NCT06529016

Using Dichoptic Therapy to Treat Intermittent Exotropia

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Virginia Commonwealth University · Academic / Other
• Sex: All
• Age: 4 Years – 7 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Exotropia Intermittent

Interventions

Type	Name	Description
DEVICE	Luminopia, a virtual reality headset	Subjects will be provided with the equipment to use in their homes for six hours usage per week (1 hour 6 days a week), for 12 weeks.
OTHER	Paper pre- survey	Pre-survey to be completed by the parent and child. Questions may be skipped. Survey developed by the study team
OTHER	Paper Survey	Post-survey to be completed by the parent and child. Questions may be skipped. Survey developed by the study team

Timeline

• Start date: 2024-07-26
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2024-07-31
• Last updated: 2025-10-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study