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New treatment option for Intermittent Exotropia
Official title Trial of Vision Therapy for Intermittent Exotropia
ClinicalTrials.gov ID: NCT04487249
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 8 to 16
You may be able to join if
- Major -
- 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
You likely can't join if
- 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)
See the full eligibility criteria
- Major -
- 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
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Fullerton, California, United States
- Stanford, California, United States
- Columbus, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Memphis, Tennessee, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 8 years to 16 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Fullerton, California, United States; Stanford, California, United States; Columbus, Ohio, United States; Philadelphia, Pennsylvania, United States; Memphis, Tennessee, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.