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Patching Strategies for Lazy Eye
(ATS22 Trial)

Recruiting in Palo Alto (17 mi)

+65 other locations

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Jaeb Center for Health Research

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

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

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.

See 18 more

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.

See 7 more

Trial 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 (Procedure)
Patching (Behavioural Intervention)

Trial OverviewThe 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

2Treatment groups

Experimental Treatment

Active Control

Group I: Simultaneous treatmentExperimental Treatment2 Interventions

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

Group II: Sequential treatmentActive Control2 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)

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:

Salus University/Pennsylvania College of OptometryPhiladelphia, PA

Cincinnati Children's HospitalCincinnati, OH

UAB Pediatric Eye Care; Birmingham Health CareBirmingham, AL

Arizonia Pediatric Eye SpecialistsPhoenix, AZ

More Trial Locations

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Who Is Running the Clinical Trial?

Jaeb Center for Health Research

Lead Sponsor

Trials

162

Patients Recruited

36,200+

National Eye Institute (NEI)

Collaborator

Trials

572

Patients Recruited

1,320,000+

Pediatric Eye Disease Investigator Group

Collaborator

Trials

Patients Recruited

4,800+

Findings from Research

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]

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]