Vision therapy for children with intermittent exotropia
A Pilot Randomized Trial Evaluating Short-Term Effectiveness of Vision Therapy in Children With Intermittent Exotropia
This study is testing if vision therapy can help children aged 8 to 16 with intermittent exotropia see better at a distance compared to just watching and waiting.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 58 (estimated) |
| Ages | 8 Years to 16 Years |
| Sex | All |
| Sponsor | Southern California College of Optometry at Marshall B. Ketchum University Academic / other |
| Locations | 6 sites (Birmingham, Alabama and 5 other locations) |
| Trial ID | NCT04487249 on ClinicalTrials.gov |
What this trial studies
This randomized trial compares the effectiveness of vision therapy to observation in controlling distance intermittent exotropia in children aged 8 to 16 years. The study aims to assess the short-term effectiveness of vision therapy over a 20-week period and evaluate the feasibility of recruiting and retaining participants for a larger trial. By addressing the gaps in existing research, this pilot trial will provide crucial data to inform future studies on the long-term effectiveness of vision therapy for this condition.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 8 to 16 years with specific criteria for intermittent exotropia.
Not a fit: Patients who have received recent treatment for intermittent exotropia or amblyopia, or those who have undergone prior vision therapy, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new effective treatment option for children suffering from intermittent exotropia.
How similar studies have performed: Previous studies on vision therapy for intermittent exotropia have been limited, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Birmingham, Alabama and 5 other locations
- University of Alabama in Birmingham — Birmingham, Alabama, United States (Recruiting)
- Southern California College of Optometry at Marshall B. Ketchum University — Fullerton, California, United States (Recruiting)
- Stanford University — Stanford, California, United States (Recruiting)
- Ohio State University — Columbus, Ohio, United States (Recruiting)
- Salus University — Philadelphia, Pennsylvania, United States (Recruiting)
- Southern College of Optometry — Memphis, Tennessee, United States (Recruiting)
Study contacts
- Study coordinator: Angela Chen, OD, MS
- Email: angelachen@ketchum.edu
- Phone: 714-463-7569
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.