Evaluation of the Retinal Health Monitoring System Thickness Module

Evaluation of the Retinal Health Monitoring System - Retinal Thickness Module in subjects with normal macular thickness and subjects with center-involving macular edema.

Inclusion criteria

• 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 criteria

• 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)