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Improving Control of Alignment in Intermittent Exotropia

Primary Purpose

Intermittent Exotropia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
dichoptic 3D movies
Sponsored by
Retina Foundation of the Southwest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intermittent Exotropia

Eligibility Criteria

3 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • diagnosis of IXT
  • IXT control assessment score at distance of 3 or 4 at baseline
  • Ocular misalignment by PACT >10 pd at distance and near or PACT >15 at distance or near

Exclusion Criteria:

  • Amblyopia
  • Prior surgery
  • Prior binocular treatment
  • Coexisting ocular or systemic condition
  • Developmental delay

Sites / Locations

  • Eileen E BirchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Group1

Group 2

Arm Description

dichoptic 3D movies

dichoptic standard movies

Outcomes

Primary Outcome Measures

Alignment Control Score
Classification system developed by PEDIG to quantify the degree of control of ocular alignment on a 0-5 scale at distance and near; 0 is best control [no exotropia unless dissociated, recovers in <1 second (phoria)] and 5 is worst control (constant exotropia)

Secondary Outcome Measures

Stereoacuity at distance
Randot Distance Stereoacuity Test
Binocular fixation stability
Stability of the vergence angle assessed by recording eye movements during 20 sec fixation
Stereoacuity at near
Randot Preschool Stereoacuity Test

Full Information

First Posted
December 11, 2019
Last Updated
October 18, 2023
Sponsor
Retina Foundation of the Southwest
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1. Study Identification

Unique Protocol Identification Number
NCT04199871
Brief Title
Improving Control of Alignment in Intermittent Exotropia
Official Title
Improving Control of Alignment in Intermittent Exotropia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 25, 2021 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Retina Foundation of the Southwest

4. Oversight

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

5. Study Description

Brief Summary
Aim 1: To determine whether use of dichoptic movies for 4 weeks may be helpful in improving control of alignment in children with intermittent exotropia (IXT), thus allowing IXT to be managed non-surgically Aim 2: To determine pre-IXT surgery use of dichoptic movies for 4 weeks post-operatively may be helpful in maintaining successful control of alignment in children who have surgical correction of IXT
Detailed Description
The most common childhood-onset exotropia is intermittent exotropia (IXT). IXT is an exotropia that is not constant and is mainly present at distance, but may also be present at near. Binocular single vision is typically present at near but may be subnormal. There is some debate in the literature about whether or not these children should be treated surgically to correct the misalignment. It can be argued that prompt surgical correction is necessary to prevent the development of suppression of the deviating eye, progression to constant exotropia, and permanent changes in sensory function that may compromise long-term post-operative outcomes. On the other hand, statistics on the natural history of IXT suggest that progression to constant XT occurs in less than 25% and up to 15% may improve spontaneously. These findings suggest a more conservative approach, using surgery only if deterioration of the IXT occurs. A recent randomized clinical trial of the two most common surgical techniques for IXT revealed a 3-year postoperative failure rate of approximately 40% (PEDIG 2019; Ophthalmology 126: 305-17). For the vast majority of children, surgical failure was due to recurrence of the exodeviation. Only about 30% of treated children had resolution of IXT at the 3-year visit. Similarly, a literature review of 28 surgical studies that included 2530 children with IXT reported a suboptimal surgical outcome at 1-year post-op in approximately 40% of children. (Coffey et al 1992; Optom Vis Sci 69: 386-404). Poor surgical results for IXT are thought to occur due to poor sensory status (suppression) or inadequate motor alignment. There are few data on the effects of non-surgical interventions designed to improve sensory status of children undergoing surgery for IXT. Although several retrospective case reviews found evidence supporting a benefit of pre-op sensory and motor fusion training on IXT surgical outcomes, there have been no prospective studies or randomized clinical trials. One of the largest retrospective case series (Cooper & Leyman 1977; Am Orthoptic J 27:61-7) compared 216 patients with IXT who had sensory and motor fusion training prior to surgery with 264 who had surgery alone and found a higher rate of good surgical outcomes (52% vs 42%). There are no published data on post-op interventions to improved sensory status. In this study, engaging movies will be presented on a handheld Nintendo to decrease suppression and engage stereoacuity. In previous research, use of dichoptic games and movies by children with amblyopia has been shown to reduce suppression and encourage sensory fusion (Birch et al 2015, JAAPOS 19:6-11; Birch et al 2019, JAAPOS [Epub ahead of print]; Kelly, Jost, et al 2016; JAMA Ophthalmol 134:1402-8.; Kelly et al Invest 2018 Ophthalmol Vis Sci 59:1221-8; Li et al 2014; Eye 28: 1246-53). This approach will be adapted by using dichoptic movies presented on a Nintendo for children with IXT to improve their stereoacuity and reduce their suppression in an effort improve control of alignment sufficiently without surgery (Aim 1) or to improve stability of post-operative alignment (Aim 2).

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group1
Arm Type
Experimental
Arm Description
dichoptic 3D movies
Arm Title
Group 2
Arm Type
Sham Comparator
Arm Description
dichoptic standard movies
Intervention Type
Other
Intervention Name(s)
dichoptic 3D movies
Other Intervention Name(s)
dichoptic standard movies
Intervention Description
dichoptic movies presented on a Nintendo 3DS
Primary Outcome Measure Information:
Title
Alignment Control Score
Description
Classification system developed by PEDIG to quantify the degree of control of ocular alignment on a 0-5 scale at distance and near; 0 is best control [no exotropia unless dissociated, recovers in <1 second (phoria)] and 5 is worst control (constant exotropia)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Stereoacuity at distance
Description
Randot Distance Stereoacuity Test
Time Frame
3 months
Title
Binocular fixation stability
Description
Stability of the vergence angle assessed by recording eye movements during 20 sec fixation
Time Frame
3 months
Title
Stereoacuity at near
Description
Randot Preschool Stereoacuity Test
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: diagnosis of IXT IXT control assessment score at distance of 3 or 4 at baseline Ocular misalignment by PACT >10 pd at distance and near or PACT >15 at distance or near Exclusion Criteria: Amblyopia Prior surgery Prior binocular treatment Coexisting ocular or systemic condition Developmental delay
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eileen E Birch, PhD
Phone
2143633911
Email
ebirch@retinafoundation.org
First Name & Middle Initial & Last Name or Official Title & Degree
Reed M Jost, MS
Phone
2143633911
Email
reedjost@retinafoundation.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eileen E Birch, PhD
Organizational Affiliation
Retina Foundation of the Southwest
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eileen E Birch
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eileen E Birch, PhD
Phone
214-363-3911
Ext
113
Email
ebirch@retinafoundation.org
First Name & Middle Initial & Last Name & Degree
Reed M Jost, MS
Phone
2143633911
Email
reedjost@retinafoundation.org
First Name & Middle Initial & Last Name & Degree
Eileen E Birch, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Improving Control of Alignment in Intermittent Exotropia

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