Dichoptic Treatment for Amblyopia in Children 4 to 7 Years of Age

Recruiting Phase 3 Interventional Study
Amblyopia
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
4 – 7
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
238 (estimated)
Sponsor
Jaeb Center for Health Research · Other
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About This Trial

In children 4 to 7 years of age, to determine if treatment with 1 hour per day 6 days per week of watching dichoptic movies/shows wearing the Luminopia headset is non-inferior to treatment with 2 hours of patching per day 7 days per week with respect to change in amblyopic eye distance VA from randomization to 26 weeks.

Trial Locations
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Eligibility Criteria
At the time of enrollment, individuals must meet all the following inclusion criteria to be eligible to participate in the study. 1. Age 4 to 7 years. 2. Visual acuity, measured in each eye without cycloplegia in current refractive correction (if applicable) using the ATS-HOTV VA protocol on a stud…
Contacts

Raymond T Kraker, MSPH

813-975-8690

rkraker@jaeb.org

CONTACT

Brooke P Fimbel

813-975-8690

bfimmel@jaeb.org

CONTACT