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Patching Strategies for Lazy Eye (ATS22 Trial)

N/A
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
Both criteria for strabismus are met for combined-mechanism amblyopia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 56 weeks
Awards & highlights

ATS22 Trial 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.Check my eligibility
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.See study design
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.

ATS22 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have never been treated for lazy eye, including wearing glasses for it.
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I have a specific type of lazy eye due to misaligned eyes.
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I have lazy eye due to uneven eye power, crossed eyes, or both.
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I have lazy eye due to uneven eye power, crossed eyes, or both.
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I am between 3 and 12 years old.
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I have a misalignment in my eyes, noticed when looking near or far.
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My other eye sees well according to age standards.
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I meet the vision test requirements with my new glasses after wearing them for 10 minutes.
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My doctor agrees to follow the study's glasses and patching treatment plan.
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.
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I have a phone or can use one and agree to be contacted for the study.
Select...
I have lazy eye due to uneven eye power, crossed eyes, or both.

ATS22 Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean Change in Amblyopic Eye logMAR distance Visual Acuity
Secondary outcome measures
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

ATS22 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)

Find a Location

Who is running the clinical trial?

National Eye Institute (NEI)NIH
546 Previous Clinical Trials
1,401,450 Total Patients Enrolled
Jaeb Center for Health ResearchLead Sponsor
152 Previous Clinical Trials
34,190 Total Patients Enrolled
Pediatric Eye Disease Investigator GroupNETWORK
17 Previous Clinical Trials
3,720 Total Patients Enrolled

Media Library

Glasses Clinical Trial Eligibility Overview. Trial Name: NCT04378790 — N/A
Lazy Eye Research Study Groups: Sequential treatment, Simultaneous treatment
Lazy Eye Clinical Trial 2023: Glasses Highlights & Side Effects. Trial Name: NCT04378790 — N/A
Glasses 2023 Treatment Timeline for Medical Study. Trial Name: NCT04378790 — N/A
Lazy Eye Patient Testimony for trial: Trial Name: NCT04378790 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are joining this research project?

"Affirmative, the research data on clinicaltrials.gov implies that this experiment is actively recruiting individuals. The trial was first posted on December 8th 2020 and updated most recently November 1st 2022. This study seeks to enrol 544 patients across 52 locations worldwide."

Answered by AI

How many medical facilities have been enlisted to participate in this investigation?

"At present, this research project is being conducted at 52 distinct sites. Locations near San Antonio, Spokane and Columbus are included in the list of places where the trial has been approved for deployment; thus, participants should consider proximity to one of these locations in order to limit travel demands."

Answered by AI

Are any new participants accepted at this point for the clinical trial?

"Correct. Per the information available on clinicaltrials.gov, this medical study is actively searching for participants to join their trial. It was initially posted on December 8th 2020 and has since been updated November 1st 2022 with a target of 544 enrollees from 52 different sites."

Answered by AI

Is there any way I could become part of this clinical experiment?

"This medical study is searching for 544 participants who are between the ages of 3 and 13 and have a diagnosis of amblyopia."

Answered by AI

Can elderly individuals partake in this experimental research?

"According to the entry requirements for this trial, enrollees must be between 3 and 13 years old. Additionally, there are 17 studies available for minors (under 18) as well as 2 studies intended for seniors (over 65)."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
Loma Linda University Health Care, Dept. of Ophthalmology
Stanford University
Western University College of Optometry
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

My vision is getting g.
PatientReceived no prior treatments
~144 spots leftby Jun 2025