Macular Edema, Macular Degeneration
Conditions
Keywords
Macular Edema, Wet AMD, Retinal Thickness, Diabetic Retinopathy, Retinal Vein Occlusion
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.
Interventions
Sponsors
Kubota Vision Inc.
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Corrected visual acuity (VA) of 20/100 or better, in the study eye(s) 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
1. History of corneal refractive surgery, photorefractive keratectomy, radial keratotomy, in the study eye 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the RHMS-RTM retinal thickness measurements | 1 day | To evaluate the ability of the RHMS-RTM device to measure retinal thickness |
| RHMS-RTM repeatability | 1 day | To assess repeatability of the RHMS-RTM device |
| Comparison of retinal thickness measurements between the RHMS-RTM and the SD-OCT | 1 month | To evaluate the agreement of measurements by the RHMS-RTM and SD-OCT |
Countries
United States
Outcome results
None listed