Status:
COMPLETED
Trial to Evaluate 2 Hours of Daily Patching for Amblyopia in Children
Lead Sponsor:
Jaeb Center for Health Research
Collaborating Sponsors:
National Eye Institute (NEI)
Conditions:
Amblyopia
Eligibility:
All Genders
3-7 years
Phase:
PHASE3
Brief Summary
The objectives of the Spectacle Phase are: * In previously untreated pure anisometropic patients (i.e. patients who have not used spectacles in the last year and who do not have strabismus), to deter...
Detailed Description
There are few data on the improvement that occurs with spectacle correction alone in cases of anisometropic amblyopia. The only published study of which we are aware is that of Moseley, et al, who fou...
Eligibility Criteria
Inclusion
- Age 3 to \<7 years
- Able to perform visual acuity using the ATS single-surround HOTV protocol
- Amblyopia associated with strabismus (comitant or incomitant), anisometropia, or both
- Visual acuity in the amblyopic eye 20/40 to 20/400 inclusive
- Visual acuity in the sound eye \>20/40
- Inter-eye acuity difference \>3 logMAR lines
- Cycloplegic refraction and ocular examination within 2 months prior to enrollment
Exclusion
- No amblyopia treatment (other than spectacles) in the past month and no more than one month of amblyopia treatment in the past 6 months
- No current vision therapy or orthoptics
- No ocular cause for reduced visual acuity
- No myopia more than a spherical equivalent of -6.00 D
- No prior intraocular or refractive surgery
- No known skin reactions to patch or bandage adhesives
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
End Date :
December 1 2005
Estimated Enrollment :
268 Patients enrolled
Trial Details
Trial ID
NCT00091923
Start Date
February 1 2004
End Date
December 1 2005
Last Update
March 24 2010
Active Locations (2)
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1
Southern California College of Optometry
Fullerton, California, United States, 92831
2
Duke University Eye Center
Durham, North Carolina, United States, 27710