Eye patch showdown: can Full-Time wear beat observation for wandering eyes?
NCT ID NCT05462821
First seen Jun 27, 2026 · Last updated Aug 04, 2026 · Updated 4 times
Summary
This study looked at whether wearing an eye patch full-time can improve control of intermittent exotropia (a type of eye misalignment) in children aged 3 to 9. Over 3 months, researchers compared patching to simply watching and waiting. The goal was to see if patching leads to better eye alignment at a distance.
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
-
73 people
The number who actually took part.
- Started
-
Nov 2022
- Finished
-
May 2025
- 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 8 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 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: Children under the care of a pediatric optometrist or pediatric ophthalmologist will be eligible for the study if they meet all the following criteria: 1. Age 3 to \< 9 years 2. IXT meeting all of the following criteria: * Intermittent or constant XT at distance (mean distance control 2.0 or more) with at least 1 control measure of 3, 4 or 5 (i.e., indicating spontaneous tropia) * Either IXT, exophoria, or orthophoria at near (cannot have control score of 5 on all 3 near assessments) * Distance exodeviation between 15∆ and 50∆ by PACT * Near exodeviation between 0∆ and 50∆ by PACT * Near exodeviation does not exceed distance by more than 10∆ by PACT (convergence insufficiency-type IXT excluded) 3. Age-normal visual acuity in both eyes: * 3 years: 20/50 or better (\>=63 letters) * 4 years: 20/40 or better (\>=68 letters) * 5-6 years: 20/32 or better (\>=73 letters) * 7-\<9 years: 20/25 or better (\>=78 letters) 4. Interocular difference in distance VA of 2 logMAR lines or less (10 letters or less on E-ETDRS for patients ≥7 years old). Testing by ATS HOTV for participants 3 to \< 7 years old and by E-ETDRS for participants ≥7 years old. 5. Cycloplegic refraction within the last 7 months. 6. Refractive error between -6.00 D SE and +2.00 D SE (inclusive) based on a cycloplegic refraction within 7 months 7. Participants with refractive error meeting any of the following based on a cycloplegic refraction within 6 months must be wearing spectacles for at least 2 weeks: * Myopia \> -0.50 D spherical equivalent (SE) in either eye * Anisometropia \> 1.00 D SE * Astigmatism in either eye \> 1.00 D 8. Any refractive correction worn at enrollment (required or not) must meet the following guidelines based on a cycloplegic refraction within 7 months: * Anisometropia SE must be within 0.50 D of the full anisometropic difference correction * Astigmatism must be corrected within 0.50 D * Axis must be within ±10 degrees if cylinder power is ≤1.00 D and within ±5 degrees if cylinder power is \>1.00 D. * For hyperopia, the spherical component can be reduced at investigator discretion provided the reduction is symmetrical and does not meet the definition of deliberate overminus (see below). * For myopia, the intent is to fully correct, but the spherical component can be undercorrected at investigator discretion provided the reduction is symmetrical and results in no more than -0.50 D SE residual (i.e., uncorrected) myopia. Deliberate overminus is not allowed. * Deliberate overminus is defined for this protocol as any refractive correction prescribed to yield lenses that are overminused by more than -0.50D SE than cycloplegic refraction SE * Less than the full cycloplegic hyperopic correction (i.e., prescribing reduced plus) is not considered the same as overminusing for this protocol (because most patients without IXT but with hyperopic SE refractions up to +2.00 D SE would not typically be prescribed a refractive correction.) * For refractive errors with an emmetropic or myopic SE, the intent is to fully correct, but the spherical component can be undercorrected at investigator discretion provided the reduction is symmetrical and results in no more than -0.50 D SE residual (i.e., uncorrected) myopia. Prescribing a correction that yields more than 0.50 D more minus SE than the cycloplegic refraction SE is considered deliberate overminus and is not allowed. * Note that the refractive correction guidelines and the requirement to wear refractive correction for at least 2 weeks apply not only to participants who require refractive correction under the above criteria but also to any other participant who is wearing refractive correction. 9. Gestational age \> 30 weeks 10. Birth weight \> 1500 grams 11. Patient and/or parent understands protocol, is willing to enroll, and is willing to accept that other (i.e., nonrandomized) treatment for IXT will not be offered by the investigator for 3 months 12. Parent has phone and is willing to be contacted by Jaeb Center staff 13. Relocation outside of area of an active PEDIG site within 3 months not anticipated Exclusion Criteria: Individuals meeting any of the following criteria at baseline will be excluded from study participation: 1. Prior strabismus, intraocular, or refractive surgery (including BOTOX injection) 2. Prior nonsurgical treatment for IXT (e.g., patching, vergence therapy, vision therapy/orthoptics, base-in prism, or deliberate overminus (more than 1.00 D) spectacles of \>1week duration within the past year 3. Previous amblyopia treatment other than refractive correction 4. Diplopia more than 2 times per day by parental assessment 5. Paretic or restrictive strabismus 6. Craniofacial malformations affecting the orbits 7. Ocular disorders which would reduce VA (except refractive error) 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 ADHD are not excluded. 9. Neurological anomaly that could affect ocular motility (e.g., cerebral palsy, Down syndrome) 10. Immediate family member (child or sibling) of any investigative site personnel directly affiliated with this study. 11. Known allergy to adhesive patches. 12. Known allergy to silicone.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Intermittent exotropia are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
Contacts and locations
Locations
-
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
-
Arkansas Childrens
Little Rock, Arkansas, 72202, United States
-
Boston Children's Hospital Waltham
Boston, Massachusetts, 02453, United States
-
Boston Medical Center
Boston, Massachusetts, 02118, United States
-
Casey Eye Institute
Portland, Oregon, 97239, United States
-
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, 64108, United States
-
Duke University Eye Center
Durham, North Carolina, 27710, United States
-
Eye Care Associates, Inc.
Poland, Ohio, 44514, 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
-
Mayo Clinic Department of Ophthalmology
Rochester, Minnesota, 55905, United States
-
Michigan College of Optometry at Ferris State Univ
Big Rapids, Michigan, 49307, United States
-
Ohio State University College of Optometry
Columbus, Ohio, 43210-1280, United States
-
Progressive Eye Care
Lisle, Illinois, 60532, United States
-
Salus University/Pennsylvania College of Optometry
Philadelphia, Pennsylvania, 19141, United States
-
Southern California College of Optometry
Fullerton, California, 92831-1699, United States
-
Southern College of Optometry
Memphis, Tennessee, 38104, United States
-
Stanford University
Palo Alto, California, 94303, United States
-
State University of New York, College of Optometry
New York, New York, 10036, United States
-
UAB Pediatric Eye Care; Birmingham Health Care
Birmingham, Alabama, 35294, United States
-
Univ of California, Irvine- Gavin Herbert Eye Institute
Irvine, California, 92697, United States
-
Univ. of California- Berkeley
Berkeley, California, 94720, United States
-
University of Nebraska Medical Center
Omaha, Nebraska, 68114, United States
-
Virginia Pediatric Eye Center
Norfolk, Virginia, 23502, United States
-
Wilmer Eye Institute
Baltimore, Maryland, 21287-9028, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Eye exercises may help children with a wandering eye, a trial puts it to the test
- Can 3D movies on a handheld game system help straighten Kids' eyes?
- Could stronger glasses tame wandering eyes in kids?
- Eye muscle surgery showdown: which fix for wandering eyes works best?
- Eye exercises at home may help control wandering eyes when looking far away
- New study tests best glasses for kids with wandering eyes and nearsightedness