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

Last updated: October 12, 2023
Sponsor: Alcon Research
Overall Status: Completed

Phase

N/A

Condition

Astigmatism

Presbyopia

Treatment

ACRYSOF IQ RESTOR +2.5 D Multifocal Toric IOL

ACRYSOF IQ RESTOR +3.0 Multifocal Toric IOL

ACRYSOF IQ RESTOR +2.5 D Multifocal IOL

Clinical Study ID

NCT03733730
ILR431b-P001
P040020
  • Ages > 22
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 productlabeling 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 (ModelSV25T0) 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

Exclusion Criteria:

  • Eyes with clinically significant ocular, including adnexa, or intraocular infection orinflammation (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.

Study Design

Total Participants: 2449
Treatment Group(s): 4
Primary Treatment: ACRYSOF IQ RESTOR +2.5 D Multifocal Toric IOL
Phase:
Study Start date:
November 27, 2018
Estimated Completion Date:
October 14, 2022

Study Description

If a second eye will participate in the study, subjects will receive the second eye cataract surgery within 20 days of the first eye surgery. 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.

Connect with a study center

  • Alcon Investigative Site

    San Juan, 00921
    Puerto Rico

    Site Not Available

  • Centro Oftalmologico Metropolitano

    San Juan, 00921
    Puerto Rico

    Site Not Available

  • Alcon Investigative Site

    Dothan, Alabama 36301
    United States

    Site Not Available

  • Trinity Research Group

    Dothan, Alabama 36301
    United States

    Site Not Available

  • Eye Doctors of Arizona

    Phoenix, Arizona 85003
    United States

    Site Not Available

  • Alcon Investigative Site

    Fresno, California 93720
    United States

    Site Not Available

  • InSight Vision Center

    Fresno, California 93720
    United States

    Site Not Available

  • Alcon Investigative Site

    Laguna Hills, California 92653
    United States

    Site Not Available

  • Harvard Eye Associates

    Laguna Hills, California 92653
    United States

    Site Not Available

  • Wolstan Goldberg Eye Associates

    Torrance, California 90505
    United States

    Site Not Available

  • Eye Center of Northern Colorado, PC

    Fort Collins, Colorado 80528
    United States

    Site Not Available

  • Alcon Investigative Site

    DeLand, Florida 32720
    United States

    Site Not Available

  • Central Florida Eye Specialists

    DeLand, Florida 32720
    United States

    Site Not Available

  • Alcon Investigative Site

    Deerfield Beach, Florida 33064
    United States

    Site Not Available

  • Rand Eye Institute

    Deerfield Beach, Florida 33064
    United States

    Site Not Available

  • Alcon Investigative Site

    Mount Dora, Florida 32757
    United States

    Site Not Available

  • Mid Florida Eye Center

    Mount Dora, Florida 32757
    United States

    Site Not Available

  • Newsom Eye and Laser Center

    Sebring, Florida 33870
    United States

    Site Not Available

  • Alcon Investigative Site

    Sunrise, Florida 33323
    United States

    Site Not Available

  • SightTrust Eye Institute

    Sunrise, Florida 33323
    United States

    Site Not Available

  • Alcon Investigative Site

    Tampa, Florida 33618
    United States

    Site Not Available

  • Gainesville Eye Associates

    Gainesville, Georgia 30501
    United States

    Site Not Available

  • Alcon Investigative Site

    Leawood, Kansas 66211
    United States

    Site Not Available

  • Sabates Eye Center

    Leawood, Kansas 66211
    United States

    Site Not Available

  • Durrie Vision

    Overland Park, Kansas 66210
    United States

    Site Not Available

  • Alcon Investigative Site

    Louisville, Kentucky 40220
    United States

    Site Not Available

  • Senior Health Services

    Louisville, Kentucky 40220
    United States

    Site Not Available

  • Alcon Investigative Site

    Shreveport, Louisiana 71105
    United States

    Site Not Available

  • Willis-Knighton Eye Institute South

    Shreveport, Louisiana 71118
    United States

    Site Not Available

  • Chu Vision Institute

    Bloomington, Minnesota 55421
    United States

    Site Not Available

  • Associated Eye Care

    Stillwater, Minnesota 55082
    United States

    Site Not Available

  • Moyes Eye Center

    Kansas City, Missouri 64154
    United States

    Site Not Available

  • Alcon Investigative Site

    Town And Country, Missouri 63017
    United States

    Site Not Available

  • St. Louis Eye Institute

    Town And Country, Missouri 63017
    United States

    Site Not Available

  • Alcon Investigative Site

    New York, New York 10013
    United States

    Site Not Available

  • Raymond Fong Eye Care

    New York, New York 10013
    United States

    Site Not Available

  • Alcon Investigative Site

    Poughkeepsie, New York 12603
    United States

    Site Not Available

  • Seeta Eye Center

    Poughkeepsie, New York 12603
    United States

    Site Not Available

  • Alcon Investigative Site

    Southern Pines, North Carolina 28387
    United States

    Site Not Available

  • Carolina Eye Associates

    Southern Pines, North Carolina 28387
    United States

    Site Not Available

  • Bergstrom Eye Research

    Fargo, North Dakota 58103
    United States

    Site Not Available

  • Alcon Investigative Site

    Cincinnati, Ohio 45242
    United States

    Site Not Available

  • Cincinnati Eye Institute

    Cincinnati, Ohio 45242
    United States

    Site Not Available

  • Alcon Investigative Site

    Nashville, Tennessee 37205
    United States

    Site Not Available

  • Vision for Life

    Nashville, Tennessee 37205
    United States

    Site Not Available

  • Alcon Investigative Site

    Arlington, Texas 76018
    United States

    Site Not Available

  • Kleinman Evangelista Eye Center of Texas

    Arlington, Texas 76018
    United States

    Site Not Available

  • Keystone Research

    Austin, Texas 78731
    United States

    Site Not Available

  • Alcon Investigative Site

    El Paso, Texas 79902
    United States

    Site Not Available

  • El Paso Eye Surgeons

    El Paso, Texas 79902
    United States

    Site Not Available

  • Alcon Investigative Site

    Fort Worth, Texas 76107
    United States

    Site Not Available

  • Chu Eye Institute

    Fort Worth, Texas 76107
    United States

    Site Not Available

  • Alcon Investigative Site

    Houston, Texas 77030
    United States

    Site Not Available

  • Baylor College of Medicine Alkek Eye Center

    Houston, Texas 77030
    United States

    Site Not Available

  • Berkeley Eye Center

    Houston, Texas 77027
    United States

    Site Not Available

  • Houston Eye Associates

    Houston, Texas 77008
    United States

    Site Not Available

  • The Eye Institute of Utah

    Salt Lake City, Utah 84107
    United States

    Site Not Available

  • Piedmont Eye Center

    Lynchburg, Virginia 24501
    United States

    Site Not Available

  • Vistar Eye Center

    Roanoke, Virginia 24011
    United States

    Site Not Available

  • Northwest Eye Surgeons

    Seattle, Washington 98133
    United States

    Site Not Available

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