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Video game therapy shows promise for lazy eye in kids

NCT ID NCT02983552

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 09, 2026 · Last updated Jul 10, 2026 · Updated 1 time

Summary

This trial tests whether playing a binocular 'Dig Rush' game on an iPad for one hour a day, five days a week, can improve vision in children aged 4 to 13 with amblyopia (lazy eye). Participants wear glasses and are randomly assigned to either play the game or receive glasses alone. The study measures changes in visual acuity after four weeks.

What this could mean

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

Active substance
Binocular Dig Rush iPad game
What this could lead to
If it works, this could offer a fun, non-invasive treatment option for lazy eye in children, potentially reducing the need for patching or eye drops.
What could go wrong
This is a relatively early study, and the improvement may be modest or no better than glasses alone. The game requires daily commitment, and results may vary by age and severity.

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

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

320 people

The number who actually took part.

Started

Mar 2017

Finished

Jul 2020

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 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 4 to \<13 years 2. 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 or without optical correction, must be no more than 5pd by SPCT at near fixation (see #6 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 * ≥1.50 D difference in astigmatism between corresponding meridians in the two eyes 3. Criteria for combined-mechanism amblyopia: Both of the following criteria must be met: * Criteria for strabismus are 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 3. No amblyopia treatment other than optical correction in the past 2 weeks (patching, atropine, Bangerter, vision therapy, binocular treatment) 4. Requirements for required refractive error correction (based on a cycloplegic refraction completed within the last 7 months): * Hypermetropia of 2.50 D or more by spherical equivalent (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: Subjects with cycloplegic refractive errors that do not fall within the requirements above for spectacle correction may be given spectacles at investigator discretion but must follow the study-specified prescribing guidelines, as detailed below. 1. Spectacle prescribing instructions referenced to the cycloplegic refraction completed within the last 7 months: * SE must be within 0.50D of fully correcting the anisometropia. * SE must not be under corrected by more than 1.50D SE, and reduction in plus sphere must be symmetric in the two eyes. * 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 undercorrected 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. Spectacle correction meeting the above criteria must be worn: * For at least 16 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 8 weeks apart). * For determining VA stability (non-improvement): * The first of two measurements may be made 1) in current spectacles, 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 that have been worn for at least 8 weeks. * Note: since this determination is a pre-study procedure, the method of measuring VA is not mandated. 5. VA, measured in each eye without cycloplegia in current spectacle correction (if applicable) within 7 days prior to randomization using the ATS-HOTV VA protocol for children \< 7 years and the E-ETDRS VA protocol for children ≥ 7 years on a study-approved device displaying single surrounded optotypes, as follows: 1. VA in the amblyopic eye 20/40 to 20/200 inclusive (ATS-HOTV) or 33 to 72 letters (E-ETDRS) 2. VA in the fellow eye 20/25 or better (ATS-HOTV) or ≥ 78 letters (E-ETDRS) 3. Interocular difference ≥ 3 logMAR lines (ATS-HOTV) or ≥ 15 letters (E-ETDRS) 6. Heterotropia with a near deviation of ≤ 5∆ (measured by SPCT) in habitual correction (Angles of ocular deviation \>5∆ are not allowed because large magnitudes of the deviation would compromise successful playing of the game.) 7. Subject is able to play the Dig Rush game (at least level 3) on the study iPad under binocular conditions (with red-green glasses). Subject must be able to see both the red "diggers" and blue "gold carts" when contrast for the non-amblyopic eye is at 20%. 8. Investigator is willing to prescribe computer game play, or continued spectacle wear per protocol. 9. Parent understands the protocol and is willing to accept randomization. 10. Parent has phone (or access to phone) and is willing to be contacted by Jaeb Center staff or other study staff. 11. Relocation outside of area of an active PEDIG site for this study within the next 8 weeks is not anticipated. Exclusion Criteria: 1. Prism in the spectacle correction at time of enrollment (eligible only if prism is discontinued 2 weeks prior to enrollment). 2. Myopia greater than -6.00D spherical equivalent in either eye. 3. Previous intraocular or refractive surgery. 4. Any treatment for amblyopia (patching, atropine, Bangerter filter, vision therapy or previous binocular treatment) during the past 2 weeks. Previous amblyopia therapy is allowed regardless of type, but must be discontinued at least 2 weeks prior to enrollment. 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 subject if the above VA criteria are met). 6. No Down syndrome or cerebral palsy 7. No severe developmental delay that would interfere with treatment or evaluation (in the opinion of the investigator). Subjects with mild speech delay or reading and/or learning disabilities are not excluded. 8. Subject has demonstrated previous low compliance with binocular treatment and/or spectacle treatment (as assessed informally by the investigator)

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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

Contacts and locations

Locations

  • Advanced Vision Center

    Schaumburg, Illinois, 60194, United States

  • Alberta Children's Hospital

    Calgary, Alberta, Canada

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

    Chicago, Illinois, 60611, United States

  • Boston Children's Hospital

    Boston, Massachusetts, 02115, United States

  • Children's Mercy Hospitals and Clinics

    Kansas City, Missouri, 64108, United States

  • Cincinnati Children's Hospital

    Cincinnati, Ohio, 45229, United States

  • Concord Ophthalmologic Associates

    Concord, New Hampshire, 03301, United States

  • Conestoga Eye

    Lancaster, Pennsylvania, 17601, United States

  • Dean A. McGee Eye Institute, University of Oklahoma

    Oklahoma City, Oklahoma, 73104, United States

  • Duke University Eye Center

    Durham, North Carolina, 27710, United States

  • Eye Care Associates, Inc.

    Poland, Ohio, 44514, United States

  • Greater Baltimore Medical Center

    Baltimore, Maryland, 21204-5809, United States

  • Helen DeVos Children's Hospital Pediatric Ophthalmology

    Grand Rapids, Michigan, 49503, United States

  • Houston Eye Associates

    The Woodlands, Texas, 77381, United States

  • Illinois College of Optometry

    Chicago, Illinois, 60616, United States

  • Indiana School of Optometry

    Bloomington, Indiana, 47405, United States

  • Loma Linda University Health Care, Dept. of Ophthalmology

    Loma Linda, California, 92354, United States

  • Marshall University

    Huntington, West Virginia, 25755, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Michael F. Gallaway, O.D., P.C.

    Marlton, New Jersey, 08053, United States

  • Michigan College of Optometry at Ferris State Univ

    Big Rapids, Michigan, 49307, United States

  • Midwestern University Eye Institute

    Glendale, Arizona, 85308, United States

  • Northwest Pediatric Ophthalmology, P.S.

    Spokane, Washington, 99202, United States

  • Nova Southeastern University College of Optometry, The Eye Institute

    Fort Lauderdale, Florida, 33382, United States

  • OHSU Casey Eye Institute

    Portland, Oregon, 97239, United States

  • Pacific University College of Optometry

    Portland, Oregon, 97205, United States

  • Pediatric Eye Associates

    Wilmette, Illinois, 60091, United States

  • Pediatric Eye Specialists

    Chattanooga, Tennessee, 37421, United States

  • Pediatric Ophthalmology Associates, Inc.

    Columbus, Ohio, 43205, United States

  • Pediatric Ophthalmology of Erie

    Erie, Pennsylvania, 16501, United States

  • Pediatric Ophthalmology, P.C.

    Grand Rapids, Michigan, 49546, United States

  • Progressive Eye Care

    Lisle, Illinois, 60532, United States

  • Saddleback Eye Medical Associates

    Mission Viejo, California, 92691, United States

  • Saint Louis University Institute

    St Louis, Missouri, 63103, United States

  • San Antonio Eye Center

    San Antonio, Texas, 78215, United States

  • Seattle Children's Hospital, University of Washington

    Seattle, Washington, 98105, United States

  • Snowy Range Vision Center

    Laramie, Wyoming, 82070, United States

  • Southern College of Optometry

    Memphis, Tennessee, 38104, United States

  • Spokane Eye Clinical Research

    Spokane, Washington, 99204, United States

  • St Luke's Hospital

    Boise, Idaho, 83702, United States

  • St. Louis Children's Hospital Eye Center

    St Louis, Missouri, 63110, United States

  • State University of New York, College of Optometry

    New York, New York, 10036, United States

  • Texas Children's Hospital - Dept. Of Ophthalmology

    Houston, Texas, 77030, United States

  • Texas Tech University Health Science Center

    Lubbock, Texas, 79430, United States

  • The Emory Eye Center

    Atlanta, Georgia, 30322, United States

  • The Ohio State University College of Optometry

    Columbus, Ohio, 43210-1280, United States

  • Ticho Eye Associates

    Chicago Ridge, Illinois, 60415, United States

  • U of MO St. Louis College of Optometry

    St Louis, Missouri, 63121, United States

  • UAB Pediatric Eye Care; Birmingham Health Care

    Birmingham, Alabama, 35294, United States

  • University Eye Center at Ketchum Health

    Anaheim, California, 92807, United States

  • University of Florida Shands Hospital

    Gainesville, Florida, 32608, United States

  • University of Houston College of Optometry

    Houston, Texas, 77204, United States

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242, United States

  • University of Minnesota-Minnesota Lions Children's Eye Clinic

    Minneapolis, Minnesota, 55454, United States

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68114, United States

  • University of North Carolina

    Chapel Hill, North Carolina, 27599-7040, United States

  • University of Wisconsin, University Station

    Madison, Wisconsin, 53705, United States

  • Virginia Pediatric Eye Center

    Norfolk, Virginia, 23502, United States

  • Western University College of Optometry

    Pomona, California, 91766, United States

  • Wilmer Eye Institute

    Baltimore, Maryland, 21287, United States

  • Wolfe Eye Clinic

    West Des Moines, Iowa, 50266, United States

  • Yale University

    New Haven, Connecticut, 06511, United States

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