Dichoptic Treatment for Lazy Eye

(ATS24 Trial)

Recruiting at 40 trial locations

Overseen By Raymond T Kraker, MSPH

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Jaeb Center for Health Research

Must not be taking: Cycloplegic eyedrops

Disqualifiers: Heterotropia, Prism, Myopia, Ocular co-morbidity, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 18 weeks

252 Participants Needed

Trial Summary

What is the purpose of this trial?

Participants eligible for the study will be randomly allocated (1:1:1) to receive either Luminopia dichoptic treatment while wearing optical correction if needed, Vivid Vision dichoptic treatment while wearing optical correction if needed, or continued optical correction alone if needed, with clinical assessments at 9- and 18-weeks post-randomization. At the 18-week primary outcome visit, participants who were randomly assigned to receive optical correction alone if needed with an IOD of 1 logMAR line (5 letters) or more, will be offered randomization to Luminopia or Vivid Vision dichoptic therapy and if they accept, followed forward with visits at 27- and 36-weeks post-randomization. The study will end for all other participants at 18 weeks.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications, but it does require stopping cycloplegic eyedrops (like atropine) two weeks before joining the study.

What data supports the effectiveness of the treatment Luminopia One for lazy eye?

Research shows that dichoptic treatments like Luminopia One, which involve presenting different images to each eye, can improve visual acuity (sharpness of vision) and encourage better adherence in children with amblyopia (lazy eye). These treatments are more engaging for children, potentially leading to better compliance and outcomes compared to traditional methods. ^{1 2 3 4 5}

Is dichoptic treatment for lazy eye safe for humans?

The research does not provide specific safety data for dichoptic treatments like Luminopia or Vivid Vision, but these treatments are generally designed to be non-invasive and involve using video games or movies to improve vision, which suggests they are likely safe for human use. ^{1 2 3 6 7}

How is the dichoptic treatment for lazy eye different from other treatments?

The dichoptic treatment for lazy eye, like Luminopia and Vivid Vision, is unique because it uses therapeutic modifications to streaming content or movies to balance visual input from each eye, making it more engaging and potentially improving adherence compared to traditional methods like eye patches or blurring drops. ^{2 3 8 9 10}

Research Team

Benajmin G Jastrzembski, MD

Principal Investigator

University of California, Davis

Marjean T Kulp, OD

Principal Investigator

Ohio State University

Eligibility Criteria

This trial is for children aged 8 to less than 13 with lazy eye (amblyopia) ranging from mild to severe (20/40 to 20/200 vision). They must have a significant difference in vision between eyes and may have associated conditions like strabismus or anisometropia. Kids with very slight eye alignment issues are included, but those with more serious unrelated health problems cannot participate.

Inclusion Criteria

I am between 8 and 12 years old.

I have lazy eye due to crossed eyes, different eye prescriptions, or both.

Refractive correction required for specific refractive errors

Exclusion Criteria

Myopia greater than -6.00D spherical equivalent in either eye

I have an eye condition that could affect my vision.

I have experienced double vision more than once in the past week.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Luminopia dichoptic treatment, Vivid Vision dichoptic treatment, or continued optical correction alone, with clinical assessments at 9- and 18-weeks post-randomization

18 weeks

2 visits (in-person) at 9 and 18 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Optional Extension

Participants initially receiving optical correction alone with an IOD of 1 logMAR line or more may opt into further dichoptic therapy and are followed with visits at 27- and 36-weeks post-randomization

18 weeks

2 visits (in-person) at 27 and 36 weeks

Treatment Details

Interventions

• Luminopia
• Vivid Vision

Trial Overview The study tests two treatments for lazy eye: Luminopia and Vivid Vision, both used alongside regular glasses if needed. It compares these therapies against just using glasses alone. Children will be randomly assigned to one of the three groups and evaluated at weeks 9 and 18, with some continuing until week 36.

Participant Groups

Group I: Vivid Vision Group Experimental Treatment 1 Intervention

dichoptic games using the Vivid Vision headset, prescribed approximately 25 minutes per day (treatment time to complete the day's sessions can be split into shorter sessions totaling about 25 minutes each day) 6 days per week with current optical correction if needed

Group II: Luminopia Group Experimental Treatment 1 Intervention

dichoptic movies/shows wearing the Luminopia headset prescribed 1 hour per day (treatment time can be split into shorter sessions totaling 1 hour each day) 6 days a week with current optical correction if needed

Group III: Continued Optical Correction Group Active Control 1 Intervention

continued full-time optical correction alone if needed

Luminopia is already approved in United States for the following indications:

Approved in United States as Luminopia One for:

• Amblyopia
• Intermittent Exotropia

Who Is Running the Clinical Trial?

Jaeb Center for Health Research

Lead Sponsor

Trials

162

Recruited

36,200+

Pediatric Eye Disease Investigator Group

Collaborator

Trials

20

Recruited

4,800+

National Eye Institute (NEI)

Collaborator

Trials

572

Recruited

1,320,000+

Findings from Research

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]

Current treatments for amblyopia, like occlusion and pharmacological blurring, have limited success, with less than two-thirds of children achieving good visual acuity in the affected eye.

There is a lack of randomized controlled trials (RCTs) on new binocular treatments for amblyopia, but non-controlled studies show promise, indicating a need for further research to establish their safety and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Binocular versus standard occlusion or blurring treatment for unilateral amblyopia in children aged three to eight years. Tailor, V., Bossi, M., Bunce, C., 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]

Active vision therapy significantly improved visual acuity in most of the 160 pseudophakic amblyopic patients aged 3.5 to 25 years, with many achieving better than 20/60 vision after 6 months of treatment.

Despite some patients experiencing a decrease in visual acuity after therapy ended, particularly those under 15 years old, their vision improved again with subsequent therapy sessions, indicating the potential for ongoing benefits from active vision therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Active vision therapy for pseudophakic amblyopia. Verma, A., Singh, D.[2019]

A new treatment method for strabismus using liquid crystal eyeglasses and computer technology was tested on 74 children with strabismus, showing promising results in improving visual function.

The method allows for precise measurements of visual acuity and fusion reserves, and it is recommended for practical use based on the positive outcomes observed in the patient group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Use of liquid crystal eyeglasses for examination and recovery of binocular vision]. Grigorian, AIu., Avetisov, ES., Kashchenko, TP., et al.[2008]

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 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]

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 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]

Diplopia, or double vision, can occur after various ocular surgeries due to strabismus, and while it may resolve on its own, persistent cases often require surgical intervention, especially if caused by a restrictive process.

Nonsurgical treatments, such as Fresnel prisms or occlusion methods, can be effective in managing diplopia before surgery or as long-term solutions if they are acceptable to the patient.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nonsurgical management of diplopia. Fraine, L.[2019]

References

1. 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]

2. England pubmed.ncbi.nlm.nih.gov

Binocular versus standard occlusion or blurring treatment for unilateral amblyopia in children aged three to eight years. [2022]

3. 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]

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

Active vision therapy for pseudophakic amblyopia. [2019]

5. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Use of liquid crystal eyeglasses for examination and recovery of binocular vision]. [2008]

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

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

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

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

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

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

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

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

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

Nonsurgical management of diplopia. [2019]