Post-Approval Study of the Tecnis® Toric IOL

Not Applicable

Completed

Brief Summary: 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

Recruitment & Eligibility

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

Primary Outcome Measures

Name	Time	Method
Rate of Severe Visual Distortions	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.

Secondary Outcome Measures

Name	Time	Method

Locations (44): 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
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Rogers, Arkansas, United States
Empire Eye & Laser Center
🇺🇸
Bakersfield, California, United States
Atlantis Eye Care
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Huntington Beach, California, United States
Scripps Clinic Medical Group
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La Jolla, California, United States
Southern California Eye Physicians & Associates
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Long Beach, California, United States
Feinerman Vision Center
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Newport Beach, California, United States
Coastal Vision
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Orange, California, United States
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Eye Center South
🇺🇸Dothan, Alabama, United States