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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a special iPad game can improve vision in children with lazy eye (amblyopia) as effectively as the traditional patching method. It will compare the results of using this binocular game app with wearing an eye patch. Children aged 4-14 who have a significant difference in vision between their eyes, wear glasses, and can play the Dig Rush game qualify as good candidates for the trial. The trial seeks to enhance visual clarity and reduce the dominance of one eye over the other. As an unphased trial, this study offers children a unique opportunity to potentially improve their vision through innovative technology.

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 prior data suggests that the binocular iPad game app is safe for children with amblyopia?

Research shows that the iPad game app used to treat lazy eye in children is generally safe. Studies have not identified any specific safety issues, indicating it is well-tolerated. One study found that children who played the game improved their vision more than those using the traditional eye patch method in just two weeks. Another study confirmed that this digital game therapy is both effective and safe for children aged 4 to 6 with a lazy eye. Participants in this trial can therefore feel confident about the safety of the game treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Binocular iPad Game App for treating lazy eye, or amblyopia, because it offers a unique and engaging approach compared to traditional methods like patching. Unlike patching, which involves covering the stronger eye to force the weaker one to work harder, the game encourages both eyes to work together through interactive gameplay. This method not only aims to improve vision but also potentially enhances depth perception and eye coordination. The convenience and appeal of using an iPad make it more appealing, especially for younger patients, potentially leading to better adherence and more effective treatment outcomes.

What evidence suggests that the binocular iPad game app is effective for improving visual acuity in amblyopic children?

Research has shown that playing a special iPad game using both eyes can greatly improve vision in children with amblyopia, also known as lazy eye. In this trial, some participants will engage in one hour per day of binocular game play. One study found that this game improved vision sharpness more in just two weeks compared to the traditional method of wearing an eye patch. Meanwhile, other participants in this trial will follow a patching regimen, which is the current standard treatment. The vision improvement from the game was not only quick but also lasted for at least three months after stopping the game. Other studies have shown that this game can be as effective as using an eye patch. Overall, the iPad game is a promising option for helping children with amblyopia see better. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6054712/

Binocular iPad Game vs Patching for Treatment of Amblyopia ... At the 2-week visit, improvement in amblyopic eye BCVA was greater with the binocular game compared with patching, with a mean (SD) improvement of 0.15 (0.08) ...

2. nature.com nature.com/articles/eye2014165

A binocular iPad treatment for amblyopic children | Eye Binocular iPad treatment rapidly improved visual acuity, and visual acuity was stable for at least 3 months following the cessation of treatment.

3. withpower.com withpower.com/trial/binocular-games-for-lazy-eye-0b4d7

Binocular Games for Lazy Eye · Info for Participants 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 ...

4. frontiersin.org frontiersin.org/journals/medicine/articles/10.3389/fmed.2025.1560203/full

Comparative effectiveness of gamified binocular treatment ... The study indicates that GBT is as effective as patching in improving amblyopic visual outcomes among Chinese children 4 to 8 years of age.

5. games.jmir.org games.jmir.org/2025/1/e60309

Effectiveness of a Gamified Mobile App in Enhancing ... A randomized trial of a binocular iPad game versus part-time patching in children aged 13 to 16 years with amblyopia. Am J Ophthalmol. Feb ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5145771/

A Randomized Trial Of A Binocular iPad Game Versus Part ... To compare visual acuity (VA) improvement in children with amblyopia treated with a binocular iPad® game versus part-time patching. Design.

7. youtube.com youtube.com/watch?v=O9ngp8rCL3s

Binocular iPad Game vs Patching for Treatment of Amblyopia ... We found that at the two-week visit children who played the binocular ipad game improve vision much more than those who had patching treatment.

8. games.jmir.org games.jmir.org/2025/1/e63384/

Transformative Gamified Binocular Therapy for Unilateral ... Binocular gamified digital therapy is effective and safe for improving visual outcomes in children aged 4-6 years with unilateral amblyopia.