Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2026-01-02 @ 12:45 AM
Study NCT ID:
NCT04499703
Status:
COMPLETED
Last Update Posted:
2021-02-18
First Post:
2020-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Retinal Health Monitoring System Thickness Module
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008269', 'term': 'Macular Edema'}, {'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D012170', 'term': 'Retinal Vein Occlusion'}], 'ancestors': [{'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D020246', 'term': 'Venous Thrombosis'}, {'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D041623', 'term': 'Tomography, Optical Coherence'}], 'ancestors': [{'id': 'D041622', 'term': 'Tomography, Optical'}, {'id': 'D061848', 'term': 'Optical Imaging'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D014054', 'term': 'Tomography'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-01-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-16', 'studyFirstSubmitDate': '2020-07-31', 'studyFirstSubmitQcDate': '2020-07-31', 'lastUpdatePostDateStruct': {'date': '2021-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of the RHMS-RTM retinal thickness measurements', 'timeFrame': '1 day', 'description': 'To evaluate the ability of the RHMS-RTM device to measure retinal thickness'}], 'secondaryOutcomes': [{'measure': 'Repeatability of RHMS-RTM retina thickness measurements', 'timeFrame': '1 day', 'description': 'To assess repeatability of the RHMS-RTM device'}, {'measure': 'Comparison of retinal thickness measurements between the RHMS-RTM and the SD-OCT', 'timeFrame': '1 day', 'description': 'To evaluate the agreement of measurements by the RHMS-RTM and SD-OCT'}, {'measure': 'Intraretinal and subretinal fluid detection', 'timeFrame': '1 day', 'description': 'To evaluate the feasibility of intra- and sub-retinal fluid detection'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Age-Related Macular Degeneration', 'macular edema', 'retinal vein occlusion', 'diabetic macular edema'], 'conditions': ['Macular Edema', 'Macular Degeneration']}, 'descriptionModule': {'briefSummary': 'Evaluate the ability and accuracy of the Retinal Health Monitoring System - Retinal Thickness Module (RHMS - RTM).', 'detailedDescription': 'Evaluation of the Retinal Health Monitoring System - Retinal Thickness Module in subjects with normal macular thickness and subjects with center-involving macular edema.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects aged ≥ 50 years old with normal macular thickness, center-involving macular edema due to wAMD, diabetic retinopathy or retinal vein occlusion.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥50.\n2. Corrected visual acuity (VA) of 20/125 or better, in the study eye(s)\n3. Media clarity, undilated pupil size, and subject cooperation sufficient to obtain adequate OCT B-scans in the study eye(s)\n4. Able to perform self-testing of retinal thickness with the RHMS-RTM after training\n5. Able and willing to provide written informed consent before undergoing any study-related procedures\n6. Group 1: Macula with normal thickness \\[central subfield thickness (CST): \\<305μm in women, and \\<320μm in men as measured by Heidelberg Spectralis SD-OCT in at least one eye. Patients diagnosed with dry AMD are eligible for enrollment into Group 1. No history of wAMD, DR, or RVO in either eye\n7. Group 2 and Group 3, in at least one and the same eye: History of center-involving macular edema due to wAMD (Group 2); or DR or RVO (Group 3); Macular edema on SD-OCT with CST ≥305 μm in women, and ≥320μm in men as measured by Heidelberg Spectralis SD-OCT.\n\nExclusion Criteria:\n\n1. History of corneal refractive surgery \\[e.g., laser-assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK), radial keratotomy (RK)\\] in the study eye(s)\n2. History of epiretinal membrane, vitreomacular traction, or macular hole in the study eye(s)\n3. Participation in any study using an investigational drug within 30 days of screening or an investigational device within 60 days of screening\n4. Refractive error within defined limits\n5. History of photocoagulation laser scar or other retinal scar in the central 3 mm of the macula, in the study eye(s)'}, 'identificationModule': {'nctId': 'NCT04499703', 'briefTitle': 'Evaluation of the Retinal Health Monitoring System Thickness Module', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kubota Vision Inc.'}, 'officialTitle': 'Evaluation of the Retinal Health Monitoring System - Retinal Thickness Module in Subjects With Normal Macular Thickness and Subjects With Center-involving Macular Edema', 'orgStudyIdInfo': {'id': 'SCT-202 D'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'Subjects with normal macular thickness in one or both eyes.', 'interventionNames': ['Device: RHMS-RTM', 'Diagnostic Test: SD-OCT']}, {'label': 'Group 2', 'description': 'Subjects with center-involving macular edema due to wAMD in one or both eyes', 'interventionNames': ['Device: RHMS-RTM', 'Diagnostic Test: SD-OCT']}, {'label': 'Group 3', 'description': 'Subjects with center-involving macular edema due to DR or RVO in one or both eyes', 'interventionNames': ['Device: RHMS-RTM', 'Diagnostic Test: SD-OCT']}], 'interventions': [{'name': 'RHMS-RTM', 'type': 'DEVICE', 'otherNames': ['Handheld swept source (SS) optical coherence tomography (OCT)'], 'description': 'Assessment of retinal thickness', 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3']}, {'name': 'SD-OCT', 'type': 'DIAGNOSTIC_TEST', 'description': 'Assessment of retinal structure', 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3010', 'city': 'Bern', 'country': 'Switzerland', 'facility': 'Inselspital, University Hospital Bern, Department of Ophthalmology', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'overallOfficials': [{'name': 'Marion Munk, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Inselspital, University Hospital Bern'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kubota Vision Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}