Dichoptic Treatment for Lazy Eye

(ATS24 Trial)

Recruiting at 52 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two new methods to treat lazy eye using special headsets that display movies or games designed to improve vision. Participants will be divided into three groups: one will use the Luminopia headset for an hour daily, another will use the Vivid Vision headset for about 25 minutes daily, and a third group will continue with only their regular glasses or contact lenses. The trial aims to determine if these headset treatments are more effective than wearing corrective lenses alone. Children aged 8 to 12 with lazy eye due to crossed eyes or a difference in vision strength between their eyes might be suitable candidates, especially if they have not tried similar treatments before. 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.

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.

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

A previous study demonstrated that Luminopia is safe for children with lazy eye. It employs a VR headset to enhance vision. The FDA has approved it for treating lazy eye in children aged 4 to under 13, confirming it meets safety standards for this age group.

Vivid Vision offers another treatment option, using engaging, game-like activities to improve vision. Research has shown it to be both successful and safe for treating lazy eye. Vivid Vision is well-tolerated, with no major safety concerns reported.

Both treatments have undergone testing and are considered safe for children with lazy eye. For any concerns, consulting a healthcare professional is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for lazy eye, or amblyopia, because they use innovative, engaging technologies to potentially improve vision. Unlike traditional treatments that often involve patching the stronger eye to force the weaker one to work harder, Luminopia and Vivid Vision offer a fun alternative through virtual reality. Luminopia uses dichoptic movies or shows, allowing patients to watch content in a headset for an hour a day, while Vivid Vision involves interactive dichoptic games for about 25 minutes daily. These methods aim to make treatment more enjoyable and consistent, which might lead to better compliance and outcomes for young patients.

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

This trial will compare the effectiveness of different treatments for lazy eye, also known as amblyopia. Participants in the Luminopia Group will use dichoptic movies and shows with the Luminopia headset. Research has shown that this method can greatly improve vision clarity in children. Meanwhile, those in the Vivid Vision Group will engage with dichoptic games using the Vivid Vision headset. Studies indicate that Vivid Vision has successfully improved vision clarity and depth perception in both children and adults, with about 60-80% of users experiencing significant improvements. Both treatments aim to enhance binocular vision, which is crucial for treating amblyopia. ^{2 6 7 8 9}

Who Is on the Research Team?

Marjean T Kulp, OD

Principal Investigator

Ohio State University

Benajmin G Jastrzembski, MD

Principal Investigator

University of California, Davis

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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 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]

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]

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]

Citations

1. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/reviews/DEN210005.pdf

DEN210005 | FDA Luminopia One is a Software as a Medical Device (SaMD) intended to improve visual acuity in pediatric patients with amblyopia (also known as lazy eye). The ...

2. healio.com healio.com/news/optometry/20240701/realworld-data-show-luminopia-improves-visual-acuity-in-children-with-amblyopia

Real-world data show Luminopia improves visual acuity in ... Analysis of a real-world patient registry of nearly 180 children with amblyopia demonstrated significant improvement in visual acuity and high adherence after ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12104753/

Assessing Previous Strategies and Presenting a Novel ... Also, the percentage of children with severe amblyopia decreased from 30% to 11% by the end of the treatment. Recent randomized clinical trials ...

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

Understanding Digital Treatments for Amblyopia Amblyopia remains the No. 1 cause of reversible vision loss in children in the United States. The Pediatric Eye Disease Investigator Group ...

5. modernod.com modernod.com/news/luminopia-one-demonstrates-safety-and-efficacy-in-phase-3-pivotal-trial/2480274/

Luminopia One Demonstrates Safety and Efficacy in Phase ... “The data from this pivotal trial validate Luminopia One as a safe and effective potential new treatment option for amblyopia in young children, ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf24/K243819.pdf

K243819 - Scott Xiao - accessdata.fda.gov Luminopia is indicated for improvement in visual acuity in amblyopia patients, aged 4 to <13, associated with anisometropia and/or with mild ...

7. luminopia.com luminopia.com/

Luminopia Binocular Therapy for Amblyopia Luminopia is an FDA-cleared, binocular therapy that uses a VR headset to stream a child's favorite shows. Treatment is only one hour a day, six days a week.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT03608150

Luminopia One Amblyopia Vision Improvement Study The objective of the study is to demonstrate the safety and efficacy of Luminopia One in amblyopia patients with amblyopia associated with anisometropia and/or ...

9. luminopia.com luminopia.com/parents-and-patients

Luminopia FDA-Cleared Medical Device Treatment for ... Luminopia is the first FDA-cleared, dual-acting binocular treatment for lazy eye. Visuals are dulled in the strong eye to help strengthen the weaker eye.