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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03791619
Recruitment Status : Recruiting
First Posted : January 2, 2019
Last Update Posted : June 24, 2020
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: Katherine Lee +1 832-291-6944 KLee161@ITS.JNJ.com

Locations
Show Show 23 study locations
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    
Other Study ID Numbers: TIOL-205-STPA
First Posted: January 2, 2019    Key Record Dates
Last Update Posted: June 24, 2020
Last Verified: June 2020
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
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