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

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ClinicalTrials.gov Identifier: NCT03733730
Recruitment Status : Recruiting
First Posted : November 7, 2018
Last Update Posted : October 29, 2020
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Brief 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.

Condition or disease Intervention/treatment Phase
Aphakia Presbyopia Astigmatism Device: ACRYSOF IQ RESTOR +3.0 Multifocal Toric IOL Device: ACRYSOF IQ RESTOR +2.5 D Multifocal Toric IOL Device: ACRYSOF IQ RESTOR +2.5 D Multifocal IOL Procedure: Cataract Surgery Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2278 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Arm 1 completed prior to the initiation of Arm 2. Within each arm, IOL assignment was parallel.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Post Approval Study of the AcrySof® IQ ReSTOR® Toric IOLs
Actual Study Start Date : November 27, 2018
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
Experimental: ACRYSOF IQ RESTOR subjects enrolled prior to July 2020 (Cohort 1)
ACRYSOF IQ RESTOR Multifocal Toric IOL (+3.0 D or +2.5 D) implanted in at least one eye during cataract surgery
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 Name: 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 Name: Models SV25T3, SV25T4, SV25T5, and SV25T6

Procedure: Cataract Surgery
Routine small incision cataract surgery with IOL implantation

Experimental: ACRYSOF IQ RESTOR subjects enrolled after July 2020 (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
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 Name: Models SND1T3, SND1T4, SND1T5, and SND1T6

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 Name: Model SV25T0

Procedure: Cataract Surgery
Routine small incision cataract surgery with IOL implantation




Primary Outcome Measures :
  1. Rate (per 1,000 implants) of post-surgical intraocular inflammation (based upon the specified case definition) reported within a 180-day post-surgical period following attempted implantation of an ACRYSOF IQ RESTOR Toric IOL or ACRYSOF IQ RESTOR IOL [ Time Frame: Up to Day 180 post implantation, each eye ]
    Post-surgical intraocular inflammation is defined as exacerbated intraocular inflammation within 180 days after IOL implantation, indicated by ≥ 3+ aqueous cell within the first 14 days post-operative, and/or ≥ 2+ aqueous cell ˃ 14 days and ≤ 60 days post-operative, and/or ≥ 1+ aqueous cell ˃ 60 days post-operatively or later. This outcome measure is pre-specified for Cohort 2.


Secondary Outcome Measures :
  1. Rate (per 1,000 implants) of Toxic Anterior Segment Syndrome (TASS) (based upon the specified case definition) reported within a 180-day post-surgical period following attempted implantation [ Time Frame: Up to Day 180 post implantation, each eye ]
    TASS is defined as exacerbated intraocular inflammation within 180 days after IOL implantation associated with the following findings: ≥ 3+ aqueous cell, non-infectious etiology, and rapid onset (up to and including 2 days post-operatively). This outcome measure is pre-specified for Cohort 2.

  2. Rate (per 1,000 implants) of acute postoperative endophthalmitis (based upon the specified case definition) reported within a 180 day post-surgical period following attempted implantation [ Time Frame: Up to Day 180 post implantation, each eye ]
    Acute postoperative endophthalmitis is defined as exacerbated intraocular inflammation within 180 days after IOL implantation associated with the following findings: ≥ 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). This outcome measure is pre-specified for Cohort 2.

  3. Rate (per 1,000 implants) of chronic postoperative endophthalmitis (based upon the specified case definition) reported within a 180 day post-surgical period following attempted implantation [ Time Frame: Up to Day 180 post implantation, each eye ]
    Chronic postoperative endophthalmitis is defined as exacerbated intraocular inflammation within 180 days after IOL implantation associated with the following findings: ≥ 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 (˃ 14 days post-operatively). This outcome measure is pre-specified for Cohort 2.

  4. Rate (per 1,000 implants) of uncategorized post-surgical intraocular inflammation (based upon the specified case definition) reported within a 180-day post-surgical period following attempted implantation [ Time Frame: Up to Day 180 post implantation, each eye ]
    Uncategorized post-surgical intraocular inflammation is defined as signs of exacerbated intraocular inflammation within 180 days after IOL implantation associated with t he following findings that do not fall in the given category of TASS, Acute Postoperative Endophthalmitis, or Chronic Postoperative Endophthalmitis: ≥ 3+ aqueous cell within the first 14 days post-op, and/or ≥ 2+ aqueous cell ˃ 14 days and ≤ 60 days post-op, and/or ≥ 1+ aqueous cell ˃ 60 days post-operatlvely or later. This outcome measure is pre-specified for Cohort 2.



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03733730


Contacts
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Contact: Alcon Call Center 1-888-451-3937 alcon.medinfo@alcon.com

Locations
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United States, Alabama
Alcon Investigative Site Recruiting
Dothan, Alabama, United States, 36301
United States, California
Alcon Investigative Site Recruiting
Fresno, California, United States, 93720
Alcon Investigative Site Recruiting
Laguna Hills, California, United States, 92653
United States, Florida
Alcon Investigative Site Recruiting
Deerfield Beach, Florida, United States, 33064
Alcon Investigative Site Recruiting
DeLand, Florida, United States, 32720
Alcon Investigative Site Recruiting
Mount Dora, Florida, United States, 32757
Alcon Investigative Site Recruiting
Sunrise, Florida, United States, 33323
Alcon Investigative Site Recruiting
Tampa, Florida, United States, 33618
United States, Kansas
Alcon Investigative Site Recruiting
Leawood, Kansas, United States, 66211
United States, Kentucky
Alcon Investigative Site Recruiting
Louisville, Kentucky, United States, 40220
United States, Louisiana
Alcon Investigative Site Recruiting
Shreveport, Louisiana, United States, 71105
Alcon Investigative Site Recruiting
Shreveport, Louisiana, United States, 71118
United States, Missouri
Alcon Investigative Site Recruiting
Town And Country, Missouri, United States, 63017
United States, New York
Alcon Investigative Site Recruiting
New York, New York, United States, 10013
Alcon Investigative Site Recruiting
Poughkeepsie, New York, United States, 12603
United States, North Carolina
Alcon Investigative Site Recruiting
Southern Pines, North Carolina, United States, 28387
United States, Ohio
Alcon Investigative Site Recruiting
Cincinnati, Ohio, United States, 45242
United States, Tennessee
Alcon Investigative Site Recruiting
Nashville, Tennessee, United States, 37205
United States, Texas
Alcon Investigative Site Recruiting
Arlington, Texas, United States, 76018
Alcon Investigative Site Recruiting
El Paso, Texas, United States, 79902
Alcon Investigative Site Recruiting
Fort Worth, Texas, United States, 76107
Alcon Investigative Site Recruiting
Houston, Texas, United States, 77008
Alcon Investigative Site Recruiting
Houston, Texas, United States, 77027
Alcon Investigative Site Recruiting
Houston, Texas, United States, 77030
Puerto Rico
Alcon Investigative Site Recruiting
San Juan, Puerto Rico, 00921
Sponsors and Collaborators
Alcon Research
Investigators
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Study Director: Sr. Clinical Trial Lead, CDMA Surgical Alcon Research
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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT03733730    
Other Study ID Numbers: ILR431b-P001
First Posted: November 7, 2018    Key Record Dates
Last Update Posted: October 29, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Alcon Research:
cataract
Additional relevant MeSH terms:
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Astigmatism
Presbyopia
Aphakia
Refractive Errors
Eye Diseases
Lens Diseases