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

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ClinicalTrials.gov Identifier: NCT03791619
Recruitment Status : Recruiting
First Posted : January 1, 2019
Last Update Posted : March 6, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Cataract Corneal Astigmatism Device: Higher Cylinder Toric IOL Device: Lower Cylinder Toric IOL Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 634 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Post-Approval Study of the TECNIS SYMFONY® Toric Lenses
Actual Study Start Date : December 13, 2018
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022

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




Primary Outcome Measures :
  1. Rate of bothersome visual symptoms [ Time Frame: 6 months ]
    The rate of subjects reporting one or more of these items as very or extremely bothersome and impacting daily life via questionnaire. The unit of measure will be percent.

  2. Rate of difficulty with an activity due to the visual symptoms [ Time Frame: 6 months ]
    The rate of subjects reporting one or more of these items as very or extremely bothersome and impacting daily life via questionnaire. The unit of measure will be percent.



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03791619


Contacts
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Contact: Rosangela Nolasco, DMD, MPH 714-247-8624 RNolasc2@its.jnj.com

Locations
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United States, California
Empire Eye & Laser Center Recruiting
Bakersfield, California, United States, 93309
Scripps Clinic Medical Group Not yet recruiting
La Jolla, California, United States, 92037
Southern California Eye Physicians & Associates Recruiting
Long Beach, California, United States, 90805
Santa Monica Eye Medical Group Not yet recruiting
Santa Monica, California, United States, 90404
Wolstan & Goldberg Eye Associates Recruiting
Torrance, California, United States, 90505
United States, Florida
Florida Eye Microsurgical Institute, Inc. Recruiting
Boynton Beach, Florida, United States, 33426
The Eye Associates of Manatee Not yet recruiting
Bradenton, Florida, United States, 34209
Levenson Eye Associates Recruiting
Jacksonville, Florida, United States, 32204
North Florida Eye Surgeons, LLC dba Florida Eye Specialist Recruiting
Jacksonville, Florida, United States, 32256
Center For Sight Not yet recruiting
Sarasota, Florida, United States, 34239
United States, Illinois
Virdi Eye Clinic & Laser Vision Care Not yet recruiting
Rock Island, Illinois, United States, 61201
United States, Maryland
Chesapeake Eye Care & Laser Not yet recruiting
Annapolis, Maryland, United States, 21401
United States, Michigan
Oakland Ophthalmic Surgery Not yet recruiting
Birmingham, Michigan, United States, 48009
United States, Missouri
Tekwani Vision Center Recruiting
Saint Louis, Missouri, United States, 63128
United States, New Jersey
Northern New Jersey Eye Institute PA Not yet recruiting
South Orange, New Jersey, United States, 07079
United States, Pennsylvania
Ludwick Eye Center Not yet recruiting
Chambersburg, Pennsylvania, United States, 17201
United States, South Carolina
Carolina Cataract & Laser Center Not yet recruiting
Ladson, South Carolina, United States, 29456
United States, South Dakota
Vance Thompson Vision Not yet recruiting
Sioux Falls, South Dakota, United States, 57108
United States, Tennessee
Memphis Eye & Cataract Associates, PLLC Not yet recruiting
Memphis, Tennessee, United States, 38119
United States, Texas
Cornea Associates of Texas Not yet recruiting
Dallas, Texas, United States, 75231
Texas Eye & Laser Center Recruiting
Hurst, Texas, United States, 76054
Focal Point Vision Not yet recruiting
San Antonio, Texas, United States, 78209
United States, Washington
Clarus Eye Centre Recruiting
Lacey, Washington, United States, 98503
Sponsors and Collaborators
Johnson & Johnson Surgical Vision, Inc.
Investigators
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Study Director: Devi Priya Janakiraman, OD, FAAO Johnson & Johnson Surgical Vision

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Responsible Party: Johnson & Johnson Surgical Vision, Inc.
ClinicalTrials.gov Identifier: NCT03791619     History of Changes
Other Study ID Numbers: TIOL-205-STPA
First Posted: January 1, 2019    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Cataract
Astigmatism
Lens Diseases
Eye Diseases
Refractive Errors