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Could stronger glasses tame wandering eyes in kids?

NCT ID NCT02807350

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 compares overminus spectacles (glasses with extra focusing power) to standard glasses in children aged 3 to 11 with intermittent exotropia, a condition where one eye occasionally drifts outward. The goal is to see if overminus lenses improve eye control over 12 months of wear and whether any benefit lasts after stopping treatment. The study involves 386 participants and measures eye alignment using a standard scoring system.

What this could mean

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

Active substance
Overminus spectacles
What this could lead to
If effective, overminus glasses could offer a non-surgical way to better control eye drifting in children with intermittent exotropia.
What could go wrong
This is a mid-stage trial; results may show no lasting benefit after treatment stops, and overminus glasses can cause eye strain or blurred vision.

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

386 people

The number who actually took part.

Started

Jan 2017

Finished

Feb 2022

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 10 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: * Age 3 years to \< 11 years * Intermittent exotropia (manifest deviation) meeting all of the following criteria: * At distance: intermittent exotropia or constant exotropia o Mean distance control score of 2 points or more (mean of 3 assessments over the exam) * At near: intermittent exotropia, exophoria, or orthophoria o Subject cannot have a score of 5 points on all 3 near assessments of control * Exodeviation at least 15∆ at distance measured by PACT * Near deviation does not exceed distance deviation by more than 10∆ by PACT (convergence insufficiency type IXT excluded) * Distance visual acuity (any optotype method) in each eye of 0.4 logMAR (20/50) or better if age 3 years and 0.3 logMAR (20/40) or better if 4 years or older. * Interocular difference of distance visual acuity ≤0.2 logMAR (2 lines on a logMAR chart) * Refractive error between -6.00 diopters (D) standard error (SE) and +1.00D SE (inclusive) in the most myopic / least hyperopic eye based on a cycloplegic refraction performed within the past 2 months or at the end of the enrollment exam. * If refractive error (based on cycloplegic refraction performed within past 2 months or at the end of the enrollment exam) meets any of the following criteria, then pre-study spectacles are required and must have been worn for at least 1 week prior to enrollment: * SE anisometropia ≥1.00D * Astigmatism ≥1.50D in either eye * SE myopia ≥-1.00D in either eye Pre-study refractive correction, if worn, must meet the following criteria relative to the cycloplegic refraction performed within past 2 months or at the end of the enrollment exam: * SE anisometropia must be corrected within \<1.00D of the SE anisometropic difference * Astigmatism must be corrected within \<1.00D of full magnitude; axis must be within 10 degrees. * The SE of the spectacles must not meet the definition of substantial overminus (see exclusion criteria below) * Gestational age ≥ 32 weeks * Birth weight \> 1500 grams * Parent understands the protocol and is willing to accept randomization to overminus spectacles or non-overminus spectacles * Parent has home phone (or access to phone) and is willing to be contacted by Jaeb Center staff and Investigator's site staff * Relocation outside of area of an active PEDIG site within next 18 months is not anticipated Exclusion Criteria: * Treatment for IXT or amblyopia (other than refractive correction) within the past 4 weeks, including vision therapy, patching, atropine, or other penalization. * Current contact lens wear * Substantial deliberate overminus treatment within the past 6 months, defined as spectacles overminused by more than 1.00D SE than the cycloplegic refractive error (within 2 months or at the end of the enrollment exam) * Prior strabismus, intraocular, or refractive surgery (including BOTOX injection) * Abnormality of the cornea, lens, or central retina * Down syndrome or cerebral palsy * Severe developmental delay which would interfere with treatment or evaluation (in the opinion of the investigator). Subjects with mild speech delays or reading and/or learning disabilities are not excluded. * Any disease known to affect accommodation, vergence, and ocular motility such as multiple sclerosis, Graves orbitopathy, dysautonomia, myasthenia gravis, or current use of atropine for amblyopia * Anti-seizure medications \[e.g., carbamazepine (Tegretol, Carbatrol, Epitol, or Equetro), diazepam (Valium or Diastat), clobazam (Frisium or Onfri), clonazepam (Klonopin), lorazepam (Ativan), ethosuximide (Zarontin), felbamate (Felbatol), lacosamide (VIMPAT), gabapentin (Neurontin), oxcarbazepine (Oxtellar XR or Trileptal), phenobarbital, phenytoin (Dilantin or Phenytek), pregabalin (Lyrica), tiagabine (Gabitril), topiramate (Topamax), valproate (Depakote), or zonisamide (Zonegran), vigabatrin (Sabril)\]

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Conditions

The condition(s) this trial relates to.

alternating exotropia intermittent squint

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Intermittent exotropia

Contacts and locations

Locations

  • Akron Children's Hospital

    Akron, Ohio, 44308, United States

  • Alberta Children's Hospital

    Calgary, Alberta, Canada

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

    Chicago, Illinois, 60611, United States

  • Arkansas Childrens

    Little Rock, Arkansas, 72202, United States

  • Boston Medical Center

    Boston, Massachusetts, 02118, United States

  • CHU - Sainte-Justine

    Montreal, Quebec, H3T 1C5, Canada

  • Casey Eye Institute

    Portland, Oregon, 97239, United States

  • Children's Eye Care PC

    West Bloomfield, Michigan, 48322, 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

  • Gundersen Health System

    La Crosse, Wisconsin, 54601, 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 University School Of Optometry

    Bloomington, Indiana, 47405, United States

  • Loma Linda University Health Care, Dept. of Ophthalmology

    Loma Linda, California, 92354, United States

  • Marshall B. Ketchum University

    Fullerton, California, 92831, United States

  • Mayo Clinic Department of Ophthalmology

    Rochester, Minnesota, 55905, United States

  • Medical University of South Carolina, Storm Eye Institute

    Charleston, South Carolina, 29425, United States

  • Midwestern U Chicago College of Optometry

    Downers Grove, Illinois, 60515, United States

  • Midwestern University Eye Institute

    Glendale, Arizona, 85308, United States

  • Nemours Children's Clinic

    Jacksonville, Florida, 32207, United States

  • Nova Southeastern University College of Optometry, The Eye Institute

    Fort Lauderdale, Florida, 33382, 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, P.C.

    Grand Rapids, Michigan, 49546, United States

  • Riley Hospital for Children

    Indianapolis, Indiana, 46202, United States

  • Saddleback Eye Medical Associates

    Mission Viejo, California, 92691, United States

  • Salus University/Pennsylvania College of Optometry

    Philadelphia, Pennsylvania, 19141, United States

  • Southern College of Optometry

    Memphis, Tennessee, 38104, United States

  • St Luke's Hospital

    Boise, Idaho, 83702, 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

  • 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 Eye Specialist Center, LLC

    Munster, Indiana, 46321, United States

  • The Eye Specialists Center, LLC

    Chicago Ridge, Illinois, 60415, United States

  • The Ohio State University College of Optometry

    Columbus, Ohio, 43210-1280, United States

  • Tufts Medical Center

    Boston, Massachusetts, 02111, United States

  • U of MO St. Louis College of Optometry

    St Louis, Missouri, 63121, United States

  • UPMC Children's Eye Center of Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, 15224, United States

  • University Eye Center at Ketchum Health

    Anaheim, California, 92807, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294, United States

  • University of California San Francisco Department of Ophthalmology

    San Francisco, California, 94143, 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 Kentucky Department of Neurology

    Lexington, Kentucky, 40536, United States

  • University of Minnesota

    Minneapolis, Minnesota, 55454, United States

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68114, 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, 21287-9028, United States

  • Wolfe Eye Clinic

    West Des Moines, Iowa, 50266, United States

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