Post-Approval Study of the Tecnis® Toric IOL

Completed · Not applicable

Conditions studied: Cataract

In brief

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

Key facts

Study ID

NCT02566083

Run by

Abbott Medical Optics

People needed

365

Starts

2015-10-21

Expected to finish

2019-05-23

Last updated by the study team

2020-01-18

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Eye Center South — Dothan, Alabama, United States
• Arizona Eye Cente — Chandler, Arizona, United States
• Fishkind, Bakewell & Maltzman Eye Care & Surgery Cente — Tucson, Arizona, United States
• Boozman-Hof Regional Eye Clinic — Rogers, Arkansas, United States
• Empire Eye & Laser Center — Bakersfield, California, United States
• Atlantis Eye Care — Huntington Beach, California, United States
• Scripps Clinic Medical Group — La Jolla, California, United States
• Southern California Eye Physicians & Associates — Long Beach, California, United States
• Feinerman Vision Center — Newport Beach, California, United States
• Coastal Vision — Orange, California, United States
• California Eye Medical Specialists — Pasadena, California, United States
• Wolstan & Goldberg Eye Associates — Torrance, California, United States
• Florida Eye Microsurgical Institute, Inc. — Boynton Beach, Florida, United States
• Katzen Eye Care & Laser Center — Boynton Beach, Florida, United States
• The Eye Associates — Bradenton, Florida, United States
• Cape Coral Eye Center — Cape Coral, Florida, United States
• Levenson Eye Associates, Inc. — Jacksonville, Florida, United States
• Northwestern University Feinberg School of Medicine — Chicago, Illinois, United States
• Virdi Eye Clinic & Laser Vision Center — Rock Island, Illinois, United States
• Senior Health Services — Louisville, Kentucky, United States
• Chesapeake Eye Care and Laser Center — Annapolis, Maryland, United States
• Solomon Eye Associates — Bowie, Maryland, United States
• Eye Doctors of Washington — Chevy Chase, Maryland, United States
• Oakland Ophthalmic Surgery, P.C. — Birmingham, Michigan, United States
• TLC Eye Care and Laser Centers — Chelsea, Michigan, United States

Full record on ClinicalTrials.gov

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