Digital therapeutic improves visual acuity and encourages high adherence in amblyopic children in open-label pilot study

• Published in: Journal of AAPOS Vol. 25; no. 2; pp. 87.e1 - 87.e6
• Main Authors: Xiao, Scott, Gaier, Eric D., Wu, Hank C., Angjeli, Endri, Nuth, Pauline L., Bohra, Lisa I., Miller, Aaron M., Mazow, Malcolm L., Stout, Ann U., Morse, Christie L., Blumenfeld, Louis C., Glaser, Stephen R., Crouch, Eric, Ekdawi, Noha S., Lyon, Don W., Silbert, David I., Hunter, David G.
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.04.2021
• ISSN: 1091-8531; 1528-3933
• DOI: 10.1016/j.jaapos.2020.11.022

The effectiveness of amblyopia therapy can be limited by poor adherence. Dichoptic therapies are a new approach, but recent trials have demonstrated difficulty maintaining high adherence over extended periods of at-home treatment. We evaluated the efficacy and adherence of Luminopia One—a dichoptic treatment that applies therapeutic modifications to streaming content chosen by the patient. This single-arm, multicenter prospective pilot study enrolled children aged 4-12 with anisometropic, strabismic, or mixed amblyopia at 10 pediatric ophthalmic and optometric practices across the United States. The therapeutic was prescribed for 1 hour/day, 6 days/week for 12 weeks of at-home use. The primary endpoint was best-corrected visual acuity (BCVA) at the 12-week follow-up visit. In total, 90 participants (mean age, 6.7 ± 2.0 years) were enrolled, and 73/90 participants (81%) had prior treatment beyond refractive correction. For those who completed the 12-week visit, mean amblyopic eye BCVA improved from 0.50 logMAR to 0.35 logMAR (1.5 logMAR lines; 95% CI, 1.2-1.8 lines; P < 0.0001). Mean stereoacuity improved by 0.28 log arcsec (95% CI, 0.14-0.42 log arcsec; P < 0.0001). Median adherence was 86% (interquartile range, 70%-97%). In our study cohort, adherence over the 12-week study period was high, and participants demonstrated clinically and statistically significant improvements in visual acuity and stereoacuity.