Clinical Investigation of the Safety and Effectiveness of an Investigational Model of the TECNIS® Intraocular Lens
NCT ID: NCT03949335
Last Updated: 2021-08-27
Study Results
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View full resultsBasic Information
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COMPLETED
NA
272 participants
INTERVENTIONAL
2019-07-31
2020-06-18
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
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.
Study Groups
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Investigational
Bilateral implantation with investigational IOL Model ZFR00V
IOL Model ZFR00V
Bilateral implantation with Investigational IOL Model ZFR00V
Control
Bilateral implantation with control IOL Model ZCB00
IOL Model ZCB00
Bilateral Implantation with control IOL Model ZCB00
Interventions
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IOL Model ZFR00V
Bilateral implantation with Investigational IOL Model ZFR00V
IOL Model ZCB00
Bilateral Implantation with control IOL Model ZCB00
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
22 Years
ALL
No
Sponsors
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Johnson & Johnson Surgical Vision, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Johnson & Johnson Surgical Vision Clinical Trials
Role: STUDY_DIRECTOR
Johnson & Johnson Surgical Vision
Locations
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Empire Eye & Laser Center
Bakersfield, California, United States
Wolstan & Goldberg Eye Associates
Torrance, California, United States
Katzen Eye Care & Laser Center
West Palm Beach, Florida, United States
Jones Eye Clinic
Sioux City, Iowa, United States
Chesapeake Eye Care & Laser Center
Annapolis, Maryland, United States
Cincinnati Eye Institute
Blue Ash, Ohio, United States
Scott & Christie and Associates, PC
Cranberry Township, Pennsylvania, United States
Carolina EyeCare Physicians
Mt. Pleasant, South Carolina, United States
Vance Thompson Vision
Sioux Falls, South Dakota, United States
Key-Whitman Eye Center
Dallas, Texas, United States
Berkeley Eye Institute
Houston, Texas, United States
Texas Eye and Laser Center
Hurst, Texas, United States
Lehmann Eye Center
Nacogdoches, Texas, United States
Focal Point Vision
San Antonio, Texas, United States
Clarus Eye Centre
Lacey, Washington, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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SUR-CAT-652-2001
Identifier Type: -
Identifier Source: org_study_id
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