Real-world effectiveness of a digital treatment for amblyopia

Abstract Amblyopia is a neurodevelopmental condition of vision affecting 2-4% of children. Patching therapy is marred by low adherence; over half of patients carry residual functional deficits into adulthood. Luminopia, a prescription digital treatment that incorporates therapeutic modifications into children’s programming via a head-mounted display, was shown to improve visual acuity in a randomized clinical trial (RCT) for amblyopia and led to FDA-clearance, available by prescription. This multicenter registry study compared real-world outcomes to RCT results. Among 40 registry patients, similar in age and amblyopia characteristics, amblyopic eye best-corrected visual acuity improved 1.7 lines (95% CI: 1.2-2.2) after 12 weeks, equivalent to RCT gains (1.8 lines; p=0.0375). Real-world adherence (73%) exceeded that for patching. No adverse events were reported. These findings demonstrate Luminopia's effectiveness in clinical practice, offering a binocular alternative to traditional treatments with high adherence and meaningful visual improvements. Trial Registration: NCT06429280