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

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 8
Maximum Age: 16
Healthy Volunteers: f
View:

• 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

Locations
United States
Alabama
University of Alabama in Birmingham
RECRUITING
Birmingham
California
Southern California College of Optometry at Marshall B. Ketchum University
RECRUITING
Fullerton
Stanford University
RECRUITING
Stanford
Ohio
Ohio State University
RECRUITING
Columbus
Pennsylvania
Salus University
RECRUITING
Philadelphia
Tennessee
Southern College of Optometry
RECRUITING
Memphis
Contact Information
Primary
Angela Chen, OD, MS
angelachen@ketchum.edu
714-463-7569
Time Frame
Start Date: 2021-10-01
Estimated Completion Date: 2025-12
Participants
Target number of participants: 58
Treatments
Experimental: Vision Therapy
Participants will receive 20 consecutive weeks of office-based vision therapy with home therapy.
No_intervention: Observation
Participants will receive no treatment for IXT is received during the study unless one of the deterioration criteria is met.
Related Therapeutic Areas
Sponsors
Leads: Southern California College of Optometry at Marshall B. Ketchum University
Collaborators: Stanford University, American Academy of Optometry, Southern College of Optometry, Salus University, University of Alabama at Birmingham, Case Western Reserve University, Ohio State University

This content was sourced from clinicaltrials.gov

Similar Clinical Trials