Post Approval Study of the AcrySof® IQ Toric Intraocular Lens (IOL) Models SN6AT6-SN6AT9

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the use of toric high cylinder power intraocular lenses in a larger population in clinical practice and assure the continued safety of these approved devices.

Detailed Description
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In this prospective, non-randomized, unmasked study, subjects with pre-existing corneal astigmatism ≥2.57 diopters will choose to be implanted with either the AcrySof® IQ Toric High Cylinder Power IOL or the AcrySof® IQ Aspheric NATURAL monofocal IOL.

Official Title
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Post Approval Study of the AcrySof® IQ Toric High Cylinder Power IOL Models SN6AT6-SN6AT9

Conditions
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Cataracts, Astigmatism

Intervention / Treatment
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* Device: SN6AT6 Intraocular Lens
* Device: SN6AT7 Intraocular Lens
* Device: SN6AT8 Intraocular Lens
* Device: SN6AT9 Intraocular Lens
* Device: SN60WF Intraocular Lens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with bilateral cataracts and in the targeted astigmatism range. Planned cataract removal by phacoemulsification. Pupil size greater than or equal to 6 mm after dilation. Able to undergo second eye surgery within 30 days of first eye surgery. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Irregular corneal astigmatism. Any inflammation or swelling of the cornea. Any corneal abnormality other than regular corneal astigmatism. Previous corneal refractive surgery. Amblyopia. Diabetic retinopathy. Uncontrolled glaucoma. Currently participating in another investigational drug or device study that may confound the results of this investigation. Other protocol-defined exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 21 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Toric High Cylinder Power IOL<br>Toric high cylinder power intraocular lens implanted during cataract surgery in the first operative eye, with the second operative eye implanted within 30 days of the first implantation. | Device: SN6AT6 Intraocular Lens<br>* Acrylic intraocular lens with cylinder power at the IOL plane of 3.75 diopters. Intraocular lenses are implanted during cataract surgery as a replacement for the natural crystalline lens and are intended for long term use over the lifetime of the cataract subject.<br>* Other names: AcrySof® IQ Toric Model SN6AT6;Device: SN6AT7 Intraocular Lens<br>* Acrylic intraocular lens with cylinder power at the IOL plane of 4.50 diopters. Intraocular lenses are implanted during cataract surgery as a replacement for the natural crystalline lens and are intended for long term use over the lifetime of the cataract subject.<br>* Other names: AcrySof® IQ Toric Model SN6AT7;Device: SN6AT8 Intraocular Lens<br>* Acrylic intraocular lens with cylinder power at the IOL plane of 5.25 diopters. Intraocular lenses are implanted during cataract surgery as a replacement for the natural crystalline lens and are intended for long term use over the lifetime of the cataract subject.<br>* Other names: AcrySof® IQ Toric Model SN6AT8;Device: SN6AT9 Intraocular Lens<br>* Acrylic intraocular lens with cylinder power at the IOL plane of 6.00 diopters. Intraocular lenses are implanted during cataract surgery as a replacement for the natural crystalline lens and are intended for long term use over the lifetime of the cataract subject.<br>* Other names: AcrySof® IQ Toric Model SN6AT9;|
| Monofocal IOL<br>Monofocal intraocular lens implanted during cataract surgery in the first operative eye, with the second operative eye implanted within 30 days of the first implantation. | Device: SN60WF Intraocular Lens<br>* Acrylic aspheric monofocal intraocular lens. Intraocular lenses are implanted during cataract surgery as a replacement for the natural crystalline lens and are intended for long term use over the lifetime of the cataract subject.<br>* Other names: AcrySof® IQ Aspheric NATURAL Model SN60WF;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Severe Visual Distortions | As assessed by a Patient Reported Outcomes (PRO) questionnaire. Subjects will be categorized as experiencing a severe visual distortion if they indicate severe as a response to any of the three visual distortion-related questions on the questionnaire. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cataracts, Intraocular lens, Astigmatism, Toric