Using Dichoptic Therapy to Treat Intermittent Exotropia
ConditionExotropia Intermittent
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-7
SponsorVirginia Commonwealth University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosed with IXT
one eye that is their preferred eye
ages 4-7
distance control scores of <= 4
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Luminopia, a virtual reality headset
DeviceSubjects 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 interventionPre-survey to be completed by the parent and child. Questions may be skipped. Survey developed by the study team
Paper Survey
Other interventionPost-survey to be completed by the parent and child. Questions may be skipped. Survey developed by the study team
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Luminopia VR headset treatmentExperimental treatment 3 interventions
Trial outcomes
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.
Time frame
3 months for primary response, and 6 months after a washout period (3 months without the device)Secondary outcomes
1
Change of amplitude of exotropia as measured by Alternating Prism Cover Test
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
Time frame
3 months for primary response, and 6 months after a washout period (3 months without the device)2
Change of scores from the Pediatric Eye Disease Investigator Group (PEDIG) intermittent exotropia questionnaire
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)
Time frame
3 months for primary response, and 6 months after a washout period (3 months without the device)Sponsors and contacts
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Source ClinicalTrials.gov