Trial of Vision Therapy for Intermittent Exotropia (NCT04487249) | Clinical Trial Compass
RecruitingNot Applicable
Trial of Vision Therapy for Intermittent Exotropia
United States58 participantsStarted 2021-10-01
Plain-language 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.
Who can participate
Age range8 Years – 16 Years
SexALL
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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)
What they're measuring
1
Mean Distance Control Score
Timeframe: 21 weeks
Trial details
NCT IDNCT04487249
SponsorSouthern California College of Optometry at Marshall B. Ketchum University