Full-Time Occlusion Therapy for Intermittent Exotropia in Children

NCT05462821 | Completed Phase 3 Results DMC

• 2 other identifiers: IXT72U10EY011751
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 25

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).

Conditions

Intermittent Exotropia

Keywords

IXT; intermittent exotropia; occlusion therapy

Outcome Measures

Primary Outcomes (1)

• Number of Participants With a Change in Mean Distance Control Scores at 3 Months

  To determine if participants with IXT undergoing full-time patching have more improvement in mean distance control between baseline and 3 months than participants being observed without treatment. The Office Control Score provides a rating of exodeviation control on a 0 to 5 scale, in subjects with intermittent exotropia. Scores 3 to 5 reflect the proportion of time a spontaneous manifest exotropia is present during 30 seconds of observation (\<50% score 3; \>50% score 4; 100% score 5). If no spontaneous manifest exotropia is observed, scores 0 to 2 reflect the longest time to regain fusion after three, 10-second dissociations (\>5 seconds score 2; 1-5 seconds score 1; \<1 second score 0).

  3 months

Study Arms (2)

Observation Group

NO INTERVENTION

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

Full Time Patching

EXPERIMENTAL

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.

Device: Eye Patch

Interventions

Eye Patch DEVICE

adhesive patch to cover eye

Full Time Patching

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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:
• years: 20/50 or better (\>=63 letters)
• years: 20/40 or better (\>=68 letters)
• years: 20/32 or better (\>=73 letters)
• \<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.

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.

Sponsors & Collaborators

• Jaeb Center for Health Research: lead
• National Eye Institute (NEI): collaborator
• Pediatric Eye Disease Investigator Group: collaborator

Study Sites (25)

UAB Pediatric Eye Care; Birmingham Health Care

Birmingham, Alabama, 35294, United States

Location

Arkansas Childrens

Little Rock, Arkansas, 72202, United States

Location

Univ. of California- Berkeley

Berkeley, California, 94720, United States

Location

Southern California College of Optometry

Fullerton, California, 92831-1699, United States

Location

Univ of California, Irvine- Gavin Herbert Eye Institute

Irvine, California, 92697, United States

Location

Loma Linda University Health Care, Dept. of Ophthalmology

Loma Linda, California, 92354, United States

Location

Stanford University

Palo Alto, California, 94303, United States

Location

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

Chicago, Illinois, 60611, United States

Location

Progressive Eye Care

Lisle, Illinois, 60532, United States

Location

Indiana School of Optometry

Bloomington, Indiana, 47405, United States

Location

Wilmer Eye Institute

Baltimore, Maryland, 21287-9028, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Boston Children's Hospital Waltham

Boston, Massachusetts, 02453, United States

Location

Michigan College of Optometry at Ferris State Univ

Big Rapids, Michigan, 49307, United States

Location

Mayo Clinic Department of Ophthalmology

Rochester, Minnesota, 55905, United States

Location

Children's Mercy Hospitals and Clinics

Kansas City, Missouri, 64108, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68114, United States

Location

State University of New York, College of Optometry

New York, New York, 10036, United States

Location

Duke University Eye Center

Durham, North Carolina, 27710, United States

Location

Ohio State University College of Optometry

Columbus, Ohio, 43210-1280, United States

Location

Eye Care Associates, Inc.

Poland, Ohio, 44514, United States

Location

Casey Eye Institute

Portland, Oregon, 97239, United States

Location

Salus University/Pennsylvania College of Optometry

Philadelphia, Pennsylvania, 19141, United States

Location

Southern College of Optometry

Memphis, Tennessee, 38104, United States

Location

Virginia Pediatric Eye Center

Norfolk, Virginia, 23502, United States

Location

Related Publications (1)

• 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.

  PMID: 34793970 BACKGROUND

Results Point of Contact

• Title: Victoria Woodard, Publications Manager
• Organization: Jaeb Center for Health Research - Pediatric Eye Disease Investigator Group

pedigpublications@jaeb.org

813-975-8690

Study Officials

• Stephen P Christiansen, MD

  Boston Children's Hospital

  STUDY CHAIR

• Erin C Jenewein, OD

  Salus University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2022
• First Posted: July 18, 2022
• Study Start: November 1, 2022
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: December 2, 2025
• Results First Posted: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be made available after publication of each primary manuscript
• Access Criteria: Users accessing the data must enter an email address.

Locations

US (25)