VR Games for Lazy Eye

Recruiting in Palo Alto (17 mi)

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Marjean Kulp

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

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

The goal of this study is to compare the change in amblyopic eye acuity between treatment periods in children with amblyopia, aged 5-17 years. The main question it aims to answer is: 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 for improvement in amblyopic-eye VA, binocularity (stereoacuity, suppression, alignment), contrast sensitivity, attention, oculomotor function, visual-motor integration, and quality of life than 16 weeks of continued glasses alone? Participants will each serve as their own control and complete: Treatment period 1: Continued optical correction (glasses) alone for 16 weeks; Treatment period 2: Vivid Vision Therapeutic (Dichoptic) Virtual Reality Games for 16 weeks (approx. 25min/day, 6 days/week) plus continued optical correction

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 data supports the effectiveness of the treatment Vivid Vision Therapeutic (Dichoptic) Virtual Reality Games for lazy eye?

Research suggests that using virtual reality games for treating amblyopia (lazy eye) can improve depth perception and visual processing speed. Studies have shown that dichoptic video gaming, which presents different images to each eye, can enhance stereoacuity (3D vision) and reduce eye suppression, making it a promising alternative to traditional treatments. ^{1 2 3 4 5}

Is the VR game treatment for lazy eye safe for humans?

The VR game treatment for lazy eye, using Vivid Vision software, has been tested in clinical trials and no serious adverse events were reported, indicating it is generally safe for humans. ^{2 6 7 8 9}

How is the Vivid Vision Therapy treatment for lazy eye different from other treatments?

Vivid Vision Therapy uses virtual reality games to present different images to each eye, helping to improve depth perception and reduce eye suppression, which is different from traditional methods like patching one eye. ^{1 2 3 4 5}

Research Team

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Vivid Vision Therapeutic (Dichoptic) Virtual Reality Games (Other)

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.

Participant Groups

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 Canada for the following indications:

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+

Findings from Research

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]

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]

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]

References

1. England 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. [2022]

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

Virtual Reality Game Playing in Amblyopia Therapy: A Randomized Clinical Trial. [2021]

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

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

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

Dichoptic Game Training in Strabismic Amblyopia Improves the Visual Evoked Response. [2023]

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

Comparison of Dichoptic Therapy Versus Occlusion Therapy in Children With Anisometropic Amblyopia: A Prospective Randomized Study. [2023]

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

Adherence to home-based videogame treatment for amblyopia in children and adults. [2021]

7. Germany pubmed.ncbi.nlm.nih.gov

Barriers to successful dichoptic treatment for amblyopia in young children. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Randomized Controlled Trial of Patching versus Dichoptic Stimulation Using Virtual Reality for Amblyopia Therapy. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Binocular treatment of amblyopia using videogames (BRAVO): study protocol for a randomised controlled trial. [2019]