Trial Comparing Daily Atropine Versus Weekend Atropine

Completed · Phase 4

Conditions studied: Amblyopia

In brief

The goals of this study are: * To compare the visual acuity outcome in the amblyopic eye after 17 weeks of daily use of atropine versus weekend-only use of atropine. * To compare the proportion of patients achieving a complete treatment response (defined as amblyopic eye acuity \>20/25 or equal to that of the sound eye in the absence of a reduction in the sound eye acuity from baseline) with daily atropine versus weekend-only atropine.

Key facts

Study ID

NCT00094614

Run by

Jaeb Center for Health Research

People needed

168

Starts

2002-06-01

Expected to finish

2003-04-01

Last updated by the study team

2010-03-25

Who can join

Age: 3 and older, up to 7. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age < 7 years
• Able to measure surrounded single optotype visual acuity using the ATS single-surround HOTV protocol (this will in effect exclude all patients <2 years old and many <3 years old)
• Amblyopia associated with strabismus, anisometropia, or both
• If anisometropia is present (as per protocol definition), refractive error corrected with spectacles for a minimum of 4 weeks
• Visual acuity in the amblyopic eye < 20/40 and >20/80
• Visual acuity in the sound eye > 20/40 and inter-eye acuity difference >3 logMAR lines

You may not qualify if…

• Amblyopia treatment (other than spectacles) in the past month and no more than one month of amblyopia treatment in the past 6 months
• Myopia more than a spherical equivalent of -6.00 D in the amblyopic eye
• Myopia more than a spherical equivalent of -0.50 D in the sound eye

Where it is running

• Wilmer Eye Institute — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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