Using Dichoptic Therapy to Treat Intermittent Exotropia

NCT06529016 | Completed FDA Device

• 1 other identifier: HM20027943
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Exotropia Intermittent

Keywords

Dichoptic therapy

Outcome Measures

Primary Outcomes (1)

• Dichoptic therapy change of control of intermittent exotropia using the standard control score

  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.

  3 months for primary response, and 6 months after a washout period (3 months without the device)

Secondary Outcomes (2)

• 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)

• 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)

Study Arms (1)

Luminopia VR headset treatment

EXPERIMENTAL

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

Device: Luminopia, a virtual reality headset; Other: Paper pre- survey; Other: Paper Survey

Interventions

Luminopia, a virtual reality headset 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.

Luminopia VR headset treatment

Paper pre- survey OTHER

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

Luminopia VR headset treatment

Paper Survey OTHER

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

Also known as: Paper post-survey

Luminopia VR headset treatment

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Diagnosed with IXT
• one eye that is their preferred eye
• ages 4-7
• distance control scores of \<= 4

You may not qualify if:

• 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.

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Study Officials

• Evan Silverstein

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective pilot clinical trial

Study Record Dates

• First Submitted: July 19, 2024
• First Posted: July 31, 2024
• Study Start: July 26, 2024
• Primary Completion: April 14, 2026
• Study Completion: April 14, 2026
• Last Updated: July 15, 2026

Record last verified: 2026-07

Locations

US (1)