The purpose of this clinical trial is to evaluate the safety and effectiveness of the TECNIS Multifocal 1-Piece Intraocular Lens (IOLs), Models ZKB00 and ZLB00 which will each provide statistically better distance-corrected near visual acuity compared to the monofocal control lens. Complication and adverse event rates associated with each Multifocal IOL will be within the ISO SPE rate for posterior chamber IOLs.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
445
Fishkind, Bakewell & Maltzman Eye Care & Surgery Center
Tucson, Arizona, United States
Boozman-Hof Regional Eye Clinic
Rogers, Arkansas, United States
Mean Monocular Distance-corrected Near Visual Acuity (VA) at 40 cm
Mean (LogMAR) monocular distance-corrected near VA at 40 cm at six months postoperative
Time frame: six months
Mean Diopter Range With VA of 20/40 or Better
Mean diopter range in which VA of 20/40 or better was achieved at six months. Note: diopter range outcome measure was obtained from a substudy group that included the first 10 study sites to reach enrollment goals. Among these 10 sites, the first 60 subjects in each lens group (approximately\*) to reach the 6-month visit were included in the substudy. \* The intent was to enroll 60 subjects per group, but group #1, group #2, and the monofocal group had 59, 63, and 61 subjects, respectively.
Time frame: six months
Spectacle Independence
Number of subjects never requiring spectacles at six months. This outcome measure was obtained via questionnaire. The questionnaire was administered by phone.
Time frame: six months
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Empire Eye & Laser Center
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