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Clinical Investigation of the Safety and Effectiveness of the Next-Generation TECNIS® Symfony® Intraocular Lens Model ZHR00
An investigational IOL designed to provide improved intermediate and near visual acuity and decreased spectacle wear was evaluated for safety and effectiveness in a six-month study.
The next generation TECNIS IOL designed to provide improved intermediate and near visual acuity and decreased spectacle wear was evaluated for safety and effectiveness in a six-month interventional study and compared to a marketed monofocal IOL. Assessments included distance-corrected intermediate and near visual acuity, depth of focus at 0.2 logMAR and spectacle wear frequency.
Age
22 - No limit years
Sex
ALL
Healthy Volunteers
Yes
Wolstan & Goldberg Eye Associates
Torrance, California, United States
The Eye Associates of Manatee, LLP
Bradenton, Florida, United States
Levenson Eye Associates, Inc.
Jacksonville, Florida, United States
Jones Eye Clinic
Sioux City, Iowa, United States
Cincinnati Eye Institute
Cincinnati, Ohio, United States
Eye Care Specialists
Kingston, Pennsylvania, United States
Vance Thompson Vision Clinic, Prof LLC
Sioux Falls, South Dakota, United States
Key-Whitman Eye Center
Dallas, Texas, United States
Berkeley Eye Institute, P.A.
Houston, Texas, United States
Slade & Baker Vision
Houston, Texas, United States
Start Date
June 28, 2018
Primary Completion Date
June 5, 2019
Completion Date
June 5, 2019
Last Updated
June 25, 2020
247
ACTUAL participants
Investigational Intraocular Lens Device #1: Next Generation TECNIS IOL
DEVICE
Control Monofocal Intraocular Lens: TECNIS Monofocal IOL
DEVICE
Lead Sponsor
Johnson & Johnson Surgical Vision, Inc.
NCT06979752
NCT07362043
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06060041