Binocular Games for Lazy Eye

Overseen By Eileen E Birch, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Retina Foundation of the Southwest

Disqualifiers: Prematurity, Ocular disease, Developmental delay, 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: 4

Duration: 8 weeks

120 Participants Needed

Trial Summary

What is the purpose of this trial?

To evaluate the effectiveness of enhanced binocular amblyopia treatments in achieving a more complete and stable recovery.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, you must be willing to stop patching treatment for the 12-week study period.

What data supports the effectiveness of the treatment Binocular Amblyopia Treatment, Binocular Amblyopia Therapy, Dichoptic Training, Balanced Binocular Viewing Therapy, Luminopia, CureSight, Vivid Vision for lazy eye?

Research shows that binocular treatments, like games and movies that balance visual signals, can improve vision in children with amblyopia (lazy eye) by enhancing the use of both eyes together. Studies comparing these treatments to traditional patching methods suggest they may be effective in improving visual acuity and binocularity. ^{1 2 3 4 5}

Is binocular game therapy for amblyopia safe for humans?

The research on binocular game therapy for amblyopia, including treatments like Luminopia, suggests it is generally safe for humans, with studies focusing on its effectiveness and adherence rather than safety concerns. ^{1 2 5 6 7}

How is the Binocular Amblyopia Treatment different from other treatments for lazy eye?

Binocular Amblyopia Treatment is unique because it uses games or movies that require both eyes to work together, helping improve vision by rebalancing the images seen by each eye, unlike traditional methods like patching which cover the stronger eye to force the weaker one to work harder. ^{3 4 5 8 9}

Eligibility Criteria

This trial is for children aged 4-10 with lazy eye, who have a certain level of vision in their amblyopic (weak) and fellow eyes. They must be able to play binocular games, have not received similar treatments recently, and agree to avoid patching during the study. Children with significant strabismus, premature birth history, other diseases or developmental delays cannot participate.

Inclusion Criteria

Parent's informed consent

Your "lazy" eye has a visual acuity between 0.3 and 0.8 on a special eye chart.

My child's eye doctor and we agree not to use patching treatment for 12 weeks.

Exclusion Criteria

I have an eye or other health condition alongside my main illness.

I have received treatment for lazy eye in the last 3 months.

You were born more than 8 weeks early.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo binocular amblyopia treatment using contrast-rebalanced games for 8 weeks

8 weeks

Weekly visits for monitoring

Stereoacuity Training

Children achieving ≤0.4 logMAR at 8 weeks receive stereoacuity training

4 weeks

1 visit at 8 weeks, followed by training

Additional Amblyopia Treatment

Children with residual amblyopia receive dichoptic movies for further treatment

4 weeks

1 visit at 8 weeks, followed by treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

Treatment Details

Interventions

• Binocular Amblyopia Treatment

Trial Overview The trial tests if playing specially designed binocular games can more effectively treat lazy eye in kids compared to traditional methods. It aims for a complete and stable visual improvement over a 12-week period without using an eye patch.

Participant Groups

Group I: Reduced Contrast Increment Experimental Treatment 1 Intervention

Group II: No Contrast Increment Experimental Treatment 1 Intervention

Group III: Standard Contrast Increment Active Control 1 Intervention

Binocular Amblyopia Treatment is already approved in United States for the following indications:

Approved in United States as Luminopia for:

• Amblyopia associated with anisometropia and/or mild strabismus in children aged 4-7 years

Approved in United States as CureSight for:

• Amblyopia in children aged 4-<9 years with anisometropic, small-angle strabismic or mixed-mechanism amblyopia

Who Is Running the Clinical Trial?

Retina Foundation of the Southwest

Lead Sponsor

Trials

15

Recruited

1,600+

National Eye Institute (NEI)

Collaborator

Trials

572

Recruited

1,320,000+

Findings from Research

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 182 children aged 4 to 6 years with amblyopia, the use of a binocular iPad game, Dig Rush, resulted in a greater improvement in amblyopic-eye visual acuity after 4 weeks compared to continued spectacle correction alone, with an adjusted difference of 0.5 logMAR lines.

After 8 weeks, the improvement in visual acuity was not significantly different between the two groups, suggesting that while the binocular treatment shows promise, further modifications may be needed to enhance its long-term efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Trial of Binocular Dig Rush Game Treatment for Amblyopia in Children Aged 4 to 6 Years. Manny, RE., Holmes, JM., Kraker, RT., et al.[2023]

A study involving 27 amblyopic children aged 4-10 showed that passive viewing of contrast-rebalanced dichoptic movies significantly improved visual acuity in the amblyopic eye over a 2-week period.

The improvement in visual acuity was comparable to that achieved through more traditional treatments like binocular games or occlusion therapy, indicating that this passive method could be an effective alternative for treating amblyopia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Binocular amblyopia treatment with contrast-rebalanced movies. Birch, EE., Jost, RM., De La Cruz, A., et al.[2020]

In a study of 103 Chinese children aged 3-13 with anisometropic amblyopia, the combined treatment of a binocular game and part-time patching showed the greatest improvement in amblyopic-eye visual acuity (VA) after 3 months, although patching alone was more effective than the binocular game.

The binocular game improved binocularity and stereoacuity, but it was not superior to patching in enhancing amblyopic-eye VA, suggesting that while the game has benefits, traditional patching remains a more effective treatment for visual acuity improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Binocular game versus part-time patching for treatment of anisometropic amblyopia in Chinese children: a randomised clinical trial. Yao, J., Moon, HW., Qu, X.[2020]

This study is evaluating a new binocular game treatment for amblyopia in children aged 4 to 12, comparing its effectiveness to traditional patching therapy in a randomized trial with 44 participants.

The primary goal is to measure changes in visual acuity in the amblyopic eye after 3 months, using innovative methods like red-green anaglyphic glasses to enhance treatment engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of binocular game and patching in treating mild to moderate anisometropic amblyopia: a study protocol for a randomized controlled trial. Razavi, ME., Najjaran, M., Mohseni, J., et al.[2022]

In a study involving 90 children aged 4-12 with amblyopia, the dichoptic treatment Luminopia One led to significant improvements in visual acuity, with best-corrected visual acuity (BCVA) improving from 0.50 logMAR to 0.35 logMAR after 12 weeks (P < 0.0001).

The treatment also showed high adherence rates, with a median adherence of 86%, indicating that children were able to consistently engage with the therapy over the 12-week period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital therapeutic improves visual acuity and encourages high adherence in amblyopic children in open-label pilot study. Xiao, S., Gaier, ED., Wu, HC., et al.[2021]

Recent research has revealed that amblyopia, traditionally treated with patching the stronger eye, can benefit from new therapies that are effective beyond the early sensitive period of development, suggesting ongoing neural plasticity.

Innovative treatments such as perceptual learning, video games, and binocular methods are showing promise in improving amblyopia by addressing the disorder's binocular nature, rather than relying solely on monocular approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rethinking amblyopia 2020. Levi, DM.[2021]

In a study involving 25 children aged 8 to 18 with amblyopia, the use of a self-administered perceptual learning video game did not lead to significant improvements in visual function compared to traditional patching methods.

While no overall benefits were observed, better compliance with the perceptual learning therapy was associated with some positive outcomes, suggesting that increasing adherence to treatment might enhance effectiveness in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-term Perceptual Learning Game Does Not Improve Patching-Resistant Amblyopia in Older Children. Lee, YH., Maniglia, M., Velez, F., et al.[2021]

In a study involving 50 preschool children with amblyopia, those who played binocular iPad games for at least 4 hours a week showed significant improvement in visual acuity compared to those who played sham games, with a notable decrease in logMAR scores from 0.43 to 0.34 after 4 weeks.

Children who engaged in the binocular games for 8 hours or more experienced even greater improvements in visual acuity, highlighting the importance of compliance in treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Binocular iPad treatment for amblyopia in preschool children. Birch, EE., Li, SL., Jost, RM., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

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

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

A Randomized Trial of Binocular Dig Rush Game Treatment for Amblyopia in Children Aged 4 to 6 Years. [2023]

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

Binocular amblyopia treatment with contrast-rebalanced movies. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Binocular game versus part-time patching for treatment of anisometropic amblyopia in Chinese children: a randomised clinical trial. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Comparison of binocular game and patching in treating mild to moderate anisometropic amblyopia: a study protocol for a randomized controlled trial. [2022]

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

Digital therapeutic improves visual acuity and encourages high adherence in amblyopic children in open-label pilot study. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Rethinking amblyopia 2020. [2021]

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

Short-term Perceptual Learning Game Does Not Improve Patching-Resistant Amblyopia in Older Children. [2021]

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

Binocular iPad treatment for amblyopia in preschool children. [2022]