VR Games for Lazy Eye

Overseen By Marjean T Kulp, OD, MS

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Marjean Kulp

Disqualifiers: Myopia, Previous surgery, Ocular co-morbidity, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

8 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if virtual reality (VR) games can improve vision in children with amblyopia, commonly known as "lazy eye." Researchers seek to find out if playing these VR games for about 25 minutes a day, six days a week, is more effective than wearing glasses alone. Children aged 5-17 with moderate to severe amblyopia, who have worn glasses for at least 16 weeks and have not received amblyopia treatment in the last two weeks, may be suitable candidates for this trial. Participants will initially continue with glasses alone, then incorporate Vivid Vision Therapeutic (Dichoptic) Virtual Reality Games into their routine. As an unphased trial, this study provides a unique opportunity to explore innovative treatments that could enhance vision improvement strategies for children.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. It focuses on using glasses and virtual reality games for treatment.

What prior data suggests that these virtual reality games are safe for children with amblyopia?

Research has shown that virtual reality games, such as Vivid Vision Therapeutic games, offer a promising treatment for amblyopia, or "lazy eye." Studies have found that these games can enhance depth perception and speed up the brain's processing of visual information.

Regarding safety, several studies have examined VR games for treating amblyopia and found them generally well-tolerated. Significant harmful effects have not been reported, indicating that most users did not experience major negative reactions.

For those considering joining a clinical trial for this treatment, it is reassuring to know that VR games have been used in other studies without causing serious problems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of Vivid Vision Therapeutic Virtual Reality Games for treating lazy eye because it introduces an innovative approach compared to standard treatments like patching or atropine drops. Unlike these traditional methods, which focus on covering the stronger eye to encourage the weaker one to work harder, this VR-based treatment engages both eyes simultaneously through dichoptic stimulation, potentially enhancing visual processing and brain integration. Additionally, the interactive and engaging nature of virtual reality games could improve patient compliance and make the treatment experience more enjoyable, especially for children.

What evidence suggests that Vivid Vision Therapeutic Virtual Reality Games might be an effective treatment for amblyopia?

Research has shown that virtual reality games can improve vision in people with amblyopia, also known as lazy eye. These games enhance depth perception and speed up the brain's visual processing. In studies with adults, Vivid Vision's VR games led to clearer vision and better depth perception. In this trial, participants will experience both study conditions: one arm involves Therapeutic (Dichoptic) Virtual Reality Games plus continued optical correction, while the other involves optical correction alone. The games encourage the brain to focus more on the weaker eye, improving how well the eyes work together. Overall, these findings suggest that VR games might effectively treat amblyopia. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

Children aged 5-17 with lazy eye (amblyopia) who haven't had treatment in the last 2 weeks. They must have moderate to severe amblyopia due to anisometropia or strabismus, and a stable vision with glasses if needed. Excluded are those with high myopia, seizure risks from light, simulator sickness, other serious eye issues, frequent double vision, Down syndrome or cerebral palsy, severe developmental delays that affect treatment adherence.

Inclusion Criteria

Your eyes are a certain distance apart, between 52 and 72 millimeters.

You have been wearing glasses for at least 16 weeks, or until your vision has stayed the same for at least 8 weeks.

Your eyesight is very different between your two eyes.

Exclusion Criteria

You have Down syndrome or cerebral palsy.

You have a significant delay in your development that would make it hard for you to receive treatment or be evaluated by the doctor.

I have had eye surgery before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Period 1

Participants receive continued optical correction (glasses) alone for 16 weeks

16 weeks

Regular visits for monitoring

Treatment Period 2

Participants receive Vivid Vision Therapeutic (Dichoptic) Virtual Reality Games for 16 weeks plus continued optical correction

16 weeks

Regular visits for monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Vivid Vision Therapeutic (Dichoptic) Virtual Reality Games

Trial Overview

The study tests whether playing therapeutic virtual reality games for about 25 minutes daily is more effective than just wearing glasses for improving visual acuity and other aspects of vision in children with lazy eye over a period of 16 weeks. Each child will first continue their normal glasses wear then switch to including the VR games.

How Is the Trial Designed?

Group I: Therapeutic (Dichoptic) Virtual Reality Games plus Continued Optical Correction Experimental Treatment 2 Interventions

Therapeutic (Dichoptic) Virtual Reality Games plus continued optical correction (16 weeks) (Each participant will complete both study conditions.)

Group II: Optical Correction alone Active Control 1 Intervention

Optical correction alone (16 weeks) (Each participant will complete both study conditions.)

Vivid Vision Therapeutic (Dichoptic) Virtual Reality Games is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Vivid Vision Therapy for:

• Amblyopia (lazy eye)
• Strabismus (eye misalignment)
• Convergence insufficiency
• Binocular vision problems

Approved in European Union as Vivid Vision Therapy for:

• Amblyopia (lazy eye)
• Strabismus (eye misalignment)
• Convergence insufficiency
• Binocular vision problems

Approved in Canada as Vivid Vision Therapy for:

• Amblyopia (lazy eye)
• Strabismus (eye misalignment)
• Convergence insufficiency
• Binocular vision problems

Who Is Running the Clinical Trial?

Marjean Kulp

Lead Sponsor

Trials

1

Recruited

8+

Beta Sigma Kappa - College of Optometrists in Vision Development

Collaborator

Trials

1

Recruited

8+

VividVision

Collaborator

Trials

1

Recruited

8+

Published Research Related to This Trial

Dichoptic stimulation, which presents a common background to both eyes while enriching the foreground for the amblyopic eye, shows promise as a treatment for amblyopia, with improvements similar to traditional patching methods (0.1-0.2 logMAR).

A large randomized control trial indicated that dichoptic stimulation is not inferior to patching, while a smaller trial suggested that video games designed for therapy may offer superior results, highlighting the need for further research due to existing methodological issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of video games for the treatment of amblyopia. Foss, AJ.[2022]

In a study involving 105 participants with amblyopia, adherence to home-based videogame treatment was only 65% of the prescribed hours, indicating that many patients did not fully engage with the treatment as intended.

Participants, especially children, tended to play in short sessions averaging 21.5 minutes with frequent pauses, which may reduce the effectiveness of the treatment by interrupting the necessary sustained visual stimulation for improving amblyopia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to home-based videogame treatment for amblyopia in children and adults. Gao, TY., Black, JM., Babu, RJ., et al.[2021]

In a clinical trial involving 91 newly diagnosed amblyopic children, only 17 started treatment with dichoptic VR video games, and half of them did not complete it, primarily due to their young age and inability to understand the game.

Factors such as loss of interest in the game and compliance issues were significant barriers to treatment success, indicating that while VR may be a novel approach, its effectiveness is limited for younger children, particularly those under 5.5 years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Barriers to successful dichoptic treatment for amblyopia in young children. Kadhum, A., Tan, ETC., Levi, DM., et al.[2021]

In a pilot study involving 18 children aged 2-7 years with amblyopia, both computer game play and close work during occlusion treatment led to improvements in visual acuity, but the difference in effectiveness between the two methods was not statistically significant.

The study suggests that while both activities can be beneficial, a larger randomized controlled trial is needed to determine if one method is superior to the other in improving vision in children with amblyopia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot Study Evaluating the Feasibility of Comparing Computer Game Play with Close Work During Occlusion in Children Aged 2-7 Years with Amblyopia. Jukes, C., Bjerre, A., Coupe, J., et al.[2022]

Supervised dichoptic video gaming training, using a virtual reality system, significantly improved stereoacuity and visual processing speed in patients with strabismic amblyopia, despite no change in visual acuity.

The training involved at least 20 hours of gaming, showing that this method can effectively reduce suppression in the amblyopic eye, as indicated by improved visual evoked potentials (VEPs).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dichoptic Game Training in Strabismic Amblyopia Improves the Visual Evoked Response. Blavakis, E., Spaho, J., Chatzea, M., et al.[2023]

In a study of 86 subjects with moderate to severe amblyopia, both virtual reality (VR) treatment and traditional patching showed significant improvements in visual acuity after 10 weeks, with no serious adverse events reported.

The VR group demonstrated comparable visual acuity improvements to the patching group, suggesting that VR could be an effective alternative treatment for amblyopia, especially in adults and severe cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Controlled Trial of Patching versus Dichoptic Stimulation Using Virtual Reality for Amblyopia Therapy. Meqdad, Y., El-Basty, M., Awadein, A., et al.[2023]

The BRAVO study is a double-blind, randomized, placebo-controlled trial involving 108 participants aged 7 years and older, aimed at evaluating a novel home-based binocular treatment using a videogame for amblyopia.

The primary goal is to determine if this interactive treatment can significantly improve visual acuity in the amblyopic eye compared to a placebo, marking a potential new approach for treating amblyopia in older children and adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Binocular treatment of amblyopia using videogames (BRAVO): study protocol for a randomised controlled trial. Guo, CX., Babu, RJ., Black, JM., et al.[2019]

In a study involving 50 children aged 4 to 10 with unilateral amblyopia, both occlusion therapy (patching) and virtual reality game playing significantly improved visual acuity, but the virtual reality group showed a greater improvement in letter recognition.

The results suggest that virtual reality therapy is at least as effective as traditional patching for treating amblyopia, making it a promising new option for therapy in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality Game Playing in Amblyopia Therapy: A Randomized Clinical Trial. Rajavi, Z., Soltani, A., Vakili, A., et al.[2021]

Dichoptic video game therapy led to greater improvements in contrast sensitivity and near stereoacuity compared to traditional occlusion therapy in children with anisometropic amblyopia, suggesting it may be a more effective treatment option.

Both therapies resulted in similar improvements in distance and near vision after 3 months, indicating that while the video game therapy has advantages, it does not compromise overall visual acuity outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Dichoptic Therapy Versus Occlusion Therapy in Children With Anisometropic Amblyopia: A Prospective Randomized Study. Roy, S., Saxena, R., Dhiman, R., et al.[2023]

Citations

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VR Games for Lazy Eye

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In a pilot study involving 17 adults aged 17-69 with anisometropic amblyopia, after 4 weeks of Vivid Vision® games played in twice-weekly ...

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VR Research

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Novel Amblyopia Treatment With Virtual Reality Games

Is a 16-week course of amblyopia treatment using Vivid Vision Therapeutic (Dichoptic) Virtual Reality Games for approx. 25 min/day, 6 days/week more effective ...

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Moreover, despite improvements in visual acuity by patch therapy, children with amblyopia often face difficulties with hand-eye coordination; ...

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sciencedirect.com

sciencedirect.com/org/science/article/pii/S2561326X2500410X

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Several studies have already explored the therapeutic effects of VR games for amblyopia treatment [16-18]. Žiak et al [16] reported a 30% improvement in visual ...

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VIRTUAL REALITY (VR) TREATMENT FOR AMBLYOPIA ( ...

There was no retrievable evidence on the cost or cost-effectiveness of VIVID® Vision VR treatment for amblyopia (lazy eye). However, various price or fees of VR ...

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Stereoptic serious games as a visual rehabilitation tool for ...

Amblyopia is the most common developmental vision disorder in children. The initial treatment consists of refractive correction.