Using Dichoptic Therapy to Treat Intermittent Exotropia

October 6, 2025 updated by: Virginia Commonwealth University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Luminopia VR headset treatment
Using Dichoptic Therapy to Improve Intermittent Exotropia Control in children ages 4-7
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
Other Names:
  • Paper post-survey

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dichoptic therapy change of control of intermittent exotropia using the standard control score
Time Frame: 3 months for primary response, and 6 months after a washout period (3 months without the device)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of amplitude of exotropia as measured by Alternating Prism Cover Test
Time Frame: 3 months for primary response, and 6 months after a washout period (3 months without the device)
The alternate prism cover test is similar to the alternate cover test, with the addition of a prism held over one eye to quantify the misalignment. The examiner performs the alternate cover test while changing the prism over the deviated eye until the misalignment is neutralized
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
Time Frame: 3 months for primary response, and 6 months after a washout period (3 months without the device)
The Intermittent Exotropia Questionnaire (IXTQ) is a patient-derived, intermittent exotropia-specific instrument designed to evaluate health-related quality of life (HRQOL) in children with intermittent exotropia. The12-item assessment ivalues were converted to 0 (best) to 100 (worst)
3 months for primary response, and 6 months after a washout period (3 months without the device)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Virginia Commonwealth University

Investigators

  • Principal Investigator: Evan Silverstein, Virginia Commonwealth University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 26, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

July 19, 2024

First Submitted That Met QC Criteria

July 25, 2024

First Posted (Actual)

July 31, 2024

Study Record Updates

Last Update Posted (Estimated)

October 8, 2025

Last Update Submitted That Met QC Criteria

October 6, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HM20027943

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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