A Randomized Controlled Trial of Autostereoscopic 3D Vision Therapy for Amblyopia

Condition(s) studied

Investigational drug(s) / intervention(s)

Autostereoscopic 3D Training: Daily 20-minute autostereoscopic 3D amblyopia training session, 5+ days per week for 6 months. Training consists of 15 minutes of monocular perceptual learning with Gabor patches (adaptive difficulty algorithm) and 5 minutes of binocular vergence training. Home-based training with remote data monitoring.

Conventional Patching: Daily continuous 2-hour occlusion of the non-amblyopic eye using medical adhesive eye patches, 5+ days per week for 6 months. Patients are encouraged to perform near visual activities (reading, writing, puzzles) during patching to enhance amblyopic eye stimulation. Parent-supervised home therapy with daily patching logs.

Study summary

The goal of this clinical trial is to learn if an autostereoscopic 3D amblyopia training system works to improve vision in children and adolescents with amblyopia. It will also learn about the safety and tolerability of the 3D training system. The main questions it aims to answer are:

* Does autostereoscopic 3D vision training improve best corrected visual acuity in the amblyopic eye compared to conventional patching therapy?
* What side effects or discomfort do participants experience during 3D training versus patching? Researchers will compare the autostereoscopic 3D training system to conventional daily eye patching to see which treatment works better for improving vision in amblyopia.

Participants will:

* Be randomly assigned to either the 3D training group or the patching group
* Complete daily home treatment for 6 months - either 20 minutes of 3D vision training or 2 hours of continuous eye patching
* Visit the clinic at baseline, 1 month, 3 months, and 6 months for eye exams and vision tests
* Have their treatment progress monitored remotely through training data logs or patching diaries

Eligibility

Primary outcome measure(s)

• Best Corrected Visual Acuity (BCVA) — baseline to 6 months

Trial sites (1)

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