03-13', 'studyFirstSubmitDate': '2016-09-16', 'studyFirstSubmitQcDate': '2016-09-30', 'lastUpdatePostDateStruct': {'date': '2017-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'retinal thickness', 'timeFrame': 'completion of the study, up to 5 years'}, {'measure': 'Retinal Nerve Fibre Layer Thickness', 'timeFrame': 'completion of the study, up to 5 years'}, {'measure': 'Optic Nerve Head Topography', 'timeFrame': 'completion of the study, up to 5 years'}, {'measure': 'Cup/Disc Ratio', 'timeFrame': 'completion of the study, up to 5 years'}]}, 'conditionsModule': {'conditions': ['Retinal Disease', 'Glaucoma']}, 'descriptionModule': {'briefSummary': 'This study is designed to evaluate and compare in-tissue performance of OCT scans on the new Optos P200TE, versus the predicate Optos Spectral OCT/SLO device.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female subjects 18 years of age or older who have full legal capacity to volunteer;\n2. Subjects who have signed the informed consent;\n3. Subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination date;\n4. Subjects who agree to participate in the study;\n5. Subjects with current BSCVA 20/400 or better in the ocular disease study eye(s);\n6. Subjects diagnosed with ocular disease including but not limited to: Macular Degeneration, Diabetic Macular Edema, Diabetic Retinopathy, Central Serous Retinopathy, Macular Hole, Epiretinal Membrane, Macular Edema, Glaucoma, and others in the retinal disease study eye(s) as confirmed at the study visit or within the past six (6) months.\n\nExclusion Criteria:\n\n1. Subjects unable to tolerate ophthalmic imaging;\n2. Subjects with ocular media not sufficiently clear to obtain acceptable OCT images;\n3. Subjects without ocular disease in study eye(s), as determined by self-report and/or investigator assessment at the study visit;\n4. Subjects with history of leukemia, dementia or multiple sclerosis.'}, 'identificationModule': {'nctId': 'NCT02921568', 'briefTitle': 'Side-by-Side Comparison of P200TE and Spectral OCT/SLO on Diseased Eyes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Optos, PLC'}, 'officialTitle': 'Side-by-Side Comparison of P200TE and Spectral OCT/SLO on Diseased Eyes', 'orgStudyIdInfo': {'id': 'OPT1018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'All patients', 'description': 'All patients will be imaged on the P200TE and Spectral OCT/SLO devices.', 'interventionNames': ['Device: P200TE', 'Device: Spectral OCT/SLO']}], 'interventions': [{'name': 'P200TE', 'type': 'DEVICE', 'description': 'Optical Coherence Tomography and Scanning Laser Ophthalmoscope device.', 'armGroupLabels': ['All patients']}, {'name': 'Spectral OCT/SLO', 'type': 'DEVICE', 'description': 'Optical Coherence Tomography and Scanning Laser Ophthalmoscope device.', 'armGroupLabels': ['All patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78240', 'city': 'San Antonio', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Cathy Ellis, BS, MT', 'role': 'CONTACT', 'email': 'cathy@mcoaeyecare.com', 'phone': '210-697-2036', 'phoneExt': '2270'}, {'name': 'Michael Singer, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Darren J Bell, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'James Burns, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Richard Evans, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Medical Center Ophthalmology Associates', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Optos, PLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Optos, Inc.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}