Full-Time Occlusion Therapy for Intermittent Exotropia in Children

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Description

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

Targeted Conditions

Study Overview

Start Date
November 21, 2022
Completion Date
December 1, 2024
Enrollment
72
Date Posted
July 18, 2022
Accepts Healthy Volunteers?
No
Gender
All

Locations

Full Address
UAB Pediatric Eye Care; Birmingham Health Care
Birmingham, Alabama 35294, United States

University of Arizona
Tucson, Arizona 85711, United States

Arkansas Childrens
Little Rock, Arkansas 72202, United States

Univ. of California- Berkeley
Berkeley, California 94720, United States

Southern California College of Optometry
Fullerton, California 92831-1699, United States

Univ of California, Irvine- Gavin Herbert Eye Institute
Irvine, California 92697, United States

Progressive Eye Care
Lisle, Illinois 60532, United States

Boston Medical Center
Boston, Massachusetts 02118, United States

Boston Children's Hospital Waltham
Boston, Massachusetts 02453, United States

Michigan College of Optometry at Ferris State Univ
Big Rapids, Michigan 49307, United States

Mayo Clinic Department of Ophthalmology
Rochester, Minnesota 55905, United States

Children's Mercy Hospitals and Clinics
Kansas City, Missouri 64108, United States

University of Nebraska Medical Center
Omaha, Nebraska 68114, United States

State University of New York, College of Optometry
New York, New York 10036, United States

Cincinnati Children's Hospital
Cincinnati, Ohio 45229, United States

Ohio State University College of Optometry
Columbus, Ohio 43210-1280, United States

Eye Care Associates, Inc.
Poland, Ohio 44514, United States

Pacific University College of Optometry
Portland, Oregon 97205, United States

Casey Eye Institute
Portland, Oregon 97239, United States

Salus University/Pennsylvania College of Optometry
Philadelphia, Pennsylvania 19141, United States

Southern College of Optometry
Memphis, Tennessee 38104, United States

University of Houston College of Optometry
Houston, Texas 77204, United States

Virginia Pediatric Eye Center
Norfolk, Virginia 23502, United States

Eligibility

Minimum Age (years)
3
Maximum Age (years)
8
Eligibility Criteria
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:

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).
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.
Gestational age > 30 weeks
Birth weight > 1500 grams
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
Parent has phone and is willing to be contacted by Jaeb Center staff
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:

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.

Study Contact Info

Study Contact Name
Raymond T Kraker, MSPH; Katie M Stutz
Study Contact Email
Study Contact Phone

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
No
Detailed Description
Understanding the effectiveness of intensive patching has important implications for managing children with IXT. If full-time patching is associated with improvement in distance control vs an observation group, then future studies can be conducted to evaluate different durations of full-time patching treatment, whether the effect is maintained off-treatment, and how full-time patching compares to other treatment strategies.

The purpose of this study is to determine whether full-time patching is more effective than observation for improving distance control of IXT after 3 months of treatment (on-treatment outcome).
NCTid (if applicable)
NCT05462821