Dichoptic Treatment for Lazy Eye

(ATS23 Trial)

Recruiting at 51 trial locations

Overseen by Robert Henderson, MS

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Jaeb Center for Health Research

Must not be taking: Cycloplegic eyedrops

Disqualifiers: Heterotropia, Prism lenses, Myopia, others

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

In children 4 to 7 years of age, to determine if treatment with 1 hour per day 6 days per week of watching dichoptic movies/shows wearing the Luminopia headset is non-inferior to treatment with 2 hours of patching per day 7 days per week with respect to change in amblyopic eye distance VA from randomization to 26 weeks.

Will I have to stop taking my current medications?

The trial requires that participants stop using cycloplegic eyedrops (like atropine) at least 2 weeks before enrolling. Other treatments are allowed up to enrollment but must be discontinued once the trial begins.

What data supports the effectiveness of the treatment Dichoptic Treatment, Luminopia, Dichoptic Therapy for lazy eye?

Research shows that dichoptic treatments, like Luminopia, can improve vision in children with lazy eye by presenting different images to each eye, which helps balance visual input. These treatments are more engaging for children, potentially leading to better adherence and outcomes compared to traditional methods. ^{1 2 3 4 5}

Is dichoptic treatment for lazy eye safe for humans?

The available research does not provide specific safety data for dichoptic treatment, but it focuses on its effectiveness and adherence in treating amblyopia (lazy eye). ^{4 6 7 8 9}

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

Dichoptic treatment for lazy eye is unique because it uses movies or games to present different images to each eye, helping to balance visual input and improve vision without the need for eye patches. This approach is more engaging for children, potentially leading to better adherence compared to traditional methods like patching or blurring. ^{1 2 4 5 10}

Research Team

Aparna Raghuram, OD, PhD

Principal Investigator

Boston Children's Hospital/ Harvard Medical School

Kammi Gunton, MD

Principal Investigator

Wills Eye Hospital

Robert Henderson, MS

Principal Investigator

Jaeb Center for Health Research

Eligibility Criteria

This trial is for children aged 4 to 7 with lazy eye (amblyopia) who have a small misalignment of the eyes or a history of strabismus, a significant difference in vision between eyes, and normal vision in the non-affected eye. Children with severe eye deviations or other conditions that could interfere with treatment are not eligible.

Inclusion Criteria

I meet all the required criteria to join the study.

I am between 4 and 7 years old.

I had strabismus in the past, but it's now resolved.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either dichoptic treatment with the Luminopia headset or patching treatment for amblyopia

26 weeks

Clinical assessments at 13 and 26 weeks post-randomization

Follow-up

Participants are monitored for safety and effectiveness after treatment

13 weeks

Visits at 39 and 52 weeks post-randomization for those switching to Luminopia therapy

Treatment Details

Interventions

• Dichoptic Treatment (Behavioural Intervention)

Trial Overview The study compares two treatments for lazy eye: watching special movies/shows using the Luminopia headset for one hour per day versus wearing an eye patch for two hours per day. The goal is to see if the Luminopia method is as effective as patching after 26 weeks.

Participant Groups

Group I: Luminopia Group Experimental Treatment 1 Intervention

watching 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 optical correction, if needed.

Group II: Patching Group Active Control 1 Intervention

patching of the fellow eye 2 hours per day (treatment time can be split into shorter sessions totaling 2 hours each day) 7 days per week with optical correction, if needed.

Who Is Running the Clinical Trial?

Jaeb Center for Health Research

Lead Sponsor

Trials

162

Recruited

36,200+

National Eye Institute (NEI)

Collaborator

Trials

572

Recruited

1,320,000+

Pediatric Eye Disease Investigator Group

Collaborator

Trials

20

Recruited

4,800+

Findings from Research

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]

Dichoptic training significantly improved visual acuity and stereoacuity in children with amblyopia, with the NPT group showing a 0.15 logMAR improvement and the PT group a 0.06 logMAR improvement after 17 to 22 training sessions.

The training led to a substantial increase in stereoacuity, particularly in the PT group (64.2% improvement), indicating that dichoptic training can effectively enhance visual processing in amblyopic children, even those who previously did not respond to patching.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dichoptic Perceptual Training in Children With Amblyopia With or Without Patching History. Liu, XY., Zhang, YW., Gao, F., 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]

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]

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]

LogMAR-based acuity charts are recommended for diagnosing and monitoring amblyopia, and refractive errors should be corrected for at least 4 months before starting occlusion or penalization therapies.

Occlusion therapy shows a clear dose-response relationship, with 2 hours of daily patching yielding similar results to longer durations in moderate amblyopia, while atropine penalization is equally effective as patching for improving visual acuity and stereoacuity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current concepts in the management of amblyopia. de Zárate, BR., Tejedor, J.[2022]

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]

Recent advancements in understanding compliance with amblyopia treatments have improved the effectiveness of patching methods, particularly through the use of quantitative monitoring with occlusion dose monitors.

This review highlights the importance of compliance in both patching and atropine treatments for amblyopia, suggesting that better adherence to treatment protocols can enhance patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Compliance and patching and atropine amblyopia treatments. Wang, J.[2022]

Amblyopia, often referred to as 'lazy eye', is a complex visual disorder that affects not just visual acuity but also other visual functions like contrast sensitivity and spatial orientation, and it can be classified into four main types based on its causes.

Effective treatment requires addressing the specific factors contributing to amblyopia, using methods such as occlusion therapy, optical penalties, and computer vision therapy, while also emphasizing the importance of family involvement and building trust to ensure compliance and motivation in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Functional amblyopia]. Avram, E., Stănilă, A.[2022]

Dichoptic training is a new method for treating amblyopia that uses video games to stimulate both eyes simultaneously, aiming to improve vision in the weaker eye by balancing its contrast with the stronger eye.

Current studies show that dichoptic training achieves an average visual acuity improvement of only 0.20 ± 0.07 logMAR, which is not significantly better than existing treatments like monocular patching.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Dichoptic training for amblyopia]. Bach, M.[2018]

References

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

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

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

Dichoptic Perceptual Training in Children With Amblyopia With or Without Patching History. [2021]

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

Active vision therapy for pseudophakic amblyopia. [2019]

4. 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]

5. England pubmed.ncbi.nlm.nih.gov

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

6. New Zealand pubmed.ncbi.nlm.nih.gov

Current concepts in the management of amblyopia. [2022]

7. 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]

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

Compliance and patching and atropine amblyopia treatments. [2022]

9. Romania pubmed.ncbi.nlm.nih.gov

[Functional amblyopia]. [2022]

10. Germany pubmed.ncbi.nlm.nih.gov

[Dichoptic training for amblyopia]. [2018]