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Completed

NCT Number: NCT06529016

Using Dichoptic Therapy to Treat Intermittent Exotropia

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.

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Key information

Conditions

Exotropia Intermittent

Age range

4 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Paper pre- survey

Other

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

Paper Survey

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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)

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 31, 2024
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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