Clinical trial NCT04487249: Trial of Vision Therapy for Intermittent Exotropia
Official title: A Pilot Randomized Trial Evaluating Short-Term Effectiveness of Vision Therapy in Children With Intermittent Exotropia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intermittent Exotropia
Keywords: Intermittent Exotropia
Vision Therapy
Lead sponsor: Southern California College of Optometry at Marshall B. Ketchum University
Sponsor class: OTHER
Collaborators: name: Stanford University
name: Ohio State University
name: Salus University
name: University of Alabama at Birmingham
name: Southern College of Optometry
name: Case Western Reserve University
name: American Academy of Optometry
First posted: 2020-07-27
Enrollment: 58
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

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)

Primary outcomes:
measure: Mean Distance Control Score
timeFrame: 21 weeks
Secondary outcomes:
measure: No Spontaneous Tropia
timeFrame: 21 weeks
measure: Change in Distance Control
timeFrame: 21 weeks
Other outcomes:
measure: Change in Vergence and Accommodative Measures
timeFrame: 21 weeks
measure: Suppression Status
timeFrame: 21 weeks
measure: Objective Eye Movement Recordings
timeFrame: 21 weeks
Locations:
city: Birmingham
country: United States
facility: University of Alabama in Birmingham
state: Alabama
city: Fullerton
country: United States
facility: Southern California College of Optometry at Marshall B. Ketchum University
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Philadelphia
country: United States
facility: Salus University
state: Pennsylvania
city: Memphis
country: United States
facility: Southern College of Optometry
state: Tennessee
Study officials:
affiliation: Southern California College of Optometry at Marshall B. Ketchum University
name: Angela Chen, OD, MS
role: STUDY_CHAIR
References: