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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore new methods to improve vision in individuals with amblyopia, commonly known as "lazy eye," which can cause poor vision and difficulty seeing contrasts. Researchers will test three treatments: playing video games (Video Game Vision Training), engaging in visual tasks to enhance perception (Perceptual Learning), and wearing an eye patch over the stronger eye to encourage use of the weaker one (Occlusion Therapy). Individuals with amblyopia or normal vision who experience a noticeable difference in vision between their eyes may be suitable for this study. Participants must commit to sessions several times a week for about one to six months. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could lead to new treatment options 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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that using video games for vision training is generally safe and well-tolerated for treating amblyopia, also known as "lazy eye." Studies have found that children who play digital games as part of their vision therapy improve their vision without major safety issues. In one study, children handled the treatment well, and researchers noticed better vision after just a few hours of gameplay.

For perceptual learning, studies have shown it to be a safe and effective way to treat amblyopia. Participants experienced significant improvements in visual skills, such as seeing details and recognizing positions, with few side effects. This method uses the brain's ability to change and adapt, known as neuroplasticity, to help improve vision in people with amblyopia.

Both video game vision training and perceptual learning offer promising options for improving vision in people with amblyopia, with evidence supporting their safety and effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for lazy eye because they leverage innovative approaches like video games and perceptual learning. Unlike traditional occlusion therapy, which involves covering the dominant eye to strengthen the weaker one, video game vision training and perceptual learning engage both eyes in activities that improve visual skills. This new method not only makes the treatment process more enjoyable and engaging, especially for young patients, but also targets key visual functions such as visual acuity and contrast sensitivity. By making therapy fun and interactive, these novel treatments could improve adherence and outcomes in ways standard treatments haven’t.

What evidence suggests that this trial's treatments could be effective for amblyopia?

Research has shown that playing video games, an activity participants in this trial may engage in, can be as effective as wearing an eye patch for treating lazy eye (amblyopia) in children. In some cases, games that use both eyes have improved symptoms faster than an eye patch. Another treatment arm in this trial involves special visual exercises, known as perceptual learning. Studies indicate these exercises can enhance visual clarity and the ability to distinguish between different shades. In one study, over 80% of participants experienced better vision, suggesting long-term benefits. Both video game training and these visual exercises offer promising alternatives to traditional treatments for lazy eye, such as occlusion therapy, which is also being evaluated in this trial. ^{6 7 8 9 10}

Who Is on the Research Team?

Roger W Li, OD, PhD

Principal Investigator

Nova Southeastern University College of Optometry

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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]

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]

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]

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]

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]

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