At a glance
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Post Approval Study of the AcrySof® IQ ReSTOR® Toric IOLs
In Brief
A clinical study evaluating ACRYSOF IQ RESTOR +3.0 Multifocal Toric IOL, ACRYSOF IQ RESTOR +2.5 D Multifocal Toric IOL, and 2 other interventions for Aphakia and 2 related conditions. Completed, enrolled 2,449 participants across 38 sites in 2 countries.
Detailed Summary
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.
Study Details
Timeline
Interventions
Intraocular lens (IOL) intended for visual correction of aphakia in adult patients with and without presbyopia, who desire near, intermediate and distance vision, reduction of residual cylinder and increased spectacle independence. IOLs are implantable medical devices and are intended for long term use over the lifetime of the cataract subject.
Intraocular lens (IOL) intended for visual correction of aphakia in adult patients with and without presbyopia, who desire near, intermediate and distance vision, reduction of residual cylinder and increased spectacle independence. IOLs are implantable medical devices and are intended for long term use over the lifetime of the cataract subject.
Intraocular lens (IOL) intended for visual correction of aphakia in adult patients with and without presbyopia, who desire near, intermediate and distance vision with increased spectacle independence. IOLs are implantable medical devices and are intended for long term use over the lifetime of the cataract subject.
Routine small incision cataract surgery with IOL implantation