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

Trial Summary

What is the purpose of this trial?

Intermittent exotropia is difficult to treat. The mainstay of treatment involves surgery, and in one long-term study authors found that as many as 60% of IXT required at least one re-operation.Patching of the non-dominant eye has also been tested in a large, multi-center randomized control trial and was not found to have a large benefit. More non-surgical treatment modalities are critical to improve the care in 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.

How is the treatment Luminopia for intermittent exotropia different from other treatments?

Luminopia, also known as Luminopia One or Dichoptic Therapy, is unique because it uses a virtual reality headset to deliver visual therapy, which is a non-surgical and engaging way to treat intermittent exotropia by training the eyes to work together, unlike traditional methods that often rely on surgery or corrective lenses. ^{1 2 3 4 5}

Research Team

Evan Silverstein

Principal Investigator

Virginia Commonwealth University

Eligibility Criteria

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

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

Distance control scores of 5

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. Australia pubmed.ncbi.nlm.nih.gov

Intermittent exotropia: comparison of treatments. [2016]

2. Switzerland pubmed.ncbi.nlm.nih.gov

The Effects of Orthoptic Therapy on the Surgical Outcome in Children with Intermittent Exotropia: Randomised Controlled Clinical Trial. [2023]

3. China pubmed.ncbi.nlm.nih.gov

[Hot topics in treatment of intermittent exotropia]. [2018]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Two therapeutic concepts in intermittent divergent squint. [2019]

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

Overminus Lens Therapy for Children 3 to 10 Years of Age With Intermittent Exotropia: A Randomized Clinical Trial. [2022]