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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.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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.

United States1 site
  • Eileen E Birch

    Dallas, Texas, 75231

Other trials in United States

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).

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 groups in NCT04199871
Study groupRoleWhat they receive
Group1Experimentaldichoptic 3D movies
Receives: Other: dichoptic 3D movies
Group 2Sham comparatordichoptic standard movies
Receives: Other: dichoptic 3D movies

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)
  1. Stereoacuity at distance

    Randot Distance Stereoacuity Test

    Measured: 3 months

  2. Binocular fixation stability

    Stability of the vergence angle assessed by recording eye movements during 20 sec fixation

    Measured: 3 months

  3. 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.

  1. First posted16 Dec 2019
  2. Study start25 Mar 2021
  3. Primary completionJun 2027 (estimated)
  4. Study completionJun 2028 (estimated)

Resources

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)
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

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.

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