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



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:22 - Any
Updated:3/8/2019
Start Date:March 21, 2016
End Date:January 28, 2019

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

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.


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
We found this trial at
20
sites
4101 Taylorsville Road
Louisville, Kentucky 40220
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Louisville, KY
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Albuquerque, New Mexico 87109
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Albuquerque, NM
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Annapolis, Maryland 21401
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Annapolis, MD
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Boynton Beach, Florida 33426
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Boynton Beach, FL
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Chandler, Arizona
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Chandler, AZ
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Cherry Hill, New Jersey 08002
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Cherry Hill, NJ
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Chevy Chase, Maryland 20815
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Chevy Chase, MD
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Dothan, Alabama 36301
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Dothan, AL
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Hurst, Texas 76054
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Hurst, TX
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Jacksonville, Florida 32204
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Jacksonville, FL
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La Jolla, California 92037
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La Jolla, CA
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Lacey, Washington 98503
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Lacey, WA
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137 Gateway Drive
Ladson, South Carolina 29456
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Ladson, SC
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Long Beach, CA
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New York, New York 10021
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New York, NY
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Pleasant, South Carolina 29464
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Pleasant, SC
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Rock Island, Illinois 61201
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Rock Island, IL
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Sioux Falls, South Dakota 57105
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Sioux Falls, SD
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Springfield, Missouri 65806
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Springfield, MO
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Tucson, AZ
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