Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001864
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Amblyopia Lazy Eye Treatment Study
Sponsor:
National Eye Institute NEI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Amblyopia Treatment Study
Status:
COMPLETED
Status Verified Date:
2001-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 childs 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 childs doctor believes treatment should continue If the initial daily drop does not improve the vision in the weak eye the childs eyeglasses may be changed to try to further blur the vision in the good eye
After 6 months treatment may be stopped if it has not been successful If treatment has been successful after 6 months it may be continued at a reduced amount or stopped
Follow-up visits will be scheduled every 4 weeks for the first 6 months and every 2 to 4 months after that until the end of the 2-year study During each visit the eyes will be examined for eye movements and vision and the pupils will be dilated to examine the inside of the eye
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 childs 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 childs doctor believes treatment should continue If the initial daily drop does not improve the vision in the weak eye the childs eyeglasses may be changed to try to further blur the vision in the good eye
After 6 months treatment may be stopped if it has not been successful If treatment has been successful after 6 months it may be continued at a reduced amount or stopped
Follow-up visits will be scheduled every 4 weeks for the first 6 months and every 2 to 4 months after that until the end of the 2-year study During each visit the eyes will be examined for eye movements and vision and the pupils will be dilated to examine the inside of the eye
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 99-EI-0110 | None | None | None |