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Trial of Vision Therapy for Intermittent Exotropia (VT-IXT)

Primary Purpose

Intermittent Exotropia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vision Therapy
Sponsored by
Southern California College of Optometry at Marshall B. Ketchum University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intermittent Exotropia focused on measuring Intermittent Exotropia, Vision Therapy

Eligibility Criteria

8 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University of Alabama in BirminghamRecruiting
  • Southern California College of Optometry at Marshall B. Ketchum UniversityRecruiting
  • Stanford UniversityRecruiting
  • Ohio State UniversityRecruiting
  • Salus UniversityRecruiting
  • Southern College of OptometryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Vision Therapy

Observation

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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.

Full Information

First Posted
July 17, 2020
Last Updated
May 19, 2022
Sponsor
Southern California College of Optometry at Marshall B. Ketchum University
Collaborators
Stanford University, Ohio State University, Salus University, University of Alabama at Birmingham, Southern College of Optometry, Case Western Reserve University, American Academy of Optometry
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1. Study Identification

Unique Protocol Identification Number
NCT04487249
Brief Title
Trial of Vision Therapy for Intermittent Exotropia
Acronym
VT-IXT
Official Title
A Pilot Randomized Trial Evaluating Short-Term Effectiveness of Vision Therapy in Children With Intermittent Exotropia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Southern California College of Optometry at Marshall B. Ketchum University
Collaborators
Stanford University, Ohio State University, Salus University, University of Alabama at Birmingham, Southern College of Optometry, Case Western Reserve University, American Academy of Optometry

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intermittent Exotropia
Keywords
Intermittent Exotropia, Vision Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
58 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vision Therapy
Arm Type
Experimental
Arm Description
Participants will receive 20 consecutive weeks of office-based vision therapy with home therapy.
Arm Title
Observation
Arm Type
No Intervention
Arm Description
Participants will receive no treatment for IXT is received during the study unless one of the deterioration criteria is met.
Intervention Type
Other
Intervention Name(s)
Vision Therapy
Other Intervention Name(s)
Orthoptics
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean Distance Control Score
Description
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 Outcome Measure Information:
Title
No Spontaneous Tropia
Description
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
Title
Change in Distance Control
Description
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
Other Pre-specified Outcome Measures:
Title
Change in Vergence and Accommodative Measures
Description
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.
Time Frame
21 weeks
Title
Suppression Status
Description
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).
Time Frame
21 weeks
Title
Objective Eye Movement Recordings
Description
Frequency of intermittent exotropia by objective eye movement recordings will be compared between treatment groups.
Time Frame
21 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Angela Chen, OD, MS
Phone
714-463-7569
Email
angelachen@ketchum.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angela Chen, OD, MS
Organizational Affiliation
Southern California College of Optometry at Marshall B. Ketchum University
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alabama in Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristine Hopkins, OD, MSPH
Phone
205-996-1678
Email
kbhopkins@uab.edu
Facility Name
Southern California College of Optometry at Marshall B. Ketchum University
City
Fullerton
State/Province
California
ZIP/Postal Code
92831
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angela Chen, OD, MS
Phone
714-463-7569
Email
angelachen@ketchum.edu
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tawna Roberts, OD, PhD
Phone
650-723-1143
Email
tawnar@stanford.edu
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ann Morrison, OD, MS
Phone
614-247-0010
Email
morrison.421@osu.edu
Facility Name
Salus University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erin Jenewein, OD, MS
Phone
215-276-6053
Email
ejenewein@salus.edu
Facility Name
Southern College of Optometry
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie Bodack, OD
Phone
901-722-3349
Email
mbodack@sco.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Trial of Vision Therapy for Intermittent Exotropia

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