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

Post-Approval Study of the TECNIS® Toric IOL Extended Cylinder Range (ECR), Models ZCT450, ZCT525 and ZCT600

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.

Study Overview

• Status: Completed
• Conditions: Cataract; Astigmatism
• Intervention / Treatment: Device: TECNIS Toric Models ZCT450, ZCT525 or ZCT600

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.

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Dothan, Alabama, United States, 36301
      • Eye Center South
  • Arizona
    • Chandler, Arizona, United States, 85225
      • Arizona Eye Center
    • Tucson, Arizona, United States, 85704
      • Fishkind, Bakewell & Maltzman Eye Care & Surgery Center
  • California
    • La Jolla, California, United States, 92037
      • Scripps Clinical Medical Group
    • Long Beach, California, United States, 90805
      • Southern California Eye Physicians & Associates
  • Florida
    • Boynton Beach, Florida, United States, 33426
      • Katzen Eye Care & Laser Center
    • Jacksonville, Florida, United States, 32204
      • Levenson Eye Associates, Inc.
  • Illinois
    • Rock Island, Illinois, United States, 61201
      • Virdi Eye Clinic & Laser Vision Center
  • Kentucky
    • Louisville, Kentucky, United States, 40220
      • Senior Health Services
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • Chesapeake Eye Care and Laser Center
    • Chevy Chase, Maryland, United States, 20815
      • Eye Doctors of Washington
  • Missouri
    • Springfield, Missouri, United States, 65804
      • Mercy Research
  • New Jersey
    • Cherry Hill, New Jersey, United States, 08002
      • Kindermann Eye Associates
  • New Mexico
    • Albuquerque, New Mexico, United States, 87109
      • Eye Associates of New Mexico
  • New York
    • New York, New York, United States, 10065
      • Pamel Vision & Laser Group
  • South Carolina
    • Ladson, South Carolina, United States, 29456
      • Carolina Cataract & Laser Center
    • Pleasant, South Carolina, United States, 29464
      • Carolina EyeCare Physicians, LLC
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57108
      • Vance Thompson Vision
  • Texas
    • Hurst, Texas, United States, 76054
      • Texas Eye and Laser Center
  • Washington
    • Lacey, Washington, United States, 98503
      • Clarus Eye Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Extended Cylinder IOL; Approved toric intraocular lenses, Model ZCT450, ZCT525 or ZCT600	Device: TECNIS Toric Models ZCT450, ZCT525 or ZCT600; Approved toric intraocular lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Severe Visual Distortions	Rate of severe visual distortions based on data from a self administered subject questionnaire	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of IOL Repositioning Due to IOL Misalignment	Rate of IOL repositioning due to IOL misalignment in primary and fellow eyes with a high cylinder toric IOL	6 months
Percent Change in Cylinder	Percent change in cylinder= ((postop refractive cylinder-preop keratometric cylinder) / (Target refractive cylinder-preop keratometric cylinder))*100	6 months

Collaborators and Investigators

• Sponsor: Abbott Medical Optics
• Investigators: Study Director: Devi Priya Janakiraman, OD,FAAO, Abbott Medical Optics

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2016
• Primary Completion (Actual): August 27, 2018
• Study Completion (Actual): January 28, 2019

Study Registration Dates

• First Submitted: January 6, 2016
• First Submitted That Met QC Criteria: January 6, 2016
• First Posted (Estimate): January 8, 2016

Study Record Updates

• Last Update Posted (Actual): January 22, 2020
• Last Update Submitted That Met QC Criteria: January 13, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Refractive Errors; Cataract; Astigmatism
• Other Study ID Numbers: TIOL-204-EPAS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No