Post-Approval Study of the TECNIS SYMFONY® Toric Lenses
ANCORA
1 other identifier
interventional
475
1 country
23
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2018
Longer than P75 for not_applicable
23 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
December 11, 2018
CompletedStudy Start
First participant enrolled
December 13, 2018
CompletedFirst Posted
Study publicly available on registry
January 2, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 8, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 8, 2022
CompletedResults Posted
Study results publicly available
August 29, 2023
CompletedAugust 29, 2023
August 1, 2023
3.7 years
December 11, 2018
July 7, 2023
August 7, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Rate of Bothersome Visual Symptoms
The rate of subjects reporting one or more of these items as very or extremely bothersome and impacting daily life via questionnaire.
6-month
Rate of Difficulty With an Activity Due to the Visual Symptoms
The rate of reported difficulty with an activity due to one or more of visual symptoms impacting daily life via questionnaire.
6-month
Study Arms (2)
Higher Cylinder Toric IOL
ACTIVE COMPARATORConsented 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
ACTIVE COMPARATORConsented 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Empire Eye & Laser Center
Bakersfield, California, 93309, United States
Southern California Eye Physicians & Associates
Long Beach, California, 90805, United States
Santa Monica Eye Medical Group
Santa Monica, California, 90404, United States
Wolstan & Goldberg Eye Associates
Torrance, California, 90505, United States
Florida Eye Microsurgical Institute, Inc.
Boynton Beach, Florida, 33426, United States
The Eye Associates of Manatee
Bradenton, Florida, 34209, United States
Levenson Eye Associates
Jacksonville, Florida, 32204, United States
North Florida Eye Surgeons, LLC dba Florida Eye Specialist
Jacksonville, Florida, 32256, United States
Center For Sight
Sarasota, Florida, 34239, United States
Virdi Eye Clinic & Laser Vision Care
Rock Island, Illinois, 61201, United States
Chesapeake Eye Care & Laser
Annapolis, Maryland, 21401, United States
Oakland Ophthalmic Surgery
Birmingham, Michigan, 48009, United States
Tekwani Vision Center
St Louis, Missouri, 63128, United States
Northern New Jersey Eye Institute PA
South Orange, New Jersey, 07079, United States
Ludwick Eye Center
Chambersburg, Pennsylvania, 17201, United States
Carolina Cataract & Laser Center
Ladson, South Carolina, 29456, United States
Vance Thompson Vision
Sioux Falls, South Dakota, 57108, United States
Memphis Eye & Cataract Associates, PLLC
Memphis, Tennessee, 38119, United States
Cornea Associates of Texas
Dallas, Texas, 75231, United States
Texas Eye & Laser Center
Hurst, Texas, 76054, United States
Focal Point Vision
San Antonio, Texas, 78209, United States
Parkhurst NuVision
San Antonio, Texas, 78229, United States
Clarus Eye Centre
Lacey, Washington, 98503, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Luis Vargas, MD
- 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
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 11, 2018
First Posted
January 2, 2019
Study Start
December 13, 2018
Primary Completion
August 8, 2022
Study Completion
August 8, 2022
Last Updated
August 29, 2023
Results First Posted
August 29, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will not share