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)

Compensation: Varies

Number of Visits: 10

Duration: 2-4 weeks

96 Participants Needed

Trial Summary

What is the purpose of this trial?

1. To determine whether a binocular iPad game app is effective in improving visual acuity and reducing interocular suppression in amblyopic children 2. To compare the amount of visual acuity improvement achieved with the binocular game app to the amount achieved with patching (standard treatment for amblyopia)

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Binocular iPad Game App and Patching for lazy eye?

Research shows that using a binocular iPad game can improve vision in children and teenagers with amblyopia (lazy eye), and it may be as effective as traditional patching methods. Studies comparing these treatments found that both can help improve visual acuity (sharpness of vision) in children and teenagers. ^{1 2 3 4 5}

Is the Binocular Games for Lazy Eye treatment safe for humans?

The research does not specifically mention safety concerns for the Binocular Games for Lazy Eye treatment, suggesting it is generally considered safe for use in humans. ^{1 2 3 6 7}

How is the Binocular iPad Game App treatment for lazy eye different from other treatments?

The Binocular iPad Game App is unique because it uses a fun, interactive game to improve vision in both eyes simultaneously, unlike traditional treatments like patching, which cover the stronger eye to force the weaker one to work harder. ^{1 2 3 8 9}

Eligibility Criteria

This trial is for children aged 4-14 with lazy eye (amblyopia) who can play an iPad game. They must have a certain level of vision in their eyes and have been wearing glasses, if needed, for stability. Kids with developmental delays, significant eye misalignment, extreme prematurity or other eye/systemic diseases cannot join.

Inclusion Criteria

Must be able to demonstrate understanding and ability to play the Dig Rush game app during the enrollment visit.

Signed informed consent obtained

Children aged 4 to 14 with a lazy eye, where the vision in the weaker eye is between 20/40 and 20/125, the vision in the stronger eye is between 20/16 and 20/25, and there is a big difference in vision between the two eyes.

Exclusion Criteria

You have delayed development.

You have a severe eye alignment problem (strabismus).

You were born at least 8 weeks early.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly assigned to either patching or playing a binocular iPad game app to improve visual acuity and reduce interocular suppression

2-4 weeks

Baseline and primary outcome visits at 2 or 4 weeks

Crossover Treatment

Patching group crosses over to play the iPad game app for additional improvement in visual acuity

4 weeks

Secondary outcome visits at 4 or 8 weeks

Follow-up

Participants are monitored for maintenance of visual acuity gains and reduction in interocular suppression

4-8 weeks

Testing every 4 weeks

Treatment Details

Interventions

• Binocular iPad Game App
• Patching

Trial Overview The study tests if a binocular iPad game app can improve vision in kids with lazy eye better than the standard treatment which involves patching the stronger eye to make the weaker one work harder.

Participant Groups

Group I: binocular games Experimental Treatment 1 Intervention

1 hour per day (5 days per week) binocular game play

Group II: patching (occlusion therapy) Active Control 1 Intervention

2 hours per day patching of the sound eye (for strabismic, anisometropic, and combined mechanism amblyopia) or current patching regimen (deprivation amblyopia)

Who Is Running the Clinical Trial?

Retina Foundation of the Southwest

Lead Sponsor

Trials

15

Recruited

1,600+

Findings from Research

A total of 42 amblyopia-related games were found in mobile app stores, with most categorized as medical, but only 7% involved eye care professionals in their development.

The lack of professional input in the majority of these games suggests a need for quality assurance from qualified eye care professionals to improve trust and efficacy in amblyopia treatment through these apps.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone Applications for Amblyopia Treatment: A Review of Current Apps and Professional Involvement. Paudel, N.[2019]

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]

A pilot randomized controlled trial involving 60 children aged 3-8 years with moderate to severe amblyopia showed that computer-based activities are generally acceptable and accessible to families as part of amblyopia treatment.

The study found high compliance with prescribed near activities (94% for moderate amblyopes) but lower compliance for severe amblyopes (64%), indicating that while computer games are a promising adjunct to treatment, adherence may vary based on the severity of amblyopia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prescribed computer games in addition to occlusion versus standard occlusion treatment for childhood amblyopia: a pilot randomised controlled trial. Tailor, VK., Glaze, S., Khandelwal, P., et al.[2020]

A study involving 40 children aged 4 to 18 years found that a 12-week video game treatment for amblyopia is as effective as traditional eye patching, demonstrating non-inferiority in visual acuity outcomes.

The video game therapy, which requires less time commitment and may be more engaging for children, could improve treatment compliance and offer additional long-term benefits through perceptual learning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a Novel Video Game Platform in the Treatment of Pediatric Amblyopia. Poltavski, D., Adams, RJ., Biberdorf, D., et al.[2023]

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]

References

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

A Randomized Trial of a Binocular iPad Game Versus Part-Time Patching in Children Aged 13 to 16 Years With Amblyopia. [2021]

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

A Randomized Trial of Binocular Dig Rush Game Treatment for Amblyopia in Children Aged 7 to 12 Years. [2020]

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

Smartphone Applications for Amblyopia Treatment: A Review of Current Apps and Professional Involvement. [2019]

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

Supervised dichoptic gaming versus monitored occlusion therapy for childhood amblyopia: Effectiveness and efficiency. [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. England pubmed.ncbi.nlm.nih.gov

Prescribed computer games in addition to occlusion versus standard occlusion treatment for childhood amblyopia: a pilot randomised controlled trial. [2020]

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

Effectiveness of a Novel Video Game Platform in the Treatment of Pediatric Amblyopia. [2023]

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

Reliability and validity of an automated computerized visual acuity and stereoacuity test in children using an interactive video game. [2022]