Clinical Investigation of the Safety and Effectiveness of an Investigational Model of the TECNIS® Intraocular Lens (BRAVO)

August 3, 2021 updated by: Johnson & Johnson Surgical Vision, Inc.

This study will be a prospective, multicenter, bilateral, comparative, three-way masked (Sponsor, subject and evaluator), randomized clinical investigation conducted at up to 15 sites. Up to 300 subjects will be enrolled to achieve approximately 270 bilaterally implanted subjects, resulting in approximately 244 evaluable subjects (122 per lens group) at 6 months. After informed consent is obtained and confirmation that all eligibility criteria are met, the eye(s) may be treated according to randomization.

After signing the informed consent form, subjects meeting all eligibility criteria will be randomized in a masked fashion to a treatment group: either the investigational IOL Model ZFR00V or the control IOL Model ZCB00. Prior to randomization, the investigator will choose which eye to operate on first for each subject at his/her discretion based on his/her standard clinical practice (e.g., the eye with the worse cataract, poorer best corrected distance vision and/or more severe optical/visual complaints). All subjects are intended to have bilateral cataract surgery with the second eye surgery occurring after the 1-week postoperative exam for the first eye, but no more than 30 days after the first eye surgery. All subjects will be examined through 6 months postoperatively according to the visit schedule

Study Overview

Status

Completed

Study Type

Interventional

Enrollment (Actual)

272

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Bakersfield, California, United States, 93309
        • Empire Eye & Laser Center
      • Torrance, California, United States, 90505
        • Wolstan & Goldberg Eye Associates
    • Florida
      • West Palm Beach, Florida, United States, 33401
        • Katzen Eye Care & Laser Center
    • Iowa
      • Sioux City, Iowa, United States, 51104
        • Jones Eye Clinic
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Chesapeake Eye Care & Laser Center
    • Ohio
      • Blue Ash, Ohio, United States, 45242
        • Cincinnati Eye Institute
    • Pennsylvania
      • Cranberry Township, Pennsylvania, United States, 16066
        • Scott & Christie and Associates, PC
    • South Carolina
      • Mount Pleasant, South Carolina, United States, 29464
        • Carolina Eyecare Physicians
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57108
        • Vance Thompson Vision
    • Texas
      • Dallas, Texas, United States, 75243
        • Key-Whitman Eye Center
      • Houston, Texas, United States, 77027
        • Berkeley Eye Institute
      • Hurst, Texas, United States, 76054
        • Texas Eye and Laser Center
      • Nacogdoches, Texas, United States, 75965
        • Lehmann Eye Center
      • San Antonio, Texas, United States, 78209
        • Focal Point Vision
    • Washington
      • Lacey, Washington, United States, 98503
        • Clarus Eye Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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:

  • currently participating in any other clinical study or have participated in a clinical study during the last 60 days
  • have a certain disease/illness such as poorly-controlled diabetes
  • have certain ocular conditions such as uncontrolled glaucoma
  • Is taking medication that may affect vision
  • Subject is pregnant, plan to become pregnant during the study, or is breastfeeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Investigational
Bilateral implantation with investigational IOL Model ZFR00V
Bilateral implantation with Investigational IOL Model ZFR00V
Active Comparator: Control
Bilateral implantation with control IOL Model ZCB00
Bilateral Implantation with control IOL Model ZCB00

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Distance-Corrected Near Visual Acuity (DCNVA) at 40 cm
Time Frame: 6 months (postoperative)
mean photopic monocular Distance Corrected Near Visual Acuity results at 40 cm for ZFR00 and control first eyes in the safety population at 6 months
6 months (postoperative)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Monocular Distance-Corrected Intermediate Visual Acuity at 66 cm
Time Frame: 6 months (postoperative)
mean photopic monocular Distance-Corrected Intermediate Visual Acuity results at 6 months for ZFR00 and control first eyes in the safety population
6 months (postoperative)
Monocular Distance-Corrected Near Visual Acuity at 33 cm
Time Frame: 6 months postoperative
mean photopic monocular Distance-Corrected Near Visual Acuity results at 33 cm for ZFR00 and control first eyes in the safety population at 6 months
6 months postoperative
Monocular Photopic Best-Corrected Distance Visual Acuity
Time Frame: 6 months postoperative
mean monocular Best-Corrected Distance Visual Acuity results at 6 months for ZFR00 and control first eyes in the safety population.
6 months postoperative
Monocular Distance-Corrected Defocus Curve
Time Frame: 6 months postoperative
Mean monocular (first eye) distance-corrected defocus curve for each lens group at 6 months in the safety population
6 months postoperative
Spectacle Wear
Time Frame: 6 months postoperative
Spectacle wear is determined via the PRO questionnaire instrument and defined as wearing glasses or contacts "none of the time" in all 4 conditions (distance vision, intermediate vision, near vision and overall vision) at 6 months postoperative.
6 months postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 31, 2019

Primary Completion (Actual)

June 18, 2020

Study Completion (Actual)

June 18, 2020

Study Registration Dates

First Submitted

May 1, 2019

First Submitted That Met QC Criteria

May 13, 2019

First Posted (Actual)

May 14, 2019

Study Record Updates

Last Update Posted (Actual)

August 27, 2021

Last Update Submitted That Met QC Criteria

August 3, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • SUR-CAT-652-2001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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