This is a prospective, multicenter, post-approval active surveillance study. The purpose of this study is to report the rate of post-surgical intraocular inflammation (based upon a specified case definition) reported within a 180-day post-surgical period following attempted implantation of an ACRYSOF IQ RESTOR Toric or ACRYSOF IQ RESTOR IOL in the US.
If a second eye will participate in the study, subjects will receive the second eye cataract surgery within 60 days of the screening Visit 0. Four postoperative follow-up visits are planned to occur at 1-2 days, 7-14 days, 30-60 days, and 90-180 days, for each enrolled eye. Subject participation in this study is expected to last up to 7 months, including a total of 6 study visits for subjects implanted in one eye and up to 11 visits for subjects implanted in both eyes. Upon completion of the 180 days follow-up visit, subjects will be exited from the study.
| Condition | Aphakia, Presbyopia, Astigmatism |
|---|---|
| Treatment | cataract surgery, ACRYSOF IQ RESTOR +3.0 D Toric IOL, ACRYSOF IQ RESTOR +2.5 D Toric IOL, ACRYSOF IQ RESTOR +3.0 Multifocal Toric IOL, ACRYSOF IQ RESTOR +2.5 D Multifocal Toric IOL, ACRYSOF IQ RESTOR +2.5 D Multifocal IOL |
| Clinical Study Identifier | NCT03733730 |
| Sponsor | Alcon Research |
| Last Modified on | 7 February 2023 |
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