Clinical Trial: Amblyopia (Lazy Eye) Treatment Study
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Amblyopia Treatment Study
Brief Summary:
The purpose of this study is to compare the results of two standard treatments for amblyopia in order to find out if one is more effective than the other. Amblyopia, which develops in childhood, is also called "lazy eye," because one eye is not being used properly. The brain favors the other eye for some reason, such as crossing or turning out of the eyes, and vision in the weak eye is reduced.
Amblyopia is treated by forcing the child to use the weak eye. There are two ways to do this: 1) a patch placed over the "good" eye forces the child to use the weak eye; or 2) an eye drop placed in the "good" eye once a day to blur vision in that eye makes the child rely on the weak eye. The success rates with both of these methods have been reported to be about the same; this study will try to identify if one is more effective than the other.
Children will be randomly assigned by computer to one of the following two treatment methods:
Patch
The child initially will wear a patch over the "good" eye for 8 to 12 hours every day. If vision in the weak eye improves, the patching time will be decreased. If vision remains good after 3 months, the patching will be stopped, unless the child's doctor believes treatment should continue. If vision in the weak eye does not improve, the patching time will be increased.
Eye Drops
The child will be given one drop per day of atropine in the "good" eye. If vision in the weak eye improves, the drops will be given less often. If the vision remains good after 3 months, the drops will be stopped, unless the child's doctor believes treatment should continue.
Detailed Summary:
The Amblyopia Treatment Study (ATS) has been designed as a randomized, controlled single-masked multi-center clinical trial with the following objectives:
To determine whether the success rate with atropine treatment of amblyopia due to strabismus or anisometropia in patients less than 7 years old is equivalent to the success rate with occlusion (patching) therapy.
To develop more precise estimates of the success rates of amblyopia treatment.
To identify factors that may be associated with successful treatment of amblyopia.
To collect data on the clinical course of treated amblyopia to provide more precise estimates of treatment kinetics than now available.
Sponsor: National Eye Institute (NEI)
Current Primary Outcome:
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: National Institutes of Health Clinical Center (CC)
Dates:
Date Received: November 3, 1999
Date Started: May 1999
Date Completion: November 2001
Last Updated: March 3, 2008
Last Verified: November 2001
