Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04487249

Trial of Vision Therapy for Intermittent Exotropia

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

8 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama in Birmingham, Birmingham, Alabama, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Vision Therapy

Other

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

Primary outcomes

  1. Mean Distance Control Score

    Time frame: 21 weeks

    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).

Secondary outcomes

  1. No Spontaneous Tropia

    Time frame: 21 weeks

    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.

  2. Change in Distance Control

    Time frame: 21 weeks

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

Other outcomes

  1. Change in Vergence and Accommodative Measures

    Time frame: 21 weeks

    The near point of convergence, positive and negative fusional vergence ranges at distance and near, vergence facility, accommodative amplitude, and accommodative facility at outcome will be compared between treatment groups adjusting for the corresponding baseline value. The analysis will be completed separately for each vergence and accommodative measures.

  2. Suppression Status

    Time frame: 21 weeks

    Suppression status will be compared at outcome between treatment groups, adjusting for baseline suppression status. Suppression status when the participant's eyes are in tropic position will be assessed using the suppression scale ranging from 0 (negligible suppression) to 4 (dense suppression).

  3. Objective Eye Movement Recordings

    Time frame: 21 weeks

    Frequency of intermittent exotropia by objective eye movement recordings will be compared between treatment groups.

Study contacts

Contact information is provided by the study sponsor or research team.

Angela Chen, OD, MS

CONTACT

[email protected]

714-463-7569

Sponsors and collaborators

Lead sponsor

Southern California College of Optometry at Marshall B. Ketchum University

Other

Collaborators

  • American Academy of Optometry
  • Case Western Reserve University
  • Ohio State University
  • Salus University
  • Southern College of Optometry
  • Stanford University
  • University of Alabama at Birmingham

Registry information

Official study title

A Pilot Randomized Trial Evaluating Short-Term Effectiveness of Vision Therapy in Children With Intermittent Exotropia

Acronym: VT-IXT

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jul 27, 2020
Registry last updated
Mar 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.