Post-Approval Study of the TECNIS SYMFONY® Toric Lenses
- Conditions
- Corneal AstigmatismCataract
- Interventions
- Device: Higher Cylinder Toric IOLDevice: Lower Cylinder Toric IOL
- Registration Number
- NCT03791619
- Lead Sponsor
- Johnson & Johnson Surgical Vision, Inc.
- Brief Summary
This study is a prospective, multicenter, bilateral, non-randomized, open-label, comparative, 6-month clinical study conducted at up to 50 sites in the USA.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 475
- be at least 22 years old
- 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
- Currently participating in any other clinical study or have participated in a clinical study during the last 30 days
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Higher Cylinder Toric IOL 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. Lower Cylinder Toric 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.
- Primary Outcome Measures
Name Time Method Rate of Bothersome Visual Symptoms 6-month The rate of subjects reporting one or more of these items as very or extremely bothersome and impacting daily life via questionnaire.
Rate of Difficulty With an Activity Due to the Visual Symptoms 6-month The rate of reported difficulty with an activity due to one or more of visual symptoms impacting daily life via questionnaire.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (23)
Florida Eye Microsurgical Institute, Inc.
🇺🇸Boynton Beach, Florida, United States
Empire Eye & Laser Center
🇺🇸Bakersfield, California, United States
Parkhurst NuVision
🇺🇸San Antonio, Texas, 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
The Eye Associates of Manatee
🇺🇸Bradenton, Florida, United States
North Florida Eye Surgeons, LLC dba Florida Eye Specialist
🇺🇸Jacksonville, Florida, United States
Levenson Eye Associates
🇺🇸Jacksonville, Florida, United States
Tekwani Vision Center
🇺🇸Saint Louis, Missouri, 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
Northern New Jersey Eye Institute PA
🇺🇸South Orange, New Jersey, United States
Ludwick Eye Center
🇺🇸Chambersburg, Pennsylvania, United States
Focal Point Vision
🇺🇸San Antonio, Texas, United States
Carolina Cataract & Laser Center
🇺🇸Ladson, South Carolina, United States
Memphis Eye & Cataract Associates, PLLC
🇺🇸Memphis, Tennessee, United States
Texas Eye & Laser Center
🇺🇸Hurst, Texas, United States
Cornea Associates of Texas
🇺🇸Dallas, Texas, United States
Clarus Eye Centre
🇺🇸Lacey, Washington, United States
Oakland Ophthalmic Surgery
🇺🇸Birmingham, Michigan, United States
Vance Thompson Vision
🇺🇸Sioux Falls, South Dakota, United States