VR video games could be the new treatment for lazy eye in children

NCT ID NCT06524882

Disease control Sponsor: Jaeb Center for Health Research Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tests whether playing special video games or watching movies through a virtual reality headset can improve vision in children aged 8 to 12 with amblyopia (lazy eye). About 252 kids will be randomly assigned to use one of two VR treatments or just wear glasses. The main goal is to see if the VR treatments improve vision more than glasses alone after 18 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Vivid Vision (VR dichoptic video games) and Luminopia (VR dichoptic movies/shows)
What this could lead to: If successful, this could offer a non-invasive, engaging treatment option for older children with amblyopia, potentially improving vision without eye patches or drops.
What could go wrong: This is a Phase 3 trial, but the treatment is still experimental. It may not work for all children, and the improvement in vision might be modest. The novelty of VR could also affect adherence.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 252 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

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

8 to 12 years

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age 8 to \<13 years. 2. VA, measured in each eye without cycloplegia in current refractive correction (if applicable) using the E-ETDRS VA protocol on a study-approved device displaying single surrounded optotypes, as follows: 1. VA in the amblyopic eye 20/40 to 20/200 inclusive (33 to 72 letters with E-ETDRS). 2. VA in the fellow eye 20/25 or better (≥ 78 letters with E-ETDRS). 3. Interocular difference ≥ 3 logMAR lines (≥ 15 letters) i.e., amblyopic eye VA at least 3 logMAR lines worse than fellow eye VA). 3. Amblyopia associated with strabismus, anisometropia, or both (previously treated or untreated). 1. Criteria for strabismic amblyopia: At least one of the following must be met: * Presence of a heterotropia on examination at distance or near fixation (with optical correction), must be \<=5 prism diopters (∆) by SPCT at distance and near fixation. * Documented history of strabismus which is no longer present (which in the judgment of the investigator could have caused amblyopia). 2. Criteria for anisometropia: At least one of the following criteria must be met: * ≥1.00 D difference between eyes in spherical equivalent (SE). * ≥1.50 D difference in astigmatism between corresponding meridians in the two eyes. 3. Criteria for combined-mechanism: Both of the following criteria must be met: * A criterion for strabismus is met (see above). * ≥1.00 D difference between eyes in SE OR ≥1.50 D difference in astigmatism between corresponding meridians in the two eyes. 4. No more than 2 weeks (cumulative) of prior dichoptic treatment 5. No treatment with cycloplegic eyedrops (e.g., atropine) in the past 2 weeks; other treatments allowed up to enrollment but then must be discontinued. 6. Refractive correction is required (single vision lenses or contact lenses) for any of the following refractive errors based on a cycloplegic refraction completed within the last 7 months: * Hypermetropia of 2.50 D or more by SE * Myopia of amblyopic eye of 0.50D or more SE * Astigmatism of 1.00D or more * Anisometropia of more than 0.50D SE NOTE: Children with cycloplegic refractive errors that do not fall within the requirements above for refractive correction may be given refractive correction at investigator discretion but must follow the study-specified prescribing guidelines, as detailed below. NOTE: Monocular or binocular contact lens wear is allowed provided the contact lenses meet the refractive error correction requirements below. For each child, all testing must be performed using the same form of optical correction (i.e., no changing between contacts and spectacles). 1. Spectacles/contact lens correction prescribing instructions referenced to the cycloplegic refraction completed within the last 7 months: * SE must be within 0.50D of fully correcting the anisometropia (if new glasses are prescribed, reduction in plus sphere must be symmetric in the two eyes). * SE must not be under corrected by more than 1.50D SE. * Cylinder power in both eyes must be within 0.50D of fully correcting the astigmatism. * Axis must be within +/- 10 degrees if cylinder power is ≤1.00D, and within +/- 5 degrees if cylinder power is \>1.00D. * Myopia must not be under corrected by more than 0.25D or over corrected by more than 0.50D SE, and any change must be symmetrical in the two eyes. 2. Spectacles/contact lens correction (with or without other treatment such as patching) meeting the above criteria must be worn: * For at least 18 weeks OR until VA stability is documented (defined as \<1-line change by the same testing method measured on 2 consecutive exams at least 9 weeks apart). * For determining VA stability (non-improvement): * The first of two measurements may be made 1) in current correction, or 2) in trial frames with or without cycloplegia or 3) without correction (if new correction is prescribed), * The second measurement must be made without cycloplegia in the correct spectacles/contact lens correction that has been worn for at least 9 weeks. * NOTE: Because this determination is a pre-randomization, the method of measuring VA is not mandated. 7. Participant is willing to wear a headset. 8. Participant is willing to continue full-time spectacles/contact lens wear (if needed). 9. Interpupillary distance of 52mm to 72mm inclusive. 10. Investigator is willing to prescribe continued spectacles/contact lens correction (if needed) or either dichoptic device per protocol. 11. Participant is willing to accept assignment to either continued spectacles/ contact lens wear alone, dichoptic movies/shows (view 1 hour per day 6 days per week) OR dichoptic games (play approximately 25 minutes per day, 6 days per week) for 19 weeks. 12. Parent understands the protocol and is willing to accept randomization. 13. Parent has phone (or access to phone) and is willing to be contacted by JAEB Center staff. 14. Relocation outside of area of an active PEDIG site for this study within the next 36 weeks is not anticipated. Exclusion Criteria: 1. Heterotropia more than 5∆ at distance or near (measured by SPCT in current correction) 2. Prism greater than a total of 8 diopters horizontal and 1 diopter vertical in the refractive correction at time of enrollment. 3. Current bifocal spectacles (eligible only if bifocal discontinued 2 weeks prior to enrollment). 4. Myopia greater than -6.00D spherical equivalent in either eye. 5. Ocular co-morbidity that may reduce VA determined by an ocular examination performed within the past 7 months (Note: nystagmus per se does not exclude the participant if the above visual acuity criteria are met using patch occlusion. Fogging is not permitted). 6. Diplopia more than once per week over the last week prior to enrollment by parental report. 7. History of light-induced seizures. 8. Known simulator sickness. 9. Severe developmental delay that would interfere with treatment or evaluation (in the opinion of the investigator). Participants with mild speech delay or reading and/or learning disabilities are not excluded. 10. Immediate family member (biological or legal guardian, child, sibling, parent) of investigative site personnel directly affiliated with this study or an employee of the JAEB center for Health Research.

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Conditions

The condition(s) this trial relates to.

amblyopia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Amblyopia

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

58 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

Ann & Robert H. Lurie Children's Hospital of Chicago
RECRUITING

Chicago, Illinois, 60611, United States
Arkansas Childrens
RECRUITING

Little Rock, Arkansas, 72202, United States
Baylor College of Medicine
RECRUITING

Houston, Texas, 77030, United States
Boston Children's Hospital Waltham
RECRUITING

Boston, Massachusetts, 02453, United States
Boston Medical Center
RECRUITING

Boston, Massachusetts, 02118, United States
Children's Mercy Hospitals and Clinics
RECRUITING

Kansas City, Missouri, 64108, United States
Cincinnati Children's Hospital
RECRUITING

Cincinnati, Ohio, 45229, United States
Cole Eye Institute
RECRUITING

Cleveland, Ohio, 44195, United States
Conestoga Eye
RECRUITING

Lancaster, Pennsylvania, 17601, United States
Duke University Eye Center
RECRUITING

Durham, North Carolina, 27710, United States
Greater Baltimore Medical Center
RECRUITING

Baltimore, Maryland, 21204-5809, United States
Illinois College of Optometry
RECRUITING

Chicago, Illinois, 60616, United States
Indiana School of Optometry
RECRUITING

Bloomington, Indiana, 47405, United States
Mayo Clinic Department of Ophthalmology
RECRUITING

Rochester, Minnesota, 55905, United States
McFarland Eye Care Center
RECRUITING

Little Rock, Arkansas, 72205, United States
Michigan College of Optometry at Ferris State Univ
RECRUITING

Big Rapids, Michigan, 49307, United States
Midwestern University Eye Institute
RECRUITING

Glendale, Arizona, 85308, United States
Midwestern University Eye Institute
RECRUITING

Downers Grove, Illinois, 60515, United States
NYU Langone Health
RECRUITING

New York, New York, 10017, United States
New England College of Optometry
RECRUITING

Boston, Massachusetts, 02115, United States
Nova Southeastern University College of Optometry, The Eye Institute
RECRUITING

Fort Lauderdale, Florida, 33382, United States
OHSU Casey Eye Institute
RECRUITING

Portland, Oregon, 97239, United States
Ohio State University College of Optometry
RECRUITING

Columbus, Ohio, 43210-1280, United States
Pediatric Ophthalmology of Erie
RECRUITING

Erie, Pennsylvania, 16501, United States
Pediatric Ophthalmology, P.C.
RECRUITING

Grand Rapids, Michigan, 49546, United States
Phoenix Children's Medical Group - Ophthalmology
RECRUITING

Scottsdale, Arizona, 85255, United States
PineCone Vision Center
RECRUITING

Sartell, Minnesota, 56377, United States
Progressive Eye Care
RECRUITING

Lisle, Illinois, 60532, United States
Rainbow Babies and Children's Hospital Dept of Ophth
RECRUITING

Mayfield Heights, Ohio, 44124, United States
River View Family Eyecare
RECRUITING

Albany, Oregon, 97321, United States
Salus University/Pennsylvania College of Optometry
RECRUITING

Philadelphia, Pennsylvania, 19141, United States
San Antonio Eye Center
RECRUITING

San Antonio, Texas, 78215, United States
Southern College of Optometry
RECRUITING

Memphis, Tennessee, 38104, United States
Spokane Eye Clinical Research
RECRUITING

Spokane, Washington, 99204, United States
Stanford University
RECRUITING

Palo Alto, California, 94303, United States
State University of New York, College of Optometry
RECRUITING

New York, New York, 10036, United States
Storm Eye Institute
RECRUITING

Mt. Pleasant, South Carolina, 29464, United States
UAB Pediatric Eye Care; Birmingham Health Care
RECRUITING

Birmingham, Alabama, 35294, United States
Univ of California, Irvine- Gavin Herbert Eye Institute
RECRUITING

Irvine, California, 92697, United States
Univ. of California- Berkeley
RECRUITING

Berkeley, California, 94720, United States
University Eye Center at Ketchum Health
RECRUITING

Anaheim, California, 92807, United States
University of Arizona
RECRUITING

Tucson, Arizona, 85711, United States
University of California San Francisco Department of Ophthalmology
RECRUITING

San Francisco, California, 94143, United States
University of California, Davis
RECRUITING

Sacramento, California, 95817, United States
University of Houston - College of Optometry
RECRUITING

Houston, Texas, 77204, United States
University of Houston College of Optometry
RECRUITING

Houston, Texas, 77204, United States
University of Iowa
RECRUITING

Iowa City, Iowa, 52242, United States
University of Kansas Dept of Ophthalmology
RECRUITING

Prairie Village, Kansas, 66208, United States
University of Minnesota-Minnesota Lions Children's Eye Clinic
RECRUITING

Minneapolis, Minnesota, 55454, United States
University of Nebraska Medical Center
RECRUITING

Omaha, Nebraska, 68114, United States
University of North Carolina
RECRUITING

Chapel Hill, North Carolina, 27599, United States
University of North Dakota
RECRUITING

Grand Forks, North Dakota, 58202, United States
University of South Florida (USF) Eye
RECRUITING

Tampa, Florida, 33620, United States
Virginia Pediatric Eye Center
RECRUITING

Norfolk, Virginia, 23502, United States
Western University College of Optometry
RECRUITING

Pomona, California, 91766, United States
Wills Eye Hospital
RECRUITING

Philadelphia, Pennsylvania, 19107, United States
Wilmer Eye Institute
RECRUITING

Baltimore, Maryland, 21287-9028, United States
Zenith Vision Development Center
RECRUITING

Duluth, Minnesota, 55811, United States

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