This study is a 6-month, prospective, multicenter, bilateral, randomized subject- and evaluator-masked, clinical investigation of the TECNIS Eyhance IOL versus the TECNIS 1-piece IOL. The study will be conducted at up to 15 sites in the U.S.A and will enroll approximately 220 subjects to achieve approximately 200 randomized and bilaterally implanted subjects, resulting in approximately 100 evaluable subjects in each lens group at 6 months. Subjects are to be implanted with the same IOL in both eyes: TECNIS Eyhance IOL or the TECNIS 1-Piece IOL. The eye implanted first will be considered the primary study eye.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
228
Investigational intraocular lens replaces the natural lens removed during cataract surgery in both eyes.
Control intraocular lens replaces the natural lens removed during cataract surgery in both eyes.
Empire Eye & Laser Center
Bakersfield, California, United States
Southern California Eye Physicians and Associates
Long Beach, California, United States
Center For Sight
Sarasota, Florida, United States
Jones Eye Clinic
Sioux City, Iowa, United States
Chesapeake Eye Care & Laser Center
Annapolis, Maryland, United States
Tekwani Vision Center
St Louis, Missouri, United States
Scott & Christie and Associates, PC
Cranberry Township, Pennsylvania, United States
Eye Care Specialists
Kingston, Pennsylvania, United States
Key-Whitman Eye Center
Dallas, Texas, United States
Berkeley Eye Institute, P.A.
Houston, Texas, United States
...and 5 more locations
MONOCULAR BEST-CORRECTED DISTANCE VISUAL ACUITY (BCDVA)
the mean monocular difference in Best-Corrected Distance Visual Acuity for the first eye between lens groups
Time frame: 6 months
MONOCULAR DISTANCE-CORRECTED INTERMEDIATE VISUAL ACUITY AT 66 CM (DCVA66)
the mean monocular difference in Distance-Corrected Intermediate Visual Acuity at 66cm for first eyes between lens groups
Time frame: 6 months
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