Status:
COMPLETED
Correction of Myopia Evaluation Trial 2
Lead Sponsor:
Jaeb Center for Health Research
Collaborating Sponsors:
National Eye Institute (NEI)
Conditions:
Myopia
Eligibility:
All Genders
8-11 years
Phase:
PHASE3
Brief Summary
The purpose of the study is to determine if progressive addition lenses (PALs) versus single vision lenses (SVLs) slow the progression of low myopia in children with poor accommodative responses (i.e....
Detailed Description
Myopia is a significant public health problem that affects at least 34% of children in the United States and a much higher percentage in Asia. It is a predisposing factor for retinal detachment, myopi...
Eligibility Criteria
Inclusion
- Refractive error determined by cycloplegic autorefraction which meets all of the following:
- Spherical equivalent: -0.50 to -3.00 D in both eyes
- Astigmatism \<= 1.5 D in both eyes
- Anisometropia \<= 1.00 D difference between eyes in spherical equivalent
- Visual acuity is at least 20/20 with best subjective refraction in both eyes
- Accommodative response at near (33 cm) is less than 2.0D by non-cycloplegic autorefraction
- Near esophoria (\>= 2.0 PD) present by alternate prism and cover test (APCT) at near using best refractive correction determined from non-cycloplegic subjective refraction
Exclusion
- Strabismus present by cover-uncover test at far, near, and/or near with +2.00D over best subjective refraction
- Current or prior use of PALs, bifocals, or contact lenses in either eye (prior or current use of SVLs is allowed)
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT00320593
Start Date
April 1 2005
End Date
March 1 2010
Last Update
July 19 2016
Active Locations (8)
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1
University of Alabama- Birmingham, School of Optometry
Birmingham, Alabama, United States, 35294
2
Southern California College of Optometry
Fullerton, California, United States, 92831-1699
3
Indiana School of Optometry
Bloomington, Indiana, United States, 47405
4
New England College of Optometry
Boston, Massachusetts, United States, 02215-3468