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

NCT07709832 | Not Yet Recruiting

• 1 other identifier: TREC2025-KY194
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Amblyopia; Visual Training; Visual Functions; Visual Health

Outcome Measures

Primary Outcomes (1)

• Best Corrected Visual Acuity (BCVA)

  baseline to 6 months

Secondary Outcomes (7)

• Distance Stereoacuity

  baseline to 6 months

• Near Stereoacuity

  Baseline to 6 months

• Contrast Sensitivity Function

  Baseline to 6 months

• Computer Vision Syndrome Questionnaire (CVS-Q) Score

  Baseline to 6 months

• Simulator Sickness Questionnaire (SSQ) Score

  Baseline to 6 months

Study Arms (2)

Autostereoscopic 3D Training Group

EXPERIMENTAL

Device: Autostereoscopic 3D Training

Conventional Patching Group

ACTIVE COMPARATOR

Device: Conventional Patching

Interventions

Conventional Patching DEVICE

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.

Conventional Patching Group

Autostereoscopic 3D Training DEVICE

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.

Autostereoscopic 3D Training Group

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Tongren Hospital: lead

Study Sites (1)

Beijing Tongren Hospital

Beijing, China

Location

MeSH Terms

Conditions

Amblyopia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jin Yuan

  Beijing Tongren Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jin Yuan

CONTACT

010-58366699; yuanjincornea@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President of Beijing Tongren Hospital

Study Record Dates

• First Submitted: July 12, 2026
• First Posted: July 17, 2026
• Study Start: July 31, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: July 17, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)