- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03949335
Clinical Investigation of the Safety and Effectiveness of an Investigational Model of the TECNIS® Intraocular Lens (BRAVO)
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Bakersfield, California, United States, 93309
- Empire Eye & Laser Center
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Torrance, California, United States, 90505
- Wolstan & Goldberg Eye Associates
-
-
Florida
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West Palm Beach, Florida, United States, 33401
- Katzen Eye Care & Laser Center
-
-
Iowa
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Sioux City, Iowa, United States, 51104
- Jones Eye Clinic
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-
Maryland
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Annapolis, Maryland, United States, 21401
- Chesapeake Eye Care & Laser Center
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-
Ohio
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Blue Ash, Ohio, United States, 45242
- Cincinnati Eye Institute
-
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Pennsylvania
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Cranberry Township, Pennsylvania, United States, 16066
- Scott & Christie and Associates, PC
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South Carolina
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Mount Pleasant, South Carolina, United States, 29464
- Carolina Eyecare Physicians
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South Dakota
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Sioux Falls, South Dakota, United States, 57108
- Vance Thompson Vision
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Texas
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Dallas, Texas, United States, 75243
- Key-Whitman Eye Center
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Houston, Texas, United States, 77027
- Berkeley Eye Institute
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Hurst, Texas, United States, 76054
- Texas Eye and Laser Center
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Nacogdoches, Texas, United States, 75965
- Lehmann Eye Center
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San Antonio, Texas, United States, 78209
- Focal Point Vision
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Washington
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Lacey, Washington, United States, 98503
- Clarus Eye Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SUR-CAT-652-2001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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