Using Dichoptic Therapy to Treat Intermittent Exotropia
- Conditions
- Exotropia Intermittent
- Interventions
- Device: Luminopia, a virtual reality headsetOther: Paper pre- surveyOther: Paper Survey
- Registration Number
- NCT06529016
- Lead Sponsor
- Virginia Commonwealth University
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
- Diagnosed with IXT
- one eye that is their preferred eye
- ages 4-7
- distance control scores of <= 4
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Luminopia VR headset treatment Paper pre- survey Using Dichoptic Therapy to Improve Intermittent Exotropia Control in children ages 4-7 Luminopia VR headset treatment Paper Survey Using Dichoptic Therapy to Improve Intermittent Exotropia Control in children ages 4-7 Luminopia VR headset treatment Luminopia, a virtual reality headset Using Dichoptic Therapy to Improve Intermittent Exotropia Control in children ages 4-7
- Primary Outcome Measures
Name Time Method Dichoptic therapy change of control of intermittent exotropia using the standard control score 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 Outcome Measures
Name Time Method 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) The alternate prism cover test is similar to the alternate cover test, with the addition of a prism held over one eye to quantify the misalignment. The examiner performs the alternate cover test while changing the prism over the deviated eye until the misalignment is neutralized
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) The Intermittent Exotropia Questionnaire (IXTQ) is a patient-derived, intermittent exotropia-specific instrument designed to evaluate health-related quality of life (HRQOL) in children with intermittent exotropia. The12-item assessment ivalues were converted to 0 (best) to 100 (worst)
Trial Locations
- Locations (1)
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States