Full-Time Occlusion Therapy for Intermittent Exotropia in Children

NCT ID: NCT05462821

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2025-05-01

Brief Summary

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

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).

Conditions

Intermittent Exotropia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Observation Group

Participants randomized to observation alone will not be allowed to receive any other treatment for IXT, except refractive correction, for 3 months.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Full Time Patching

Participants randomized to the full-time patching group will patch full-time (all waking hours) for 3 months up until the day before the 3-month primary outcome visit. Daily alternate patching will be prescribed (right eye on even days, left eye on odd days). No other treatment for IXT will be used, except for refractive correction.

Group Type: EXPERIMENTAL

Eye Patch

Intervention Type: DEVICE

adhesive patch to cover eye

Interventions

Eye Patch

adhesive patch to cover eye

Intervention Type: DEVICE

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:

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Eye Institute (NEI)

NIH

Sponsor Role: collaborator

Pediatric Eye Disease Investigator Group

NETWORK

Sponsor Role: collaborator

Jaeb Center for Health Research

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen P Christiansen, MD

Role: STUDY_CHAIR

Boston Children's Hospital

Erin C Jenewein, OD

Role: STUDY_CHAIR

Salus University

Locations

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

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

Countries

United States

References

Hatt SR, Leske DA, Holmes JM, Henderson RJ, Chandler DL, Morrison DG, Summers AI, Cotter SA. Testing depth of suppression in childhood intermittent exotropia. J AAPOS. 2022 Feb;26(1):36-38.e1. doi: 10.1016/j.jaapos.2021.08.303. Epub 2021 Nov 16.

Reference Type: BACKGROUND

PMID: 34793970 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2U10EY011751

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IXT7

Identifier Type: -

Identifier Source: org_study_id