Overview

Combined Patching-Atropine for Residual Amblyopia

Status:
Terminated
Trial end date:
2009-09-01
Target enrollment:
Participant gender:
Summary
This study is designed to evaluate the effectiveness of treatment of residual amblyopia in children ages 3 to < 10 years with visual acuity of 20/32 to 20/63 in the amblyopic eye. The study is a randomized clinical trial comparing intensive treatment (42 hours per week of patching plus daily atropine) with a control group that will have rapid weaning of existing treatment followed by spectacle correction only (if needed). The primary objective is to determine if this intensive treatment will improve visual acuity in patients with residual amblyopia. The primary outcome assessment is amblyopic eye visual acuity at 10 weeks. The primary analytic approach for the amblyopic eye acuity will be a treatment group comparison of the proportion of patients with at least two lines of visual acuity improvement.
Phase:
Phase 3
Details
Lead Sponsor:
Jaeb Center for Health Research
Collaborator:
National Eye Institute (NEI)
Treatments:
Atropine