Patching Strategies for Lazy Eye

(ATS22 Trial)

Recruiting at 71 trial locations

Overseen By Brooke P Fimbel

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Jaeb Center for Health Research

Disqualifiers: Myopia > -6.00 D, Surgery, Allergies, 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: 9

Duration: 56 weeks

544 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best way to treat lazy eye (amblyopia) in children using glasses and eye patches. Researchers aim to determine if starting glasses and patches simultaneously is as effective as starting with glasses and adding patches only if necessary. Children aged 3 to 13 who have not received treatment for lazy eye and have vision issues like uneven eyesight or crossed eyes may qualify. Participants will wear glasses (also known as spectacles or eyeglasses) full-time, and some will also wear an eye patch for a few hours daily. The goal is to identify the most effective approach to improve vision in children with amblyopia. 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 amblyopia.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, it does mention that participants must be willing to forego contact lens wear during the study.

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

Research has shown that both glasses and patching are generally safe and well-tolerated treatments for amblyopia, also known as lazy eye. Glasses, a common treatment, are safe for children, help correct vision, and have no major side effects.

Studies have found that patching, which involves covering the stronger eye with a patch to strengthen the weaker eye, is also safe. Specifically, one study found that wearing a patch for two hours a day can improve vision in children with moderate to severe lazy eye. Although some children might resist wearing the patch, this treatment poses no serious health risks.

Both glasses and patching have been safely used in children for many years, making them reliable options for treating lazy eye. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these patching strategies for lazy eye because they offer two innovative approaches to treatment. The simultaneous treatment combines full-time glasses with part-time patching, aiming for continuous improvement with minimal disruption to daily life. On the other hand, the sequential treatment starts with full-time glasses and only adds patching if necessary, which could mean fewer interventions for some patients. Both strategies focus on personalizing care and potentially reducing the burden of treatment compared to traditional full-time patching, making them promising alternatives for managing lazy eye.

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

Studies have shown that wearing glasses can improve vision in children with amblyopia, often called "lazy eye." Glasses alone have been found to enhance vision in the weaker eye by about 1.8 lines on an eye chart for children aged 3 to 6, and 0.8 lines for those aged 7 to 12. Another method, patching, involves covering the stronger eye to encourage the weaker one to work harder. Research shows that wearing a patch for two hours a day can significantly improve vision, with some studies noting an average improvement of 3.6 lines for more severe cases.

In this trial, participants will be assigned to one of two treatment strategies: the simultaneous treatment arm, which includes full-time spectacle correction and part-time patching for 2 hours per day, or the sequential treatment arm, which starts with full-time spectacle correction and adds patching only if needed. Combining glasses and patching is a common way to achieve the best results. ^{2 6 7 8 9}

Who Is on the Research Team?

Vivian Manh

Principal Investigator

Seattle Children's Hospital, University of Washington

Michael Gray

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Are You a Good Fit for This Trial?

This trial is for children aged 3 to under 13 with lazy eye (amblyopia) who haven't been treated before. It's open to those with a certain type of misalignment in their eyes (strabismus), a difference in prescription between the eyes, or both. Kids can't join if they have severe nearsightedness, previous eye surgery, allergies to silicone or adhesive patches, or developmental delays that could affect treatment.

Inclusion Criteria

I have never been treated for lazy eye, including wearing glasses for it.

Your two eyes have a big difference in astigmatism.

I have a specific type of lazy eye due to misaligned eyes.

Exclusion Criteria

You have worn glasses or contact lenses continuously for more than 24 hours before.

You are allergic to adhesive patches.

You are allergic to silicone.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline

Participants are prescribed spectacles and return for a baseline visit to confirm eligibility before randomization

1 day

1 visit (in-person)

Treatment

Participants receive either sequential or simultaneous treatment with spectacles and patching, with follow-up visits every 8 weeks

56 weeks

7 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Glasses
• Patching

Trial Overview The study tests two ways of treating lazy eye: wearing glasses alone first and then patching the stronger eye if needed (sequential), versus using glasses and patching at the same time from the start (simultaneous). Children will be randomly assigned to one of these two approaches.

How Is the Trial Designed?

Group I: Simultaneous treatment Experimental Treatment 2 Interventions

full-time spectacle correction and part-time patching for 2 hours per day/7 days per week

Group II: Sequential treatment Active Control 2 Interventions

full-time spectacle correction first, with subsequent patching for 2 hours per day/7 days per week only if needed (no improvement (stable/worsening) and residual)

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

In a study of 52 children with amblyopia, compliance with prescribed patching therapy was low, with only 57.5% compliance for 3 hours of patching and 41.2% for 6 hours, indicating that many children did not wear the patches as directed.

Despite no significant differences in visual acuity outcomes between the 3-hour and 6-hour patching groups, a clear dose-effect relationship was observed, where children who effectively patched for more than 3 hours showed significant improvement in visual acuity, highlighting the importance of increasing effective patching time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of unilateral strabismic and mixed amblyopia using occlusion dose monitors to record compliance. Awan, M., Proudlock, FA., Gottlob, I.[2006]

A study of 37 families with children aged 3-16 diagnosed with unilateral amblyopia found that the attitude and insight of families significantly correlated with their compliance to patching treatment, indicating that understanding the importance of the treatment is crucial.

To enhance compliance, it is essential to address not only educational aspects but also the physical discomforts associated with the patches, such as heat and irritation, suggesting a need for better patch design.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Compliance to patching in the treatment of amblyopia. Al-Yahya, A., Al-Odan, K., Allam, K., et al.[2022]

In a study involving 107 children aged 3-7 with moderate amblyopia, both adhesive skin patches and over-glasses patches showed similar improvements in visual acuity after 17 weeks, indicating that both methods are effective treatments.

Over-glasses patching is a viable alternative for children who experience discomfort from adhesive patches, as it resulted in less redness of the eye or eyelids, making it a more comfortable option without compromising treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison between over-glasses patching and adhesive patching for children with moderate amblyopia: a prospective randomized clinical trial. Kim, SJ., Jeon, H., Jung, JH., et al.[2018]

Both patching and penalization therapies significantly improved visual acuity in amblyopia patients aged 7 to 16 years, indicating their effectiveness beyond the traditionally accepted critical age for treatment.

After six months of treatment, both methods showed positive changes in visual evoked potential measurements, with decreased latency and increased amplitude, suggesting improvements in visual processing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the efficacies of patching and penalization therapies for the treatment of amblyopia patients. Cabi, C., Sayman Muslubas, IB., Aydin Oral, AY., et al.[2021]

In a study involving 180 children aged 3 to 7 with moderate to severe amblyopia, 2 hours of daily patching combined with 1 hour of near visual activities led to a significant improvement in visual acuity compared to wearing spectacles alone.

After 5 weeks, the patching group showed an average improvement of 1.1 lines in visual acuity, while the control group improved by only 0.5 lines, indicating that the patching method is more effective for treating amblyopia in young children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial to evaluate 2 hours of daily patching for strabismic and anisometropic amblyopia in children. Wallace, DK., Edwards, AR., Cotter, SA., et al.[2022]

In a study of 41 children under 6 years old who struggled with patching for amblyopia, using elbow splints significantly improved compliance, with 83% of participants adhering to patching guidelines after splint use.

The intervention led to improved visual acuity in 95% of the children, demonstrating that elbow splints can be an effective method to enhance treatment outcomes without causing harm to the fellow eye.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Elbow splinting as a method to increase patching compliance in amblyopia therapy. Sabri, K., Easterbrook, B., Wakeman, B., et al.[2018]

A study involving 40 children aged 4 to 18 years found that a 12-week video game treatment for amblyopia is as effective as traditional eye patching, demonstrating non-inferiority in visual acuity outcomes.

The video game therapy, which requires less time commitment and may be more engaging for children, could improve treatment compliance and offer additional long-term benefits through perceptual learning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a Novel Video Game Platform in the Treatment of Pediatric Amblyopia. Poltavski, D., Adams, RJ., Biberdorf, D., et al.[2023]

A randomized clinical trial involving 75 children aged 4 to 8 years with amblyopia is testing the effectiveness of a novel treatment called I-BiT™, which uses 3D technology and computer games, compared to traditional methods.

The trial will assess changes in visual acuity over 6 weeks of treatment, aiming to improve compliance and outcomes in amblyopia treatment, which traditionally suffers from low adherence to patching therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation and development of a novel binocular treatment (I-BiT™) system using video clips and interactive games to improve vision in children with amblyopia ('lazy eye'): study protocol for a randomised controlled trial. Foss, AJ., Gregson, RM., MacKeith, D., et al.[2021]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38757545/

Effectiveness of optical treatment in amblyopia and ... The main outcome was an increase in amblyopic eye VA from baseline to 16 weeks. Results: Sixty-five children entered the optical treatment period. Mean age ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4701128/

Amblyopia in children (aged 7 years or less) - PMC Visual outcomes. Glasses compared with no treatment Wearing glasses may be more effective at improving the best-corrected visual acuity of the worse-seeing eye ...

3. escrs.org escrs.org/eurotimes-articles/a-new-ground-breaking-treatment-for-amblyopia

A New “Ground-Breaking” Treatment for Amblyopia The results show dichoptic therapy is very effective in improving visual acuity and stereopsis in adult amblyopia, especially when caused by ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0002939420304190

Amblyopia Outcomes Through Clinical Trials and Practice ... Mean amblyopic eye visual acuity improved 1.8 lines for children 3-6 years of age and 0.8 lines for 7-12 years, but mean residual amblyopia was more than 2 ...

5. bmcophthalmol.biomedcentral.com bmcophthalmol.biomedcentral.com/articles/10.1186/s12886-023-03116-8

Factors affecting the benefit of glasses alone in treating ... To evaluate factors associated with better outcomes from optical treatment alone in amblyopic children from 3 up to 7 years.

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK430890/

Amblyopia - StatPearls - NCBI Bookshelf - NIH Amblyopia is a visual disorder due to the failure of cortical visual development in one or both eyes due to ocular pathology early in life.

7. nova-sight.com nova-sight.com/curesight-amblyopia-treatment/

CureSight amblyopia treatment The CureSight is a digital eye tracking based lazy eye treatment using a special device and red-blue treatment glasses. ... safety and efficacy results were ...

8. bynocs.com bynocs.com/7-precautions-to-safeguard-your-childs-vision-from-lazy-eye/

7 Precautions to Safeguard Your Child's Vision from Lazy ... Learn 7 essential precaution to safeguard your child's vision from lazy eye with tips on early detection, screen time, management, and more.

9. aao.org aao.org/eye-health/news/digital-glasses-lazy-eye

Digital Glasses For Lazy Eye A new study shows that electronic programmable glasses that act like a digital eye patch are just as effective as fabric eye patches for lazy eye.