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.

ABSTRACT:

Objectives

This study aimed to evaluate the safety of dichoptic balanced binocular viewing (BBV) for amblyopia in children, plus feasibility, adherence, acceptability, trial methodology and clinical measures of visual function.

Design

We carried out an observer-masked parallel-group phase 2a feasibility randomised controlled trial.

Setting

Two study sites, a secondary/tertiary and a community site.

Participants

We enrolled 32 children aged 3-8 years with unilateral amblyopia who had completed optical adaptation where indicated. 20 children attended the 16-week exit visit (retention 63%).

Interventions

Children were randomised to BBV (movies customised to interocular acuity difference at baseline) for 1 hour a day (active intervention) or standard managem

SUBMITTER: Dahlmann-Noor AH 

PROVIDER: S-EPMC11407205 | biostudies-literature | 2024 Jul

REPOSITORIES: biostudies-literature