← Back to Search

Patching Strategies for Lazy Eye (ATS22 Trial)

Phase 3

Recruiting

Research Sponsored by Jaeb Center for Health Research

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No previous treatment for amblyopia, including no more than 24 hours of spectacle wear

Amblyopia associated with anisometropia, strabismus, or both

Must not have

Previous intraocular or refractive surgery

Any previous treatment for amblyopia (patching, atropine, Bangerter filter, vision therapy, or binocular treatment)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 56 weeks

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial is testing whether two different treatments for amblyopia (lazy eye) have the same outcome.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Wearing glasses usually has no side effects other than possible discomfort adjusting to them. Patching may cause skin irritation where it sticks around the eye and might lead to some emotional distress due to its visibility.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Select...

I have lazy eye due to uneven eye power, crossed eyes, or both.

Select...

I am between 3 and 12 years old.

Select...

I have a misalignment in my eyes, noticed when looking near or far.

Select...

I have not been treated for lazy eye, including wearing glasses for it.

Select...

I had strabismus in the past, but it's now resolved.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had eye surgery before.

Select...

I have had treatment for lazy eye before.

Select...

I am willing to not wear contact lenses during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 56 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~56 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 56 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mean Change in Amblyopic Eye logMAR distance Visual Acuity

Secondary study objectives

Change in binocularity levels

Difference in Mean Change of Distance Visual Acuity after 8 Weeks on Randomized Treatment

Difference in mean change in amblyopic-eye log contrast sensitivity

+4 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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)

0 / 9Eligibility criteria met