A Smart Mobile Application to Monitor Visual Function in Diabetic Retinopathy and Age-Related Macular Degeneration: The CLEAR Study.

Purpose: The purpose of this study was to determine if a mobile application, the Checkup Vision Assessment System, could reliably monitor visual acuity (VA) and metamorphopsia remotely versus standard VA reference tests in the clinic. With the current COVID-19 pandemic, an even greater need for remote monitoring exists. Mobile tools enhance the ability to monitor patients virtually by enabling remote monitoring of VA and Amsler grid findings.

Design: Prospective, multicenter reliability analysis.

Methods: Participants: Patients (N = 108) with near corrected VA better than 20/200 and a diagnosis of age-related macular degeneration, diabetic retinopathy, or healthy patients without retinal disease (best-corrected visual acuity [BCVA] of 20/32 or better).

Intervention: participants were tested using the Checkup, reference VA, and Amsler tests, with the order of testing (Checkup or reference) randomized. Patients monitored their vision using Checkup at least twice a week at home between office visits. Main outcome measurements were near corrected VA and Amsler grid test results.

Results: Agreement was strong between Checkup and reference tests for VA (r = 0.86) and Amsler grid (sensitivity: 93%; specificity: 92%). Home versus clinic testing showed excellent agreement (r = 0.96). Patients reported successful home use. There were no serious adverse events or discontinuations. Patients rated the usability of Checkup to be excellent.

Conclusions: There was good agreement between Checkup and in-clinic test results for VA and Amsler grid. The low variance of Checkup testing, agreement between in-clinic and home results, and excellent usability support Checkup as a reliable method for monitoring retinal pathology in clinic and home settings.