Status:
COMPLETED
Trial Comparing Atropine to Atropine Plus a Plano Lens for the Sound Eye for Amblyopia in Children 3 to <7 Years Old
Lead Sponsor:
Jaeb Center for Health Research
Collaborating Sponsors:
National Eye Institute (NEI)
Conditions:
Amblyopia
Eligibility:
All Genders
3-6 years
Phase:
PHASE3
Brief Summary
The purpose of the study is: * To compare the effectiveness and safety of weekend atropine augmented with a plano lens for the sound eye versus weekend atropine alone for moderate amblyopia (20/40 to...
Detailed Description
Atropine is an effective treatment of moderate amblyopia. Reduction of the plus sphere for the sound eye is an accepted method of enhancing and possibly accelerating the treatment effect. Demonstratin...
Eligibility Criteria
Inclusion
- Patients must be 3 to less than 7 years old with amblyopia associated with strabismus, anisometropia, or both.
- Visual acuity in the amblyopic eye must be between 20/40 and 20/400 inclusive, visual acuity in the sound eye 20/40 or better and inter-eye acuity difference \> 3 logMAR lines.
- Spectacles, if needed, must be worn for at least 16 weeks or until visual acuity documented to be stable.
Exclusion
- Atropine treatment within 6 months of enrollment and other amblyopia treatment of any type (other than normal spectacle lenses) used within one month of enrollment
- No myopia in amblyopic eye
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT00315302
Start Date
February 1 2005
End Date
January 1 2008
Last Update
July 19 2016
Active Locations (2)
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1
Southern California College of Optometry
Fullerton, California, United States, 92831
2
UT Southwestern Medical Center
Dallas, Texas, United States, 75235