Study Evaluating Retinal Health Monitoring System Thickness Module
NCT ID: NCT04428242
Last Updated: 2021-02-21
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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WITHDRAWN
OBSERVATIONAL
2020-04-30
2020-07-31
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 w/AMD 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. Media clarity, undilated pupil size, OCT-B scans, axial length measurements in the study eye(s)
3. Able to perform self-testing of retinal thickness with the RHMS-RTM after training
4. Able and willing to give informed consent
5. Group 1:
1. Macula with normal thickness \[central subfield thickness (CST) below 305 microns as measured by SD-OCT\] in at least one eye
2. Patients with dry AMD are eligible for enrollment into Group 1
3. No history of wet AMD, DR, or RVO in either eye
6. Group 2 and Group 3 (in at least one or the same eye):
1. History of center-involving macular edema due to wet AMD (Group 2); or DR or RVO (Group 3)
2. Macular edema on SD-OCT with CST ≥ 305 microns
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 or screening or investigational device within 60 days of screening
4. Refractive error: spherical equivalent of \> 3 diopters of hyperopia or \> 6 diopters of myopia, or \> 2 diopters cylinder in the study eye(s)
5. History of photocoagulation laser scar or other retinal scar in the central 3 mm of the macula, in the study eye(s)
18 Years
ALL
Yes
Sponsors
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Kubota Vision Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jeff Gregory, MD
Role: STUDY_DIRECTOR
Kubota Vision Inc.
Locations
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Retinal Consultants Medical Group, Inc
Sacramento, California, United States
Countries
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Other Identifiers
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SCT-202
Identifier Type: -
Identifier Source: org_study_id
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