Dichoptic Therapy for Intermittent Exotropia

Overseen By Evan Silverstein

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Virginia Commonwealth University

Disqualifiers: Distance control score 5, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to discover a new non-surgical treatment for intermittent exotropia, a condition where one eye occasionally turns outward. It will test a virtual reality headset treatment called Luminopia, which uses special visual exercises to improve eye control. The trial seeks children aged 4 to 7 who have been diagnosed with intermittent exotropia and can tolerate wearing the headset for an hour a day, six days a week, for 12 weeks. Children meeting these criteria and struggling with eye alignment may find this trial beneficial. As an unphased trial, this study offers a unique opportunity to explore innovative treatment options for this condition.

Do I need to stop my current medications for the trial?

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

What prior data suggests that this dichoptic therapy is safe for children with intermittent exotropia?

Research has shown that Luminopia, a virtual reality treatment, has been safe in earlier studies. In one study with 179 children, Luminopia improved their vision over 12 weeks without any serious side effects, indicating it was well-tolerated. The FDA has approved Luminopia for treating amblyopia (lazy eye) in children, further supporting its safety. While these results are promising, individual experiences may vary. Prospective participants should consult a healthcare provider about any concerns before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Luminopia because it offers a fresh approach to managing intermittent exotropia, a condition where one eye occasionally drifts outward. Unlike typical treatments such as patching or corrective glasses, Luminopia uses a virtual reality (VR) headset to deliver dichoptic therapy. This method simultaneously shows different images to each eye, encouraging the brain to improve eye coordination and control. The VR delivery method is not only engaging for young children but also promises a non-invasive and potentially more effective way to treat this eye misalignment.

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

Research shows that Luminopia, which participants in this trial will use, can improve vision clarity in people with vision problems. In a study with 179 participants, 81% experienced noticeable improvement in their vision after just 12 weeks of using Luminopia. This treatment helps the brain coordinate both eyes, which is crucial for conditions like intermittent exotropia, where the eyes sometimes drift outward. While researchers continue to study the long-term effects beyond 12 weeks, the early results are encouraging. Luminopia offers a non-surgical option that could serve as a useful alternative for those with intermittent exotropia. ^{2 5 6 7 8}

Who Is on the Research Team?

Evan Silverstein

Principal Investigator

Virginia Commonwealth University

Are You a Good Fit for This Trial?

This trial is for children aged 4-7 with intermittent exotropia, a condition where one eye occasionally drifts outward. They must have a preferred eye and mild symptoms of the condition. Kids who can't wear a virtual reality headset regularly or have significant differences in vision between eyes cannot participate.

Inclusion Criteria

Has one eye that is their preferred eye

Distance control scores of <= 4

I have been diagnosed with intermittent exotropia (IXT).

Exclusion Criteria

Distance control scores of 5

Visual acuity with vision that is worse in one eye by greater than two lines

Unable to tolerate wearing the headset for 1 hour/day, 6 days/week, for 12 weeks

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the Luminopia VR headset for dichoptic therapy to improve intermittent exotropia control

3 months

Regular use at home

Washout

Participants undergo a washout period without the device to assess the durability of treatment effects

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Luminopia

Trial Overview The study tests dichoptic therapy using Luminopia, a virtual reality headset, to treat intermittent exotropia without surgery. Participants will also complete paper surveys before and after treatment to assess changes.

How Is the Trial Designed?

Group I: Luminopia VR headset treatment Experimental Treatment 3 Interventions

Using Dichoptic Therapy to Improve Intermittent Exotropia Control in children ages 4-7

Luminopia is already approved in United States for the following indications:

Approved in United States as Luminopia One for:

• Amblyopia
• Intermittent Exotropia

Who Is Running the Clinical Trial?

Virginia Commonwealth University

Lead Sponsor

Trials

732

Recruited

22,900,000+

Published Research Related to This Trial

In a study of 136 children aged 7 to 17 with intermittent exotropia, early postoperative orthoptic therapy significantly reduced the likelihood of suboptimal surgical outcomes, with only 20.5% of patients in the therapy group experiencing issues compared to 42.6% in the control group.

The therapy also led to improvements in stereopsis, fusional exotropia control, and convergence amplitude, indicating that orthoptic therapy enhances both surgical success and binocular function after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Orthoptic Therapy on the Surgical Outcome in Children with Intermittent Exotropia: Randomised Controlled Clinical Trial. Xu, M., Peng, Y., Zheng, F., et al.[2023]

Surgery is the primary treatment for intermittent exotropia, which is the most common and challenging type of strabismus, and its long-term success depends on various factors including age, disease progression, and surgical techniques.

The paper emphasizes the importance of standardizing the diagnosis and treatment of intermittent exotropia to improve surgical outcomes and success rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Hot topics in treatment of intermittent exotropia]. Wang, L., Zhao, K.[2018]

In a review of 183 patients treated for intermittent exotropia across two centers, different surgical techniques (recession and resection vs. bimedial resection) were employed, highlighting the variability in treatment approaches for this condition.

The study suggests that there are distinct clinical presentations of intermittent exotropia, which may require tailored diagnostic and treatment strategies, including the evaluation of prism acceptance in a prospective group of patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two therapeutic concepts in intermittent divergent squint. Lange, W., De Decker, W.[2019]

Overminus spectacle therapy significantly improved distance control of intermittent exotropia (IXT) in children after 12 months of treatment, with a mean control score of 1.8 compared to 2.8 in the nonoverminus group (P < 0.001).

However, the improvement in exotropia control was not sustained after the treatment was tapered off, as scores were similar between groups at 18 months, and the overminus group experienced a greater myopic shift, with 17% of children showing a shift greater than 1.00 D.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overminus Lens Therapy for Children 3 to 10 Years of Age With Intermittent Exotropia: A Randomized Clinical Trial. Chen, AM., Erzurum, SA., Chandler, DL., et al.[2022]

In a study of 150 patients with intermittent exotropia, combining surgery with orthoptic/occlusion therapy showed the highest success rates in treatment, significantly outperforming other methods.

The combination treatment not only led to greater reductions in exodeviation at all follow-up points but also proved more effective in terms of the amount of correction achieved per millimetre of surgery performed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermittent exotropia: comparison of treatments. Figueira, EC., Hing, S.[2016]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03608150

Luminopia One Amblyopia Vision Improvement Study The objective of the study is to demonstrate the safety and efficacy of Luminopia One in amblyopia patients with amblyopia associated with anisometropia and/or ...

2. prnewswire.com prnewswire.com/news-releases/real-world-data-reinforces-efficacy-of-luminopia-in-improving-vision-for-patients-with-amblyopia-302174917.html

Real-World Data Reinforces Efficacy of Luminopia in ... This initial registry analysis of 179 patients from 10 clinical sites showed significant improvement in visual acuity after 12 weeks of Luminopia treatment in ...

3. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/reviews/DEN210005.pdf

DEN210005 | FDA Safety and effectiveness of Luminopia One therapy beyond 12 weeks is unknown and was not evaluated in the clinical study. • The durability of benefit from ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11867222/

Factors associated with visual acuity improvement with a ... Visual acuity improved ≥1 line in 81% of participants after 12 weeks of therapy. Treatment response was not found to be associated with age, severity of ...

5. aao.org aao.org/young-ophthalmologists/yo-info/article/understanding-digital-treatments-for-amblyopia

Understanding Digital Treatments for Amblyopia Visual acuity improved slightly over two lines with patching, versus almost three lines with CureSight. (Putting Luminopia's data into VA lines ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7239850/

Improved adherence and treatment outcomes with an ... We found that amblyopic eye vision improved significantly after 12 weeks of treatment, with higher adherence than that of available treatments.

7. ophthalmologytimes.com ophthalmologytimes.com/view/data-demonstrates-efficacy-of-fda-approved-therapy-for-treating-amblyopia-in-children

Data demonstrates efficacy of FDA-approved therapy for ... The first registry analysis of 179 patients from 10 clinical sites showed significant improvement in visual acuity after 12 weeks of Luminopia ...

8. withpower.com withpower.com/trial/phase-exotropia-8-2024-d6a38

Dichoptic Therapy for Intermittent Exotropia In a study of 136 children aged 7 to 17 with intermittent exotropia, early postoperative orthoptic therapy significantly reduced the likelihood of suboptimal ...