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

Locations

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 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	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

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 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

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 Names:

Models SND1T3, SND1T4, SND1T5, and SND1T6

Device: ACRYSOF IQ RESTOR +2.5 D Multifocal Toric IOL

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

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

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

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.
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.
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.
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:

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

	Site	City	State	Country	Postal Code
1	Alcon Investigative Site	Dothan	Alabama	United States	36301
2	Alcon Investigative Site	Fresno	California	United States	93720
3	Alcon Investigative Site	Laguna Hills	California	United States	92653
4	Alcon Investigative Site	Deerfield Beach	Florida	United States	33064
5	Alcon Investigative Site	DeLand	Florida	United States	32720
6	Alcon Investigative Site	Mount Dora	Florida	United States	32757
7	Alcon Investigative Site	Sunrise	Florida	United States	33323
8	Alcon Investigative Site	Tampa	Florida	United States	33618
9	Alcon Investigative Site	Leawood	Kansas	United States	66211
10	Alcon Investigative Site	Louisville	Kentucky	United States	40220
11	Alcon Investigative Site	Shreveport	Louisiana	United States	71105
12	Alcon Investigative Site	Shreveport	Louisiana	United States	71118
13	Alcon Investigative Site	Town And Country	Missouri	United States	63017
14	Alcon Investigative Site	New York	New York	United States	10013
15	Alcon Investigative Site	Poughkeepsie	New York	United States	12603
16	Alcon Investigative Site	Southern Pines	North Carolina	United States	28387
17	Alcon Investigative Site	Cincinnati	Ohio	United States	45242
18	Alcon Investigative Site	Nashville	Tennessee	United States	37205
19	Alcon Investigative Site	Arlington	Texas	United States	76018
20	Alcon Investigative Site	El Paso	Texas	United States	79902
21	Alcon Investigative Site	Fort Worth	Texas	United States	76107
22	Alcon Investigative Site	Houston	Texas	United States	77008
23	Alcon Investigative Site	Houston	Texas	United States	77027
24	Alcon Investigative Site	Houston	Texas	United States	77030
25	Alcon Investigative Site	San Juan		Puerto Rico	00921

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 8, 2021

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

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:

Astigmatism

Presbyopia

Aphakia

Study Results

No Results Posted as of Dec 8, 2021