Improving Control of Intermittent Exotropia
1 other identifier
interventional
40
1 country
1
Brief Summary
To determine whether use of dichoptic movies for 8 weeks may be helpful in improving control alignment in children with intermittent exotropia (IXT), thus allowing IXT to be managed non-surgically
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2026
Typical duration for not_applicable
1 active site
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
November 19, 2025
CompletedFirst Posted
Study publicly available on registry
December 9, 2025
CompletedStudy Start
First participant enrolled
April 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2028
April 8, 2026
April 1, 2026
1.8 years
November 19, 2025
April 2, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Improvement in control of intermittent exotropia
change percent time alignment is present at 8 weeks vs at baseline
8 weeks
Secondary Outcomes (7)
Improvement in control of intermittent exotropia
4 weeks
Improvement in control of intermittent exotropia
12 weeks off-treatment
Change in distance stereoacuity
4 weeks
Change in distance stereoacuity
8 weeks
Change in distance stereoacuity
12 weeks off-treatment
- +2 more secondary outcomes
Study Arms (2)
Group 1: Dichoptic Videos
EXPERIMENTALdichoptic videos streamed at home 1 hour per day, 5 days per week
Group 2: Standard Videos
SHAM COMPARATORstandard videos streamed at home 1 hour per day, 5 days per week
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of IXT or XT at Distance \& IXT or XP at near (Basic or Pseudo Divergence Excess subtype of IXT)
- No surgery planned for 6 months
You may not qualify if:
- Prior eye muscle surgery
- Prior binocular treatment or vision therapy
- Amblyopia
- Neurological conditions, seizure disorders, vestibular abnormalities, or frequent headache
- Other eye conditions (refractive error OK)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Retina Foundation of the Southwest
Dallas, Texas, 75231, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Eileen E Birch
Retina Foundation of the Southwest
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Pediatric Vision Laboratory
Study Record Dates
First Submitted
November 19, 2025
First Posted
December 9, 2025
Study Start
April 1, 2026
Primary Completion (Estimated)
February 1, 2028
Study Completion (Estimated)
August 1, 2028
Last Updated
April 8, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share