A Randomized Controlled Trial of Autostereoscopic 3D Vision Therapy for Amblyopia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Autostereoscopic 3D Training, Conventional Patching.
- Who it may be relevant to
- Registry conditions: Amblyopia, Visual Training, Visual Functions, Visual Health. Basic parameters: 7 years — 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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
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.
Primary outcome measures
- Best Corrected Visual Acuity (BCVA) [Time frame: baseline to 6 months]
Secondary outcome measures (7)
- Distance Stereoacuity [Time frame: baseline to 6 months]
- Near Stereoacuity [Time frame: Baseline to 6 months]
- Contrast Sensitivity Function [Time frame: Baseline to 6 months]
- Computer Vision Syndrome Questionnaire (CVS-Q) Score [Time frame: Baseline to 6 months]
- Simulator Sickness Questionnaire (SSQ) Score [Time frame: Baseline to 6 months]
- Adherence [Time frame: Baseline to 6 months]
- Intraocular Pressure (IOP) [Time frame: Baseline to 6 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Beijing Tongren Hospital — Beijing
Identifiers
NCT: NCT07709832 · TREC2025-KY194