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

Completed · Not applicable

Conditions studied: Aphakia, Presbyopia, Astigmatism

In brief

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.

Key facts

Study ID

NCT03733730

Run by

Alcon Research

People needed

2449

Starts

2018-11-27

Expected to finish

2022-10-14

Last updated by the study team

2023-11-01

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Trinity Research Group — Dothan, Alabama, United States
• Eye Doctors of Arizona — Phoenix, Arizona, United States
• InSight Vision Center — Fresno, California, United States
• Harvard Eye Associates — Laguna Hills, California, United States
• Wolstan Goldberg Eye Associates — Torrance, California, United States
• Eye Center of Northern Colorado, PC — Fort Collins, Colorado, United States
• Rand Eye Institute — Deerfield Beach, Florida, United States
• Central Florida Eye Specialists — DeLand, Florida, United States
• Mid Florida Eye Center — Mt. Dora, Florida, United States
• Newsom Eye and Laser Center — Sebring, Florida, United States
• SightTrust Eye Institute — Sunrise, Florida, United States
• Gainesville Eye Associates — Gainesville, Georgia, United States
• Sabates Eye Center — Leawood, Kansas, United States
• Durrie Vision — Overland Park, Kansas, United States
• Senior Health Services — Louisville, Kentucky, United States
• Willis-Knighton Eye Institute South — Shreveport, Louisiana, United States
• Chu Vision Institute — Bloomington, Minnesota, United States
• Associated Eye Care — Stillwater, Minnesota, United States
• Moyes Eye Center — Kansas City, Missouri, United States
• St. Louis Eye Institute — Town and Country, Missouri, United States
• Raymond Fong Eye Care — New York, New York, United States
• Seeta Eye Center — Poughkeepsie, New York, United States
• Carolina Eye Associates — Southern Pines, North Carolina, United States
• Bergstrom Eye Research — Fargo, North Dakota, United States
• Cincinnati Eye Institute — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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