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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
Amblyopia associated with anisometropia, strabismus, or both
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 belowSelect...
I have never been treated for lazy eye, including wearing glasses for it.
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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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I have not been treated for lazy eye, including wearing glasses for it.
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I had strabismus in the past, but it's now resolved.
ATS22 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 56 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~56 weeks
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 moreATS22 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
547 Previous Clinical Trials
1,401,497 Total Patients Enrolled
Jaeb Center for Health ResearchLead Sponsor
153 Previous Clinical Trials
34,370 Total Patients Enrolled
Pediatric Eye Disease Investigator GroupNETWORK
18 Previous Clinical Trials
3,958 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.Your eyes have a big difference in how they focus, or in the shape of the front surface of the eye.Your vision will be measured with trial frames and the glasses your doctor plans to give you.I have lazy eye due to uneven eye power, crossed eyes, or both.The difference in prescription strength between your eyes is more than 1.00 diopters.I had eye misalignment in the past, but it's resolved now.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.I have an eye condition that could affect my vision, confirmed by a recent exam.I am between 3 and 12 years old.I have a misalignment in my eyes, noticed when looking near or far.I have had eye surgery before.The difference in vision between your eyes is very big.My other eye sees well according to age standards.I meet the vision test requirements with my new glasses after wearing them for 10 minutes.My doctor agrees to follow the study's glasses and patching treatment plan.I have or had a misalignment of my eyes that could cause lazy eye.I have had treatment for lazy eye before.I am scheduled for eye muscle surgery within the next 56 weeks.I have not been treated for lazy eye, including wearing glasses for it.You have very severe nearsightedness in at least one eye.The doctor plans to correct your vision with glasses based on a specific eye exam.I had strabismus in the past, but it's now resolved.I have a phone or can use one and agree to be contacted for the study.I am willing to not wear contact lenses during the study.
Research Study Groups:
This trial has the following groups:- Group 1: Simultaneous treatment
- Group 2: Sequential treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Lazy Eye Patient Testimony for trial: Trial Name: NCT04378790 — N/A
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