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

ArmDescriptionAssigned Intervention
Experimental
Vision Therapy 		Participants will receive 20 consecutive weeks of office-based vision therapy with home therapy.
  • 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.
    Other names:
    • Orthoptics
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

University of Alabama in Birmingham
Birmingham, Alabama 35294
Contact:
Kristine Hopkins, OD, MSPH
205-996-1678
kbhopkins@uab.edu

More Details

Status
Recruiting
Sponsor
Southern California College of Optometry at Marshall B. Ketchum University

Study Contact

Angela Chen, OD, MS
714-463-7569
angelachen@ketchum.edu

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.