Post-market Study to Obtain Surgeon Feedback on Clinical Outcome in Eyes Implanted With TECNIS Toric II IOL

Study Overview
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Brief Summary
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This is a multicenter, prospective, single-arm, open-label, clinical study of the commercially available TECNIS Toric II, Model ZCU IOL. The study will be conducted in up to 1100 subjects enrolled with 1,000 subjects needing unilateral or bilateral cataract surgery across up to 50 US study sites.

Official Title
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Post-market Evaluation of Surgeon Feedback on TECNIS® TORIC II Intraocular Lens (IOL)

Conditions
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Cataract, Corneal Astigmatism

Intervention / Treatment
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* Device: TECNIS® TORIC II Intraocular Lens (IOL)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Unilateral or bilateral cataracts for which phacoemulsification extraction and posterior chamber IOL implantation have been planned; Preoperative corneal astigmatism of one diopter or more in the operative eye; Potential for postoperative best corrected distance visual acuity (BCDVA) of 20/30 Snellen or better; Clear intraocular media other than cataract in each eye; Ability to understand, read and write English in order to consent to study participation; Availability, willingness, sufficient cognitive awareness to comply with examination procedures; Signed Informed Consent Document (ICD) and Health Insurance Portability and Accountability Act (HIPAA) authorization. Exclusion Criteria: Recurrent severe anterior or posterior segment inflammation or uveitis; Compromised eye due to previous trauma or developmental defects in which appropriate support of the IOL is not possible; Circumstances that would result in damage to the endothelium during implantation; Suspected ocular microbial infection; 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, in the opinion of the investigator, may affect visual acuity or require surgical intervention during the course of the study, [macular degeneration, cystoid macular edema, proliferative diabetic retinopathy (severe), uncontrolled glaucoma, irregular corneal astigmatism, choroidal hemorrhage, concomitant severe eye disease, extremely shallow anterior chamber, microphthalmos, non-age related cataract, severe corneal dystrophy, severe optic nerve atrophy, etc.]; Planned monovision correction; Concurrent participation or participation within 30 days prior to the preoperative visit in any other clinical study.

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TECNIS® TORIC II Intraocular Lens (IOL)<br>Subjects will be implanted with the TECNIS Toric II IOL in one or both eyes qualified for study inclusion | Device: TECNIS® TORIC II Intraocular Lens (IOL)<br>* Surgeons will perform standardized, small-incision, cataract surgery and implant in one or both eyes the study lenses.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Surgeon Satisfaction of the Clinical Outcome of Eye Implanted With the TECNIS Toric II | Percent of Eyes Rated Very Satisfied or Satisfied with Clinical Outcomes. This endpoint was assessed based on the question Please rate your overall level of satisfaction with the clinical outcomes achieved in the implanted eye in the Surgeon Satisfaction Questionnaire (SSQ). | 3 months postoperative |