Clinical Investigation of the TECNIS® Next-Generation Intraocular Lens

Last updated: April 24, 2025
Sponsor: Johnson & Johnson Surgical Vision, Inc.
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Vision Loss

Eye Disorders/infections

Eye Disease

Treatment

Test IOL Model DEN00V

Control IOL Model DCB00

Clinical Study ID

NCT06377514
PCOL109PHNG
  • Ages > 22
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

Prospective, multicenter, bilateral, interventional, controlled, masked (sponsor, subjects, and evaluators), randomized clinical trial.

Eligibility Criteria

Inclusion

INCLUSION CRITERIA

To be considered for enrollment in this study, patient must:

  • be at least 22 years old

  • have cataracts in both eyes

  • sign the written informed consent

  • be willing and able to comply with examination procedures

  • understand, read and write English to complete informed consent and questionnaires

  • be available for study follow-up visits EXCLUSION CRITERIA

Patient will not be eligible to take part in the study if:

  • currently participating in any other clinical study or have participated in a clinical study during the last 30 days

  • have a certain disease/illness, such as poorly controlled diabetes

  • have certain ocular conditions, such as uncontrolled pressure in the eye

  • taking medication that may affect vision

  • pregnant, plan to become pregnant during the study, or are breastfeeding

Study Design

Total Participants: 250
Treatment Group(s): 2
Primary Treatment: Test IOL Model DEN00V
Phase:
Study Start date:
June 03, 2024
Estimated Completion Date:
July 27, 2025

Connect with a study center

  • Empire Eye & Laser Center

    Bakersfield, California 93309
    United States

    Site Not Available

  • Harvard Eye Associates

    Laguna Hills, California 92653
    United States

    Site Not Available

  • Levenson Eye Associates

    Jacksonville, Florida 32204
    United States

    Site Not Available

  • Jones Eye Center

    Sioux City, Iowa 51104
    United States

    Site Not Available

  • OCLI Vision

    Garden City, New York 11530
    United States

    Site Not Available

  • Cleveland Eye Clinic

    Brecksville, Ohio 44141
    United States

    Site Not Available

  • Vance Thompson Vision

    Sioux Falls, South Dakota 57108
    United States

    Site Not Available

  • Berkeley Eye Center

    Houston, Texas 77027
    United States

    Site Not Available

  • Whitsett Vision Group

    Houston, Texas 77055
    United States

    Site Not Available

  • Parkhurst NuVision

    San Antonio, Texas 78229
    United States

    Site Not Available

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