The purpose of this study is to evaluate the safety and performance of the SBL-3 intraocular lens.
The purpose of this study is to evaluate the safety (adverse events) and performance (visual acuity, spectacle independence) of the SBL-3 intraocular lens.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
499
The SBL-3 intraocular lens will be implanted after the cataractous natural lens has been removed, in those patients randomized into this group
The Control intraocular lens will be implanted after the cataractous natural lens has been removed, in those patients randomized into this group
Eye Center South
Dothan, Alabama, United States
Shepard Eye Center
Santa Maria, California, United States
Cape Coral Eye Center
Cape Coral, Florida, United States
photopic, distance corrected, monocular near visual acuity
a measure of near vision
Time frame: 1 year following implantation
presence or absence of adverse events
presence or absence of adverse events
Time frame: 1 year following implantation
photopic, distance corrected, monocular intermediate visual acuity
a measure of intermediate vision
Time frame: 1 year following implantation
photopic, best corrected, monocular distance visual acuity
a measure of distance vision
Time frame: 1 year following implantation
Proportion of subjects who are independent of spectacles
a measure of the independence from spectacles
Time frame: 1 year following implantation
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Eye Centers of Florida
Fort Myers, Florida, United States
Newsom Eye & Laser Center
Sebring, Florida, United States
Family Eye Centers
Willmar, Minnesota, United States
The Eye Center of Central PA
Allenwood, Pennsylvania, United States
Eye Care Specialists
Kingston, Pennsylvania, United States
Carolina Eyecare Physicians
Mt. Pleasant, South Carolina, United States
Loden Vision Center
Goodlettsville, Tennessee, United States
...and 3 more locations