Augmented Reality Training for Amblyopia After Congenital Cataract Surgery

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Congenital Cataract; Deprivation Amblyopia
• Intervention / Treatment: Device: Augmented Reality Amblyopia Training; Behavioral: Conventional Patching

Detailed Description

This is a multicenter, randomized, parallel-group, superiority clinical trial designed to evaluate the efficacy and safety of augmented reality training for children with unilateral amblyopia after congenital cataract surgery.

The study plans to enroll 88 participants aged 5 to 12 years who have unilateral amblyopia after congenital cataract surgery. Eligible participants will be randomly assigned in a 1:1 ratio to either the experimental group or the control group. The experimental group will receive augmented reality amblyopia training for 2 hours per day for 4 months. The control group will receive conventional patching of the fellow eye for 4 hours per day for 4 months.

The study includes a screening period, a baseline visit, and follow-up visits after 1 month and 4 months of treatment. The primary outcome is the change from baseline in best-corrected visual acuity of the amblyopic eye, measured in logMAR units, at 4 months. Secondary outcomes include contrast sensitivity, suppression status, stereoacuity, and quality of life assessed using the Chinese version of the PedsQL 4.0 Generic Core Scales. Safety outcomes include computer vision symptoms assessed using the CVSS-6 scale and the incidence of adverse events, including dizziness, headache, eye fatigue, blurred vision, and skin allergy.

The purpose of this trial is to determine whether augmented reality amblyopia training provides superior improvement in visual acuity compared with conventional patching, while also assessing its effects on binocular visual function and treatment safety in this patient population.

• Study Type: Interventional
• Enrollment (Estimated): 88
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ruixin Wang; Phone Number: +86-20-87332702; Email: wangruixin@gzzoc.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Augmented Reality Amblyopia Training; Participants in this arm 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 record training duration, task completion, and adherence data.	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.
Active Comparator: Conventional Patching; Participants in this arm 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Best-Corrected Visual Acuity of the Amblyopic Eye at 4 Months	Best-corrected visual acuity of the amblyopic eye will be measured using the ETDRS visual acuity chart and recorded in logMAR units. The primary outcome is defined as the change from baseline to 4 months, calculated as baseline logMAR BCVA minus 4-month logMAR BCVA. A larger positive value indicates greater visual acuity improvement.	Baseline, 4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Contrast Sensitivity at 1 Month and 4 Months	Contrast sensitivity will be measured using the CSV-1000 test at different spatial frequencies, including 3, 6, 12, and 18 cycles per degree. Changes from baseline to 1 month and 4 months will be evaluated.	Baseline, 4 months
Change From Baseline in Suppression Status at 1 Month and 4 Months	Suppression status will be assessed using the Bagolini striated glasses test and the Worth 4-dot test. The presence or absence of suppression and abnormal retinal correspondence will be recorded and compared across study visits.	Baseline, 4 months
Change From Baseline in Stereoacuity at 1 Month and 4 Months	Stereoacuity will be assessed using the Randot stereotest for distance and near stereoacuity and the Titmus stereotest for near stereoacuity. Improvement will be defined as an improvement of at least one stereoacuity level from baseline or a change from no measurable stereoacuity to measurable stereoacuity.	Baseline, 4 months
Change From Baseline in Quality of Life at 1 Month and 4 Months	Quality of life will be assessed using the Chinese version of the Pediatric Quality of Life Inventory 4.0 Generic Core Scales. The scale includes physical, emotional, social, and school functioning domains. Changes from baseline to 1 month and 4 months will be evaluated.	Baseline, 4 months
Change From Baseline in Computer Vision Symptoms at 1 Month and 4 Months	Computer vision symptoms will be assessed using the CVSS-6 scale. The scale evaluates symptoms including eye fatigue, blurred vision, dry eye sensation, burning or stinging sensation, increased tearing or discharge, and headache. The total score ranges from 0 to 18, with higher scores indicating more severe symptoms.	Baseline, 4 months
Incidence of Adverse Events During the Study	Adverse events will be recorded throughout the study, including dizziness, headache, eye fatigue, blurred vision, skin allergy, and other discomforts. The incidence, severity, management, outcome, and relationship to the study intervention will be documented.	4 months

Collaborators and Investigators

• Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
• Collaborators: Shenzhen Eye Hospital; Zhengzhou Second Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: July 2, 2026
• First Submitted That Met QC Criteria: July 2, 2026
• First Posted (Actual): July 9, 2026

Study Record Updates

• Last Update Posted (Actual): July 9, 2026
• Last Update Submitted That Met QC Criteria: July 2, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Amblyopia; Augmented Reality
• Additional Relevant MeSH Terms: Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Eye Diseases; Vision Disorders; Sensation Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Amblyopia
• Other Study ID Numbers: SQIIT-2026-035

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No