Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2026-01-01 @ 7:04 PM
Study NCT ID:
NCT06846151
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-02-25
First Post:
2025-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retinal Investigation Using Optos OCT Device
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D012174', 'term': 'Retinitis Pigmentosa'}, {'id': 'D003930', 'term': 'Diabetic Retinopathy'}], 'ancestors': [{'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D015785', 'term': 'Eye Diseases, Hereditary'}, {'id': 'D058499', 'term': 'Retinal Dystrophies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003925', 'term': 'Diabetic Angiopathies'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'all participants receive a single intervention at a single point in time'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-20', 'studyFirstSubmitDate': '2025-02-13', 'studyFirstSubmitQcDate': '2025-02-20', 'lastUpdatePostDateStruct': {'date': '2025-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'OCT physical response data', 'timeFrame': '6 months from recruitment start', 'description': 'Response data per participant will be collected and analyzed'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['AMD - Age-Related Macular Degeneration', 'Retinitis Pigmentosa (RP)', 'Diabetic Retinopathy', 'Control Patients']}, 'descriptionModule': {'briefSummary': 'Retinal investigation using OCT with control and diseased eyes'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female participants 18 years of age or older who have full legal capacity to volunteer on the date the informed consent is signed.\n2. Participants who understand the study and patient information sheet and can follow the instructions.\n3. Participants who agree to participate in the study.\n4. Control group where no retinal abnormalities were detected as part of the standard basic ophthalmic examination.\n5. Participants with retinal disease in at least one eye including: Early dry age-related macular degeneration, late stage dry age-related macular degeneration specifically geographic atrophy, Wet age-related macular degeneration, Retinitis pigmentosa, Diabetic retinopathy and other macular atrophic diseases\n\nExclusion Criteria:\n\n1. Inability to understand written and verbal English sufficiently to comprehend the study and provide informed consent\n2. Ophthalmic disease other than condition under investigation.\n3. Participants unable to tolerate ophthalmic imaging.\n4. Cataract (unless deemed mild in the opinion of the investigator)\n5. Participants with significant ocular media not sufficiently clear to obtain acceptable OCT images.\n6. Diabetes (unless part of the diabetic eye disease group)\n7. Binocular visual acuity worse than 6/18\n8. Strabismus (squint)\n9. Age related macular degeneration groups: polypoidal choroidal vasculopathy\n10. Participants with photo sensitivity epilepsy, experience of seizures, or sensitivity to flickering light (based on self-report)\n11. Pregnant'}, 'identificationModule': {'nctId': 'NCT06846151', 'briefTitle': 'Retinal Investigation Using Optos OCT Device', 'organization': {'class': 'INDUSTRY', 'fullName': 'Optos, PLC'}, 'officialTitle': 'Clinical Investigation of Optos OCT in Patients with Retinal Pathologies', 'orgStudyIdInfo': {'id': 'OPT1105'}, 'secondaryIdInfos': [{'id': 'REC ref: 25/NS/0018', 'type': 'OTHER', 'domain': 'The North of Scotland Research Ethics Committee'}, {'id': 'IRAS Project ID: 338297', 'type': 'OTHER', 'domain': 'Integrated Research Application System'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'standard imaging process', 'description': 'All participants will undergo the same imaging', 'interventionNames': ['Device: retinal functional imaging']}], 'interventions': [{'name': 'retinal functional imaging', 'type': 'DEVICE', 'otherNames': ['OCT'], 'description': 'this is a proof of concept study', 'armGroupLabels': ['standard imaging process']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Optos, PLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}