Last updated on July 2019

Post Approval Study of the AcrySof IQ ReSTOR Toric IOLs


Brief description of study

The purpose of this post-approval 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 Intraocular Lens (IOL) in the US.

Detailed Study Description

Qualified subjects will receive cataract surgery followed by implantation of the ACRYSOF IQ RESTOR +3.0 D Toric IOL or an ACRYSOF IQ RESTOR +2.5 D Toric IOL at the surgery visit. If a second eye will participate in the study, subjects will receive the second eye cataract surgery within 60 days of the screening visit. 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.

Clinical Study Identifier: NCT03733730

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