Abstracto

An eye-tracking-based binocular amblyopia treatment improving both visual acuity and binocularity: One year follow-up.

Tamara Wygnanski-Jafe, Michael Belkin, Oren Yehezkel

Background: Amblyopia is a neurodevelopmental disorder resulting from abnormal visual experience early in life.

Purpose: To evaluate the efficacy and safety of a novel binocular eye-tracking-based passive home treatment system delivering personalized amblyopia therapy.

Methods: Real-time foveal area blur was induced on the dominant eye of 20 participants (aged 4-15 years) with anisometropic, strabismic (<5 PD), or mixed amblyopia in a prospective single- arm proof-of-concept human study. Subjects were trained over 12 weeks with 5 weekly sessions and then for an additional 12 weeks with 3 weekly sessions. Primary outcome was improvement in Best Corrected Visual Acuity (BCVA) and stereoacuity. Secondary outcomes were adherence, improvement persistence and patient-reported comfort.

Results: Mean BCVA significantly improved by 0.19 ± 0.11 logMAR for distance crowded VA, 0.27 ± 0.13 logMAR for near crowded VA, and by 0.22 ± 0.15 logMAR for distance single letter VA (p<0.001 for each). Stereoacuity improved by 198 ± 218 arcsec (p=0.001). Binocular VA improved 0.09 ± 0.13 logMAR for distance crowded VA (p=0.007), 0.12 ± 0.11 logMAR for near crowded VA (p<0.001) and 0.07 ± 0.12 logMAR for distance single letter VA (p=0.018). The adherence rate was 89% ± 27%. No patient reported discomfort. At 52 weeks, distance crowded VA, distance single letter VA, and stereoacuity were not significantly different from the end-of- treatment measurements.

Conclusion: The system improved VA and stereoacuity and produced a high adherence rate with no reported discomfort. Improvement persisted for 6+ months.

Translational relevance: A novel binocular treatment based on passive viewing of customized content, modified to reinforce the amblyopic eye, resulted in VA and stereoacuity improvement in a small, first-in-human study, suggesting that this treatment might reduce interocular suppression.