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RecruitingNCT07272005Updated Apr 8, 2026

Improving Control of Intermittent Exotropia

An interventional study of dichoptic videos and standard videos in Intermittent Exotropia, sponsored by Retina Foundation of the Southwest. Recruiting at 1 site in United States. Open to participants aged 4 Years to 10 Years. Per ClinicalTrials.gov, last updated 2026-04-08.

Sponsored by Retina Foundation of the Southwest · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
4 Years to 10 Years
Sex
All
01

Study 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

Read the detailed description

Intermittent exotropia (IXT) is the most common form of strabismus, characterized by an outward deviation of the eyes that is primarily manifest during distance fixation and can intermittently be controlled by fusional mechanisms. Less than 30% of children have good long-term outcomes following treatment for spontaneously manifest IXT with current non-surgical treatments (prism therapy, over-minus lenses, or vision therapy). The limited efficacy of current non-surgical treatments for IXT is thought to arise from underlying sensory deficits, particularly interocular suppression, which compromises binocular function. This underscores the need for sensory-directed interventions aimed at reducing suppression and thereby enhancing the potential for stable binocular outcomes.

In this study, children will be randomized to watch engaging videos streamed at home that are either dichoptic or standard (control) format. The aim is to determine whether the dichoptic format will decrease suppression and improve control of eye alignment . In previous research, use of dichoptic games and movies by children with amblyopia has shown to reduce suppression.

02

Conditions studied

  • Intermittent Exotropia
03

Who can participate

Ages eligible
4 Years to 10 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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)
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Group 1: Dichoptic Videos

    dichoptic videos streamed at home 1 hour per day, 5 days per week

    Other: dichoptic videos

  • Sham comparator
    Group 2: Standard Videos

    standard videos streamed at home 1 hour per day, 5 days per week

    Other: standard videos

Interventions

  • Otherdichoptic videos

    custom designed dichoptic videos

  • Otherstandard videos

    standard videos

05

What researchers measure

Primary outcomes

  1. Improvement in control of intermittent exotropia

    change percent time alignment is present at 8 weeks vs at baseline

    Time frame: 8 weeks

Secondary outcomes

  1. Improvement in control of intermittent exotropia

    change percent time alignment is present at 4 weeks vs at baseline

    Time frame: 4 weeks

  2. Improvement in control of intermittent exotropia

    change percent time alignment is present at 12 weeks off-treatment weeks vs at baseline

    Time frame: 12 weeks off-treatment

  3. Change in distance stereoacuity

    change in Distance Randot test score at 4 weeks vs at baseline

    Time frame: 4 weeks

  4. Change in distance stereoacuity

    change in Distance Randot test score at 8 weeks vs at baseline

    Time frame: 8 weeks

  5. Change in distance stereoacuity

    change in Distance Randot test score at 12 weeks off-treatment vs at baseline

    Time frame: 12 weeks off-treatment

  6. Change in quality of life

    Change in IXTQ questionnaire (Rasch-scored on a 0-100 scale) at 8 weeks vs at baseline

    Time frame: 8 weeks

  7. Change in quality of life

    Change in IXTQ questionnaire (Rasch-scored on a 0-100 scale) ay 12 weeks off-treatment vs at baseline

    Time frame: 12 weeks off-treatment

06

Study locations

1 of 1 sites recruiting
  • Retina Foundation of the Southwest
    Dallas, Texas 75231, United States
    • Pediatric Laboratory · Contact · 2143633911
    • Eileen E Birch, PhD · Principal investigator
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07272005
Lead sponsor
Retina Foundation of the Southwest
Responsible party
Eileen Birch (Director, Pediatric Vision Laboratory, Retina Foundation of the Southwest) — Principal investigator
First posted
Dec 9, 2025
Start date
Apr 1, 2026
Primary completion
Feb 2028 (estimated)
Completion
Aug 2028 (estimated)
Last update
Apr 8, 2026

Study contacts

Eileen Birch, PhD
Contact
ebirch@retinafoundation.org
2143633911
Reed Jost, MS
Contact
reedjost@retinafoundation.org
2143633911
Eileen E Birch
principal investigator · Retina Foundation of the Southwest

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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