Post-Approval Study of the Tecnis® Toric IOL

Post-Approval Study of the Tecnis® Toric IOL, Models ZCT300 and ZCT400

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

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Device: non-toric intraocular lens; Device: toric intraocular lens

• Study Type: Interventional
• Enrollment (Actual): 365
• 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 Cente
    • Tucson, Arizona, United States, 85704
      • Fishkind, Bakewell & Maltzman Eye Care & Surgery Cente
  • Arkansas
    • Rogers, Arkansas, United States, 72757
      • Boozman-Hof Regional Eye Clinic
  • California
    • Bakersfield, California, United States, 93309
      • Empire Eye & Laser Center
    • Huntington Beach, California, United States, 92647
      • Atlantis Eye Care
    • La Jolla, California, United States, 92037
      • Scripps Clinic Medical Group
    • Long Beach, California, United States, 90805
      • Southern California Eye Physicians & Associates
    • Newport Beach, California, United States, 92663
      • Feinerman Vision Center
    • Orange, California, United States, 92868
      • Coastal Vision
    • Pasadena, California, United States, 91107
      • California Eye Medical Specialists
    • Torrance, California, United States, 90505
      • Wolstan & Goldberg Eye Associates
  • Florida
    • Boynton Beach, Florida, United States, 33426
      • Florida Eye Microsurgical Institute, Inc.
    • Boynton Beach, Florida, United States, 33426
      • Katzen Eye Care & Laser Center
    • Bradenton, Florida, United States, 34209
      • The Eye Associates
    • Cape Coral, Florida, United States, 336904
      • Cape Coral Eye Center
    • Jacksonville, Florida, United States, 32204
      • Levenson Eye Associates, Inc.
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University Feinberg School of Medicine
    • 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
    • Bowie, Maryland, United States, 20716
      • Solomon Eye Associates
    • Chevy Chase, Maryland, United States, 20815
      • Eye Doctors of Washington
  • Michigan
    • Birmingham, Michigan, United States, 48009
      • Oakland Ophthalmic Surgery, P.C.
    • Chelsea, Michigan, United States, 48118
      • TLC Eye Care and Laser Centers
  • Missouri
    • Saint Louis, Missouri, United States, 63131
      • Ophthalmology Associates
    • Saint Louis, Missouri, United States, 63131
      • Ophthalmology Consultants
    • Springfield, Missouri, United States, 65804
      • Mercy Clinic Eye Specialist
  • New Jersey
    • Cherry Hill, New Jersey, United States, 08002
      • Kindermann Eye Associates
    • Pennington, New Jersey, United States, 08534
      • Matossian 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
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Fine, Hoffman & Sims
  • Pennsylvania
    • Allenwood, Pennsylvania, United States, 17810
      • The Eye Center of Central PA
    • Chambersburg, Pennsylvania, United States, 17201
      • Ludwick Eye Center
    • Cranberry Township, Pennsylvania, United States, 16066
      • Scott & Christie and Associates, PC
  • South Carolina
    • Ladson, South Carolina, United States, 29456
      • Carolina Cataract & Laser Center
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57105
      • Vance Thompson Vision
  • Tennessee
    • Goodlettsville, Tennessee, United States, 37072
      • Loden Vision Centers
  • Texas
    • Houston, Texas, United States, 77055
      • Whitsett Vision Group
    • Houston, Texas, United States, 77025
      • Houston Eye Associates
    • San Antonio, Texas, United States, 78229
      • Focal Point Vision
    • San Antonio, Texas, United States, 78248
      • San Antonio Eye Specialists
  • 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 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: non-toric intraocular lens; non-toric approved intraocular lens	Device: non-toric intraocular lens; TECNIS One-piece Monofocal Model ZCB00
Active Comparator: toric intraocular lens; approved toric intraocular lens	Device: toric intraocular lens; TECNIS One-piece Toric Models ZCT300 or ZCT400

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months

Collaborators and Investigators

• Sponsor: Abbott Medical Optics
• Investigators: Study Director: Devi Priya Janakiraman, OD, FAAO, Johnson & Johnson Surgical Vision

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2015
• Primary Completion (Actual): December 11, 2018
• Study Completion (Actual): May 23, 2019

Study Registration Dates

• First Submitted: September 30, 2015
• First Submitted That Met QC Criteria: September 30, 2015
• First Posted (Estimate): October 1, 2015

Study Record Updates

• Last Update Posted (Actual): January 18, 2020
• Last Update Submitted That Met QC Criteria: January 9, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: TIOL-202-TPAS

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes