Trial of Vision Therapy for Intermittent Exotropia

Not Applicable

Recruiting

• Conditions: Intermittent Exotropia

• Registration Number: NCT04487249
• Lead Sponsor: Southern California College of Optometry at Marshall B. Ketchum University

Brief 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.

Study Timeline

• Study First Submitted: 2020-07-17
• Study First Submitted QC: 2020-07-22
• Study First Posted: 2020-07-27
• Study Start: 2021-10-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-04
• Last Update Posted: 2025-03-05
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Mean Distance Control Score	21 weeks	The primary analysis will be an intent-to-treat comparison of mean distance control score, determine by the intermittent exotropia office control scale, at outcome using an analysis of covariance model, which will adjust for baseline distance control. The intermittent exotropia office control scale grades the control on a scale of 0 (best control; phoria) to 5 (worst control; constant exotropia).

Secondary Outcome Measures

Name	Time	Method
No Spontaneous Tropia	21 weeks	The proportion of participants with no spontaneous tropia at outcome will be compared between treatment groups.No spontaneous tropia is defined as control score of 2 or less on all three assessments of control at distance and near and no exotropia lasting more than 5 seconds throughout the examination.
Change in Distance Control	21 weeks	The proportion of participants with \>= 1 point change in control and \>= 2 points change in control will be compared between treatment groups.

Trial Locations

Locations (6)

University of Alabama in Birmingham; 🇺🇸 Birmingham, Alabama, United States

Southern California College of Optometry at Marshall B. Ketchum University; 🇺🇸 Fullerton, California, United States

Stanford University; 🇺🇸 Stanford, California, United States

Ohio State University; 🇺🇸 Columbus, Ohio, United States

Salus University; 🇺🇸 Philadelphia, Pennsylvania, United States

Southern College of Optometry; 🇺🇸 Memphis, Tennessee, United States