Dichoptic Treatment for Amblyopia in Children 8 to 12 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
8 – 12
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
252 (estimated)
Sponsor
Jaeb Center for Health Research · Other
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About This Trial
Participants eligible for the study will be randomly allocated (1:1:1) to receive either Luminopia dichoptic treatment while wearing optical correction if needed, Vivid Vision dichoptic treatment while wearing optical correction if needed, or continued optical correction alone if needed, with clinical assessments at 9- and 18-weeks post-randomization. At the 18-week primary outcome visit, partici…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Age 8 to \<13 years. 2. VA, measured in each eye without cycloplegia in current refractive correction (if applicable) using the E-ETDRS VA protocol on a study-approved device displaying single surrounded optotypes, as follows: 1. VA in the amblyopic eye 20/40 to 20/200 in…
Contacts

Raymond T Kraker, MSPH

813-975-8690

rkraker@jaeb.org

CONTACT

Brooke P Fimbel

813-975-8690

bfimbel@jaeb.org

CONTACT