Post-Approval Study of the TECNIS SYMFONY® Toric Lenses
NCT ID: NCT03791619
Last Updated: 2023-08-29
Study Results
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View full resultsBasic Information
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COMPLETED
NA
475 participants
INTERVENTIONAL
2018-12-13
2022-08-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Higher Cylinder Toric IOL
Consented subjects that are eligible will have both eyes implanted with a TECNIS Symfony IOL. Each eye may have a different TECNIS Symfony IOL implanted, as determined by the surgeon and the TECNIS Symfony Toric IOL calculator; however, at least one eye must be implanted with either a Symfony Toric IOL Model ZXT150 (lower-cylinder group) or a Model ZXT300 or ZXT375 (higher-cylinder group) and the fellow eye must have the same or a lower toric power. The eye with the highest toric power IOL will determine the model group.
Higher Cylinder Toric IOL
Symfony Toric models ZXT300 and ZXT375 IOL
Lower Cylinder Toric IOL
Consented subjects that are eligible will have both eyes implanted with a TECNIS Symfony IOL. Each eye may have a different TECNIS Symfony IOL implanted, as determined by the surgeon and the TECNIS Symfony Toric IOL calculator; however, at least one eye must be implanted with either a Symfony Toric IOL Model ZXT150 (lower-cylinder group) or a Model ZXT300 or ZXT375 (higher-cylinder group) and the fellow eye must have the same or a lower toric power. The eye with the highest toric power IOL will determine the model group.
Lower Cylinder Toric IOL
Symfony Toric model ZXT150 IOL
Interventions
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Higher Cylinder Toric IOL
Symfony Toric models ZXT300 and ZXT375 IOL
Lower Cylinder Toric IOL
Symfony Toric model ZXT150 IOL
Eligibility Criteria
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Inclusion Criteria
* have cataracts in both eyes
* have a certain degree of astigmatism in at least one eye
* 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
Both eyes must qualify to be eligible to participate in the study
Exclusion Criteria
* Have a certain disease/illness such as poorly-controlled diabetes
* Have certain ocular conditions such as uncontrolled glaucoma
* Taking medication that may affect subject vision
* Have irregular corneal astigmatism
* 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
Southern California Eye Physicians & Associates
Long Beach, California, United States
Santa Monica Eye Medical Group
Santa Monica, California, United States
Wolstan & Goldberg Eye Associates
Torrance, California, United States
Florida Eye Microsurgical Institute, Inc.
Boynton Beach, Florida, United States
The Eye Associates of Manatee
Bradenton, Florida, United States
Levenson Eye Associates
Jacksonville, Florida, United States
North Florida Eye Surgeons, LLC dba Florida Eye Specialist
Jacksonville, Florida, United States
Center For Sight
Sarasota, Florida, United States
Virdi Eye Clinic & Laser Vision Care
Rock Island, Illinois, United States
Chesapeake Eye Care & Laser
Annapolis, Maryland, United States
Oakland Ophthalmic Surgery
Birmingham, Michigan, United States
Tekwani Vision Center
St Louis, Missouri, United States
Northern New Jersey Eye Institute PA
South Orange, New Jersey, United States
Ludwick Eye Center
Chambersburg, Pennsylvania, United States
Carolina Cataract & Laser Center
Ladson, South Carolina, United States
Vance Thompson Vision
Sioux Falls, South Dakota, United States
Memphis Eye & Cataract Associates, PLLC
Memphis, Tennessee, United States
Cornea Associates of Texas
Dallas, Texas, United States
Texas Eye & Laser Center
Hurst, Texas, United States
Focal Point Vision
San Antonio, Texas, United States
Parkhurst NuVision
San Antonio, Texas, United States
Clarus Eye Centre
Lacey, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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TIOL-205-STPA
Identifier Type: -
Identifier Source: org_study_id
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