Randomized clinical trial of streaming dichoptic movies versus patching for treatment of amblyopia in children aged 3 to 7 years

Abstract

Contrast-rebalanced dichoptic movies have been shown to be an effective binocular treatment for amblyopia in the laboratory. Yet, at-home therapy is a more practical approach. In a randomized clinical trial, we compared dichoptic movies, streamed at-home on a handheld 3D-enabled game console, versus patching as amblyopia treatment. Sixty-five amblyopic children (3-7 years; 20/32-125) were randomly assigned to one of two parallel arms, binocular treatment (3 movies/week) or patching (14 h/week). The primary outcome, change in best corrected visual acuity (BCVA) at the 2-week visit was completed by 28 and 30, respectively. After the primary outcome, both groups of children had the option to complete up to 6 weeks of binocular treatment. At the 2-week primary outcome visit, BCVA had improved in the movie (0.07 ± 0.02 logMAR; p < .001) and patching (0.06 ± 0.01 logMAR; p < 0.001) groups. There was no significant difference between groups (CI₉₅%: - 0.02 to 0.04; p = .48). Visual acuity improved in both groups with binocular treatment up to 6 weeks (0.15 and 0.18 logMAR improvement, respectively). This novel, at-home, binocular movie treatment improved amblyopic eye BCVA after 2 weeks (similar to patching), with additional improvement up to 6 weeks. Repeated binocular visual experience with contrast-rebalanced binocular movies provides an additional treatment option for amblyopia.Clincaltrials.gov identifier: NCT03825107 (31/01/2019).

Figure 1

CONSORT diagram.

Figure 2

Amblyopic eye visual acuity improvement relative to baseline for 60 children randomized to watch contrast rebalanced dichoptic movies or patching for 2 weeks. Also shown are visual acuity differences from baseline extracted from medical records at 1, 3, and 6 months prior to the baseline/randomization visit and further visual acuity improvement with continued viewing of dichoptic movies by children in the dichoptic movie group at 4 and 6 weeks and by children who crossed over to watch dichoptic movies after their initial two weeks of patching treatment and participated through 8 weeks.

Figure 3

Visual acuity improvement in the movie and patching groups in children who had a clinical history of prior visual acuity improvement when treated with glasses and patching and children who had no visual acuity improvement when treated with glasses and patching. Numbers to the right of each data point indicate the n at each timepoint for each subgroup. Note that 3 children in the movie group and 1 child in the patching group were too young to provide visual acuity data on two visits prior to the enrollment visit and, as a result, could not be categorized as no response or response. These children were excluded from this analysis.