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NOT YET RECRUITING
NCT07709832
NA

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

Sponsor: Beijing Tongren Hospital

View on ClinicalTrials.gov

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

Official title: 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

Key Details

Gender

All

Age Range

7 Years - 12 Years

Study Type

INTERVENTIONAL

Enrollment

34

Start Date

2026-07-31

Completion Date

2027-07-31

Last Updated

2026-07-17

Healthy Volunteers

No

Interventions

DEVICE

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.

DEVICE

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.

Locations (1)

Beijing Tongren Hospital

Beijing, China