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TERMINATED
NCT05574959
NA

Clinical Investigation of the TECNIS® Next-Generation Intraocular Lens, Model DEN00V

Sponsor: Johnson & Johnson Surgical Vision, Inc.

View on ClinicalTrials.gov

Summary

Prospective, multicenter, bilateral, masked (sponsor, subject and evaluator), randomized clinical trial to evaluate the safety and effectiveness of the TECNIS IOL, Model DEN00V in comparison to an aspheric monofocal IOL.

Key Details

Gender

All

Age Range

22 Years - Any

Study Type

INTERVENTIONAL

Enrollment

243

Start Date

2022-10-24

Completion Date

2023-10-24

Last Updated

2026-08-11

Healthy Volunteers

No

Conditions

Interventions

DEVICE

investigational IOL Model DEN00V

Eligible subjects will be randomized in a 1:1 ratio to receive either the investigational IOL Model DEN00V or Control Model ZCB00/DCB00 in both eyes for the duration of the study.

DEVICE

control IOL Model ZCB00/DCB00

Eligible subjects will be randomized in a 1:1 ratio to receive either the investigational IOL Model DEN00V or Control Model ZCB00/DCB00 in both eyes for the duration of the study.

Locations (10)

Empire Eye & Laser Center

Bakersfield, California, United States

Southern California Eye Physicians and Associates

Long Beach, California, United States

Wolstan & Goldberg Eye Associates

Torrance, California, United States

Jones Eye Center

Sioux City, Iowa, United States

OCLI Vision

Garden City, New York, United States

Cincinnati Eye Institute

Cincinnati, Ohio, United States

Carolina EyeCare Physicians, LLC

Mt. Pleasant, South Carolina, United States

Whitsett Vision Group

Houston, Texas, United States

Focal Point Vision

San Antonio, Texas, United States

Parkhurst NuVision

San Antonio, Texas, United States