Deerfield Beach, Florida 33064

  • Astigmatism

Purpose:

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 summary:

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.


Criteria:

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.


NCT ID:

NCT03733730


Primary Contact:

Study Director
Sr. Clinical Trial Lead, CDMA Surgical
Alcon Research

Alcon Call Center
Phone: 1-888-451-3937
Email: alcon.medinfo@alcon.com


Backup Contact:

N/A


Location Contact:

Deerfield Beach, Florida 33064
United States



There is no listed contact information for this specific location.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 19, 2021

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