Augmented Reality Training for Amblyopia After Congenital Cataract Surgery (NCT07693790) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Augmented Reality Training for Amblyopia After Congenital Cataract Surgery
88 participantsStarted 2026-07-01
Plain-language 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.
Who can participate
Age range
5 Years – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Aged 5 to 12 years, male or female.
. Diagnosed with unilateral amblyopia after congenital cataract surgery.
. 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.
. Underwent cataract extraction at age ≤5 years and has stable ocular status at least 2 months after intraocular lens implantation.
. If refractive error is present, optical correction has been worn for at least 3 months.
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change From Baseline in Best-Corrected Visual Acuity of the Amblyopic Eye at 4 Months
Timeframe: Baseline, 4 months
Trial details
NCT IDNCT07693790
SponsorZhongshan Ophthalmic Center, Sun Yat-sen University
. Able to understand the study procedures, and written informed consent is obtained from the participant and/or legal guardian as required.
Exclusion criteria
. Childhood cataract caused by causes other than congenital cataract, including traumatic, drug-induced, steroid-related, secondary, or metabolic cataract.
. 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.
. 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.
. 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.
. 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.
. 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.
. Facial trauma, craniofacial deformity, or head and facial structural abnormality that may affect normal wearing, positioning, or safe use of the augmented reality device.
. Severe psychiatric, cognitive, developmental, or behavioral disorder that may prevent understanding of study procedures, completion of training, or follow-up.