Back to Trials
NCT04487249NARecruiting

Trial of Vision Therapy for Intermittent Exotropia

Southern California College of Optometry at Marshall B. Ketchum University

Start Date

10/1/2021

Completion Date

12/1/2025

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.

Detailed 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.

Eligibility Criteria

Age Range: 8 years to 16 years

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)

Interventions

OTHER

Vision Therapy

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Intermittent Exotropia

Locations

University of Alabama in Birmingham

Birmingham, Alabama 35294

United States

Southern California College of Optometry at Marshall B. Ketchum University

Fullerton, California 92831

United States

Stanford University

Stanford, California 94305

United States

Ohio State University

Columbus, Ohio 43210

United States

Salus University

Philadelphia, Pennsylvania 19141

United States

Southern College of Optometry

Memphis, Tennessee 38104

United States