40 Participants NeededMy employer runs this trial

Dichoptic Videos for Intermittent Exotropia

RJ
EB
Overseen ByEileen Birch, PhD
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Retina Foundation of the Southwest
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether special "dichoptic" videos can help children with intermittent exotropia (IXT), a condition where the eyes sometimes drift outward. The goal is to determine if watching these videos at home for an hour a day can improve eye alignment without surgery. Participants will watch either dichoptic videos or regular ones as part of the study. Children diagnosed with IXT or similar conditions who do not plan to undergo surgery in the next six months might be suitable candidates. As an unphased trial, this study provides a unique opportunity to explore non-surgical treatment options for IXT.

What prior data suggests that dichoptic videos are safe for children with intermittent exotropia?

Research has shown that watching special 3D videos is generally safe for children with intermittent exotropia, a condition where the eyes sometimes drift outward. Studies indicate that using these 3D movies at home can improve eye alignment without significant side effects. In these studies, children handled the videos well, and researchers reported no major safety issues. The FDA has approved this treatment for similar uses, confirming its thorough safety testing.12345

Why are researchers excited about this trial?

Researchers are excited about dichoptic videos for treating intermittent exotropia because they offer a novel approach compared to traditional methods like surgery, eye patches, or corrective lenses. Unlike these standard treatments, dichoptic videos work by presenting different images to each eye, encouraging the brain to improve coordination and alignment between the eyes naturally. This method is non-invasive and can be conveniently done at home, making it a more accessible and potentially more appealing option for patients. Additionally, it targets the root cause of the condition by enhancing binocular vision, which could lead to more sustainable improvements.

What evidence suggests that dichoptic videos might be an effective treatment for intermittent exotropia?

Research has shown that special videos called dichoptic videos might help treat intermittent exotropia (IXT), a condition where the eyes sometimes drift outward. In this trial, one group of participants will watch dichoptic videos, where each eye sees a slightly different picture, to improve the use of both eyes together. Previous studies found that people who tried this therapy could better control their eye alignment. Specifically, one study suggested that an 8-week home program using these videos improved eye control in children with IXT. These findings suggest that dichoptic videos might help manage IXT without surgery. Meanwhile, another group of participants will watch standard videos for comparison.12367

Who Is on the Research Team?

EE

Eileen E Birch

Principal Investigator

Retina Foundation of the Southwest

Are You a Good Fit for This Trial?

Inclusion Criteria

I don't have any surgeries planned for the next 6 months.
I have been diagnosed with certain types of eye misalignment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants watch dichoptic or standard videos streamed at home for 8 weeks

8 weeks
Home-based intervention

Follow-up

Participants are monitored for changes in distance stereoacuity, quality of life, and control of intermittent exotropia

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Dichoptic Videos

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Group 1: Dichoptic VideosExperimental Treatment1 Intervention
Group II: Group 2: Standard VideosPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Retina Foundation of the Southwest

Lead Sponsor

Trials
15
Recruited
1,600+

Citations

Impact of Online Video Game-Based Dichoptic Training ... - PMC

Dichoptic training presents a promising avenue for the restoration of binocular vision in the patients with intermittent exotropia after surgery ...

Virtual Reality–Based Vision Therapy for Intermittent ...

Secondary efficacy outcomes included changes from baseline to week 12 in exotropia control score at near (score range: 0-5, with higher values ...

A pilot, randomized clinical trial of dichoptic 3D movies ...

Surgical and nonsurgical treatments of childhood intermittent exotropia (IXT) often have unsatisfactory results due to poor sensory status. Dichoptic 3D ...

Pilot Study Indicates Potential Intermittent Exotropia ...

“This pilot study offers promising early data and underscores the potential of dichoptic therapy to transform care for children with ...

Effectiveness of binocular vision therapy in managing patients ...

BVT for 20 online sessions is an effective method to improve control of IXT with improvement in NCS-Home, Near Stereopsis, and convergence ...

Improving Control of Alignment in Intermittent Exotropia

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 ...

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41276155/

A pilot, randomized clinical trial of dichoptic 3D movies ...

Conclusions: In our study cohort, at-home dichoptic 3D animated movie treatment significantly improved IXT triple office distance control scores ...