Transformative Gamified Binocular Therapy for Unilateral Amblyopia in Young Children: Pilot Prospective Efficacy and Safety Study.

Background: Amblyopia is a common cause of visual impairment in children. Compliance with traditional treatments for amblyopia is challenging due to negative psychosocial impacts. Recent shifts in amblyopia treatment have moved from suppressing the dominant eye to enhancing binocular visual function. Binocular digital therapy has become a promising approach.

Objective: The aim of this study was to evaluate the effects of binocular gamified digital therapy on visual acuity and stereoacuity (SA) in children with unilateral amblyopia.

Methods: This pilot prospective study enrolled 11 children aged 4-6 years with unilateral amblyopia. Following at least 8 weeks of refractive correction, participants underwent binocular gamified digital therapy for 60 minutes per day, 5 days a week. The therapy used a roguelike shooting game delivered under binocular conditions through two independent channels with a real-time artificial intelligence visual engine. Assessments of distance visual acuity (DVA), near visual acuity (NVA), and SA were conducted at baseline and again at 4, 8, and 12 weeks.

Results: At 12 weeks, the following significant improvements were noted: amblyopic eye DVA improved by 1.0 line (P=.01; d=0.77), binocular DVA improved by 0.7 lines (P=.006; d=1.00), and SA improved by 0.3 logarithm (log) arcseconds (P=.01; d=0.97). At 8 weeks, improvements included amblyopic eye DVA by 0.9 lines (P=.046; d=1.00) and SA by 0.28 log arcseconds (P=.02; d=0.90). No significant adverse events were observed, although one participant developed progressive esotropia.

Conclusions: Binocular gamified digital therapy is effective and safe for improving visual outcomes in children aged 4-6 years with unilateral amblyopia.