Status:
COMPLETED
Evaluation of the Retinal Health Monitoring System Thickness Module
Lead Sponsor:
Kubota Vision Inc.
Conditions:
Macular Edema
Macular Degeneration
Eligibility:
All Genders
50+ years
Brief Summary
Evaluate the ability and accuracy of the Retinal Health Monitoring System - Retinal Thickness Module (RHMS - RTM).
Detailed Description
Evaluation of the Retinal Health Monitoring System - Retinal Thickness Module in subjects with normal macular thickness and subjects with center-involving macular edema.
Eligibility Criteria
Inclusion
- Age ≥50.
- Corrected visual acuity (VA) of 20/125 or better, in the study eye(s)
- Media clarity, undilated pupil size, and subject cooperation sufficient to obtain adequate OCT B-scans in the study eye(s)
- Able to perform self-testing of retinal thickness with the RHMS-RTM after training
- Able and willing to provide written informed consent before undergoing any study-related procedures
- 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
- 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
- History of corneal refractive surgery \[e.g., laser-assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK), radial keratotomy (RK)\] in the study eye(s)
- History of epiretinal membrane, vitreomacular traction, or macular hole in the study eye(s)
- Participation in any study using an investigational drug within 30 days of screening or an investigational device within 60 days of screening
- Refractive error within defined limits
- History of photocoagulation laser scar or other retinal scar in the central 3 mm of the macula, in the study eye(s)
Key Trial Info
Start Date :
November 11 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 25 2021
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04499703
Start Date
November 11 2020
End Date
January 25 2021
Last Update
February 18 2021
Active Locations (1)
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1
Inselspital, University Hospital Bern, Department of Ophthalmology
Bern, Switzerland, 3010