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

Sponsor
Johnson & Johnson Surgical Vision, Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03791619
Collaborator
(none)
473
23
2
44.6
20.6
0.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Higher Cylinder Toric IOL
  • Device: Lower Cylinder Toric IOL
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
473 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 :
Dec 13, 2018
Anticipated Primary Completion Date :
Aug 31, 2022
Anticipated Study Completion Date :
Aug 31, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Rate of bothersome visual symptoms [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
22 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Empire Eye & Laser Center Bakersfield California United States 93309
2 Southern California Eye Physicians & Associates Long Beach California United States 90805
3 Santa Monica Eye Medical Group Santa Monica California United States 90404
4 Wolstan & Goldberg Eye Associates Torrance California United States 90505
5 Florida Eye Microsurgical Institute, Inc. Boynton Beach Florida United States 33426
6 The Eye Associates of Manatee Bradenton Florida United States 34209
7 Levenson Eye Associates Jacksonville Florida United States 32204
8 North Florida Eye Surgeons, LLC dba Florida Eye Specialist Jacksonville Florida United States 32256
9 Center For Sight Sarasota Florida United States 34239
10 Virdi Eye Clinic & Laser Vision Care Rock Island Illinois United States 61201
11 Chesapeake Eye Care & Laser Annapolis Maryland United States 21401
12 Oakland Ophthalmic Surgery Birmingham Michigan United States 48009
13 Tekwani Vision Center Saint Louis Missouri United States 63128
14 Northern New Jersey Eye Institute PA South Orange New Jersey United States 07079
15 Ludwick Eye Center Chambersburg Pennsylvania United States 17201
16 Carolina Cataract & Laser Center Ladson South Carolina United States 29456
17 Vance Thompson Vision Sioux Falls South Dakota United States 57108
18 Memphis Eye & Cataract Associates, PLLC Memphis Tennessee United States 38119
19 Cornea Associates of Texas Dallas Texas United States 75231
20 Texas Eye & Laser Center Hurst Texas United States 76054
21 Focal Point Vision San Antonio Texas United States 78209
22 Parkhurst NuVision San Antonio Texas United States 78229
23 Clarus Eye Centre Lacey Washington United States 98503

Sponsors and Collaborators

  • Johnson & Johnson Surgical Vision, Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Johnson & Johnson Surgical Vision, Inc.
ClinicalTrials.gov Identifier:
NCT03791619
Other Study ID Numbers:
  • TIOL-205-STPA
First Posted:
Jan 2, 2019
Last Update Posted:
Aug 9, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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:

Study Results

No Results Posted as of Aug 9, 2022