Intermittent ExotropiaNCT07272005
Improving Control of Intermittent Exotropia
A study testing dichoptic videos and standard videos in people with Intermittent Exotropia, run by Retina Foundation of the Southwest at 1 site in United States.
Trial summary
To determine whether use of dichoptic movies for 8 weeks may be helpful in improving control alignment in children with intermittent exotropia (IXT), thus allowing IXT to be managed non-surgically Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Intermittent Exotropia
- What is being tested?
- dichoptic videos and standard videos
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2026to Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of IXT or XT at Distance \& IXT or XP at near (Basic or Pseudo Divergence Excess subtype of IXT)
- No surgery planned for 6 months
Who cannot join
- Prior eye muscle surgery
- Prior binocular treatment or vision therapy
- Amblyopia
- Neurological conditions, seizure disorders, vestibular abnormalities, or frequent headache
- Other eye conditions (refractive error OK)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Retina Foundation of the Southwest
Dallas, Texas, 75231
Pediatric Laboratory, 2143633911 ext. 113
Eileen E Birch, PhD
About this study
To determine whether use of dichoptic movies for 8 weeks may be helpful in improving control alignment in children with intermittent exotropia (IXT), thus allowing IXT to be managed non-surgically
Read the detailed description
Intermittent exotropia (IXT) is the most common form of strabismus, characterized by an outward deviation of the eyes that is primarily manifest during distance fixation and can intermittently be controlled by fusional mechanisms. Less than 30% of children have good long-term outcomes following treatment for spontaneously manifest IXT with current non-surgical treatments (prism therapy, over-minus lenses, or vision therapy). The limited efficacy of current non-surgical treatments for IXT is thought to arise from underlying sensory deficits, particularly interocular suppression, which compromises binocular function. This underscores the need for sensory-directed interventions aimed at reducing suppression and thereby enhancing the potential for stable binocular outcomes.
In this study, children will be randomized to watch engaging videos streamed at home that are either dichoptic or standard (control) format. The aim is to determine whether the dichoptic format will decrease suppression and improve control of eye alignment . In previous research, use of dichoptic games and movies by children with amblyopia has shown to reduce suppression.
- Conditions
- Intermittent Exotropia
- Being tested
- dichoptic videos, standard videos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dichoptic videosOther
custom designed dichoptic videos
standard videosOther
standard videos
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Dichoptic Videos | Experimental | dichoptic videos streamed at home 1 hour per day, 5 days per week Receives: Other: dichoptic videos |
| Group 2: Standard Videos | Sham comparator | standard videos streamed at home 1 hour per day, 5 days per week Receives: Other: standard videos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in control of intermittent exotropia
change percent time alignment is present at 8 weeks vs at baseline
Measured: 8 weeks
Secondary outcomes (7)
Improvement in control of intermittent exotropia
change percent time alignment is present at 4 weeks vs at baseline
Measured: 4 weeks
Improvement in control of intermittent exotropia
change percent time alignment is present at 12 weeks off-treatment weeks vs at baseline
Measured: 12 weeks off-treatment
Change in distance stereoacuity
change in Distance Randot test score at 4 weeks vs at baseline
Measured: 4 weeks
Change in distance stereoacuity
change in Distance Randot test score at 8 weeks vs at baseline
Measured: 8 weeks
Change in distance stereoacuity
change in Distance Randot test score at 12 weeks off-treatment vs at baseline
Measured: 12 weeks off-treatment
Change in quality of life
Change in IXTQ questionnaire (Rasch-scored on a 0-100 scale) at 8 weeks vs at baseline
Measured: 8 weeks
Change in quality of life
Change in IXTQ questionnaire (Rasch-scored on a 0-100 scale) ay 12 weeks off-treatment vs at baseline
Measured: 12 weeks off-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start1 Apr 2026
- Primary completionFeb 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intermittent ExotropiaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Retina Foundation of the Southwest
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eileen Birch, Retina Foundation of the Southwest
- Investigators
- Eileen E Birch, Principal investigator, Retina Foundation of the Southwest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07272005
- Sponsor's protocol ID
- 03 IXT2 2026
- Status last verified
- Apr 2026
- First submitted
- 19 Nov 2025
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Control of Intermittent Exotropia
- ClinicalTrials.gov ID
- NCT07272005
- Acronym / sponsor ID
- 03 IXT2 2026
- Conditions
- Intermittent Exotropia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Retina Foundation of the SouthwestUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 9 Dec 2025 (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.
To determine whether use of dichoptic movies for 8 weeks may be helpful in improving control alignment in children with intermittent exotropia (IXT), thus allowing IXT to be managed non-surgically
Detailed description
Intermittent exotropia (IXT) is the most common form of strabismus, characterized by an outward deviation of the eyes that is primarily manifest during distance fixation and can intermittently be controlled by fusional mechanisms. Less than 30% of children have good long-term outcomes following treatment for spontaneously manifest IXT with current non-surgical treatments (prism therapy, over-minus lenses, or vision therapy). The limited efficacy of current non-surgical treatments for IXT is thought to arise from underlying sensory deficits, particularly interocular suppression, which compromises binocular function. This underscores the need for sensory-directed interventions aimed at reducing suppression and thereby enhancing the potential for stable binocular outcomes.
In this study, children will be randomized to watch engaging videos streamed at home that are either dichoptic or standard (control) format. The aim is to determine whether the dichoptic format will decrease suppression and improve control of eye alignment . In previous research, use of dichoptic games and movies by children with amblyopia has shown to reduce suppression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Dichoptic Videos | Experimental | Other: dichoptic videosdichoptic videos streamed at home 1 hour per day, 5 days per week |
| Group 2: Standard Videos | Sham comparator | Other: standard videosstandard videos streamed at home 1 hour per day, 5 days per week |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Diagnosis of IXT or XT at Distance \& IXT or XP at near (Basic or Pseudo Divergence Excess subtype of IXT)
- No surgery planned for 6 months
Key exclusion criteria (5 listed)
- Prior eye muscle surgery
- Prior binocular treatment or vision therapy
- Amblyopia
- Neurological conditions, seizure disorders, vestibular abnormalities, or frequent headache
- Other eye conditions (refractive error OK)
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 |
|---|---|---|
| dichoptic videoscustom designed dichoptic videos | Other | Group 1: Dichoptic Videos |
| standard videosstandard videos | Other | Group 2: Standard Videos |
Primary outcome
Improvement in control of intermittent exotropia
Time frame: 8 weeks
change percent time alignment is present at 8 weeks vs at baseline
7 secondary outcomes
Improvement in control of intermittent exotropia
Time frame: 4 weeks
Improvement in control of intermittent exotropia
Time frame: 12 weeks off-treatment
Change in distance stereoacuity
Time frame: 4 weeks
Change in distance stereoacuity
Time frame: 8 weeks
Change in distance stereoacuity
Time frame: 12 weeks off-treatment
Change in quality of life
Time frame: 8 weeks
Change in quality of life
Time frame: 12 weeks off-treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Intermittent Exotropia
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A Comparative Study of the Efficacy of Myopia Control Lenses With Different Mechanisms on Controlling Myopia Progression in Patients With Intermittent Exotropia
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Visual Therapy for Intermittent Strabismus
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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.
Eileen E Birch principal investigator
Retina Foundation of the Southwest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dichoptic videos and standard videos in people with Intermittent Exotropia, run by Retina Foundation of the Southwest 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 2 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 8 Apr 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eileen Birch, PhD (2143633911, ebirch@retinafoundation.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in control of intermittent exotropia (time frame: 8 weeks). 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 8 Apr 2026.