Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
58 participants
INTERVENTIONAL
2021-10-01
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Vision Therapy
Participants will receive 20 consecutive weeks of office-based vision therapy with home therapy.
Vision 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.
Observation
Participants will receive no treatment for IXT is received during the study unless one of the deterioration criteria is met.
No interventions assigned to this group
Interventions
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Vision 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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)
8 Years
16 Years
ALL
No
Sponsors
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Stanford University
OTHER
Ohio State University
OTHER
Salus University
OTHER
University of Alabama at Birmingham
OTHER
Southern College of Optometry
OTHER
Case Western Reserve University
OTHER
American Academy of Optometry
OTHER
Southern California College of Optometry at Marshall B. Ketchum University
OTHER
Responsible Party
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Principal Investigators
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Angela Chen, OD, MS
Role: STUDY_CHAIR
Southern California College of Optometry at Marshall B. Ketchum University
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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20-08
Identifier Type: -
Identifier Source: org_study_id
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