Clinical Investigation of the Safety and Effectiveness of an Investigational Model of the TECNIS® Intraocular Lens
BRAVO
1 other identifier
interventional
272
1 country
15
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2019
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 1, 2019
CompletedFirst Posted
Study publicly available on registry
May 14, 2019
CompletedStudy Start
First participant enrolled
July 31, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 18, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 18, 2020
CompletedResults Posted
Study results publicly available
August 27, 2021
CompletedAugust 27, 2021
August 1, 2021
11 months
May 1, 2019
June 16, 2021
August 3, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Distance-Corrected Near Visual Acuity (DCNVA) at 40 cm
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 Outcomes (5)
Monocular Distance-Corrected Intermediate Visual Acuity at 66 cm
6 months (postoperative)
Monocular Distance-Corrected Near Visual Acuity at 33 cm
6 months postoperative
Monocular Photopic Best-Corrected Distance Visual Acuity
6 months postoperative
Monocular Distance-Corrected Defocus Curve
6 months postoperative
Spectacle Wear
6 months postoperative
Study Arms (2)
Investigational
EXPERIMENTALBilateral implantation with investigational IOL Model ZFR00V
Control
ACTIVE COMPARATORBilateral implantation with control IOL Model ZCB00
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Empire Eye & Laser Center
Bakersfield, California, 93309, United States
Wolstan & Goldberg Eye Associates
Torrance, California, 90505, United States
Katzen Eye Care & Laser Center
West Palm Beach, Florida, 33401, United States
Jones Eye Clinic
Sioux City, Iowa, 51104, United States
Chesapeake Eye Care & Laser Center
Annapolis, Maryland, 21401, United States
Cincinnati Eye Institute
Blue Ash, Ohio, 45242, United States
Scott & Christie and Associates, PC
Cranberry Township, Pennsylvania, 16066, United States
Carolina EyeCare Physicians
Mt. Pleasant, South Carolina, 29464, United States
Vance Thompson Vision
Sioux Falls, South Dakota, 57108, United States
Key-Whitman Eye Center
Dallas, Texas, 75243, United States
Berkeley Eye Institute
Houston, Texas, 77027, United States
Texas Eye and Laser Center
Hurst, Texas, 76054, United States
Lehmann Eye Center
Nacogdoches, Texas, 75965, United States
Focal Point Vision
San Antonio, Texas, 78209, United States
Clarus Eye Centre
Lacey, Washington, 98503, United States
Related Publications (1)
Chang DH, Hu JG, Lehmann RP, Thompson VM, Tsai LH, Thomas EK. Clinical performance of a hybrid presbyopia-correcting intraocular lens in patients undergoing cataract surgery in a multicenter trial. J Cataract Refract Surg. 2023 Aug 1;49(8):840-847. doi: 10.1097/j.jcrs.0000000000001205.
PMID: 37097283DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Eugenia Thomas, OD
- Organization
- Johnson & Johnson Surgical Vision
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Surgical Vision Clinical Trials
Johnson & Johnson Surgical Vision
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 1, 2019
First Posted
May 14, 2019
Study Start
July 31, 2019
Primary Completion
June 18, 2020
Study Completion
June 18, 2020
Last Updated
August 27, 2021
Results First Posted
August 27, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will share
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.