Trial of Vision Therapy for Intermittent Exotropia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Vision Therapy.
- Who it may be relevant to
- Registry conditions: Intermittent Exotropia. Basic parameters: 8 years — 16 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Pilot Randomized Trial Evaluating Short-Term Effectiveness of Vision Therapy in Children With Intermittent Exotropia
Overview
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.
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.
Interventions
- Other 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.
Primary outcome measures
- Mean Distance Control Score [Time frame: 21 weeks]
Secondary outcome measures (2)
- No Spontaneous Tropia [Time frame: 21 weeks]
- Change in Distance Control [Time frame: 21 weeks]
Eligibility 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 6 centers
- University of Alabama in Birmingham — Birmingham
- Southern California College of Optometry at Marshall B. Ketchum University — Fullerton
- Stanford University — Stanford
- Ohio State University — Columbus
- Salus University — Philadelphia
- Southern College of Optometry — Memphis
Identifiers
NCT: NCT04487249 · 20-08