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

Sponsor
Johnson & Johnson Surgical Vision, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03791619
Collaborator
(none)
634
Enrollment
23
Locations
2
Arms
50.5
Anticipated Duration (Months)
27.6
Patients Per Site
0.5
Patients Per Site Per Month

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 DiseaseIntervention/TreatmentPhase
  • Device: Higher Cylinder Toric IOL
  • Device: Lower Cylinder Toric IOL
N/A

Study Design

Study Type:
Interventional
Anticipated 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 :
Dec 13, 2018
Anticipated Primary Completion Date :
Feb 28, 2023
Anticipated Study Completion Date :
Feb 28, 2023

Arms and Interventions

ArmIntervention/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

SiteCityStateCountryPostal Code
1Empire Eye & Laser CenterBakersfieldCaliforniaUnited States93309
2Southern California Eye Physicians & AssociatesLong BeachCaliforniaUnited States90805
3Santa Monica Eye Medical GroupSanta MonicaCaliforniaUnited States90404
4Wolstan & Goldberg Eye AssociatesTorranceCaliforniaUnited States90505
5Florida Eye Microsurgical Institute, Inc.Boynton BeachFloridaUnited States33426
6The Eye Associates of ManateeBradentonFloridaUnited States34209
7Levenson Eye AssociatesJacksonvilleFloridaUnited States32204
8North Florida Eye Surgeons, LLC dba Florida Eye SpecialistJacksonvilleFloridaUnited States32256
9Center For SightSarasotaFloridaUnited States34239
10Virdi Eye Clinic & Laser Vision CareRock IslandIllinoisUnited States61201
11Chesapeake Eye Care & LaserAnnapolisMarylandUnited States21401
12Oakland Ophthalmic SurgeryBirminghamMichiganUnited States48009
13Tekwani Vision CenterSaint LouisMissouriUnited States63128
14Northern New Jersey Eye Institute PASouth OrangeNew JerseyUnited States07079
15Ludwick Eye CenterChambersburgPennsylvaniaUnited States17201
16Carolina Cataract & Laser CenterLadsonSouth CarolinaUnited States29456
17Vance Thompson VisionSioux FallsSouth DakotaUnited States57108
18Memphis Eye & Cataract Associates, PLLCMemphisTennesseeUnited States38119
19Cornea Associates of TexasDallasTexasUnited States75231
20Texas Eye & Laser CenterHurstTexasUnited States76054
21Focal Point VisionSan AntonioTexasUnited States78209
22Parkhurst NuVisionSan AntonioTexasUnited States78229
23Clarus Eye CentreLaceyWashingtonUnited States98503

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:
Oct 11, 2021
Last Verified:
Oct 1, 2021
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 Oct 11, 2021