USE OF A SMART DEVICE MOBILE APP FOR MONITORING VISUAL ACUITY AND METAMORPHOPSIA IN PATIENTS WITH DIABETIC RETINOPAHY OR AGE-RELATED MACULAR DEGENERATION

Abstract

Purpose : Mobile device-based applications for vision testing hold great potential for widespread use but warrant rigorous validation. CLEAR is a multicenter, observational pilot study to assess the agreement between Checkup Vision Assessment System (Checkup; Digisight Technologies, CA) and standard reference tests (Ref), Lebehnson near card for visual acuity (VA) and Amsler grid for metamorphopsia, and to assess test-retest repeatability in the clinic and home settings.

Methods : CLEAR (NCT02871817) is a 2-month study in subjects >18 y/o with near corrected VA better than 20/200 and a diagnosis of diabetic retinopathy (DR) or age-related macular degeneration (AMD) or with normal vision (VA 20/25 or better). At Visit 0, subjects were randomized for the duration of the study to testing with either Ref or Checkup first. Subjects wore corrective lenses if applicable. Subjects took each test twice per visit with rest in between and were evaluated at baseline and two monthly visits. In between office visits, subjects used Checkup for VA and Amsler testing at least twice per week. At the final visit, usability survey was conducted. Agreement was assessed using Lin concordance correlation coefficient (r) and McNemar statistical tests.

Results : Twenty-seven subjects were enrolled at 7 sites: neovascular AMD 15%, early AMD 41%, DR 18%, and normal 26%. All subjects successfully completed at least 6 tests at home. There was strong agreement between Checkup v Ref for both VA (r=0.83) and Amsler (sensitivity 97%). Home v Clinic testing showed excellent agreement (r =0.94). Home testing variance was 0.005 (standard deviation = 0.07 log MAR). Usability survey showed 100% successful use at home.

Conclusions : CLEAR results show good agreement between Checkup and Ref in clinic for both VA and Amsler grid tests. The low variance of Checkup home testing, agreement between in-clinic and home results, and excellent usability support the use of the Checkup as a reliable method to monitor patients with retinal pathology in clinical and home settings. A larger clinical trial to expand on these findings is planned.

This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.