Trial Comparing Atropine to Atropine Plus a Plano Lens for the Sound Eye for Amblyopia in Children 3 to <7 Years Old

Completed · Phase 3

Conditions studied: Amblyopia

In brief

The purpose of the study is: * To compare the effectiveness and safety of weekend atropine augmented with a plano lens for the sound eye versus weekend atropine alone for moderate amblyopia (20/40 to 20/100) in children 3 to less than 7 years old. * To provide data on the response of severe amblyopia (20/125 to 20/400) to atropine treatment with and without a plano lens.

Key facts

Study ID

NCT00315302

Run by

Jaeb Center for Health Research

People needed

240

Starts

2005-02-01

Expected to finish

2008-01-01

Last updated by the study team

2016-07-19

Who can join

Age: 3 and older, up to 6. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must be 3 to less than 7 years old with amblyopia associated with strabismus, anisometropia, or both.
• Visual acuity in the amblyopic eye must be between 20/40 and 20/400 inclusive, visual acuity in the sound eye 20/40 or better and inter-eye acuity difference > 3 logMAR lines.
• Spectacles, if needed, must be worn for at least 16 weeks or until visual acuity documented to be stable.

You may not qualify if…

• Atropine treatment within 6 months of enrollment and other amblyopia treatment of any type (other than normal spectacle lenses) used within one month of enrollment
• No myopia in amblyopic eye

Where it is running

• Southern California College of Optometry — Fullerton, California, United States
• UT Southwestern Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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