Using Dichoptic Therapy to Treat Intermittent Exotropia

NCT ID: NCT06529016

Last Updated: 2025-10-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-26
• Study Completion Date: 2026-06-30

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.

Conditions

Exotropia Intermittent

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Luminopia VR headset treatment

Using Dichoptic Therapy to Improve Intermittent Exotropia Control in children ages 4-7

Group Type: EXPERIMENTAL

Luminopia, a virtual reality headset

Intervention Type: DEVICE

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.

Paper pre- survey

Intervention Type: OTHER

Pre-survey to be completed by the parent and child. Questions may be skipped. Survey developed by the study team

Paper Survey

Intervention Type: OTHER

Post-survey to be completed by the parent and child. Questions may be skipped. Survey developed by the study team

Interventions

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.

Intervention Type: DEVICE

Paper pre- survey

Pre-survey to be completed by the parent and child. Questions may be skipped. Survey developed by the study team

Intervention Type: OTHER

Paper Survey

Post-survey to be completed by the parent and child. Questions may be skipped. Survey developed by the study team

Intervention Type: OTHER

Other Intervention Names

Paper post-survey

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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Evan Silverstein

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

Virginia Commonwealth University

Richmond, Virginia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Evan Silverstein

Role: CONTACT

evan.silverstein@vcuhealth.org

804-828-2467

Emilia Varrone

Role: CONTACT

emilia.varrone@vcuhealth.org

804-828-9315

Facility Contacts

Evan Silverstein, MD

Role: primary

evan.silverstein@vcuhealth.org

804-828-2467

Emilia Varrone

Role: backup

emilia.varrone@vcuhealth.org

804-828-9315

Other Identifiers

HM20027943

Identifier Type: -

Identifier Source: org_study_id