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NCT Number: NCT07709832

A Randomized Controlled Trial of Autostereoscopic 3D Vision Therapy for 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

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Key information

Conditions

Amblyopia Brain Diseases Central Nervous System Diseases Eye Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Vision Disorders Visual Functions Visual Health Visual Training

Age range

7 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Best Corrected Visual Acuity (BCVA)

    Time frame: baseline to 6 months

Secondary outcomes

  1. Distance Stereoacuity

    Time frame: baseline to 6 months

  2. Near Stereoacuity

    Time frame: Baseline to 6 months

  3. Contrast Sensitivity Function

    Time frame: Baseline to 6 months

  4. Computer Vision Syndrome Questionnaire (CVS-Q) Score

    Time frame: Baseline to 6 months

  5. Simulator Sickness Questionnaire (SSQ) Score

    Time frame: Baseline to 6 months

  6. Adherence

    Time frame: Baseline to 6 months

  7. Intraocular Pressure (IOP)

    Time frame: Baseline to 6 months

Study contacts

Contact information is provided by the study sponsor or research team.

Jin Yuan

CONTACT

[email protected]

010-58366699

Sponsors and collaborators

Lead sponsor

Beijing Tongren Hospital

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 17, 2026
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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