Video Games + Perceptual Learning for Lazy Eye

Overseen By Roger W Li, OD, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Nova Southeastern University

Disqualifiers: Ocular pathological conditions, nystagmus

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

Compensation: Varies

Number of Visits: 4

Duration: 1-6 months

180 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial involves adults and children with amblyopia practicing visual tasks or playing video games using their weaker eye. The goal is to improve vision by taking advantage of the brain's ability to adapt and change. By using their weaker eye over time, participants may see improvements in their visual abilities. Video games have been shown to be effective in improving vision and promoting brain adaptability in amblyopia treatment.

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 this treatment for lazy eye?

Research shows that video game-based perceptual learning can improve visual functions like stereoacuity (depth perception) in patients with amblyopia (lazy eye), even when traditional patching therapy is not effective. Studies indicate that these video games can enhance both binocular (using both eyes) and monocular (using one eye) vision, suggesting they could be a useful alternative or complement to traditional treatments. ^{1 2 3 4 5}

Is the video game and perceptual learning treatment for lazy eye safe for humans?

The research does not report any safety concerns for video game and perceptual learning treatments for amblyopia (lazy eye), suggesting they are generally safe for humans. ^{2 3 4 6 7}

How does the Video Games + Perceptual Learning treatment for lazy eye differ from other treatments?

This treatment is unique because it combines video game play with perceptual learning and dichoptic training, which involves using both eyes together to improve vision, unlike traditional methods that often focus on patching one eye. It offers a more engaging and potentially more effective approach to improving visual functions like visual acuity and stereoacuity, especially in older children and adults who may not respond well to conventional patching therapy. ^{3 4 5 8 9}

Research Team

Roger W Li, OD, PhD

Principal Investigator

Nova Southeastern University College of Optometry

Eligibility Criteria

This trial is for both adults and children who have normal vision or amblyopia, commonly known as 'lazy eye', where there's a noticeable difference in visual sharpness between the eyes. People with any eye diseases or involuntary eye movement (nystagmus) cannot participate.

Inclusion Criteria

I have a difference in vision between my eyes.

My vision is either normal or I have a lazy eye.

My vision is either normal or I have a lazy eye.

Exclusion Criteria

I have an eye condition.

I experience involuntary eye movements.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in video games, perceptual learning tasks, or occlusion therapy for amblyopia

1-6 months

4-5 sessions per week

Follow-up

Participants are monitored for changes in stereoacuity, contrast sensitivity, positional acuity, and visual acuity

9 months

Treatment Details

Interventions

• Occlusion Therapy
• Perceptual Learning
• Video Game Vision Training

Trial Overview The study is testing new treatments for lazy eye by using video game vision training, perceptual learning exercises, and traditional occlusion therapy which involves covering the stronger eye to improve the weaker one.

Participant Groups

Group I: Video Games Experimental Treatment 1 Intervention

Participants will be required to play video games for a period of time: 1-2 hrs per session, 4-5 sessions/week for \~1-6 months

Group II: Perceptual learning Experimental Treatment 1 Intervention

Participants will be required to practice a visual discrimination task (e.g. visual acuity, position acuity, contrast sensitivity, \& stereoacuity) for a period of time: 1-2 hrs per session, 4-5 sessions/week for \~1-6 months

Group III: Occlusion therapy Active Control 1 Intervention

Participants will be required to cover the dominant eye during the day in order to push the brain to use the fellow amblyopic eye: 1-2 hrs per session, 4-5 sessions/week for \~1-6 months

Occlusion Therapy is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Occlusion Therapy for:

• Amblyopia
• Strabismus
• Anisometropia

Approved in United States as Patching Therapy for:

• Amblyopia
• Lazy Eye
• Strabismus
• Anisometropia

Approved in Canada as Monocular Occlusion Therapy for:

• Amblyopia
• Strabismus
• Anisometropia

Who Is Running the Clinical Trial?

Nova Southeastern University

Lead Sponsor

Trials

103

Recruited

12,000+

Findings from Research

A home-based perceptual learning program using random dot stimuli (RDS) significantly improved stereoacuity in 32 children aged 7 to 14 with a history of amblyopia, showing a median improvement of 50% compared to a control group.

The study demonstrated that this innovative game-based approach not only enhanced stereoacuity during the treatment but also maintained improvements over a 6-month period, suggesting its potential as an effective alternative to traditional occlusion therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Random Dot Computer Video Game Improves Stereopsis. Portela-Camino, JA., Martín-González, S., Ruiz-Alcocer, J., et al.[2019]

A home-based dichoptic video game treatment for amblyopia was effective, with 13 out of 14 adult participants showing restored binocular perception and significant improvements in visual acuity and stereopsis after 10 to 30 hours of use.

Both anaglyphic and lenticular versions of the video game provided similar therapeutic benefits, indicating that the treatment can be conveniently adapted for at-home use without compromising efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The iPod binocular home-based treatment for amblyopia in adults: efficacy and compliance. Hess, RF., Babu, RJ., Clavagnier, S., et al.[2022]

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]

Recent studies over the last six years indicate that treatments for amblyopia, including perceptual learning, dichoptic training, and video games, have shown improvements in visual functions like visual acuity and contrast sensitivity across various age groups, including adults.

These newer methods may serve as effective alternatives or complements to traditional passive therapies, but further controlled clinical trials are needed to determine the most effective treatment approaches and the duration of their benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An updated review about perceptual learning as a treatment for amblyopia. Rodán, A., Candela Marroquín, E., Jara García, LC.[2022]

A new video game-based treatment for amblyopia, using random-dot stimuli and perceptual learning, has shown success in improving stereoacuity in children aged 7-14 who previously received amblyopia treatment, achieving at least a two-level gain in stereoacuity tests.

The treatment not only enhances stereoacuity but also maintains the improvements six months later, indicating its potential as a long-lasting solution compared to traditional occlusion methods, which are effective in fewer than 30% of cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereoacuity Improvement using Random-Dot Video Games. Martín-González, S., Portela-Camino, J., Ruiz-Alcocer, J., et al.[2020]

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]

Traditional amblyopia treatments focus on improving vision in one eye but often fail to enhance binocular vision, leading to unsatisfactory outcomes.

Two new treatment approaches for adults with amblyopia show promise: a binocular method that has shown positive results in early clinical studies, and a developing technique using noninvasive brain stimulation to adjust visual cortex activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New insights into amblyopia: binocular therapy and noninvasive brain stimulation. Hess, RF., Thompson, B.[2022]

A novel dichoptic action videogame significantly improved visual acuity in adults with amblyopia, with an average improvement of approximately 28%, comparable to traditional methods like perceptual learning and dichoptic training.

Participants in the videogame group also showed greater enhancements in stereoacuity, reading speed, and contrast sensitivity compared to those in the supervised occlusion group, indicating the game's potential as an effective treatment for adult amblyopia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A dichoptic custom-made action video game as a treatment for adult amblyopia. Vedamurthy, I., Nahum, M., Huang, SJ., et al.[2022]

The study developed a perceptual-learning video game that integrates multiple approaches to improve vision, showing broad benefits in healthy adults, including enhanced visual acuity and contrast sensitivity.

This innovative game framework not only leverages the engaging nature of video games but also maintains a strong connection to scientific methods, suggesting its potential as both a research tool and a therapeutic intervention for vision improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Broad-based visual benefits from training with an integrated perceptual-learning video game. Deveau, J., Lovcik, G., Seitz, AR.[2021]

References

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

A Random Dot Computer Video Game Improves Stereopsis. [2019]

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

The iPod binocular home-based treatment for amblyopia in adults: efficacy and compliance. [2022]

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

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

4. Spain pubmed.ncbi.nlm.nih.gov

An updated review about perceptual learning as a treatment for amblyopia. [2022]

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

Stereoacuity Improvement using Random-Dot Video Games. [2020]

6. 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]

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

New insights into amblyopia: binocular therapy and noninvasive brain stimulation. [2022]

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

A dichoptic custom-made action video game as a treatment for adult amblyopia. [2022]

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

Broad-based visual benefits from training with an integrated perceptual-learning video game. [2021]