Dichoptic therapy for treating intermittent exotropia
Using Dichoptic Therapy to Treat Intermittent Exotropia
This study is testing a virtual reality device called Luminopia to see if it can help young children with intermittent exotropia improve their eye alignment and vision without needing surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 4 Years to 7 Years |
| Sex | All |
| Sponsor | Virginia Commonwealth University Academic / other |
| Locations | 1 site (Richmond, Virginia) |
| Trial ID | NCT06529016 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of Luminopia, a dichoptic therapy device, to treat patients with intermittent exotropia (IXT) aged 4-7 years. The device, which was FDA-approved for amblyopia, aims to improve ocular alignment and visual function in children with IXT. Participants will wear the virtual reality headset for one hour a day, six days a week, over a 12-week period. The study seeks to provide a non-surgical treatment option for this challenging condition, which often requires multiple surgeries.
Who should consider this trial
Good fit: Ideal candidates are children aged 4-7 diagnosed with intermittent exotropia who have a preferred eye and specific distance control scores.
Not a fit: Patients with a distance control score of 5 or those unable to tolerate the headset may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could offer a non-invasive treatment option that improves vision and alignment in children with intermittent exotropia.
How similar studies have performed: Previous studies using dichoptic therapy have shown promising results in improving ocular alignment in similar patient populations.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Richmond, Virginia
- Virginia Commonwealth University — Richmond, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Evan Silverstein — Virginia Commonwealth University
- Study coordinator: Evan Silverstein
- Email: evan.silverstein@vcuhealth.org
- Phone: 804-828-2467
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.