Dichoptic Treatment for Lazy Eye

(ATS23 Trial)

Recruiting at 70 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 lenses, Myopia, 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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 52

Duration: 26 weeks

238 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two treatments for children aged 4 to 7 with lazy eye (amblyopia). One group will watch special movies using a headset for one hour a day, six days a week, as part of the dichoptic treatment (also known as Luminopia or Dichoptic Therapy). The other group will wear a patch over the stronger eye for two hours a day, seven days a week. The trial aims to determine if watching movies with the headset is as effective as the traditional patching method. Children with lazy eye due to crossed eyes or differences in eye prescription, who are willing to try either approach, might be a good fit. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment for lazy eye.

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.

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

Research has shown that dichoptic treatment for amblyopia, or lazy eye, is generally safe for children. This therapy involves watching special movies using a headset and is usually well-tolerated. Studies comparing different treatments found that dichoptic therapy not only improves vision but is also safe. Some children might feel slight discomfort wearing the headset, but serious side effects are rare. Overall, this treatment is considered a safe way to help children with lazy eye see better. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for lazy eye?

Researchers are excited about dichoptic treatment for lazy eye, also known as amblyopia, because it offers a fresh approach compared to traditional methods like eye patching or atropine drops. This treatment is unique as it involves watching specially designed movies or shows using a Luminopia headset, which presents different images to each eye, encouraging the brain to improve visual processing and coordination. Unlike patching, which can be uncomfortable and socially awkward, the Luminopia headset provides a more engaging and enjoyable experience for children. This innovative method could make treatment adherence better and potentially lead to faster and more effective results in improving vision.

What evidence suggests that dichoptic treatment might be an effective treatment for lazy eye?

This trial will compare dichoptic treatment with traditional patching for lazy eye. Studies have shown that dichoptic treatment, such as watching movies or shows with a special headset, can improve vision in people with amblyopia, commonly known as lazy eye. This method uses different images for each eye to help the brain improve how the eyes work together. Research indicates that this treatment can be as effective as the traditional method of covering one eye to strengthen the weaker one. Specifically, a study found that a digital device using both eyes was as effective as patching for improving vision. This suggests that dichoptic treatment is a promising option for treating lazy eye in children. ^{1 3 4 6 7}

Who Is on the Research Team?

Kammi Gunton, MD

Principal Investigator

Wills Eye Hospital

Aparna Raghuram, OD, PhD

Principal Investigator

Boston Children's Hospital/ Harvard Medical School

Robert Henderson, MS

Principal Investigator

Jaeb Center for Health Research

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Dichoptic Treatment

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.

How Is the Trial Designed?

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.

Dichoptic Treatment is already approved in United States for the following indications:

Approved in United States as Luminopia for:

• Amblyopia (lazy eye) in children aged 4-7 years

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+

Published Research Related to This Trial

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 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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34534556/

Randomized Controlled Trial of a Dichoptic Digital ... ... trial to evaluate the safety and efficacy of a dichoptic digital therapeutic for amblyopia. ... Keywords: Amblyopia; Digital therapeutic; Lazy eye; Treatment.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0161642025006803

Effectiveness of Video-Based Dichoptic Therapy vs ... Dichoptic therapy has shown promising results in improving vision in children and adults with amblyopia. ... treatment in amblyopia: A ...

3. aao.org aao.org/young-ophthalmologists/yo-info/article/understanding-digital-treatments-for-amblyopia

Understanding Digital Treatments for Amblyopia Dichoptic treatment is a binocular therapy for unilateral amblyopia. There are different systems, and each is based on the principle of showing different ...

4. ajo.com ajo.com/article/S0002-9394(24)00374-X/fulltext

High-Adherence Dichoptic Treatment Versus Patching in ... We report that the novel digital, binocular eye-tracking–based home treatment device was as effective as patching as a treatment for amblyopia ...

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

Comparative effectiveness of gamified binocular treatment ... Our randomized controlled trial demonstrated that a home-based gamified binocular treatment device was as effective as patching for amblyopia in ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40828235/

The efficacy and safety of dichoptic therapy in comparison ... This systematic review and meta-analysis compares their efficacy, compliance and safety in paediatric amblyopia. A comprehensive search of ...

7. aaojournal.org aaojournal.org/article/S0161-6420%2821%2900682-5/fulltext

Randomized Controlled Trial of a Dichoptic Digital ... ... trial to evaluate the safety and efficacy of a dichoptic digital therapeutic for amblyopia. ... Amblyopia · Digital therapeutic · Lazy eye · Treatment ...