Dichoptic Treatment for Lazy Eye (ATS23 Trial)

Phase 3

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

Pivotal Trial

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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

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: 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.

0 / 3Eligibility criteria met