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

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 Overview

• Status: Completed
• Conditions: Presbyopia; Astigmatism; Aphakia
• Intervention / Treatment: Device: ACRYSOF IQ RESTOR +3.0 Multifocal Toric IOL; Device: ACRYSOF IQ RESTOR +2.5 D Multifocal Toric IOL; Procedure: Cataract Surgery; Device: ACRYSOF IQ RESTOR +2.5 D Multifocal IOL

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 2449
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Puerto Rico
  • San Juan, Puerto Rico, 00921
    • Centro Oftalmologico Metropolitano
• United States
  • Alabama
    • Dothan, Alabama, United States, 36301
      • Trinity Research Group
  • Arizona
    • Phoenix, Arizona, United States, 85003
      • Eye Doctors of Arizona
  • California
    • Fresno, California, United States, 93720
      • InSight Vision Center
    • Laguna Hills, California, United States, 92653
      • Harvard Eye Associates
    • Torrance, California, United States, 90505
      • Wolstan Goldberg Eye Associates
  • Colorado
    • Fort Collins, Colorado, United States, 80528
      • Eye Center of Northern Colorado, PC
  • Florida
    • DeLand, Florida, United States, 32720
      • Central Florida Eye Specialists
    • Deerfield Beach, Florida, United States, 33064
      • Rand Eye Institute
    • Mount Dora, Florida, United States, 32757
      • Mid Florida Eye Center
    • Sebring, Florida, United States, 33870
      • Newsom Eye and Laser Center
    • Sunrise, Florida, United States, 33323
      • SightTrust Eye Institute
  • Georgia
    • Gainesville, Georgia, United States, 30501
      • Gainesville Eye Associates
  • Kansas
    • Leawood, Kansas, United States, 66211
      • Sabates Eye Center
    • Overland Park, Kansas, United States, 66210
      • Durrie Vision
  • Kentucky
    • Louisville, Kentucky, United States, 40220
      • Senior Health Services
  • Louisiana
    • Shreveport, Louisiana, United States, 71118
      • Willis-Knighton Eye Institute South
  • Minnesota
    • Bloomington, Minnesota, United States, 55421
      • Chu Vision Institute
    • Stillwater, Minnesota, United States, 55082
      • Associated Eye Care
  • Missouri
    • Kansas City, Missouri, United States, 64154
      • Moyes Eye Center
    • Town And Country, Missouri, United States, 63017
      • St. Louis Eye Institute
  • New York
    • New York, New York, United States, 10013
      • Raymond Fong Eye Care
    • Poughkeepsie, New York, United States, 12603
      • Seeta Eye center
  • North Carolina
    • Southern Pines, North Carolina, United States, 28387
      • Carolina Eye Associates
  • North Dakota
    • Fargo, North Dakota, United States, 58103
      • Bergstrom Eye Research
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Cincinnati Eye Institute
  • Tennessee
    • Nashville, Tennessee, United States, 37205
      • Vision for Life
  • Texas
    • Arlington, Texas, United States, 76018
      • Kleinman Evangelista Eye Center of Texas
    • Austin, Texas, United States, 78731
      • Keystone Research
    • El Paso, Texas, United States, 79902
      • El Paso Eye Surgeons
    • Fort Worth, Texas, United States, 76107
      • Chu Eye Institute
    • Houston, Texas, United States, 77027
      • Berkeley Eye Center
    • Houston, Texas, United States, 77008
      • Houston Eye Associates
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine Alkek Eye Center
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • The Eye Institute of Utah
  • Virginia
    • Lynchburg, Virginia, United States, 24501
      • Piedmont Eye Center
    • Roanoke, Virginia, United States, 24011
      • Vistar Eye Center
  • Washington
    • Seattle, Washington, United States, 98133
      • Northwest Eye Surgeons

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1; ACRYSOF IQ RESTOR Multifocal Toric IOL (+3.0 D or +2.5 D) implanted in at least one eye during cataract surgery, with implantation occurring from November 2018 through July 2020.	Device: ACRYSOF IQ RESTOR +3.0 Multifocal Toric IOL; Intraocular lens (IOL) intended for visual correction of aphakia in adult patients with and without presbyopia, who desire near, intermediate and distance vision, reduction of residual cylinder and increased spectacle independence. IOLs are implantable medical devices and are intended for long term use over the lifetime of the cataract subject.; Other Names: Models SND1T3, SND1T4, SND1T5, and SND1T6; Device: ACRYSOF IQ RESTOR +2.5 D Multifocal Toric IOL; Intraocular lens (IOL) intended for visual correction of aphakia in adult patients with and without presbyopia, who desire near, intermediate and distance vision, reduction of residual cylinder and increased spectacle independence. IOLs are implantable medical devices and are intended for long term use over the lifetime of the cataract subject.; Other Names: Models SV25T3, SV25T4, SV25T5, and SV25T6; Procedure: Cataract Surgery; Routine small incision cataract surgery with IOL implantation
Experimental: Cohort 2; ACRYSOF IQ RESTOR +3.0 D Multifocal Toric IOL or ACRYSOF IQ RESTOR +2.5 D Multifocal IOL implanted in at least one eye during cataract surgery, with implantation occurring after July 2020.	Device: ACRYSOF IQ RESTOR +3.0 Multifocal Toric IOL; Intraocular lens (IOL) intended for visual correction of aphakia in adult patients with and without presbyopia, who desire near, intermediate and distance vision, reduction of residual cylinder and increased spectacle independence. IOLs are implantable medical devices and are intended for long term use over the lifetime of the cataract subject.; Other Names: Models SND1T3, SND1T4, SND1T5, and SND1T6; Procedure: Cataract Surgery; Routine small incision cataract surgery with IOL implantation; Device: ACRYSOF IQ RESTOR +2.5 D Multifocal IOL; Intraocular lens (IOL) intended for visual correction of aphakia in adult patients with and without presbyopia, who desire near, intermediate and distance vision with increased spectacle independence. IOLs are implantable medical devices and are intended for long term use over the lifetime of the cataract subject.; Other Names: Model SV25T0

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Eyes With Post-Surgical Intraocular Inflammation - By Eye - Cohort 2	Post-surgical intraocular inflammation was defined as exacerbated intraocular inflammation within 180 days after IOL implantation, indicated by greater than or equal to 3+ aqueous cell within the first 14 days post-operative, and/or greater than or equal to 2+ aqueous cell greater than 14 days and less than or equal to 60 days post-operative, and/or greater than or equal to 1+ aqueous cell greater than 60 days post-operatively or later. The event rate (per 1000 IOL implants) was calculated as "Total # of reported events / Total # of implants X 1000." No formal safety hypothesis was pre-specified for this outcome measure. This outcome measure was pre-specified for Cohort 2 only.	Day 90 to 180 post implantation, each eye. The second eye was implanted within 20 days of the first eye.
Rate of Eyes With Post-Surgical Intraocular Inflammation - Overall Eyes - Cohort 2	Post-surgical intraocular inflammation was defined as exacerbated intraocular inflammation within 180 days after IOL implantation, indicated by greater than or equal to 3+ aqueous cell within the first 14 days post-operative, and/or greater than or equal to 2+ aqueous cell greater than 14 days and less than or equal to 60 days post-operative, and/or greater than or equal to 1+ aqueous cell greater than 60 days post-operatively or later. The event rate (per 1000 IOL implants) was calculated as "Total # of reported events / Total # of implants X 1000." No formal safety hypothesis was pre-specified for this outcome measure. This outcome measure was pre-specified for Cohort 2 only.	Day 90 to 180 post implantation, each eye. The second eye was implanted within 20 days of the first eye.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Eyes With Toxic Anterior Segment Syndrome (TASS) - By Eye - Cohort 2	TASS was defined as exacerbated intraocular inflammation within 180 days after IOL implantation associated with the following findings: Greater than or equal to 3+ aqueous cell, non-infectious etiology, and rapid onset (up to and including 2 days post-operatively). The event rate (per 1000 IOL implants) was calculated as "Total # of reported events / Total # of implants X 1000." No formal safety hypothesis was pre-specified for this outcome measure. This outcome measure was pre-specified for Cohort 2 only.	Day 90 to 180 post implantation, each eye. The second eye was implanted within 20 days of the first eye.
Rate of Eyes With Toxic Anterior Segment Syndrome (TASS) - Overall Eyes - Cohort 2	TASS was defined as exacerbated intraocular inflammation within 180 days after IOL implantation associated with the following findings: Greater than or equal to 3+ aqueous cell, non-infectious etiology, and rapid onset (up to and including 2 days post-operatively). The event rate (per 1000 IOL implants) was calculated as "Total # of reported events / Total # of implants X 1000." No formal safety hypothesis was pre-specified for this outcome measure. This outcome measure was pre-specified for Cohort 2 only.	Day 90 to 180 post second eye implantation, with the second implantation occurring up to 20 days after the first
Rate of Eyes With Acute Postoperative Endophthalmitis - By Eye - Cohort 2	Acute postoperative endophthalmitis was defined as exacerbated intraocular inflammation within 180 days after IOL implantation associated with the following findings: Greater or equal to 3+ aqueous cell, etiology (infectious per positive culture of ocular media; non-infectious per negative culture of ocular media), inflammatory cells in the vitreous and/or vitreous abscess, and rapid onset (3 to 14 days post-operatively). The event rate (per 1000 IOL implants) was calculated as "Total # of reported events / Total # of implants X 1000." No formal safety hypothesis was pre-specified for this outcome measure. This outcome measure was pre-specified for Cohort 2 only.	Day 90 to 180 post second eye implantation, with the second implantation occurring up to 20 days after the first
Rate of Eyes With Acute Postoperative Endophthalmitis - Overall Eyes - Cohort 2	Acute postoperative endophthalmitis was defined as exacerbated intraocular inflammation within 180 days after IOL implantation associated with the following findings: Greater or equal to 3+ aqueous cell, etiology (infectious per positive culture of ocular media; non-infectious per negative culture of ocular media), inflammatory cells in the vitreous and/or vitreous abscess, and rapid onset (3 to 14 days post-operatively). The event rate (per 1000 IOL implants) was calculated as "Total # of reported events / Total # of implants X 1000." No formal safety hypothesis was pre-specified for this outcome measure. This outcome measure was pre-specified for Cohort 2 only.	Day 90 to 180 post second eye implantation, with the second implantation occurring up to 20 days after the first
Rate of Eyes With Chronic Postoperative Endophthalmitis - By Eye - Cohort 2	Chronic postoperative endophthalmitis was defined as exacerbated intraocular inflammation within 180 days after IOL implantation associated with the following findings: Greater than or equal to 1+ aqueous cell, etiology (infectious per positive culture of ocular media; non-infectious per negative culture of ocular media), inflammatory cells in the vitreous, and delayed onset (greater than 14 days post-operatively). The event rate (per 1000 IOL implants) was calculated as "Total # of reported events / Total # of implants X 1000." No formal safety hypothesis was pre-specified for this outcome measure. This outcome measure was pre-specified for Cohort 2 only.	Day 90 to 180 post second eye implantation, with the second implantation occurring up to 20 days after the first
Rate of Eyes With Chronic Postoperative Endophthalmitis - Overall Eyes - Cohort 2	Chronic postoperative endophthalmitis was defined as exacerbated intraocular inflammation within 180 days after IOL implantation associated with the following findings: Greater than or equal to 1+ aqueous cell, etiology (infectious per positive culture of ocular media; non-infectious per negative culture of ocular media), inflammatory cells in the vitreous, and delayed onset (greater than 14 days post-operatively). The event rate (per 1000 IOL implants) was calculated as "Total # of reported events / Total # of implants X 1000." No formal safety hypothesis was pre-specified for this outcome measure. This outcome measure was pre-specified for Cohort 2 only.	Day 90 to 180 post second eye implantation, with the second implantation occurring up to 20 days after the first
Rate of Eyes With Uncategorized Cases of Post-Surgical Intraocular Inflammation - By Eye - Cohort 2	Uncategorized post-surgical intraocular inflammation was defined as signs of exacerbated intraocular inflammation within 180 days after IOL implantation associated with the following findings that do not fall in the given category of TASS, Acute Postoperative Endophthalmitis, or Chronic Postoperative Endophthalmitis: Greater than or equal to 3+ aqueous cell within the first 14 days post-op, and/or greater than or equal to 2+ aqueous cell greater than 14 days and less than or equal to 60 days post-op, and/or greater than or equal to 1+ aqueous cell greater than 60 days post-operatively or later. The event rate (per 1000 IOL implants) was calculated as "Total # of reported events / Total # of implants X 1000." No formal safety hypothesis was pre-specified for this outcome measure. This outcome measure was pre-specified for Cohort 2 only.	Day 90 to 180 post second eye implantation, with the second implantation occurring up to 20 days after the first
Rate of Eyes With Uncategorized Cases of Post-Surgical Intraocular Inflammation - Overall Eyes - Cohort 2	Uncategorized post-surgical intraocular inflammation was defined as signs of exacerbated intraocular inflammation within 180 days after IOL implantation associated with the following findings that do not fall in the given category of TASS, Acute Postoperative Endophthalmitis, or Chronic Postoperative Endophthalmitis: Greater than or equal to 3+ aqueous cell within the first 14 days post-op, and/or greater than or equal to 2+ aqueous cell greater than 14 days and less than or equal to 60 days post-op, and/or greater than or equal to 1+ aqueous cell greater than 60 days post-operatively or later. The event rate (per 1000 IOL implants) was calculated as "Total # of reported events / Total # of implants X 1000." No formal safety hypothesis was pre-specified for this outcome measure. This outcome measure was pre-specified for Cohort 2 only.	Day 90 to 180 post second eye implantation, with the second implantation occurring up to 20 days after the first

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Sr. Clinical Trial Lead, CRD Surgical, Alcon Research

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2018
• Primary Completion (Actual): October 14, 2022
• Study Completion (Actual): October 14, 2022

Study Registration Dates

• First Submitted: November 6, 2018
• First Submitted That Met QC Criteria: November 6, 2018
• First Posted (Actual): November 7, 2018

Study Record Updates

• Last Update Posted (Actual): November 1, 2023
• Last Update Submitted That Met QC Criteria: October 12, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: cataract
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Refractive Errors; Presbyopia; Astigmatism; Aphakia
• Other Study ID Numbers: ILR431b-P001; P040020 (Other Identifier: FDA)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes