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Post-Approval Study of the Tecnis® Toric IOL

Primary Purpose

Cataract

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
non-toric intraocular lens
toric intraocular lens
Sponsored by
Abbott Medical Optics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract

Eligibility Criteria

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

Inclusion Criteria:

  • Minimum 22 years of age
  • Bilateral cataracts
  • Preoperative keratometric cylinder in both eyes
  • Most appropriate toric IOL model choice (ZCT300 or ZCT400)

  • Predicted residual refractive cylinder, based on the AMO Toric IOL Calculator, must be:

    ≤ 0.69 D for a ZCT300 IOL or ≤ 0.88 D for a ZCT400 IOL

  • Clear intraocular media other than cataract in each eye
  • Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visits
  • Ability to understand, read and write English in order to consent to study participation and complete a study questionnaire
  • Signed informed consent and HIPAA authorization

Exclusion Criteria:

  • Irregular corneal astigmatism
  • Any corneal pathology/abnormality other than regular corneal astigmatism
  • Previous corneal surgery
  • Recent ocular trauma or intraocular surgery that is not resolved/stable or may affect visual outcomes
  • Any pupil abnormalities
  • Subjects with conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration, including pseudoexfoliation, trauma, or posterior capsule defects
  • Known ocular disease or pathology that may affect visual acuity or that may require surgical intervention during the course of the study
  • Concurrent participation or participation during 30 days prior to preoperative visit in any other clinical study
  • Planned monovision correction
  • Patient is pregnant, plans to become pregnant, is lactating or has another condition associated with the fluctuation of hormones that could lead to refractive changes

Sites / Locations

  • Eye Center South
  • Arizona Eye Cente
  • Fishkind, Bakewell & Maltzman Eye Care & Surgery Cente
  • Boozman-Hof Regional Eye Clinic
  • Empire Eye & Laser Center
  • Atlantis Eye Care
  • Scripps Clinic Medical Group
  • Southern California Eye Physicians & Associates
  • Feinerman Vision Center
  • Coastal Vision
  • California Eye Medical Specialists
  • Wolstan & Goldberg Eye Associates
  • Florida Eye Microsurgical Institute, Inc.
  • Katzen Eye Care & Laser Center
  • The Eye Associates
  • Cape Coral Eye Center
  • Levenson Eye Associates, Inc.
  • Northwestern University Feinberg School of Medicine
  • Virdi Eye Clinic & Laser Vision Center
  • Senior Health Services
  • Chesapeake Eye Care and Laser Center
  • Solomon Eye Associates
  • Eye Doctors of Washington
  • Oakland Ophthalmic Surgery, P.C.
  • TLC Eye Care and Laser Centers
  • Ophthalmology Associates
  • Ophthalmology Consultants
  • Mercy Clinic Eye Specialist
  • Kindermann Eye Associates
  • Matossian Eye Associates
  • Eye Associates of New Mexico
  • Pamel Vision & Laser Group
  • Fine, Hoffman & Sims
  • The Eye Center of Central PA
  • Ludwick Eye Center
  • Scott & Christie and Associates, PC
  • Carolina Cataract & Laser Center
  • Vance Thompson Vision
  • Loden Vision Centers
  • Houston Eye Associates
  • Whitsett Vision Group
  • Focal Point Vision
  • San Antonio Eye Specialists
  • Clarus Eye Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

non-toric intraocular lens

toric intraocular lens

Arm Description

non-toric approved intraocular lens

approved toric intraocular lens

Outcomes

Primary Outcome Measures

Rate of Severe Visual Distortions
The rate of severe visual distortions under overall circumstances for the five visual distortion items of interest (lines that slant, tilt, split or separate; flat surfaces appearing curved; objects appearing further away or closer than they are; objects appearing to have a different size or shape; and physical discomfort related to vision). The six month data were used for this endpoint if available and if not an earlier visit was used. If a subject had a lens repositioning the questionnaire prior to the repositioning was used if available.

Secondary Outcome Measures

Full Information

First Posted
September 30, 2015
Last Updated
January 9, 2020
Sponsor
Abbott Medical Optics
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1. Study Identification

Unique Protocol Identification Number
NCT02566083
Brief Title
Post-Approval Study of the Tecnis® Toric IOL
Official Title
Post-Approval Study of the Tecnis® Toric IOL, Models ZCT300 and ZCT400
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
October 21, 2015 (Actual)
Primary Completion Date
December 11, 2018 (Actual)
Study Completion Date
May 23, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Optics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is a prospective, multicenter, bilateral, non-randomized, open-label, comparative clinical study conducted at up to 80 sites in the USA. Subjects will choose to be bilaterally implanted with either 1) the TECNIS 1-Piece Toric IOLs, Model ZCT300 and/or ZCT400, or 2) the TECNIS Monofocal Model ZCB00 non-toric control IOL, according to subject preference

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
non-toric intraocular lens
Arm Type
Active Comparator
Arm Description
non-toric approved intraocular lens
Arm Title
toric intraocular lens
Arm Type
Active Comparator
Arm Description
approved toric intraocular lens
Intervention Type
Device
Intervention Name(s)
non-toric intraocular lens
Intervention Description
TECNIS One-piece Monofocal Model ZCB00
Intervention Type
Device
Intervention Name(s)
toric intraocular lens
Intervention Description
TECNIS One-piece Toric Models ZCT300 or ZCT400
Primary Outcome Measure Information:
Title
Rate of Severe Visual Distortions
Description
The rate of severe visual distortions under overall circumstances for the five visual distortion items of interest (lines that slant, tilt, split or separate; flat surfaces appearing curved; objects appearing further away or closer than they are; objects appearing to have a different size or shape; and physical discomfort related to vision). The six month data were used for this endpoint if available and if not an earlier visit was used. If a subject had a lens repositioning the questionnaire prior to the repositioning was used if available.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Minimum 22 years of age Bilateral cataracts Preoperative keratometric cylinder in both eyes Most appropriate toric IOL model choice (ZCT300 or ZCT400) Predicted residual refractive cylinder, based on the AMO Toric IOL Calculator, must be: ≤ 0.69 D for a ZCT300 IOL or ≤ 0.88 D for a ZCT400 IOL Clear intraocular media other than cataract in each eye Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visits Ability to understand, read and write English in order to consent to study participation and complete a study questionnaire Signed informed consent and HIPAA authorization Exclusion Criteria: Irregular corneal astigmatism Any corneal pathology/abnormality other than regular corneal astigmatism Previous corneal surgery Recent ocular trauma or intraocular surgery that is not resolved/stable or may affect visual outcomes Any pupil abnormalities Subjects with conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration, including pseudoexfoliation, trauma, or posterior capsule defects Known ocular disease or pathology that may affect visual acuity or that may require surgical intervention during the course of the study Concurrent participation or participation during 30 days prior to preoperative visit in any other clinical study Planned monovision correction Patient is pregnant, plans to become pregnant, is lactating or has another condition associated with the fluctuation of hormones that could lead to refractive changes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Devi Priya Janakiraman, OD, FAAO
Organizational Affiliation
Johnson & Johnson Surgical Vision
Official's Role
Study Director
Facility Information:
Facility Name
Eye Center South
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36301
Country
United States
Facility Name
Arizona Eye Cente
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85225
Country
United States
Facility Name
Fishkind, Bakewell & Maltzman Eye Care & Surgery Cente
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Boozman-Hof Regional Eye Clinic
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72757
Country
United States
Facility Name
Empire Eye & Laser Center
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Facility Name
Atlantis Eye Care
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
Scripps Clinic Medical Group
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
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
Feinerman Vision Center
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Coastal Vision
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
California Eye Medical Specialists
City
Pasadena
State/Province
California
ZIP/Postal Code
91107
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
Katzen Eye Care & Laser Center
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33426
Country
United States
Facility Name
The Eye Associates
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34209
Country
United States
Facility Name
Cape Coral Eye Center
City
Cape Coral
State/Province
Florida
ZIP/Postal Code
336904
Country
United States
Facility Name
Levenson Eye Associates, Inc.
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
Northwestern University Feinberg School of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Virdi Eye Clinic & Laser Vision Center
City
Rock Island
State/Province
Illinois
ZIP/Postal Code
61201
Country
United States
Facility Name
Senior Health Services
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40220
Country
United States
Facility Name
Chesapeake Eye Care and Laser Center
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
Solomon Eye Associates
City
Bowie
State/Province
Maryland
ZIP/Postal Code
20716
Country
United States
Facility Name
Eye Doctors of Washington
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Oakland Ophthalmic Surgery, P.C.
City
Birmingham
State/Province
Michigan
ZIP/Postal Code
48009
Country
United States
Facility Name
TLC Eye Care and Laser Centers
City
Chelsea
State/Province
Michigan
ZIP/Postal Code
48118
Country
United States
Facility Name
Ophthalmology Associates
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
Ophthalmology Consultants
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
Mercy Clinic Eye Specialist
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Facility Name
Kindermann Eye Associates
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08002
Country
United States
Facility Name
Matossian Eye Associates
City
Pennington
State/Province
New Jersey
ZIP/Postal Code
08534
Country
United States
Facility Name
Eye Associates of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Pamel Vision & Laser Group
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Fine, Hoffman & Sims
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
The Eye Center of Central PA
City
Allenwood
State/Province
Pennsylvania
ZIP/Postal Code
17810
Country
United States
Facility Name
Ludwick Eye Center
City
Chambersburg
State/Province
Pennsylvania
ZIP/Postal Code
17201
Country
United States
Facility Name
Scott & Christie and Associates, PC
City
Cranberry Township
State/Province
Pennsylvania
ZIP/Postal Code
16066
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
57105
Country
United States
Facility Name
Loden Vision Centers
City
Goodlettsville
State/Province
Tennessee
ZIP/Postal Code
37072
Country
United States
Facility Name
Houston Eye Associates
City
Houston
State/Province
Texas
ZIP/Postal Code
77025
Country
United States
Facility Name
Whitsett Vision Group
City
Houston
State/Province
Texas
ZIP/Postal Code
77055
Country
United States
Facility Name
Focal Point Vision
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
San Antonio Eye Specialists
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78248
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® Toric IOL

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