Status:
COMPLETED
Trial Comparing Daily Atropine Versus Weekend Atropine
Lead Sponsor:
Jaeb Center for Health Research
Collaborating Sponsors:
National Eye Institute (NEI)
Conditions:
Amblyopia
Eligibility:
All Genders
3-7 years
Phase:
PHASE4
Brief 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 pa...
Detailed Description
Amblyopia is the most common cause of monocular visual impairment in both children and young and middle-aged adults. Patching has been the mainstay of amblyopia therapy. It is generally held that the ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2002
Trial Type :
INTERVENTIONAL
End Date :
April 1 2003
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT00094614
Start Date
June 1 2002
End Date
April 1 2003
Last Update
March 25 2010
Active Locations (1)
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1
Wilmer Eye Institute
Baltimore, Maryland, United States, 21287-9028