Post-Approval Study of the TECNIS SYMFONY® Toric Lenses (ANCORA)

August 7, 2023 updated by: Johnson & Johnson Surgical Vision, Inc.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

475

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Bakersfield, California, United States, 93309
        • Empire Eye & Laser Center
      • Long Beach, California, United States, 90805
        • Southern California Eye Physicians & Associates
      • Santa Monica, California, United States, 90404
        • Santa Monica Eye Medical Group
      • Torrance, California, United States, 90505
        • Wolstan & Goldberg Eye Associates
    • Florida
      • Boynton Beach, Florida, United States, 33426
        • Florida Eye Microsurgical Institute, Inc.
      • Bradenton, Florida, United States, 34209
        • The Eye Associates of Manatee
      • Jacksonville, Florida, United States, 32204
        • Levenson Eye Associates
      • Jacksonville, Florida, United States, 32256
        • North Florida Eye Surgeons, LLC dba Florida Eye Specialist
      • Sarasota, Florida, United States, 34239
        • Center for Sight
    • Illinois
      • Rock Island, Illinois, United States, 61201
        • Virdi Eye Clinic & Laser Vision Care
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Chesapeake Eye Care & Laser
    • Michigan
      • Birmingham, Michigan, United States, 48009
        • Oakland Ophthalmic Surgery
    • Missouri
      • Saint Louis, Missouri, United States, 63128
        • Tekwani Vision Center
    • New Jersey
      • South Orange, New Jersey, United States, 07079
        • Northern New Jersey Eye Institute PA
    • Pennsylvania
      • Chambersburg, Pennsylvania, United States, 17201
        • Ludwick Eye Center
    • South Carolina
      • Ladson, South Carolina, United States, 29456
        • Carolina Cataract & Laser Center
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57108
        • Vance Thompson Vision
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Memphis Eye & Cataract Associates, PLLC
    • Texas
      • Dallas, Texas, United States, 75231
        • Cornea Associates of Texas
      • Hurst, Texas, United States, 76054
        • Texas Eye & Laser Center
      • San Antonio, Texas, United States, 78229
        • Parkhurst NuVision
      • San Antonio, Texas, United States, 78209
        • Focal Point Vision
    • Washington
      • Lacey, Washington, United States, 98503
        • Clarus Eye Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Device: Higher Cylinder Toric IOL
Symfony Toric models ZXT300 and ZXT375 IOL
Active Comparator: 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.
Device: Lower Cylinder Toric IOL
Symfony Toric model ZXT150 IOL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Bothersome Visual Symptoms
Time Frame: 6-month
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
Time Frame: 6-month
The rate of reported difficulty with an activity due to one or more of visual symptoms impacting daily life via questionnaire.
6-month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johnson & Johnson Surgical Vision, Inc.

Investigators

  • Study Director: Johnson & Johnson Surgical Vision Clinical Trials, Johnson & Johnson Surgical Vision

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 13, 2018

Primary Completion (Actual)

August 8, 2022

Study Completion (Actual)

August 8, 2022

Study Registration Dates

First Submitted

December 11, 2018

First Submitted That Met QC Criteria

December 31, 2018

First Posted (Actual)

January 2, 2019

Study Record Updates

Last Update Posted (Actual)

August 29, 2023

Last Update Submitted That Met QC Criteria

August 7, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TIOL-205-STPA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

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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