Evaluation of the Retinal Health Monitoring System Thickness Module
NCT ID: NCT04499703
Last Updated: 2021-02-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
60 participants
OBSERVATIONAL
2020-11-11
2021-01-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Group 1
Subjects with normal macular thickness in one or both eyes.
RHMS-RTM
Assessment of retinal thickness
SD-OCT
Assessment of retinal structure
Group 2
Subjects with center-involving macular edema due to wAMD in one or both eyes
RHMS-RTM
Assessment of retinal thickness
SD-OCT
Assessment of retinal structure
Group 3
Subjects with center-involving macular edema due to DR or RVO in one or both eyes
RHMS-RTM
Assessment of retinal thickness
SD-OCT
Assessment of retinal structure
Interventions
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RHMS-RTM
Assessment of retinal thickness
SD-OCT
Assessment of retinal structure
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Corrected visual acuity (VA) of 20/125 or better, in the study eye(s)
3. Media clarity, undilated pupil size, and subject cooperation sufficient to obtain adequate OCT B-scans in the study eye(s)
4. Able to perform self-testing of retinal thickness with the RHMS-RTM after training
5. Able and willing to provide written informed consent before undergoing any study-related procedures
6. 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
7. 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.
Exclusion Criteria
2. History of epiretinal membrane, vitreomacular traction, or macular hole in the study eye(s)
3. Participation in any study using an investigational drug within 30 days of screening or an investigational device within 60 days of screening
4. Refractive error within defined limits
5. History of photocoagulation laser scar or other retinal scar in the central 3 mm of the macula, in the study eye(s)
50 Years
ALL
Yes
Sponsors
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Kubota Vision Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Marion Munk, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Inselspital, University Hospital Bern
Locations
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Inselspital, University Hospital Bern, Department of Ophthalmology
Bern, , Switzerland
Countries
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Other Identifiers
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SCT-202 D
Identifier Type: -
Identifier Source: org_study_id
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