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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03949335
Recruitment Status : Completed
First Posted : May 14, 2019
Last Update Posted : May 4, 2021
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Surgical Vision, Inc.

Brief Summary:

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


Condition or disease Intervention/treatment Phase
Cataract Corneal Astigmatism Device: IOL Model ZFR00V Device: IOL Model ZCB00 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 297 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description:

Only the surgeon and the operative staff will know which lens type is implanted and will be unmasked throughout the study. There may also be site coordinators and other site study staff, such as those performing slit-lamp exams, who will be unmasked. Unmasked study staff and study subjects will be instructed not to disclose the lens type the subject received or to talk about the lens to any subjects or masked evaluators.

The subjects and the study technicians performing the postoperative vision tests are to be masked through study completion. To maintain subject/technician-masking through the 6-month study exams, a masking plan will be tailored for each site to detail how lens assignment information will be concealed from masked technicians.

Primary Purpose: Treatment
Official Title: Clinical Investigation of the Safety and Effectiveness of an Investigational Model of the TECNIS® Intraocular Lens
Actual Study Start Date : July 31, 2019
Actual Primary Completion Date : June 18, 2020
Actual Study Completion Date : June 18, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
Experimental: Investigational
Bilateral implantation with investigational IOL Model ZFR00V
Device: IOL Model ZFR00V
Bilateral implantation with Investigational IOL Model ZFR00V

Active Comparator: Control
Bilateral implantation with control IOL Model ZCB00
Device: IOL Model ZCB00
Bilateral Implantation with control IOL Model ZCB00




Primary Outcome Measures :
  1. Distance - corrected near visual acuity (logMAR score) [ Time Frame: 6 months ]
    LogMAR visual acuity measurements will be summarized by the mean (average) value



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03949335


Locations
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United States, California
Empire Eye & Laser Center
Bakersfield, California, United States, 93309
Wolstan & Goldberg Eye Associates
Torrance, California, United States, 90505
United States, Florida
Katzen Eye Care & Laser Center
West Palm Beach, Florida, United States, 33401
United States, Iowa
Jones Eye Clinic
Sioux City, Iowa, United States, 51104
United States, Maryland
Chesapeake Eye Care & Laser Center
Annapolis, Maryland, United States, 21401
United States, Ohio
Cincinnati Eye Institute
Blue Ash, Ohio, United States, 45242
United States, Pennsylvania
Scott & Christie and Associates, PC
Cranberry Township, Pennsylvania, United States, 16066
United States, South Carolina
Carolina EyeCare Physicians
Mount Pleasant, South Carolina, United States, 29464
United States, South Dakota
Vance Thompson Vision
Sioux Falls, South Dakota, United States, 57108
United States, Texas
Key-Whitman Eye Center
Dallas, Texas, United States, 75243
Berkeley Eye Institute
Houston, Texas, United States, 77027
Texas Eye and Laser Center
Hurst, Texas, United States, 76054
Lehmann Eye Center
Nacogdoches, Texas, United States, 75965
Focal Point Vision
San Antonio, Texas, United States, 78209
United States, Washington
Clarus Eye Centre
Lacey, Washington, United States, 98503
Sponsors and Collaborators
Johnson & Johnson Surgical Vision, Inc.
Investigators
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Study Director: Johnson & Johnson Surgical Vision Clinical Trials Johnson & Johnson Surgical Vision
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Responsible Party: Johnson & Johnson Surgical Vision, Inc.
ClinicalTrials.gov Identifier: NCT03949335    
Other Study ID Numbers: SUR-CAT-652-2001
First Posted: May 14, 2019    Key Record Dates
Last Update Posted: May 4, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
URL: http://yoda.yale.edu/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Cataract
Astigmatism
Lens Diseases
Eye Diseases
Refractive Errors