An interventional study of Augmented Reality Amblyopia Training and Conventional Patching in Deprivation Amblyopia and Congenital Cataract, sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University. Not yet recruiting. Open to participants aged 5 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-07-09.
Sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University · Not applicable, Interventional, and Treatment
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.
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.
189 studies on the registry are indexed under Amblyopia; 41 are open to participants now.
This study's planned enrollment of 88 is above the median of 60 across 137 interventional studies indexed under Amblyopia.
Browse Amblyopia studies →Zhongshan Ophthalmic Center, Sun Yat-sen University is the lead sponsor of 164 studies on the registry; 80 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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 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.
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.
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.
Time frame: Baseline, 4 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 4 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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