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

Sponsor
Alcon Research (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03733730
Collaborator
(none)
2,278
Enrollment
25
Locations
2
Arms
49.1
Anticipated Duration (Months)
91.1
Patients Per Site
1.9
Patients Per Site Per Month

Study Details

Study Description

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 DiseaseIntervention/TreatmentPhase
  • 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
N/A

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.

Study Design

Study Type:
Interventional
Anticipated 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.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 :
Nov 27, 2018
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Jan 1, 2023

Arms and Interventions

ArmIntervention/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 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: 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 Names:
  • 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 Names:
  • Model SV25T0
  • Procedure: Cataract Surgery
    Routine small incision cataract surgery with IOL implantation

    Outcome Measures

    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 [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 [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 [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 [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 [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    22 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Alcon Investigative SiteDothanAlabamaUnited States36301
    2Alcon Investigative SiteFresnoCaliforniaUnited States93720
    3Alcon Investigative SiteLaguna HillsCaliforniaUnited States92653
    4Alcon Investigative SiteDeerfield BeachFloridaUnited States33064
    5Alcon Investigative SiteDeLandFloridaUnited States32720
    6Alcon Investigative SiteMount DoraFloridaUnited States32757
    7Alcon Investigative SiteSunriseFloridaUnited States33323
    8Alcon Investigative SiteTampaFloridaUnited States33618
    9Alcon Investigative SiteLeawoodKansasUnited States66211
    10Alcon Investigative SiteLouisvilleKentuckyUnited States40220
    11Alcon Investigative SiteShreveportLouisianaUnited States71105
    12Alcon Investigative SiteShreveportLouisianaUnited States71118
    13Alcon Investigative SiteTown And CountryMissouriUnited States63017
    14Alcon Investigative SiteNew YorkNew YorkUnited States10013
    15Alcon Investigative SitePoughkeepsieNew YorkUnited States12603
    16Alcon Investigative SiteSouthern PinesNorth CarolinaUnited States28387
    17Alcon Investigative SiteCincinnatiOhioUnited States45242
    18Alcon Investigative SiteNashvilleTennesseeUnited States37205
    19Alcon Investigative SiteArlingtonTexasUnited States76018
    20Alcon Investigative SiteEl PasoTexasUnited States79902
    21Alcon Investigative SiteFort WorthTexasUnited States76107
    22Alcon Investigative SiteHoustonTexasUnited States77008
    23Alcon Investigative SiteHoustonTexasUnited States77027
    24Alcon Investigative SiteHoustonTexasUnited States77030
    25Alcon Investigative SiteSan JuanPuerto Rico00921

    Sponsors and Collaborators

    • Alcon Research

    Investigators

    • Study Director: Sr. Clinical Trial Lead, CDMA Surgical, Alcon Research

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Alcon Research
    ClinicalTrials.gov Identifier:
    NCT03733730
    Other Study ID Numbers:
    • ILR431b-P001
    First Posted:
    Nov 7, 2018
    Last Update Posted:
    Dec 2, 2021
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 2, 2021