Status:
COMPLETED
Trial Comparing Near Versus Distance Activities While Patching 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
Ths purpose of this study is to determine whether "near" activities enhance the effect of patching on visual acuity improvement in strabismic and anisometropic amblyopia when compared with "distance" ...
Detailed Description
The value of "near visual activities" while patching for amblyopia is controversial. Some pediatric eye care providers currently recommend that the child perform near visual tasks while wearing a patc...
Eligibility Criteria
Inclusion
- Patients must be 3 to less than 7 years old with amblyopia due to 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
- Prior amblyopia treatment other than spectacles in the past month.
- More than one month of amblyopia treatment in the past 6 months.
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
425 Patients enrolled
Trial Details
Trial ID
NCT00315198
Start Date
February 1 2005
End Date
December 1 2007
Last Update
March 24 2010
Active Locations (2)
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1
Indiana University School of Optometry
Bloomington, Indiana, United States, 47405
2
Mayo Clinic Department of Ophthalmology
Rochester, Minnesota, United States, 55905