Post-Approval Study of the Tecnis® Toric IOL

January 9, 2020 updated by: Abbott Medical Optics

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
365

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rate of Severe Visual Distortions
Time Frame: 6 months
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abbott Medical Optics

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Devi Priya Janakiraman, OD, FAAO, Johnson & Johnson Surgical Vision

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 21, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 11, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 23, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 30, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 1, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 18, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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