NCT04487249

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 27, 2020

Completed
1.2 years until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

March 5, 2025

Status Verified

March 1, 2025

Enrollment Period

4.2 years

First QC Date

July 17, 2020

Last Update Submit

March 4, 2025

Conditions

Intermittent Exotropia

Keywords

Intermittent ExotropiaVision Therapy

Outcome Measures

Primary Outcomes (1)

  • 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).

    21 weeks

Secondary Outcomes (2)

  • No Spontaneous Tropia

    21 weeks

  • Change in Distance Control

    21 weeks

Other Outcomes (3)

  • Change in Vergence and Accommodative Measures

    21 weeks

  • Suppression Status

    21 weeks

  • Objective Eye Movement Recordings

    21 weeks

Study Arms (2)

Vision Therapy

EXPERIMENTAL

Participants will receive 20 consecutive weeks of office-based vision therapy with home therapy.

Other: Vision Therapy

Observation

NO INTERVENTION

Participants will receive no treatment for IXT is received during the study unless one of the deterioration criteria is met.

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.

Also known as: Orthoptics
Vision Therapy

Eligibility Criteria

Age8 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

University of Alabama in Birmingham

Birmingham, Alabama, 35294, United States

RECRUITING

Southern California College of Optometry at Marshall B. Ketchum University

Fullerton, California, 92831, United States

RECRUITING

Stanford University

Stanford, California, 94305, United States

RECRUITING

Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

Salus University

Philadelphia, Pennsylvania, 19141, United States

RECRUITING

Southern College of Optometry

Memphis, Tennessee, 38104, United States

RECRUITING

MeSH Terms

Interventions

Orthoptics

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Angela Chen, OD, MS

    Southern California College of Optometry at Marshall B. Ketchum University

    STUDY CHAIR

Central Study Contacts

Angela Chen, OD, MS

CONTACT

714-463-7569angelachen@ketchum.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2020

First Posted

July 27, 2020

Study Start

October 1, 2021

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

March 5, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

US(6)