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Behavioural Intervention

Dichoptic Treatment for Lazy Eye (ATS23 Trial)

N/A
Recruiting
Led By Robert Henderson, MS
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
Age 4 to 7 years.
Amblyopia associated with strabismus, anisometropia, or both (previously treated or untreated).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

This trial aims to compare two treatments for children aged 4 to 7 with lazy eye. One treatment involves watching special movies with a headset for 1 hour per day, 6 days a week

Who is the study for?
This trial is for children aged 4 to 7 with lazy eye (amblyopia) who have a small misalignment of the eyes or a history of strabismus, a significant difference in vision between eyes, and normal vision in the non-affected eye. Children with severe eye deviations or other conditions that could interfere with treatment are not eligible.
What is being tested?
The study compares two treatments for lazy eye: watching special movies/shows using the Luminopia headset for one hour per day versus wearing an eye patch for two hours per day. The goal is to see if the Luminopia method is as effective as patching after 26 weeks.
What are the potential side effects?
Potential side effects may include discomfort from wearing the headset or patch, possible skin irritation from the patch adhesive, and temporary visual disturbances when adapting to either treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 4 and 7 years old.
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I have lazy eye due to crossed eyes, different eye prescriptions, or both.
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My vision meets the required standard for my age group.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Luminopia GroupExperimental Treatment1 Intervention
watching dichoptic movies/shows wearing the Luminopia headset prescribed 1 hour per day (treatment time can be split into shorter sessions totaling 1 hour each day) 6 days a week with optical correction, if needed.
Group II: Patching GroupActive Control1 Intervention
patching of the fellow eye 2 hours per day (treatment time can be split into shorter sessions totaling 2 hours each day) 7 days per week with optical correction, if needed.

Find a Location

Who is running the clinical trial?

National Eye Institute (NEI)NIH
551 Previous Clinical Trials
1,406,675 Total Patients Enrolled
Jaeb Center for Health ResearchLead Sponsor
157 Previous Clinical Trials
35,367 Total Patients Enrolled
Pediatric Eye Disease Investigator GroupNETWORK
19 Previous Clinical Trials
4,516 Total Patients Enrolled
~159 spots leftby Dec 2026
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