Clinical Investigation of the Next-Generation Intraocular Lenses

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Cataract

Clinical Trial Details

NCT number	NCT03372434
Study type	Interventional
Source	Abbott Medical Optics
Contact
Status	Completed
Phase	N/A
Start date	January 16, 2018
Completion date	October 30, 2018

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