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NCT07693790

Augmented Reality Training for Amblyopia After Congenital Cataract Surgery

Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University

View on ClinicalTrials.gov

Summary

This study will evaluate whether augmented reality training is effective and safe for treating unilateral amblyopia after congenital cataract surgery in children. Children aged 5 to 12 years with unilateral amblyopia after congenital cataract surgery will be enrolled from three eye hospitals in China. Participants will be randomly assigned to one of two groups. One group will receive augmented reality amblyopia training for 2 hours per day for 4 months. The other group will receive conventional patching of the fellow eye for 4 hours per day for 4 months. The main outcome is the change in best-corrected visual acuity of the amblyopic eye after 4 months of treatment. The study will also evaluate contrast sensitivity, binocular visual function, stereoacuity, vision-related symptoms, quality of life, and adverse events.

Official title: Effectiveness and Safety of Augmented Reality-Based Amblyopia Training for Postoperative Congenital Cataract Patients: A Multicenter, Superiority, Randomized, Parallel-Controlled Trial Protocol

Key Details

Gender

All

Age Range

5 Years - 12 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-07-01

Completion Date

2028-01

Last Updated

2026-07-09

Healthy Volunteers

Conditions

Deprivation Amblyopia Congenital Cataract

Interventions

DEVICE

Augmented Reality Amblyopia Training

Participants assigned to the experimental group will receive augmented reality amblyopia training for 2 hours per day for 4 months. Training may be completed in divided sessions, with each session lasting at least 30 minutes when possible. The training system will present visual training tasks and record training duration, task completion, and adherence data.

BEHAVIORAL

Conventional Patching

Participants assigned to the control group will receive conventional patching of the fellow eye for 4 hours per day for 4 months. Participants or their guardians will record daily patching duration and completion in a treatment diary, and adherence will be reviewed during follow-up visits.

Inclusion Criteria: 1. Aged 5 to 12 years, male or female. 2. Diagnosed with unilateral amblyopia after congenital cataract surgery. 3. Best-corrected visual acuity (BCVA) of the amblyopic eye ≤0.80 logMAR, BCVA of the fellow eye better than 0.15 logMAR, and interocular BCVA difference ≥0.20 logMAR. 4. Underwent cataract extraction at age ≤5 years and has stable ocular status at least 2 months after intraocular lens implantation. 5. If refractive error is present, optical correction has been worn for at least 3 months. 6. Orthophoria, or if strabismus is present, manifest deviation at distance of 6 m is ≤4 prism diopters after strabismus correction as measured by prism cover test. 7. Able to understand the study procedures, and written informed consent is obtained from the participant and/or legal guardian as required. Exclusion Criteria: 1. Childhood cataract caused by causes other than congenital cataract, including traumatic, drug-induced, steroid-related, secondary, or metabolic cataract. 2. Other ocular organic diseases that may affect visual acuity assessment or amblyopia treatment evaluation, including but not limited to significant ptosis, corneal or other media opacity, glaucoma or persistent ocular hypertension, optic nerve disease, retinal disease, or cortical visual impairment. 3. Uncontrolled or clinically unstable severe systemic disease that may affect study safety, adherence, or outcome assessment, including active malignancy, severe cardiovascular disease, uncontrolled hypertension, epilepsy, or history of photosensitive epilepsy. 4. Implanted electronic medical devices that may be affected by the study device or may affect safe use of the device, such as a pacemaker or implantable cardioverter-defibrillator. 5. Significant ocular inflammation, photophobia, tearing, eye pain, or other ocular surface or anterior segment disease at screening that may affect visual acuity testing, device wearing, or completion of training. 6. Obvious dizziness, motion sickness, acrophobia, balance disorder, or sequelae of previous brain injury that may affect safe wearing of the augmented reality device or training adherence. 7. Facial trauma, craniofacial deformity, or head and facial structural abnormality that may affect normal wearing, positioning, or safe use of the augmented reality device. 8. Severe psychiatric, cognitive, developmental, or behavioral disorder that may prevent understanding of study procedures, completion of training, or follow-up. 9. Current or planned use of medications that may affect visual acuity, refractive status, pupil status, or visual function assessment, except for short-term cycloplegic agents used for routine ophthalmic examination. 10. Unable to simultaneously perceive binocular stimuli in the device or unable to complete binocular simultaneous vision training after device screening or calibration. 11. Received amblyopia treatment other than spectacle correction within 2 weeks before screening, including patching, atropine penalization, visual training, binocular vision training, or other amblyopia-related interventions. 12. Participation in another drug clinical trial within 3 months or another medical device clinical trial within 1 month before screening. 13. Any other condition that, in the investigator's opinion, makes the participant unsuitable for the study.