Status:
COMPLETED
Trial Comparing Patching Versus Atropine for Amblyopia in 7 to < 13 Year Olds
Lead Sponsor:
Jaeb Center for Health Research
Collaborating Sponsors:
National Eye Institute (NEI)
Conditions:
Amblyopia
Eligibility:
All Genders
7-12 years
Phase:
PHASE3
Brief Summary
The purpose of this study is: * To compare the effectiveness of weekend atropine plus near activities and daily patching plus near activities for moderate amblyopia (20/40 to 20/100) and severe ambly...
Detailed Description
Although there is consensus that amblyopia can be treated effectively in young children, many eye care practitioners believe that treatment beyond a certain age is ineffective. Some clinicians have be...
Eligibility Criteria
Inclusion
- Age 7 to 12 years old (inclusive)
- Amblyopia associated with strabismus, anisometropia, or both
- Visual acuity in the amblyopic eye 19 to 71 letters on Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS©) (20/40 to 20/400 inclusive)
- Visual acuity in the sound eye 79 letters or better on E-ETDRS© (20/25 or better)
- Interocular difference \>=15 letters (3 lines)
- Spectacles, if needed, worn for at least 16 weeks or visual acuity documented to be stable
- Inclusion Criteria for Optional Ancillary Study:
- Enrolled into the main study
- Refractive error in both eyes between -0.25 and +5.00D, inclusive (to avoid the need to adjust for refractive error)
- Birth weight \>1500 grams
- No history of Central Nervous System (CNS) disease (e.g. intraventricular hemorrhage (IVH), periventricular leukomalacia (PVL), meningitis, developmental abnormalities of the brain, hydrocephalus, cerebral palsy, hypoxic ischemic encephalopathy
Exclusion
- Amblyopia treatment (other than spectacles) in the last 6 months
- Myopia (more than -0.25D spherical equivalent) in either eye
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
233 Patients enrolled
Trial Details
Trial ID
NCT00315328
Start Date
August 1 2005
End Date
January 1 2008
Last Update
June 24 2016
Active Locations (2)
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1
Pennsylvania College of Optometry
Philadelphia, Pennsylvania, United States, 19141
2
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213