Post-Approval Study of the Tecnis® Toric IOL

Study Overview
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Brief Summary
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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

Official Title
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Post-Approval Study of the Tecnis® Toric IOL, Models ZCT300 and ZCT400

Conditions
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Cataract

Intervention / Treatment
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* Device: non-toric intraocular lens
* Device: toric intraocular lens


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: non-toric intraocular lens<br>non-toric approved intraocular lens | Device: non-toric intraocular lens<br>* TECNIS One-piece Monofocal Model ZCB00<br>|
| Active Comparator: toric intraocular lens<br>approved toric intraocular lens | Device: toric intraocular lens<br>* TECNIS One-piece Toric Models ZCT300 or ZCT400<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Severe Visual Distortions | 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 |