Status:
RECRUITING
Trial of Vision Therapy for Intermittent Exotropia
Lead Sponsor:
Southern California College of Optometry at Marshall B. Ketchum University
Collaborating Sponsors:
Stanford University
Ohio State University
Conditions:
Intermittent Exotropia
Eligibility:
All Genders
8-16 years
Phase:
NA
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 resul...
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...
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)
Exclusion
Key Trial Info
Start Date :
October 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT04487249
Start Date
October 1 2021
End Date
December 1 2025
Last Update
March 5 2025
Active Locations (6)
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1
University of Alabama in Birmingham
Birmingham, Alabama, United States, 35294
2
Southern California College of Optometry at Marshall B. Ketchum University
Fullerton, California, United States, 92831
3
Stanford University
Stanford, California, United States, 94305
4
Ohio State University
Columbus, Ohio, United States, 43210