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

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ClinicalTrials.gov Identifier: NCT02649842
Recruitment Status : Completed
First Posted : January 8, 2016
Last Update Posted : March 6, 2019
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Optics

Brief Summary:
Post-Approval study to evaluate the rates of severe visual distortions for patients requiring correction of approximately 3.00 D to 4.75 D of corneal astigmatism.

Condition or disease Intervention/treatment Phase
Cataract Astigmatism Device: TECNIS Toric Models ZCT450, ZCT525 or ZCT600 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Post-Approval Study of the TECNIS® Toric IOL Extended Cylinder Range (ECR), Models ZCT450, ZCT525 and ZCT600
Actual Study Start Date : March 21, 2016
Actual Primary Completion Date : August 27, 2018
Actual Study Completion Date : January 28, 2019

Arm Intervention/treatment
Active Comparator: ZCT450
Approved toric intraocular lens, Model ZCT450
Device: TECNIS Toric Models ZCT450, ZCT525 or ZCT600
Approved toric intraocular lens

Active Comparator: ZCT525
Approved toric intraocular lens, Model ZCT525
Device: TECNIS Toric Models ZCT450, ZCT525 or ZCT600
Approved toric intraocular lens

Active Comparator: ZCT600
Approved toric intraocular lens, Model ZCT600
Device: TECNIS Toric Models ZCT450, ZCT525 or ZCT600
Approved toric intraocular lens




Primary Outcome Measures :
  1. Rate of severe visual distortions [ Time Frame: 6 months ]
    Rate of visual distortions based on data collected from a self-administered subject questionnaire


Secondary Outcome Measures :
  1. Rate of IOL repositioning procedures due to IOL misalignment [ Time Frame: 6 months ]
  2. Rate of other adverse events [ Time Frame: 6 months ]
  3. Rate of reduction in cylinder [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02649842


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

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Responsible Party: Abbott Medical Optics
ClinicalTrials.gov Identifier: NCT02649842     History of Changes
Other Study ID Numbers: TIOL-204-EPAS
First Posted: January 8, 2016    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Cataract
Astigmatism
Lens Diseases
Eye Diseases
Refractive Errors