VR headset could replace eye patches for lazy eye in kids

NCT ID NCT06380517

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

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether watching specially designed movies through a virtual reality headset for 1 hour a day, 6 days a week, can improve vision in children with lazy eye (amblyopia) as effectively as the standard treatment of wearing an eye patch for 2 hours daily. The trial involves 238 children aged 4 to 7 years. The goal is to see if the VR approach is a good alternative to patching.

What this could mean

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

Active substance: Luminopia virtual reality headset showing dichoptic movies
What this could lead to: If successful, this could offer a more engaging and convenient alternative to eye patching for treating lazy eye in young children.
What could go wrong: This is a Phase 3 trial, but results may not show non-inferiority to patching. The treatment requires consistent use and may not work for all children.

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 238 people

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

Started

Jul 2024

Expected to finish

Jan 2028

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

4 to 7 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.

At the time of enrollment, individuals must meet all the following inclusion criteria to be eligible to participate in the study. 1. Age 4 to 7 years. 2. Visual acuity, measured in each eye without cycloplegia in current refractive correction (if applicable) using the ATS-HOTV 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. 2. Age-normal VA in the fellow eye:44,45 • 4 years: 20/40 or better; 5-6 years: 20/32 or better; 7 years: 20/25 or better 3. Interocular difference ≥ 3 logMAR lines (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 (see #7 below). * 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 spherical equivalent 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: 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 \<0.1 logMAR 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 the Luminopia headset. 8. Participant is willing to continue full-time spectacles/contact lens wear (if needed). 9. Participant is willing to accept assignment to either dichoptic shows (view 1 hour per day 6 days per week) OR part-time patching (2 hours per day 7 days per week) for 26 weeks. 10. Interpupillary distance of 52mm to 72mm inclusive. 11. Investigator is willing to prescribe Luminopia or patching per protocol. 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. 14. Relocation outside area of active PEDIG site within the next 52 weeks is not anticipated. Individuals meeting any of the following criteria will be excluded from study participation. 1. Heterotropia more than 5∆ at distance or near (measured by SPCT in current correction) 2. Prism lenses or need of a prism prescription at 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. Previous intraocular or refractive surgery. 6. Known skin reactions to patch or bandage adhesives. 7. 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). 8. Diplopia more than once per week over the last week prior to enrollment by parental report. 9. History of light-induced seizures. 10. 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. 11. Participation in a prior study involving patching for amblyopia 12. 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

73 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
Boston Children's Hospital Waltham
RECRUITING

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

Boston, Massachusetts, 02118, United States
Casey Eye Institute
RECRUITING

Portland, Oregon, 97239, United States
Children's Eye Care PC
RECRUITING

West Bloomfield, Michigan, 48322, United States
Children's Hospital of Los Angeles (CHLA)
RECRUITING

Los Angeles, California, 90027, United States
Children's Mercy Hospitals and Clinics
RECRUITING

Kansas City, Missouri, 64108, 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
Corewell Health
RECRUITING

Grand Rapids, Michigan, 49503, United States
Duke University Eye Center
RECRUITING

Durham, North Carolina, 27710, United States
Earl R. Crouch, III
RECRUITING

Norfolk, Virginia, 23502-3942, United States
Eye Care Associates, Inc.
RECRUITING

Poland, Ohio, 44514, United States
Greater Baltimore Medical Center
RECRUITING

Baltimore, Maryland, 21204-5809, United States
Gundersen Health System
RECRUITING

La Crosse, Wisconsin, 54601, United States
Illinois College of Optometry
RECRUITING

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

Bloomington, Indiana, 47405, United States
Jules Stein Eye Institute at the University of California, Los Angeles
RECRUITING

Los Angeles, California, 90095, 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
Ohio State University College of Optometry
RECRUITING

Columbus, Ohio, 43210-1280, United States
Pediatric Ophthalmology Associates, Inc.
RECRUITING

Columbus, Ohio, 43205, United States
Pediatric Ophthalmology of Erie
RECRUITING

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

Grand Rapids, Michigan, 49546, United States
Pennsylvania College of Optometry, Salus at Drexel University
RECRUITING

Philadelphia, Pennsylvania, 19141, United States
Phoenix Children's Medical Group - Ophthalmology
RECRUITING

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

Sartell, Minnesota, 56377, United States
Prisma Health
RECRUITING

Columbia, South Carolina, 29203, United States
Progressive Eye Care
RECRUITING

Lisle, Illinois, 60532, United States
Rady Children's Hospital - San Diego Dept of Ophthalmology
RECRUITING

San Diego, California, 92123, United States
Rainbow Babies and Children's Hospital Dept of Ophth
RECRUITING

Mayfield Heights, Ohio, 44124, United States
Ross Eye Institute, University of Buffalo, Med School Dept Ophthalmology
RECRUITING

Buffalo, New York, 14209, United States
Seattle Children's Hospital, University of Washington
RECRUITING

Seattle, Washington, 98105, United States
Southern California College of Optometry
RECRUITING

Fullerton, California, 92831-1699, United States
Southern College of Optometry
RECRUITING

Memphis, Tennessee, 38104, United States
Specialized Pediatric Eye Care
RECRUITING

Beverly, Massachusetts, 01915, 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
Texas Children's Hospital - Dept. Of Ophthalmology
RECRUITING

Houston, Texas, 77030, United States
Texas Tech University Health Science Center
RECRUITING

Lubbock, Texas, 79430, United States
The Emory Eye Center
RECRUITING

Atlanta, Georgia, 30322, 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 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 Iowa
RECRUITING

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

Prairie Village, Kansas, 66208, United States
University of Michigan
RECRUITING

Ann Arbor, Michigan, 48105, United States
University of Minnesota
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
University of the Incarnate Word
RECRUITING

San Antonio, Texas, 78209, United States
Vanderbilt Children's Hospital
RECRUITING

Nashville, Tennessee, 37232-8808, 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
Yale University
RECRUITING

New Haven, Connecticut, 06511, United States
Zenith Vision Development Center
RECRUITING

Duluth, Minnesota, 55811, United States

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