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

  • STATUS
    Recruiting
  • days left to enroll
    40
  • participants needed
    2278
  • sponsor
    Alcon Research
Updated on 1 February 2022
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 on1 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Preoperative cataract in the study eye(s)
Planned implantation in at least one eye with
Cohort 1: An ACRYSOF IQ RESTOR +3.0 D Multifocal Toric IOL (Models SND1T3, SND1T4, SND1T5 or SND1T6) or an ACRYSOF IQ RESTOR +2.5 D Multifocal Toric IOLs (Models SV25T3, SV25T4, SV25T5, and SV25T6) in accordance with the product labeling from November 2018 to July 2020
Cohort 2: An ACRYSOF IQ RESTOR +3.0 D Multifocal Toric IOL (Models SND1T3, SND1T4, SND1T5 or SND1T6), or an ACRYSOF IQ RESTOR +2.5 D Multifocal IOL (Model SV25T0) in accordance with the product labeling after July 2020
Able to comprehend and sign a statement of informed consent
Willing and able to complete all required postoperative visits
Other protocol-specified inclusion criteria may apply

Exclusion Criteria

Eyes with clinically significant ocular, including adnexa, or intraocular infection or inflammation (at the screening visit prior to surgery or on the day of surgery)
History of any intraocular inflammation within the past 12 months (ex: uveitis, choroiditis)
Combined procedures introducing an additional medical device during cataract surgery (ex: cataract surgery with implant of glaucoma stent)
Other protocol-specified exclusion criteria may apply
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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