Trial of Vision Therapy for Intermittent Exotropia
Purpose
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.
Condition
- Intermittent Exotropia
Eligibility
- Eligible Ages
- Between 8 Years and 16 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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)
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
Recruiting Locations
Birmingham, Alabama 35294
More Details
- Status
- Recruiting
- Sponsor
- Southern California College of Optometry at Marshall B. Ketchum University
Detailed Description
Vision therapy (VT) is a commonly prescribed treatment for children with intermittent exotropia (IXT). The effectiveness of VT as a treatment modality for children with IXT is unknown because previous studies have largely limited observational or retrospective case series without comparison groups. The objective of this multi-centered pilot randomized trial of VT for IXT compared to observation is to 1) determine the short-term effectiveness of VT on distance intermittent exotropia and 2) determine the feasibility of recruitment and retention of children aged 8 to 16 years old with IXT to participate in a randomized trial of 20 weeks of in-office VT. The results of this trial will provide the needed information to plan and conduct a large-scale randomized trial to determine short-term and long-term effectiveness of VT for IXT in children, with the full-scale randomized trial helping to fill in the gaps in scientific knowledge concerning VT as a treatment for IXT.