Exotropia IntermittentNCT06529016
Using Dichoptic Therapy to Treat Intermittent Exotropia
A study testing Luminopia, a virtual reality headset, Paper pre- survey and Paper Survey in people with Exotropia Intermittent, run by Virginia Commonwealth University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 4 to 7 years
- Conditions the study is for
- Exotropia Intermittent
- What is being tested?
- Luminopia, a virtual reality headset, Paper pre- survey and Paper Survey
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jul 2024to 14 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosed with IXT
- one eye that is their preferred eye
- ages 4-7
- distance control scores of <= 4
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
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.
Read the 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
- Being tested
- Luminopia, a virtual reality headset, Paper pre- survey, Paper Survey
- Keywords
- Dichoptic therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Luminopia, a virtual reality headsetDevice
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- surveyOther
Pre-survey to be completed by the parent and child. Questions may be skipped. Survey developed by the study team
Paper SurveyOther
Also called Paper post-survey
Post-survey to be completed by the parent and child. Questions may be skipped. Survey developed by the study team
| Study group | Role | What they receive |
|---|---|---|
| Luminopia VR headset treatment | Experimental | Using Dichoptic Therapy to Improve Intermittent Exotropia Control in children ages 4-7 Receives: Device: Luminopia, a virtual reality headset; Other: Paper pre- survey; Other: Paper Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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
Measured: 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
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)
Measured: 3 months for primary response, and 6 months after a washout period (3 months without the device)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start26 Jul 2024
- Primary completion14 Apr 2026
- Study completion14 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exotropia IntermittentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective pilot clinical trial
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Evan Silverstein, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06529016
- Sponsor's protocol ID
- HM20027943
- Status last verified
- Jul 2026
- First submitted
- 19 Jul 2024
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Dichoptic Therapy to Treat Intermittent Exotropia
- ClinicalTrials.gov ID
- NCT06529016
- Acronym / sponsor ID
- HM20027943
- Conditions
- Exotropia Intermittent
- Keywords
- Dichoptic therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 26 Jul 2024 (actual)
- Primary completion
- 14 Apr 2026 (actual)
- Study completion
- 14 Apr 2026 (actual)
- First posted
- 31 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective pilot clinical trial
| Arm | Type | Receives |
|---|---|---|
| Luminopia VR headset treatment | Experimental | Device: Luminopia, a virtual reality headset, Other: Paper pre- survey, Other: Paper SurveyUsing Dichoptic Therapy to Improve Intermittent Exotropia Control in children ages 4-7 |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Diagnosed with IXT
- one eye that is their preferred eye
- ages 4-7
- distance control scores of <= 4
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Luminopia, a virtual reality headsetSubjects 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. | Device | Luminopia VR headset treatment |
| Paper pre- surveyPre-survey to be completed by the parent and child. Questions may be skipped. Survey developed by the study team | Other | Luminopia VR headset treatment |
| Paper SurveyAlso: Paper post-surveyPost-survey to be completed by the parent and child. Questions may be skipped. Survey developed by the study team | Other | Luminopia VR headset treatment |
Primary outcome
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.
2 secondary outcomes
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evan Silverstein principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Luminopia, a virtual reality headset, Paper pre- survey and Paper Survey in people with Exotropia Intermittent, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026; AzTrials last refreshed its copy on 27 Oct 2026.