Real world gains stable in children with amblyopia following digital dichoptic treatment: PUPiL registry results

OBJECTIVE: Assess outcomes and durability of best corrected visual acuity (BCVA) improvements of amblyopic children who completed treatment with a digital dichoptic treatment, Luminopia. METHODS: Retrospective analysis of PUPiL Registry (Patients Using Prescription Luminopia) data of children (< 18 years) with 20/40 or worse BCVA in the amblyopic eye and ≥ 2 lines interocular difference in BCVA who completed Luminopia treatment. Main outcome measures were BCVA changes from baseline to last follow-up visit on treatment, and durability of improvements > 6 weeks after treatment discontinuation. RESULTS: In 60 children, mean age 7.2 ± 2.5 years at treatment initiation, there was a mean 1.4 lines (95% CI[1.0, 1.8]) of improvement of BCVA with mean treatment duration of 7.0 months (95% CI[6.2, 7.7]). BCVA improvement was seen in subgroups based on severity, age at initiation, type and prior amblyopia treatment. Children with severe (< 20/100) and moderate (20/40 to > 20/100) amblyopia showed significant improvement on treatment (p < 0.001, p < 0.0001). There was no difference in BCVA line improvement in children initiated on treatment based on age (≤ 7 years vs. ≥8 years (p = 0.61), or based on type of amblyopia (anisometropic, strabismic, mixed (p = 0.18)). Patients with no history of prior amblyopia treatment showed greater improvement than children with a history of prior treatment (p < 0.001). After an average of 6.2 months (95% CI[5.4, 7.0]) follow-up post-treatment, gains in BCVA were maintained, with no statistically significant change from treatment end to final follow-up (p = 0.09). Amblyopia recurrence (> 2 line loss) was 3%. CONCLUSIONS: Children with amblyopia are typically treated with Luminopia for < 1 year and showed improved BCVA with durability after discontinuation. Visual gains were maintained independent of subsequent patching or atropine. The BCVA gains and durability were consistent in subgroups based on age of treatment initiation, amblyopia type and severity, and prior treatment history.