Feasibility of a New ‘Balanced Binocular Viewing’ Treatment for Unilateral Amblyopia in Children Aged 3–8 Years (BALANCE): Results of a Phase 2a Randomised Controlled Feasibility Trial

AI Generated Summary*

In a phase 2a feasibility trial, children aged 3 to 8 with unilateral amblyopia were randomised to 16 weeks of home treatment: an hour daily of dichoptic movies on a handheld console, or parent-chosen patching or atropine. Of 144 prescreened children, 32 (22%) enrolled and 20 (63%) completed. Dichoptic adherence averaged about 57%; patching adherence fell from 90% to 59%. VacMan suppression scores, the primary safety outcome, fell in the standard-treatment arm (p=0.002) but not with dichoptic viewing (p=0.435); the baseline-adjusted between-arm difference was -0.02 (p=0.87). Acuity gains of roughly two logMAR lines did not differ significantly between arms. Two dichoptic-arm children withdrew with headaches and one reported transient diplopia. Families found both treatments hard to fit into routines.

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