Post Approval Study of the AcrySof® IQ ReSTOR® Toric IOLs

  • STATUS
    Recruiting
  • participants needed
    2278
  • sponsor
    Alcon Research
Updated on 7 February 2023
cataract
uveitis
ocular disease
intraocular lens implantation
presbyopia

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.

Description

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.

Details
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 IdentifierNCT03733730
SponsorAlcon Research
Last Modified on7 February 2023

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