Post-Approval Study of the TECNIS SYMFONY® Toric Lenses

Study Overview
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Brief Summary
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This study is a prospective, multicenter, bilateral, non-randomized, open-label, comparative, 6-month clinical study conducted at up to 50 sites in the USA.

Official Title
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Post-Approval Study of the TECNIS SYMFONY® Toric Lenses

Conditions
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Cataract, Corneal Astigmatism

Intervention / Treatment
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* Device: Higher Cylinder Toric IOL
* Device: Lower Cylinder Toric IOL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: be at least 22 years old have cataracts in both eyes have a certain degree of astigmatism in at least one eye sign the written informed consent be willing and able to comply with examination procedures understand, read and write English to complete informed consent and questionnaires be available for study follow-up visits Both eyes must qualify to be eligible to participate in the study Exclusion Criteria: Currently participating in any other clinical study or have participated in a clinical study during the last 30 days Have a certain disease/illness such as poorly-controlled diabetes Have certain ocular conditions such as uncontrolled glaucoma Taking medication that may affect subject vision Have irregular corneal astigmatism Pregnant, plan to become pregnant during the study, or is breastfeeding

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: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Higher Cylinder Toric IOL<br>Consented subjects that are eligible will have both eyes implanted with a TECNIS Symfony IOL. Each eye may have a different TECNIS Symfony IOL implanted, as determined by the surgeon and the TECNIS Symfony Toric IOL calculator; however, at least one eye must be implanted with either a Symfony Toric IOL Model ZXT150 (lower-cylinder group) or a Model ZXT300 or ZXT375 (higher-cylinder group) and the fellow eye must have the same or a lower toric power. The eye with the highest toric power IOL will determine the model group. | Device: Higher Cylinder Toric IOL<br>* Symfony Toric models ZXT300 and ZXT375 IOL<br>|
| Active Comparator: Lower Cylinder Toric IOL<br>Consented subjects that are eligible will have both eyes implanted with a TECNIS Symfony IOL. Each eye may have a different TECNIS Symfony IOL implanted, as determined by the surgeon and the TECNIS Symfony Toric IOL calculator; however, at least one eye must be implanted with either a Symfony Toric IOL Model ZXT150 (lower-cylinder group) or a Model ZXT300 or ZXT375 (higher-cylinder group) and the fellow eye must have the same or a lower toric power. The eye with the highest toric power IOL will determine the model group. | Device: Lower Cylinder Toric IOL<br>* Symfony Toric model ZXT150 IOL<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Bothersome Visual Symptoms | The rate of subjects reporting one or more of these items as very or extremely bothersome and impacting daily life via questionnaire. | 6-month | 
| Rate of Difficulty With an Activity Due to the Visual Symptoms | The rate of reported difficulty with an activity due to one or more of visual symptoms impacting daily life via questionnaire. | 6-month |