A novel, eye-tracking-based binocular treatment is well-tolerated and demonstrates noninferiority to patching in pediatric patients with amblyopia, according to research published in Ophthalmology. The technology, which requires passive viewing, requires a shorter treatment duration and has a higher adherence rate compared with traditional patching.
Researchers included 103 patients with anisometropic, small-angle strabismic or mixed mechanism amblyopia in the prospective, multi-center, randomized, masked, controlled non-inferiority pivotal trial which was conducted at 6 clinical sites. Participants were randomized to treatment with either the novel device (n=51; mean age, 6.6 years) or with patching (n=52; mean age 6.9 years).
Patients assigned to the binocular treatment group were treated for 90 minutes per day, 5 days per week, for 16 weeks. The children assigned to the patching group wore a patch over their dominant eye for 2 hours per day, 7 days per week for 16 weeks. Visual acuity and stereoacuity were assessed at baseline and follow-up visits conducted at 4, 8, 12, and 16 weeks.
Visual acuity improved at 16 weeks among children in the binocular treatment group (0.28 logarithm of the minimum angle of resolution [logMAR] change from baseline; P <.0001), and this change was not inferior to the improvement experienced by participants treated with patching (0.23 logMAR change from baseline; P <.0001; 90% CI of difference, -0.008-0.076).
Stereoacuity improvements of 0.40 log-arcseconds were noted in both groups (P <.0001 for both). Children who were assigned to binocular home-based treatment demonstrated better adherence compared with children in the patching group (91% vs. 83%; 95% CI,-4.0% to 21%; P =.011). No serious adverse events were reported in either group.
“The majority of parents answered favorably to questions regarding adherence (including the ability to track adherence data on the system), the ease of use, and satisfaction,” according to the researchers. “Hence, our treatment may also be a beneficial option in young children whose resistance to wearing a patch, resulting from psychological and sensory factors, could adversely affect the treatment.”
A large population of children with anisometropic amblyopia, the exclusion of individuals with a tropia over 5 prism diopters, and self-reporting bias are acknowledged study limitations.
Disclosure: This research was supported by NovaSight, LTD. Multiple study authors declared affiliations with biotech, pharmaceutical, and/or clinical research organizations. Please see the original reference for a full list of authors’ disclosures.
Wygnanski–Jaffe T, Kushner BJ, Moshkovitz A, Belkin M, Yehezkel O. An eye-tracking-based dichoptic home treatment for amblyopia: a multicenter randomized clinical trial. Ophthalmology. Published online October 25, 2022. doi:10.1016/j.ophtha.2022.10.020