RecruitingNot ApplicableNCT04487249

Trial of Vision Therapy for Intermittent Exotropia

A Pilot Randomized Trial Evaluating Short-Term Effectiveness of Vision Therapy in Children With Intermittent Exotropia


Sponsor

Southern California College of Optometry at Marshall B. Ketchum University

Enrollment

58 participants

Start Date

Oct 1, 2021

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 8 YearsMax Age: 16 Years

Inclusion Criteria9

  • 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

Exclusion Criteria4

  • 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)

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Interventions

OTHERVision Therapy

20 consecutive weeks of office-based vision therapy with home therapy that aim to improve the participant's vergence skills, accommodative skills, and sensory fusion.


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

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NCT04487249


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