Dichoptic 3D Movies for Intermittent Exotropia

Recruiting in Dallas (>99 mi)

Overseen By Eileen E Birch, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Retina Foundation of the Southwest

Disqualifiers: Amblyopia, Prior surgery, Developmental delay, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

84 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

How does the dichoptic 3D movies treatment for intermittent exotropia differ from other treatments?

The dichoptic 3D movies treatment for intermittent exotropia is unique because it uses a virtual reality platform to provide visual training that helps improve eye alignment and depth perception without surgery. This approach focuses on retraining the brain's visual processing to enhance stereopsis (depth perception) and reduce the degree of eye misalignment. ^{1 2 3 4 5}

Research Team

Eileen E Birch, PhD

Principal Investigator

Retina Foundation of the Southwest

Eligibility Criteria

This trial is for children with intermittent exotropia, a condition where one eye occasionally drifts outward. They must have a certain level of misalignment in their eyes and haven't had previous binocular treatments or surgery. Kids with amblyopia, other eye/systemic conditions, or developmental delays cannot participate.

Inclusion Criteria

I have been diagnosed with intermittent exotropia (IXT).

Your eyes are not aligned properly, causing vision problems at a distance or up close.

Your score for controlling eye movements at a distance of 3 or 4 is being assessed at the beginning of the study.

Exclusion Criteria

You have a delay in your development compared to other people your age.

I have received treatment for both of my eyes.

I have been diagnosed with lazy eye.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use dichoptic movies for 4 weeks to improve control of alignment in children with intermittent exotropia

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Treatment Details

Interventions

• Dichoptic 3D Movies

Trial Overview The study tests if watching dichoptic 3D movies for four weeks can help control eye alignment in kids with intermittent exotropia either as an alternative to surgery or to maintain alignment after surgical correction.

Participant Groups

Group I: Group1 Experimental Treatment 1 Intervention

dichoptic 3D movies

Group II: Group 2 Placebo Group 1 Intervention

dichoptic standard movies

Who Is Running the Clinical Trial?

Retina Foundation of the Southwest

Lead Sponsor

Trials

15

Recruited

1,600+

References

1. China pubmed.ncbi.nlm.nih.gov

[A clinical observation on variation of crossed disparity and uncrossed disparity in intermittent exotropia]. [2006]

2. England pubmed.ncbi.nlm.nih.gov

Distance stereoacuity in intermittent exotropia. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Stereopsis in children with intermittent exotropia and dissociated vertical deviation. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Visual suppression in intermittent exotropia during binocular alignment. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Intermittent Exotropia Treatment with Dichoptic Visual Training Using a Unique Virtual Reality Platform. [2019]