Clinical trial NCT06529016: Using Dichoptic Therapy to Treat Intermittent Exotropia
Official title: Using Dichoptic Therapy to Treat Intermittent Exotropia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Exotropia Intermittent
Keywords: Dichoptic therapy
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2024-07-31
Enrollment: 20
Sex: ALL
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective pilot clinical trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Dichoptic therapy change of control of intermittent exotropia using the standard control score
timeFrame: 3 months for primary response, and 6 months after a washout period (3 months without the device)
Secondary outcomes:
measure: Change of amplitude of exotropia as measured by Alternating Prism Cover Test
timeFrame: 3 months for primary response, and 6 months after a washout period (3 months without the device)
measure: Change of scores from the Pediatric Eye Disease Investigator Group (PEDIG) intermittent exotropia questionnaire
timeFrame: 3 months for primary response, and 6 months after a washout period (3 months without the device)
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Evan Silverstein
role: PRINCIPAL_INVESTIGATOR
References: