Patching Strategies for Lazy Eye

(ATS22 Trial)

Recruiting in Columbus (<10 mi)

+66 other 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

Trial Summary

What is the purpose of this trial?

A randomized trial to determine whether simultaneous treatment with spectacles and patching has an equivalent VA outcome compared with sequential treatment, first with spectacles alone followed by patching (if needed), for previously untreated amblyopia in children 3 to \<13 years of age.

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.

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

Research shows that patching, which involves covering the stronger eye to improve the weaker one, is a traditional and effective treatment for lazy eye. Studies have explored different methods to improve compliance, such as over-glasses patching and using video games, indicating that these approaches can also be effective in improving vision in children with amblyopia. ^{1 2 3 4 5}

How does the patching treatment for lazy eye differ from other treatments?

The patching treatment for lazy eye is unique because it involves covering one eye with a patch to improve the weaker eye's vision, often combined with wearing glasses. This approach is different from other treatments like penalization, which uses eye drops to blur vision in the stronger eye, encouraging use of the weaker eye. ^{3 5 6 7 8}

Research Team

Vivian Manh

Principal Investigator

Seattle Children's Hospital, University of Washington

Michael Gray

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Elbow splinting as a method to increase patching compliance in amblyopia therapy. [2018]

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

Effectiveness of a Novel Video Game Platform in the Treatment of Pediatric Amblyopia. [2023]

3. Germany pubmed.ncbi.nlm.nih.gov

Comparison between over-glasses patching and adhesive patching for children with moderate amblyopia: a prospective randomized clinical trial. [2018]

4. England 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. [2021]

5. India pubmed.ncbi.nlm.nih.gov

Compliance to patching in the treatment of amblyopia. [2022]

6. China pubmed.ncbi.nlm.nih.gov

Comparison of the efficacies of patching and penalization therapies for the treatment of amblyopia patients. [2021]

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

A randomized controlled trial of unilateral strabismic and mixed amblyopia using occlusion dose monitors to record compliance. [2006]

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

A randomized trial to evaluate 2 hours of daily patching for strabismic and anisometropic amblyopia in children. [2022]