Trial Comparing Daily Atropine Versus Weekend Atropine

• Status: Completed
• Trial end date: 2003-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jaeb Center for Health Research
• Collaborator: National Eye Institute (NEI)
• Treatments: Atropine

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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