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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
475

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Johnson & Johnson Surgical Vision, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 13, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 8, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 8, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 11, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 31, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 2, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 29, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 7, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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