A Randomized Trial to Evaluate Sequential vs Simultaneous Patching

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
3 – 13
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
544 (estimated)
Sponsor
Jaeb Center for Health Research · Other
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About This Trial

A randomized trial to determine whether simultaneous treatment with spectacles and patching has an equivalent VA outcome compared with sequential treatment, first with spectacles alone followed by patching (if needed), for previously untreated amblyopia in children 3 to \<13 years of age.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Age 3 to \<13 years at the time of randomization 2. Amblyopia associated with anisometropia, strabismus, or both o Criteria for strabismic amblyopia: At least one of the following must be met: * Presence of a heterotropia on examination at distance or near fixation (wi…
Contacts

Raymond T Kraker, MSPH

813-975-8690

rkraker@jaeb.org

CONTACT

Brooke P Fimbel

813-975-8690

CONTACT