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Eye patch showdown: can Full-Time wear beat observation for wandering eyes?

NCT ID NCT05462821

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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

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.

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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

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Other studies related to the condition(s) this trial covers.