Using Dichoptic Therapy to Treat Intermittent Exotropia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 23
- Locations
- 1
- Primary Endpoint
- Dichoptic therapy change of control of intermittent exotropia using the standard control score
Study Overview
Brief Summary
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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 4 Years to 7 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosed with IXT
- •one eye that is their preferred eye
- •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.
Arms & Interventions
Luminopia VR headset treatment
Using Dichoptic Therapy to Improve Intermittent Exotropia Control in children ages 4-7
Intervention: Paper Survey (Other)
Luminopia VR headset treatment
Using Dichoptic Therapy to Improve Intermittent Exotropia Control in children ages 4-7
Intervention: Luminopia, a virtual reality headset (Device)
Luminopia VR headset treatment
Using Dichoptic Therapy to Improve Intermittent Exotropia Control in children ages 4-7
Intervention: Paper pre- survey (Other)
Outcomes
Primary Outcomes
Dichoptic therapy change of control of intermittent exotropia using the standard control score
Time Frame: 3 months for primary response, and 6 months after a washout period (3 months without the device)
Improvement of the control of IXT using the Exotropia control scale that runs from 0-5. 0 meaning No exotropia noted unless dissociated, recovers in \< 1 seconds (exophoria). A 5 means Constant exotropia during 30-second observation before dissociation.
Secondary Outcomes
- Change of amplitude of exotropia as measured by Alternating Prism Cover Test(3 months for primary response, and 6 months after a washout period (3 months without the device))
- Change of scores from the Pediatric Eye Disease Investigator Group (PEDIG) intermittent exotropia questionnaire(3 months for primary response, and 6 months after a washout period (3 months without the device))