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

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ClinicalTrials.gov Identifier: NCT03733730
Recruitment Status : Suspended (Management decision)
First Posted : November 7, 2018
Last Update Posted : November 13, 2019
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
The purpose of this post-approval 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 Intraocular Lens (IOL) in the US.

Condition or disease Intervention/treatment Phase
Cataract Device: ACRYSOF IQ RESTOR +3.0 D Toric IOL Device: ACRYSOF IQ RESTOR +2.5 D Toric IOL Not Applicable

Detailed Description:
Qualified subjects will receive cataract surgery followed by implantation of the ACRYSOF IQ RESTOR +3.0 D Toric IOL or an ACRYSOF IQ RESTOR +2.5 D Toric IOL at the surgery visit. If a second eye will participate in the study, subjects will receive the second eye cataract surgery within 60 days of the screening visit. 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 : 3600 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
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 : July 2023
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
Experimental: RESTOR +3.0 D Toric
ACRYSOF IQ RESTOR +3.0 D Toric IOL implanted in the capsular bag during cataract removal surgery and intended for long term use over the lifetime of the cataract subject
Device: ACRYSOF IQ RESTOR +3.0 D 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
Other Name: Models SND1T3, SND1T4, SND1T5, and SND1T6

Experimental: RESTOR +2.5 D Toric
ACRYSOF IQ RESTOR +2.5 D Toric IOL implanted in the capsular bag during cataract removal surgery and intended for long term use over the lifetime of the cataract subject
Device: ACRYSOF IQ RESTOR +2.5 D 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
Other Name: Models SV25T3, SV25T4, SV25T5, and SV25T6




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 [ 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.


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)

  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)

  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)

  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.



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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 an ACRYSOF IQ RESTOR 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
  • 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:

  • 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 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


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Sponsors and Collaborators
Alcon Research
Investigators
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Study Director: Alcon Research Alcon Research

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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT03733730     History of Changes
Other Study ID Numbers: ILR431b-P001
First Posted: November 7, 2018    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019
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
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases