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Post-Approval Study of the TECNIS® Toric Extended Cylinder Range Intraocular Lens (IOL)

Primary Purpose

Cataract, Astigmatism

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TECNIS Toric Models ZCT450, ZCT525 or ZCT600
Sponsored by
Abbott Medical Optics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cataract

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Minimum 22 years of age
  • Bilateral cataracts
  • Preoperative keratometric cylinder of at least 2.00 D in both eyes with at least one eye having approximately 3.00 D to 4.75 D of corneal astigmatism.
  • 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 or 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
  • 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 or is lactating

Sites / Locations

  • Eye Center South
  • Arizona Eye Center
  • Fishkind, Bakewell & Maltzman Eye Care & Surgery Center
  • Scripps Clinical Medical Group
  • Southern California Eye Physicians & Associates
  • Katzen Eye Care & Laser Center
  • Levenson Eye Associates, Inc.
  • Virdi Eye Clinic & Laser Vision Center
  • Senior Health Services
  • Chesapeake Eye Care and Laser Center
  • Eye Doctors of Washington
  • Mercy Research
  • Kindermann Eye Associates
  • Eye Associates of New Mexico
  • Pamel Vision & Laser Group
  • Carolina Cataract & Laser Center
  • Carolina Eyecare Physicians, LLC
  • Vance Thompson Vision
  • Texas Eye and Laser Center
  • Clarus Eye Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Extended Cylinder IOL

Arm Description

Approved toric intraocular lenses, Model ZCT450, ZCT525 or ZCT600

Outcomes

Primary Outcome Measures

Rate of Severe Visual Distortions
Rate of severe visual distortions based on data from a self administered subject questionnaire

Secondary Outcome Measures

Full Information

First Posted
January 6, 2016
Last Updated
January 13, 2020
Sponsor
Abbott Medical Optics
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1. Study Identification

Unique Protocol Identification Number
NCT02649842
Brief Title
Post-Approval Study of the TECNIS® Toric Extended Cylinder Range Intraocular Lens (IOL)
Official Title
Post-Approval Study of the TECNIS® Toric IOL Extended Cylinder Range (ECR), Models ZCT450, ZCT525 and ZCT600
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
March 21, 2016 (Actual)
Primary Completion Date
August 27, 2018 (Actual)
Study Completion Date
January 28, 2019 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is a prospective, multicenter, bilateral, non-randomized, open-label, clinical study conducted at up to 20 sites in the USA. Subjects were to be bilaterally implanted with one eye having an extended cylinder (high cylinder) toric IOL (model ZCT450, ZCT525 or ZCT600) and the fellow eye having a high cylinder toric IOL (model ZCT450, ZCT525 or ZCT600) or a lower cylinder toric IOL (ZCT300 or ZCT400). This study evaluates the outcomes for subjects implanted with at least one higher cylinder toric IOL.
Detailed Description
The purpose of this study is to evaluate the performance of the higher cylinder (ZCT450,ZCT525 and ZCT600) toric IOLs. Some subjects had the higher cylinder toric IOLs in both eyes with other subjects having a higher cylinder toric IOL in one eye and the lower cylinder toric IOL in the other eye. Per the statistical plan, data for the ZCT450/525/600 toric IOLs were to be pooled together and reported as one group. The primary endpoint is the rate of severe visual distortions reported by subject at 6 months via questionnaire. The analysis population for this endpoint will be bilaterally implanted subjects with a high cylinder IOL (ZCT450/525/600) in the primary eye and a high cylinder IOL (ZCT450/525/600) or a low cylinder IOL (ZCT300/400) in the fellow eye. There were no formal secondary endpoints. Data from a few other endpoints (rate of IOL repositioning due to IOL misalignment and percent change in cylinder) have been reported. For these endpoints the analysis population contains all subjects implanted with a ZCT450/525/600 in at least one eye. Adverse events were reported by subject for all subjects with a high cylinder IOL (ZCT450/525/600) in at least one eye.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Extended Cylinder IOL
Arm Type
Experimental
Arm Description
Approved toric intraocular lenses, Model ZCT450, ZCT525 or ZCT600
Intervention Type
Device
Intervention Name(s)
TECNIS Toric Models ZCT450, ZCT525 or ZCT600
Intervention Description
Approved toric intraocular lens
Primary Outcome Measure Information:
Title
Rate of Severe Visual Distortions
Description
Rate of severe visual distortions based on data from a self administered subject questionnaire
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Rate of IOL Repositioning Due to IOL Misalignment
Description
Rate of IOL repositioning due to IOL misalignment in primary and fellow eyes with a high cylinder toric IOL
Time Frame
6 months
Title
Percent Change in Cylinder
Description
Percent change in cylinder= ((postop refractive cylinder-preop keratometric cylinder) / (Target refractive cylinder-preop keratometric cylinder))*100
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Minimum 22 years of age Bilateral cataracts Preoperative keratometric cylinder of at least 2.00 D in both eyes with at least one eye having approximately 3.00 D to 4.75 D of corneal astigmatism. 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 or 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 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 or is lactating
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Devi Priya Janakiraman, OD,FAAO
Organizational Affiliation
Abbott Medical Optics
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 Center
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85225
Country
United States
Facility Name
Fishkind, Bakewell & Maltzman Eye Care & Surgery Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Scripps Clinical 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
Katzen Eye Care & Laser Center
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33426
Country
United States
Facility Name
Levenson Eye Associates, Inc.
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
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
Eye Doctors of Washington
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Mercy Research
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
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
Carolina Cataract & Laser Center
City
Ladson
State/Province
South Carolina
ZIP/Postal Code
29456
Country
United States
Facility Name
Carolina Eyecare Physicians, LLC
City
Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Vance Thompson Vision
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57108
Country
United States
Facility Name
Texas Eye and Laser Center
City
Hurst
State/Province
Texas
ZIP/Postal Code
76054
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 Extended Cylinder Range Intraocular Lens (IOL)

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