Full-Time Occlusion Therapy for Intermittent Exotropia in Children

Completed · Phase 3

Conditions studied: Intermittent Exotropia

In brief

Determine whether full-time patching is more effective than observation for improving distance control of IXT after 3 months of treatment (on-treatment outcome).

Key facts

Study ID

NCT05462821

Run by

Jaeb Center for Health Research

People needed

73

Starts

2022-11-01

Expected to finish

2025-05-01

Last updated by the study team

2026-08-03

Who can join

Age: 3 and older, up to 8. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Children under the care of a pediatric optometrist or pediatric ophthalmologist will be eligible for the study if they meet all the following criteria:
• Age 3 to < 9 years
• 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)
• 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)
• 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.
• Cycloplegic refraction within the last 7 months.
• Refractive error between -6.00 D SE and +2.00 D SE (inclusive) based on a cycloplegic refraction within 7 months
• 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
• 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).

You may not qualify if…

• Individuals meeting any of the following criteria at baseline will be excluded from study participation:
• Prior strabismus, intraocular, or refractive surgery (including BOTOX injection)
• 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
• Previous amblyopia treatment other than refractive correction
• Diplopia more than 2 times per day by parental assessment
• Paretic or restrictive strabismus
• Craniofacial malformations affecting the orbits
• Ocular disorders which would reduce VA (except refractive error)
• 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.
• Neurological anomaly that could affect ocular motility (e.g., cerebral palsy, Down syndrome)
• Immediate family member (child or sibling) of any investigative site personnel directly affiliated with this study.
• Known allergy to adhesive patches.
• Known allergy to silicone.

Where it is running

• Southern California College of Optometry — Fullerton, California, United States
• Univ of California, Irvine- Gavin Herbert Eye Institute — Irvine, California, United States
• Loma Linda University Health Care, Dept. of Ophthalmology — Loma Linda, California, United States
• Stanford University — Palo Alto, California, United States
• Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
• Progressive Eye Care — Lisle, Illinois, United States
• Indiana School of Optometry — Bloomington, Indiana, United States
• Wilmer Eye Institute — Baltimore, Maryland, United States
• Boston Medical Center — Boston, Massachusetts, United States
• Boston Children's Hospital Waltham — Boston, Massachusetts, United States
• Michigan College of Optometry at Ferris State Univ — Big Rapids, Michigan, United States
• Mayo Clinic Department of Ophthalmology — Rochester, Minnesota, United States
• Children's Mercy Hospitals and Clinics — Kansas City, Missouri, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• State University of New York, College of Optometry — New York, New York, United States
• Duke University Eye Center — Durham, North Carolina, United States
• Ohio State University College of Optometry — Columbus, Ohio, United States
• Eye Care Associates, Inc. — Poland, Ohio, United States
• Casey Eye Institute — Portland, Oregon, United States
• Salus University/Pennsylvania College of Optometry — Philadelphia, Pennsylvania, United States
• Southern College of Optometry — Memphis, Tennessee, United States
• Virginia Pediatric Eye Center — Norfolk, Virginia, United States
• UAB Pediatric Eye Care; Birmingham Health Care — Birmingham, Alabama, United States
• Arkansas Childrens — Little Rock, Arkansas, United States
• Univ. of California- Berkeley — Berkeley, California, United States

Full record on ClinicalTrials.gov

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