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

Primary Purpose

Cataract, Corneal Astigmatism

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Higher Cylinder Toric IOL
Lower Cylinder Toric IOL
Sponsored by
Johnson & Johnson Surgical Vision, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cataract

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Empire Eye & Laser Center
  • Southern California Eye Physicians & Associates
  • Santa Monica Eye Medical Group
  • Wolstan & Goldberg Eye Associates
  • Florida Eye Microsurgical Institute, Inc.
  • The Eye Associates of Manatee
  • Levenson Eye Associates
  • North Florida Eye Surgeons, LLC dba Florida Eye Specialist
  • Center For Sight
  • Virdi Eye Clinic & Laser Vision Care
  • Chesapeake Eye Care & Laser
  • Oakland Ophthalmic Surgery
  • Tekwani Vision Center
  • Northern New Jersey Eye Institute PA
  • Ludwick Eye Center
  • Carolina Cataract & Laser Center
  • Vance Thompson Vision
  • Memphis Eye & Cataract Associates, PLLC
  • Cornea Associates of Texas
  • Texas Eye & Laser Center
  • Focal Point Vision
  • Parkhurst NuVision
  • Clarus Eye Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Higher Cylinder Toric IOL

Lower Cylinder Toric IOL

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
December 11, 2018
Last Updated
August 7, 2023
Sponsor
Johnson & Johnson Surgical Vision, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03791619
Brief Title
Post-Approval Study of the TECNIS SYMFONY® Toric Lenses
Acronym
ANCORA
Official Title
Post-Approval Study of the TECNIS SYMFONY® Toric Lenses
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
December 13, 2018 (Actual)
Primary Completion Date
August 8, 2022 (Actual)
Study Completion Date
August 8, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johnson & Johnson Surgical Vision, Inc.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Corneal Astigmatism

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
475 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Higher Cylinder Toric IOL
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Lower Cylinder Toric IOL
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Higher Cylinder Toric IOL
Intervention Description
Symfony Toric models ZXT300 and ZXT375 IOL
Intervention Type
Device
Intervention Name(s)
Lower Cylinder Toric IOL
Intervention Description
Symfony Toric model ZXT150 IOL
Primary Outcome Measure Information:
Title
Rate of Bothersome Visual Symptoms
Description
The rate of subjects reporting one or more of these items as very or extremely bothersome and impacting daily life via questionnaire.
Time Frame
6-month
Title
Rate of Difficulty With an Activity Due to the Visual Symptoms
Description
The rate of reported difficulty with an activity due to one or more of visual symptoms impacting daily life via questionnaire.
Time Frame
6-month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johnson & Johnson Surgical Vision Clinical Trials
Organizational Affiliation
Johnson & Johnson Surgical Vision
Official's Role
Study Director
Facility Information:
Facility Name
Empire Eye & Laser Center
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Facility Name
Southern California Eye Physicians & Associates
City
Long Beach
State/Province
California
ZIP/Postal Code
90805
Country
United States
Facility Name
Santa Monica Eye Medical Group
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Wolstan & Goldberg Eye Associates
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Florida Eye Microsurgical Institute, Inc.
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33426
Country
United States
Facility Name
The Eye Associates of Manatee
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34209
Country
United States
Facility Name
Levenson Eye Associates
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
North Florida Eye Surgeons, LLC dba Florida Eye Specialist
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Center For Sight
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Virdi Eye Clinic & Laser Vision Care
City
Rock Island
State/Province
Illinois
ZIP/Postal Code
61201
Country
United States
Facility Name
Chesapeake Eye Care & Laser
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
Oakland Ophthalmic Surgery
City
Birmingham
State/Province
Michigan
ZIP/Postal Code
48009
Country
United States
Facility Name
Tekwani Vision Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Northern New Jersey Eye Institute PA
City
South Orange
State/Province
New Jersey
ZIP/Postal Code
07079
Country
United States
Facility Name
Ludwick Eye Center
City
Chambersburg
State/Province
Pennsylvania
ZIP/Postal Code
17201
Country
United States
Facility Name
Carolina Cataract & Laser Center
City
Ladson
State/Province
South Carolina
ZIP/Postal Code
29456
Country
United States
Facility Name
Vance Thompson Vision
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57108
Country
United States
Facility Name
Memphis Eye & Cataract Associates, PLLC
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Cornea Associates of Texas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Texas Eye & Laser Center
City
Hurst
State/Province
Texas
ZIP/Postal Code
76054
Country
United States
Facility Name
Focal Point Vision
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States
Facility Name
Parkhurst NuVision
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Clarus Eye Centre
City
Lacey
State/Province
Washington
ZIP/Postal Code
98503
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Post-Approval Study of the TECNIS SYMFONY® Toric Lenses

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