Video Game-Like therapy could replace eye patches for lazy eye in kids
NCT ID NCT07693790
First seen Jul 09, 2026 · Last updated Jul 10, 2026 · Updated 1 time
Summary
This study tests whether augmented reality (AR) training can help children aged 5 to 12 who have lazy eye (amblyopia) after congenital cataract surgery. Participants use an AR headset for 2 hours daily for 4 months, playing visual games designed to strengthen the weaker eye. The results will be compared to standard treatment—patching the stronger eye for 4 hours daily. The main goal is to see if AR training improves vision more than patching.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Augmented Reality Amblyopia Training (device)
- What this could lead to
- If it works, this could offer a more engaging and effective alternative to eye patching for children with lazy eye after cataract surgery.
- What could go wrong
- This is a relatively small trial (88 children) and the technology is new. It may not prove superior to patching, and long-term effects are unknown.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 88 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Jan 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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5 to 12 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
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The official record
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A doctor treating you
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