Intermittent Exotropia
Conditions
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
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.
Interventions
OTHERdichoptic videos
custom designed dichoptic videos
OTHERstandard videos
standard videos
Sponsors
Retina Foundation of the Southwest
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Years to 10 Years
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
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in control of intermittent exotropia | 8 weeks | change percent time alignment is present at 8 weeks vs at baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in control of intermittent exotropia | 4 weeks | change percent time alignment is present at 4 weeks vs at baseline |
| Change in distance stereoacuity | 4 weeks | change in Distance Randot test score at 4 weeks vs at baseline |
| Change in quality of life | 8 weeks | Change in IXTQ questionnaire (Rasch-scored on a 0-100 scale) at 8 weeks vs at baseline |
Countries
United States
Contacts
CONTACTEileen Birch, PhD
CONTACTReed Jost, MS
PRINCIPAL_INVESTIGATOREileen E Birch
Retina Foundation of the Southwest
Outcome results
None listed