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Behavioural Intervention
Patch-Free Occlusion Therapy for Lazy Eye
N/A
Recruiting
Research Sponsored by Retina Foundation of the Southwest
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6,18, and 24 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial studies if patch-free occlusion therapy improves vision in young kids with amblyopia better than using a patch. It also looks at how well kids stick to the treatment.
Who is the study for?
This trial is for boys and girls aged 3-10 with lazy eye, who have been wearing glasses for at least 8 weeks without vision improvement. They should not be using standard patching treatment during the study and must have a certain level of visual acuity difference between eyes. Children with developmental delays, born more than 8 weeks premature, or having other eye/systemic diseases or high myopia are excluded.
What is being tested?
The study compares patch-free occlusion therapy to the traditional adhesive patch method in treating lazy eye in children. It aims to see if the new method leads to better vision outcomes and if it's easier for kids to stick with the treatment plan.
What are the potential side effects?
While specific side effects are not detailed here, typical concerns may include discomfort from either treatment approach or potential psychological effects due to changes in appearance or frustration with treatment adherence.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6,18, and 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6,18, and 24 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Adherence to patching or viewing videos with glasses measured with a sensor
Change in amblyopic eye visual acuity measured with a logMAR visual acuity chart
Change in depth of suppression assessed with the contrast balance index
+6 moreAwards & Highlights
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: Patch-free occlusion therapyExperimental Treatment1 Intervention
Group II: Standard-of-care patching with an adhesive patchActive Control1 Intervention
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Who is running the clinical trial?
Retina Foundation of the SouthwestLead Sponsor
14 Previous Clinical Trials
1,521 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have worn glasses for at least 8 weeks and your vision has not changed during 2 visits that were at least 4 weeks apart.My child's eye doctor and I agree to not use patching treatment during the study.The difference in vision between your eyes is greater than a certain amount.I am either male or female.You have severe nearsightedness.You have a delay in your development.You were born more than 8 weeks early.I am between 3 to 10 years old.I have an eye or other health condition alongside my main illness.You have a type of vision problem called amblyopia, with a visual acuity between 0.3 and 0.8 logMAR.
Research Study Groups:
This trial has the following groups:- Group 1: Patch-free occlusion therapy
- Group 2: Standard-of-care patching with an adhesive patch
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.
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