At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Clinical Investigation of the TECNIS Next-Generation Intraocular Lens
In Brief
A clinical study evaluating Investigational Intraocular Lens Device #1: Model ZFR00, Investigational Intraocular Lens Device #1: Model ZYR00, and 1 other intervention for Cataract. Completed, enrolled 225 participants across 12 sites.
Detailed Summary
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 Details
Timeline
Interventions
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.