Remote Monitoring of Visual Function in Patients with Maculopathy: The Aphelion Study.

Abstract

Remote monitoring of vision, using tools such as the shape discrimination hyperacuity (SDH) test, can detect disease activity in patients with maculopathy. We determined the in-clinic accuracy and repeatability of three myVisionTrack expanded version (mVTx) tests for self-testing of visual acuity (VA) and contrast sensitivity. Aphelion, a single-arm, prospective study conducted at two sites in the USA, included adults with any maculopathy and a baseline VA of 0.7 log of minimum angle of resolution (logMAR) (Snellen 20/100) or better. Participants completed the mVTx tests (tumblingE, LandoltC, contrast sensitivity, and SDH) and standard clinical tests (near and distance Early Treatment Diabetic Retinopathy Study [ETDRS] charts and the Pelli-Robson contrast sensitivity chart). Test-retest repeatability and agreement between the mVTx tests and the corresponding clinical test were assessed by Bland-Altman analyses. Participants also completed a usability survey. The mean age of the 122 participants was 67years. The most common diagnosis was age-related macular degeneration (42% of patients). The tumblingE test had a test-retest 95% limit of agreement (LoA) of ± 0.18logMAR; the LandoltC test, ± 0.23logMAR; the SDH test, ± 0.24logMAR; and the contrast sensitivity test, ± 0.32 log contrast threshold (logCT). Compared with the distance ETDRS chart, the LoA was ± 0.35logMAR for the tumblingE test (mean difference, - 0.07logMAR) and ± 0.39logMAR for the LandoltC test (mean difference, 0.03logMAR). For the contrast sensitivity test, the LoA compared with the Pelli-Robson chart was ± 0.30 logCT (mean difference, - 0.25logCT). Most participants (85%) reported that they learned the tests quickly. The tumblingE test scored the highest on ease of use. The mVTx tests of VA are accurate and repeatable, supporting their potential use alongside the SDH test to detect disease progression remotely between clinic visits.