Intermittent ExotropiaNCT04199871
Improving Control of Alignment in Intermittent Exotropia
A study testing dichoptic 3D movies in people with Intermittent Exotropia, run by Retina Foundation of the Southwest at 1 site in United States.
Trial summary
Aim 1: To determine whether use of dichoptic movies for 4 weeks may be helpful in improving control of alignment in children with intermittent exotropia (IXT), thus allowing IXT to be managed non-surgically Aim 2: To determine pre-IXT surgery use of dichoptic movies for 4 weeks post-operatively may be helpful in… Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Intermittent Exotropia
- What is being tested?
- dichoptic 3D movies
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2021to Jun 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 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- diagnosis of IXT
- IXT control assessment score at distance of 3 or 4 at baseline
- Ocular misalignment by PACT >10 pd at distance and near or PACT >15 at distance or near
Who cannot join
- Amblyopia
- Prior surgery
- Prior binocular treatment
- Coexisting ocular or systemic condition
- Developmental delay
Trial locations and contacts
1 site in 1 country.
About this study
Aim 1: To determine whether use of dichoptic movies for 4 weeks may be helpful in improving control of alignment in children with intermittent exotropia (IXT), thus allowing IXT to be managed non-surgically Aim 2: To determine pre-IXT surgery use of dichoptic movies for 4 weeks post-operatively may be helpful in maintaining successful control of alignment in children who have surgical correction of IXT
Read the detailed description
The most common childhood-onset exotropia is intermittent exotropia (IXT). IXT is an exotropia that is not constant and is mainly present at distance, but may also be present at near. Binocular single vision is typically present at near but may be subnormal. There is some debate in the literature about whether or not these children should be treated surgically to correct the misalignment. It can be argued that prompt surgical correction is necessary to prevent the development of suppression of the deviating eye, progression to constant exotropia, and permanent changes in sensory function that may compromise long-term post-operative outcomes. On the other hand, statistics on the natural history of IXT suggest that progression to constant XT occurs in less than 25% and up to 15% may improve spontaneously. These findings suggest a more conservative approach, using surgery only if deterioration of the IXT occurs. A recent randomized clinical trial of the two most common surgical techniques for IXT revealed a 3-year postoperative failure rate of approximately 40% (PEDIG 2019; Ophthalmology 126: 305-17). For the vast majority of children, surgical failure was due to recurrence of the exodeviation. Only about 30% of treated children had resolution of IXT at the 3-year visit. Similarly, a literature review of 28 surgical studies that included 2530 children with IXT reported a suboptimal surgical outcome at 1-year post-op in approximately 40% of children. (Coffey et al 1992; Optom Vis Sci 69: 386-404).
Poor surgical results for IXT are thought to occur due to poor sensory status (suppression) or inadequate motor alignment. There are few data on the effects of non-surgical interventions designed to improve sensory status of children undergoing surgery for IXT. Although several retrospective case reviews found evidence supporting a benefit of pre-op sensory and motor fusion training on IXT surgical outcomes, there have been no prospective studies or randomized clinical trials. One of the largest retrospective case series (Cooper \& Leyman 1977; Am Orthoptic J 27:61-7) compared 216 patients with IXT who had sensory and motor fusion training prior to surgery with 264 who had surgery alone and found a higher rate of good surgical outcomes (52% vs 42%). There are no published data on post-op interventions to improved sensory status.
In this study, engaging movies will be presented on a handheld Nintendo to decrease suppression and engage stereoacuity. In previous research, use of dichoptic games and movies by children with amblyopia has been shown to reduce suppression and encourage sensory fusion (Birch et al 2015, JAAPOS 19:6-11; Birch et al 2019, JAAPOS [Epub ahead of print]; Kelly, Jost, et al 2016; JAMA Ophthalmol 134:1402-8.; Kelly et al Invest 2018 Ophthalmol Vis Sci 59:1221-8; Li et al 2014; Eye 28: 1246-53). This approach will be adapted by using dichoptic movies presented on a Nintendo for children with IXT to improve their stereoacuity and reduce their suppression in an effort improve control of alignment sufficiently without surgery (Aim 1) or to improve stability of post-operative alignment (Aim 2).
- Conditions
- Intermittent Exotropia
- Being tested
- dichoptic 3D movies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dichoptic 3D moviesOther
Also called dichoptic standard movies
dichoptic movies presented on a Nintendo 3DS
| Study group | Role | What they receive |
|---|---|---|
| Group1 | Experimental | dichoptic 3D movies Receives: Other: dichoptic 3D movies |
| Group 2 | Sham comparator | dichoptic standard movies Receives: Other: dichoptic 3D movies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alignment Control Score
Classification system developed by PEDIG to quantify the degree of control of ocular alignment on a 0-5 scale at distance and near; 0 is best control [no exotropia unless dissociated, recovers in <1 second (phoria)] and 5 is worst control (constant exotropia)
Measured: 3 months
Secondary outcomes (3)
Stereoacuity at distance
Randot Distance Stereoacuity Test
Measured: 3 months
Binocular fixation stability
Stability of the vergence angle assessed by recording eye movements during 20 sec fixation
Measured: 3 months
Stereoacuity at near
Randot Preschool Stereoacuity Test
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2019
- Study start25 Mar 2021
- Primary completionJun 2027 (estimated)
- Study completionJun 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 84 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, PhD, Principal investigator, Retina Foundation of the Southwest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04199871
- Sponsor's protocol ID
- STU-2019-1430
- Status last verified
- Aug 2026
- First submitted
- 11 Dec 2019
- Last updated
- 25 Aug 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 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Control of Alignment in Intermittent Exotropia
- ClinicalTrials.gov ID
- NCT04199871
- Acronym / sponsor ID
- STU-2019-1430
- Conditions
- Intermittent Exotropia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Retina Foundation of the SouthwestUniversity, hospital or other
- Study start
- 25 Mar 2021 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 16 Dec 2019 (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.
Aim 1: To determine whether use of dichoptic movies for 4 weeks may be helpful in improving control of alignment in children with intermittent exotropia (IXT), thus allowing IXT to be managed non-surgically Aim 2: To determine pre-IXT surgery use of dichoptic movies for 4 weeks post-operatively may be helpful in maintaining successful control of alignment in children who have surgical correction of IXT
Detailed description
The most common childhood-onset exotropia is intermittent exotropia (IXT). IXT is an exotropia that is not constant and is mainly present at distance, but may also be present at near. Binocular single vision is typically present at near but may be subnormal. There is some debate in the literature about whether or not these children should be treated surgically to correct the misalignment. It can be argued that prompt surgical correction is necessary to prevent the development of suppression of the deviating eye, progression to constant exotropia, and permanent changes in sensory function that may compromise long-term post-operative outcomes. On the other hand, statistics on the natural history of IXT suggest that progression to constant XT occurs in less than 25% and up to 15% may improve spontaneously. These findings suggest a more conservative approach, using surgery only if deterioration of the IXT occurs. A recent randomized clinical trial of the two most common surgical techniques for IXT revealed a 3-year postoperative failure rate of approximately 40% (PEDIG 2019; Ophthalmology 126: 305-17). For the vast majority of children, surgical failure was due to recurrence of the exodeviation. Only about 30% of treated children had resolution of IXT at the 3-year visit. Similarly, a literature review of 28 surgical studies that included 2530 children with IXT reported a suboptimal surgical outcome at 1-year post-op in approximately 40% of children. (Coffey et al 1992; Optom Vis Sci 69: 386-404).
Poor surgical results for IXT are thought to occur due to poor sensory status (suppression) or inadequate motor alignment. There are few data on the effects of non-surgical interventions designed to improve sensory status of children undergoing surgery for IXT. Although several retrospective case reviews found evidence supporting a benefit of pre-op sensory and motor fusion training on IXT surgical outcomes, there have been no prospective studies or randomized clinical trials. One of the largest retrospective case series (Cooper \& Leyman 1977; Am Orthoptic J 27:61-7) compared 216 patients with IXT who had sensory and motor fusion training prior to surgery with 264 who had surgery alone and found a higher rate of good surgical outcomes (52% vs 42%). There are no published data on post-op interventions to improved sensory status.
In this study, engaging movies will be presented on a handheld Nintendo to decrease suppression and engage stereoacuity. In previous research, use of dichoptic games and movies by children with amblyopia has been shown to reduce suppression and encourage sensory fusion (Birch et al 2015, JAAPOS 19:6-11; Birch et al 2019, JAAPOS [Epub ahead of print]; Kelly, Jost, et al 2016; JAMA Ophthalmol 134:1402-8.; Kelly et al Invest 2018 Ophthalmol Vis Sci 59:1221-8; Li et al 2014; Eye 28: 1246-53). This approach will be adapted by using dichoptic movies presented on a Nintendo for children with IXT to improve their stereoacuity and reduce their suppression in an effort improve control of alignment sufficiently without surgery (Aim 1) or to improve stability of post-operative alignment (Aim 2).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group1 | Experimental | Other: dichoptic 3D moviesdichoptic 3D movies |
| Group 2 | Sham comparator | Other: dichoptic 3D moviesdichoptic standard movies |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- diagnosis of IXT
- IXT control assessment score at distance of 3 or 4 at baseline
- Ocular misalignment by PACT >10 pd at distance and near or PACT >15 at distance or near
Key exclusion criteria (5 listed)
- Amblyopia
- Prior surgery
- Prior binocular treatment
- Coexisting ocular or systemic condition
- Developmental delay
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 3D moviesAlso: dichoptic standard moviesdichoptic movies presented on a Nintendo 3DS | Other | Group 2, Group1 |
Primary outcome
Alignment Control Score
Time frame: 3 months
Classification system developed by PEDIG to quantify the degree of control of ocular alignment on a 0-5 scale at distance and near; 0 is best control [no exotropia unless dissociated, recovers in <1 second (phoria)] and 5 is worst control (constant exotropia)
3 secondary outcomes
Stereoacuity at distance
Time frame: 3 months
Binocular fixation stability
Time frame: 3 months
Stereoacuity at near
Time frame: 3 months
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 25 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Eileen E Birch, PhD 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 3D movies 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 3 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: under way, not looking for participants, as of the sponsor's last update on 25 Aug 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?
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?
Alignment Control Score (time frame: 3 months). 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 25 Aug 2026.