This study is a 6-month, prospective, multicenter, subject/evaluator-masked, bilateral, randomized clinical investigation of the TECNIS Next-Generation Model ZFR00 and Model ZYR00 IOLs versus the TECNIS Multifocal Model ZLB00 control IOL. The study will be conducted at up to 14 sites in the U.S.A and will enroll up to 260 subjects to achieve approximately 220 randomized and bilaterally-implanted subjects, resulting in approximately 195 evaluable subjects (65 in each test group and 65 in the control group) at 1 and 6 months. Subjects are to be implanted with the same IOL in both eyes, the ZFR00 IOL, the ZYR00 IOL or the ZLB00 control IOL. The eye implanted first will be considered the primary study eye.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
225
IOL replaces the natural lens removed during cataract surgery.
IOL replaces the natural lens removed during cataract surgery.
IOL replaces the natural lens removed during cataract surgery.
Empire Eye & Laser Center
Bakersfield, California, United States
Katzen Eye Care and Laser Center
Boynton Beach, Florida, United States
Chesapeake Eye Care & Laser Center
Annapolis, Maryland, United States
Eye Doctors of Washington
Chevy Chase, Maryland, United States
Scott & Christie and Associates, PC
Cranberry Township, Pennsylvania, United States
Carolina EyeCare Physicians, LLC
Mt. Pleasant, South Carolina, United States
Loden Vision Centers
Goodlettsville, Tennessee, United States
Eye Specialty Group
Memphis, Tennessee, United States
Texas Eye and Laser Center
Hurst, Texas, United States
Lehmann Eye Center
Nacogdoches, Texas, United States
...and 2 more locations
Distance Corrected Intermediate Visual Acuity
Visual Acuity (VA) was assessed monocularly (each eye separately) under photopic (well-lit) conditions using best distance correction (distance refraction) and high contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart at 66 cm from spectacle plane. It was measured in logarithm of the minimum angle of resolution (logMAR), on an ETDRS chart. A lower numeric value represented better VA. This analysis was pre-specified for the first operative eye only.
Time frame: 1 month
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