Lazy eye study tests best order for glasses and patching

NCT ID NCT04378790

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

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at the best way to treat lazy eye (amblyopia) in children aged 3 to under 13. Some children get glasses and an eye patch at the same time, while others start with glasses alone and add patching later if needed. The goal is to see if both approaches lead to similar vision improvement. About 544 children will take part.

What this could mean

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

Active substance: Glasses and eye patch
What this could lead to: If successful, this could show that starting both treatments at once is just as effective, potentially simplifying care for children with lazy eye.
What could go wrong: This is a large phase 3 trial, but it compares timing of existing treatments, not a new cure. Results may not apply to all types of amblyopia.

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 544 people

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

Started

Dec 2020

Expected to finish

May 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

3 to 13 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 3 to \<13 years at the time of randomization 2. Amblyopia associated with anisometropia, strabismus, or both o 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) * Documented history of strabismus which is no longer present (which in the judgment of the investigator could have caused amblyopia) * 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 * 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 previous treatment for amblyopia, including no more than 24 hours of spectacle wear. 4. Investigator planning to initiate spectacle correction of refractive error meeting the following criteria based on a cycloplegic refraction that has been performed within 30 days: 1. Full correction of anisometropia 2. Full correction of astigmatism with the same axis found by the cycloplegic refraction 3. Full correction of any myopia 4. Hyperopia must not be under corrected by more than 1.50 D, and reduction in plus sphere must be symmetric in the two eyes. 5. At enrollment, single VA measured in each eye assessed in trial frames with the spectacle correction the investigator plans to prescribe, using the investigator's routine method as follows: * VA in the amblyopic eye 20/40 to 20/200 inclusive. * Age-normal VA in the fellow eye:40,41 * 3 years: 0.4 logMAR (20/50) or better * 4 years: 0.3 logMAR (20/40) or better * 5-6 years: 0.2 logMAR (20/32) or better * 7-12 years: 0.12 logMAR (78 letters) or better * Interocular difference ≥ 3 logMAR lines (0.3 logMAR) or ≥ 15 letters o When participants return for the Spectacle Baseline / Randomization Visit with their new spectacles, they will need to meet the same criteria as above using the ATS-HOTV or E-ETDRS protocol after wearing the new spectacles for at least 10 minutes (based upon the mean of a test and retest of VA in those new spectacles). 6. Investigator is willing to prescribe spectacle wear followed sequentially by patching or simultaneous spectacles and patching treatment per protocol. 7. Parent understands the protocol and is willing to accept randomization. 8. Parent has phone (or access to phone) and is willing to be contacted by Jaeb Center staff or other study staff. 9. Relocation outside of area of an active PEDIG site for this study within the next 56 weeks is not anticipated. Exclusion Criteria: 1. Myopia greater than -6.00 D spherical equivalent in either eye. 2. Previous intraocular or refractive surgery. 3. Planned strabismus surgery in the next 56 weeks. 4. Any previous treatment for amblyopia (patching, atropine, Bangerter filter, vision therapy, or binocular treatment). 5. Previous spectacle or contact lens wear for more than 24 hours. 6. Parent and participant willing to forego option of contact lens wear for the duration of the study. 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 VA criteria are met). 8. 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 or attention deficit hyperactivity disorder (ADHD) are not excluded. 9. Known allergy to adhesive patches. 10. Known allergy to silicone.

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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

68 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

Akron Children's Hospital
RECRUITING

Akron, Ohio, 44308, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
RECRUITING

Chicago, Illinois, 60611, United States
Arizonia Pediatric Eye Specialists
RECRUITING

Phoenix, Arizona, 85006, 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
Casey Eye Institute
RECRUITING

Portland, Oregon, 97239, 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
Cincinnati Children's Hospital
RECRUITING

Cincinnati, Ohio, 45229, United States
Conestoga Eye
RECRUITING

Lancaster, Pennsylvania, 17601, United States
Corewell Health
RECRUITING

Grand Rapids, Michigan, 49503, United States
Dean A. McGee Eye Institute
RECRUITING

Oklahoma City, Oklahoma, 73104, United States
Duke University Eye Center
RECRUITING

Durham, North Carolina, 27710, United States
Eye Physicians & Surgeons, PC
RECRUITING

Milford, Connecticut, 06460, United States
Indiana School of Optometry
RECRUITING

Bloomington, Indiana, 47405, United States
Indiana University School of Optometry
RECRUITING

Indianapolis, Indiana, 47405, United States
Loma Linda University Health Care, Dept. of Ophthalmology
RECRUITING

Loma Linda, California, 92354, United States
Marshall B. Ketchum University
RECRUITING

Fullerton, California, 92831, United States
Mayo Clinic
RECRUITING

Rochester, Minnesota, 55905, United States
Midwestern U Chicago College of Optometry
RECRUITING

Downers Grove, Illinois, 60515, United States
Midwestern University Eye Institute
RECRUITING

Glendale, Arizona, 85308, United States
NYU Langone Health
RECRUITING

New York, New York, 10017, United States
Nemours Children's Clinic
RECRUITING

Jacksonville, Florida, 32207, United States
Nova Southeastern University College of Optometry, The Eye Institute
RECRUITING

Fort Lauderdale, Florida, 33382, United States
Ohio State University College of Optometry
RECRUITING

Columbus, Ohio, 43210-1280, United States
Pediatric Eye Specialists, LLP
RECRUITING

Fort Worth, Texas, 76014, United States
Pediatric Ophthalmology of Erie
RECRUITING

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

Grand Rapids, Michigan, 49546, 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
River View Family Eyecare
RECRUITING

Albany, Oregon, 97321, United States
Rocky Mountain Eye Care Associates
RECRUITING

Salt Lake City, Utah, 84107, United States
Ross Eye Institute, University of Buffalo, Med School Dept Ophthalmology
RECRUITING

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

Seattle, Washington, 98105, United States
Snowy Range Vision Center
RECRUITING

Laramie, Wyoming, 82070, United States
Southern College of Optometry
RECRUITING

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

Spokane, Washington, 99204, United States
St Luke's Hospital
RECRUITING

Boise, Idaho, 83702, United States
St. Louis Children's Hospital Eye Center
RECRUITING

St Louis, Missouri, 63110, 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
Texas Tech University Health Science Center
RECRUITING

Lubbock, Texas, 79430, United States
Ticho Eye Associates
RECRUITING

Chicago Ridge, Illinois, 60415, United States
U of MO St. Louis College of Optometry
RECRUITING

St Louis, Missouri, 63121, United States
UAB Pediatric Eye Care; Birmingham Health Care
RECRUITING

Birmingham, Alabama, 35294, United States
UPMC Children's Eye Center of Children's Hospital of Pittsburgh
RECRUITING

Pittsburgh, Pennsylvania, 15224, 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 Alabama at Birmingham
RECRUITING

Birmingham, Alabama, 35294, 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 Incarnate Word Rosenberg School of Optometry
RECRUITING

San Antonio, Texas, 78229, 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 South Florida (USF) Eye
RECRUITING

Tampa, Florida, 33620, United States
University of the Incarnate Word
RECRUITING

San Antonio, Texas, 78209, United States
Vanderbilt University Medical Center - Vanderbilt Eye Institute
RECRUITING

Nashville, Tennessee, 37232, 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
Wolfe Eye Clinic
RECRUITING

West Des Moines, Iowa, 50266, United States
Zenith Vision Development Center
RECRUITING

Duluth, Minnesota, 55811, United States

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