Using Dichoptic Therapy to Treat Intermittent Exotropia
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Details and patient eligibility
About
Intermittent exotropia is difficult to treat. The mainstay of treatment involves surgery, and in one long-term study authors found that as many as 60% of IXT required at least one re-operation.Patching of the non-dominant eye has also been tested in a large, multi-center randomized control trial and was not found to have a large benefit. More non-surgical treatment modalities are critical to improve the care in this condition.
Full description
Luminopia, a dichoptic therapy device, was approved by the FDA in 2021 for use in amblyopia in children aged 4-7 years. The device was shown to improve vision in the amblyopic eye by lines in three months of use. Patients with strabismic amblyopia were also enrolled in the trial and found to have similar gains in vision in the amblyopic eye.
Li et al. used an investigational dichoptic therapy device in patients with intermittent exotropia and had a statistically significant improvement in ocular alignment as measured in prism diopters.The dichoptic therapy this study used is not commercially available, therefore using Luminopia to study this population may result in an immediately available non-surgical treatment for intermittent exotropia patients.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Diagnosed with IXT
- one eye that is their preferred eye
- ages 4-7
- distance control scores of <= 4
Exclusion criteria
- distance control scores of 5
- patients with visual acuity with vision that is worse in one eye by greater than two lines
- no preferred eye
- patients who would be unable to tolerate wearing the headset for 1 hour/day, 6 days/week, for 12 weeks.
Trial design
Primary purpose
Allocation
Interventional model
Masking
20 participants in 1 patient group
Trial contacts and locations
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Central trial contact
Evan Silverstein; Emilia Varrone
Data sourced from clinicaltrials.gov
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