Trial of Vision Therapy for Intermittent Exotropia

Southern California College of Optometry at Marshall B. Ketchum University58 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Intermittent Exotropia

Interventions

Vision TherapyOTHER

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.

Eligibility

Sex: ALLMin age: 8 YearsMax age: 16 Years

Medical Language ↔ Plain English

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)

Locations (6)

University of Alabama in Birmingham

Birmingham, Alabama, United States

RECRUITING

Southern California College of Optometry at Marshall B. Ketchum University

Fullerton, California, United States

RECRUITING

Stanford University

Stanford, California, United States

Outcomes

Primary Outcomes

Mean Distance Control Score

The primary analysis will be an intent-to-treat comparison of mean distance control score, determine by the intermittent exotropia office control scale, at outcome using an analysis of covariance model, which will adjust for baseline distance control. The intermittent exotropia office control scale grades the control on a scale of 0 (best control; phoria) to 5 (worst control; constant exotropia).

Time frame: 21 weeks

Secondary Outcomes

No Spontaneous Tropia

The proportion of participants with no spontaneous tropia at outcome will be compared between treatment groups.No spontaneous tropia is defined as control score of 2 or less on all three assessments of control at distance and near and no exotropia lasting more than 5 seconds throughout the examination.

Time frame: 21 weeks

Change in Distance Control

The proportion of participants with \>= 1 point change in control and \>= 2 points change in control will be compared between treatment groups.

Time frame: 21 weeks

Central Contacts

Angela Chen, OD, MS

CONTACT

714-463-7569 angelachen@ketchum.edu

Data from ClinicalTrials.gov

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