Trial of Vision Therapy for Intermittent Exotropia

Last updated: March 4, 2025
Sponsor: Southern California College of Optometry at Marshall B. Ketchum University
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Vision Therapy

Clinical Study ID

NCT04487249
20-08
  • Ages 8-16
  • All Genders

Study Summary

The main objective of this randomized trial comparing vision therapy to observation is to determine the short-term effectiveness of vision therapy on distance intermittent exotropia control. The results will help determine whether to proceed to a full-scale, long-term randomized trial.

Eligibility Criteria

Inclusion

Major Inclusion Criteria-

  • Age 8 - 16 years

  • Intermittent exotropia meeting all of the following:

  • Distance exodeviation of 15∆ to 35∆ by prism alternating cover test (PACT)

  • IXT, exophoria, or orthophoria at near

  • Near exodeviation that does not exceed the distance exodeviation by more than 10∆

  • Mean distance control score of 2 points or more with at least one measure being 3 points or higher

  • Mean near control score less than 5 points

  • Random dot stereopsis of 200" or better on Preschool Randot Stereotest

  • Willingness to accept randomization and no plan to relocate in the next 6 months

Major Exclusion Criteria-

  • Treatment for IXT or amblyopia (other than refractive correction) within 3 months prior to enrollment

  • Office-based vision therapy for IXT within 6 months prior to enrollment

  • Prior office-based vision therapy for IXT of ≥10 sessions

  • Prior strabismus, intraocular, or refractive surgery (including BOTOX injection)

Study Design

Total Participants: 58
Treatment Group(s): 1
Primary Treatment: Vision Therapy
Phase:
Study Start date:
October 01, 2021
Estimated Completion Date:
December 31, 2025

Study Description

Vision therapy (VT) is a commonly prescribed treatment for children with intermittent exotropia (IXT). The effectiveness of VT as a treatment modality for children with IXT is unknown because previous studies have largely limited observational or retrospective case series without comparison groups. The objective of this multi-centered pilot randomized trial of VT for IXT compared to observation is to 1) determine the short-term effectiveness of VT on distance intermittent exotropia and 2) determine the feasibility of recruitment and retention of children aged 8 to 16 years old with IXT to participate in a randomized trial of 20 weeks of in-office VT. The results of this trial will provide the needed information to plan and conduct a large-scale randomized trial to determine short-term and long-term effectiveness of VT for IXT in children, with the full-scale randomized trial helping to fill in the gaps in scientific knowledge concerning VT as a treatment for IXT.

Connect with a study center

  • University of Alabama in Birmingham

    Birmingham, Alabama 35294
    United States

    Active - Recruiting

  • Southern California College of Optometry at Marshall B. Ketchum University

    Fullerton, California 92831
    United States

    Active - Recruiting

  • Stanford University

    Stanford, California 94305
    United States

    Active - Recruiting

  • Ohio State University

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • Salus University

    Philadelphia, Pennsylvania 19141
    United States

    Active - Recruiting

  • Southern College of Optometry

    Memphis, Tennessee 38104
    United States

    Active - Recruiting

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