JMIR Publications

ABSTRACT

Background:

Conventional amblyopia treatment involves the occlusion of the fellow eye using an eye patch. However, this approach places psychological and physical burdens on pediatric patients with amblyopia. However, this approach imposes a substantial psychological and physical burden on pediatric patients with amblyopia, resulting in low adherence and suboptimal visual outcomes. As responsiveness to therapy declines beyond early childhood, treatments that can enhance adherence and improve efficacy are needed. We developed a virtual reality (VR) dichoptic training application (VR app) that integrates gamification and hand-eye coordination training in pediatric patients with amblyopia.

Objective:

This study investigated the effect of a VR app on visual acuity improvement in pediatric patients with amblyopia compared with conventional occlusion therapy using an eye patch.

Methods:

This multicenter, open-label, prospective, randomized controlled trial at three centers in Tokyo, Japan. Pediatric patients aged 3 to 10 years with anisometropic, strabismic, or refractive amblyopia will be enrolled. Participants will be assigned 1:1 to a VR‑app group or a control group. The VR‑app group will use the VR app at home for 1 h per day for 6 months. The control group underwent conventional occlusion therapy with an eye patch for 6 months. Each group comprised 15 participants (30 participants in total). Ophthalmologic examinations will be performed at baseline and at weeks 4, 8, 12, 16, 20, and 24. The primary endpoint was the change in the best-corrected visual acuity (BCVA) in the amblyopic eye from baseline to week 12. Secondary endpoints will include changes in BCVA, stereopsis, and ocular deviation through week 24. We also assessed treatment adherence, defined as the ratio of the cumulative actual treatment time to the cumulative prescribed time, recorded adverse events, and evaluated usability in the VR‑app group. Longitudinal changes in outcome measures were analyzed using a mixed-effects model.

Results:

Participant enrollment will start from October 1, 2025, to March 31, 2026. The data will be analyzed on September 30, 2026, and the results will be reported on December 31, 2026.

Conclusions:

This study will clarify the effectiveness of the newly developed VR‑app in improving treatment outcomes and adherence among pediatric patients with amblyopia. By addressing the limitations of conventional occlusion therapy and providing a potentially more efficacious and acceptable treatment option, the VR‑app may enhance clinical outcomes and represent a paradigm shift in the treatment of pediatric amblyopia.