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

A Randomized Controlled Trial Evaluating the Efficacy and Safety of an Autostereoscopic 3D Vision Therapy System for Visual Function Rehabilitation in Children With Unilateral Amblyopia

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

Inclusion Criteria:

• Unilateral amblyopia (anisometropic, strabismic, or ametropic)
• Age: 7 to 12 years
• Amblyopic eye BCVA: 0.1 to 0.8 LogMAR
• Fellow eye BCVA: ≥ 0.8 LogMAR
• Stable refractive status (≤ ±0.50D change in past 6 months)
• Written informed consent from participant and guardian

Exclusion Criteria:

• Deprivation amblyopia (congenital cataract, ptosis, etc.)
• Organic ocular disease (glaucoma, retinopathy, optic neuropathy)
• Previous ocular surgery or trauma
• Severe dry eye or other ocular surface disorders
• Uncontrolled systemic diseases (diabetes, hypertension)
• Neuropsychiatric conditions preventing cooperation
• Participation in other clinical trials within 3 months