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

October 12, 2023 updated by: Alcon Research
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2449

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rate of Eyes With Post-Surgical Intraocular Inflammation - By Eye - Cohort 2
Time Frame: Day 90 to 180 post implantation, each eye. The second eye was implanted within 20 days of the first eye.
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
Time Frame: Day 90 to 180 post implantation, each eye. The second eye was implanted within 20 days of the first eye.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rate of Eyes With Toxic Anterior Segment Syndrome (TASS) - By Eye - Cohort 2
Time Frame: Day 90 to 180 post implantation, each eye. The second eye was implanted within 20 days of the first eye.
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
Time Frame: Day 90 to 180 post second eye implantation, with the second implantation occurring up to 20 days after the first
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
Time Frame: Day 90 to 180 post second eye implantation, with the second implantation occurring up to 20 days after the first
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
Time Frame: Day 90 to 180 post second eye implantation, with the second implantation occurring up to 20 days after the first
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
Time Frame: Day 90 to 180 post second eye implantation, with the second implantation occurring up to 20 days after the first
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
Time Frame: Day 90 to 180 post second eye implantation, with the second implantation occurring up to 20 days after the first
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
Time Frame: Day 90 to 180 post second eye implantation, with the second implantation occurring up to 20 days after the first
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
Time Frame: Day 90 to 180 post second eye implantation, with the second implantation occurring up to 20 days after the first
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Alcon Research

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Sr. Clinical Trial Lead, CRD Surgical, Alcon Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 27, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 14, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 14, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 6, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 7, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 1, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 12, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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