Real-world effectiveness of a binocular, dual-mechanism therapy in severe amblyopia: analysis from the PUPiL Registry.
BACKGROUND Occlusion therapy for severe amblyopia is challenging because of low visual function of the unoccluded eye and lengthy duration of daily therapy, which may then be hindered by low adherence. This study evaluates real-world effectiveness of a binocular digital treatment in patients with severe amblyopia. METHODS The records of children <18 years with best-corrected visual acuity (BCVA) of 20/100 or worse in their amblyopic eye who were prescribed Luminopia in the PUPiL Registry were retrospectively analyzed. The treatment utilizes contrast reduction and dichoptic masking overlayed on patient-selected programming. Primary outcome was BCVA improvement from baseline to last follow-up. Secondary outcomes included associations between BCVA improvement and total treatment hours, prior amblyopia treatment, age, and amblyopia type. Statistical analyses included correlation, t tests, and regression analyses. RESULTS In 57 children with severe amblyopia (mean age, 7.1 ± 2.6 years), mean BCVA improved 1.8 lines (95% CI, 1.0-2.6), with average treatment of 166 hours over 11.8 months. Of the 57 patients, 26 (46%) achieved ≥2-line gains. Treatment-naive patients showed greater improvement (n = 7; 4.4 lines [95% CI, 2.1-6.7]) versus previously treated patients (n = 50; 1.5 lines [95% CI, 0.6-2.3; P = 0.0183]). Worse baseline BCVA (Spearman r = 0.33, P = 0.013) and greater treatment hours (Spearman r = 0.51, P < 0.001), but not age or amblyopia type, were associated with greater BCVA improvement. CONCLUSIONS Luminopia demonstrated significant improvements in Registry patients with severe amblyopia, particularly in treatment-naive patients, supporting its use as a viable treatment option that may address key limitations of traditional approaches.