Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2026-02-21 @ 5:08 PM
Study NCT ID:
NCT04169802
Status:
COMPLETED
Last Update Posted:
2021-02-21
First Post:
2019-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Evaluating Retinal Health Monitoring System Visual Acuity Module.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008268', 'term': 'Macular Degeneration'}], 'ancestors': [{'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-04-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-18', 'studyFirstSubmitDate': '2019-11-17', 'studyFirstSubmitQcDate': '2019-11-19', 'lastUpdatePostDateStruct': {'date': '2021-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of the repeatability of CNVA measured by the RHMS Visual Acuity Module and the Reference Chart', 'timeFrame': '1 day', 'description': 'To determine the precision (repeatability and reproducibility) of corrected near visual acuity (CNVA) measured by the RHMS Visual Acuity Module and an in-clinic, near logarithmic Sloan Letter chart (Reference Chart).'}, {'measure': 'Comparison of the reproducibility of CNVA measured by the RHMS Visual Acuity Module and the Reference Chart', 'timeFrame': '1 day', 'description': 'To evaluate the agreement of CNVA measured by the RHMS Visual Acuity Module and the Reference Chart'}, {'measure': 'Agreement of CNVA measured by the RHMS Visual Acuity Module and the Reference Chart', 'timeFrame': '1 day', 'description': 'To evaluate the usability of the RHMS Visual Acuity Module'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Age-Related Macular Degeneration', 'visual acuity'], 'conditions': ['Age Related Macular Degeneration']}, 'descriptionModule': {'briefSummary': 'Assess the performance and usability of the RHMS Visual Acuity Module.', 'detailedDescription': 'This 510(k)-enabling study is designed to assess the performance and usability of the RHMS Visual Acuity Module in normal patients and patients with neovascular AMD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects aged ≥ 50 years, with a normal central macula or with neovascular AMD', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nCohort 1 - Normal subjects\n\n1. Age ≥ 50 years\n2. Corrected distance or near visual acuity (VA) of ≥ 20/25 Snellen equivalent, in the study eye\n3. Able to perform self-testing with the Visual Acuity Module of the RHMS after training\n4. Able and willing to give informed consent\n\nCohort 2 - Subjects with neovascular AMD\n\n1. Age ≥ 50 years\n2. History of neovascular age-related macular degeneration, in the study eye\n3. Corrected distance or near VA of ≥ 20/200 Snellen equivalent, in the study eye\n\nExclusion Criteria:\n\nCohort 1 - Normal subjects\n\n1. History of ophthalmic disease resulting in decrease in visual acuity per the Investigator, in the study eye\n2. Use of any investigational drug in the past 30 days, or investigational, interventional device in the past 60 days\n\nCohort 2 - Subjects with neovascular AMD\n\n1. History of geographic atrophy or macular atrophy within the central 3 mm of the macula, in the study eye\n2. History of macular hole in the study eye\n3. Use of any investigational drug in the past 30 days, or investigational, interventional device in the past 60 days'}, 'identificationModule': {'nctId': 'NCT04169802', 'briefTitle': 'Study Evaluating Retinal Health Monitoring System Visual Acuity Module.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kubota Vision Inc.'}, 'officialTitle': 'An Observational, Non-Significant Risk Study Of The Retinal Health Monitoring System (RHMS) - Visual Acuity Module - In Normal Patients And Patients With Neovascular Age-Related Macular Degeneration (AMD)', 'orgStudyIdInfo': {'id': 'SCT-201'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Normal subjects', 'description': 'Age ≥ 50 years, Corrected distance or near visual acuity (VA) of ≥ 20/25 Snellen equivalent, in the study eye.', 'interventionNames': ['Diagnostic Test: Retinal Health Monitoring System Visual Acuity Module', 'Diagnostic Test: Sloan letter, logarithmic near visual acuity chart (Reference Chart)']}, {'label': 'Subjects with neovascular AMD', 'description': 'Age ≥ 50 years, History of neovascular age-related macular degeneration, in the study eye, Corrected distance or near VA of ≥ 20/200 Snellen equivalent, in the study eye.', 'interventionNames': ['Diagnostic Test: Retinal Health Monitoring System Visual Acuity Module', 'Diagnostic Test: Sloan letter, logarithmic near visual acuity chart (Reference Chart)']}], 'interventions': [{'name': 'Retinal Health Monitoring System Visual Acuity Module', 'type': 'DIAGNOSTIC_TEST', 'description': 'Assessment of corrected near visual acuity', 'armGroupLabels': ['Normal subjects', 'Subjects with neovascular AMD']}, {'name': 'Sloan letter, logarithmic near visual acuity chart (Reference Chart)', 'type': 'DIAGNOSTIC_TEST', 'description': 'Assessment of corrected near visual acuity', 'armGroupLabels': ['Normal subjects', 'Subjects with neovascular AMD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85053', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Retina Consultants of Arizona', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}], 'overallOfficials': [{'name': 'Jeff Gregory, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kubota Vision Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kubota Vision Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}