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

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

ACRYSOF IQ RESTOR +3.0 Multifocal Toric IOL

ACRYSOF IQ RESTOR +2.5 D Multifocal Toric IOL

ACRYSOF IQ RESTOR +2.5 D Multifocal IOL

Cataract Surgery

About this trial

This is an interventional treatment trial for Aphakia focused on measuring cataract

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

ACRYSOF IQ RESTOR subjects enrolled prior to July 2020 (Cohort 1)

ACRYSOF IQ RESTOR subjects enrolled after July 2020 (Cohort 2)

Arm Description

ACRYSOF IQ RESTOR Multifocal Toric IOL (+3.0 D or +2.5 D) implanted in at least one eye during cataract surgery

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

Outcomes

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

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

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

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

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

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.

Full Information

NCT ID

NCT03733730

First Posted

November 6, 2018

Last Updated

October 24, 2022

Sponsor

Alcon Research

1. Study Identification

Unique Protocol Identification Number

NCT03733730

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Completed

Study Start Date

November 27, 2018 (Actual)

Primary Completion Date

October 14, 2022 (Actual)

Study Completion Date

October 14, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Alcon Research

4. Oversight

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

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Aphakia, Presbyopia, Astigmatism

Keywords

cataract

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Arm 1 completed prior to the initiation of Arm 2. Within each arm, IOL assignment was parallel.

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

1971 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ACRYSOF IQ RESTOR subjects enrolled prior to July 2020 (Cohort 1)

Arm Type

Experimental

Arm Description

ACRYSOF IQ RESTOR Multifocal Toric IOL (+3.0 D or +2.5 D) implanted in at least one eye during cataract surgery

Arm Title

ACRYSOF IQ RESTOR subjects enrolled after July 2020 (Cohort 2)

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

ACRYSOF IQ RESTOR +3.0 Multifocal Toric IOL

Other Intervention Name(s)

Models SND1T3, SND1T4, SND1T5, and SND1T6

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

ACRYSOF IQ RESTOR +2.5 D Multifocal Toric IOL

Other Intervention Name(s)

Models SV25T3, SV25T4, SV25T5, and SV25T6

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

ACRYSOF IQ RESTOR +2.5 D Multifocal IOL

Other Intervention Name(s)

Model SV25T0

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Cataract Surgery

Intervention Description

Routine small incision cataract surgery with IOL implantation

Primary Outcome Measure Information:

Title

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

Description

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.

Time Frame

Up to Day 180 post implantation, each eye

Secondary Outcome Measure Information:

Title

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

Description

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.

Time Frame

Up to Day 180 post implantation, each eye

Title

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

Description

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.

Time Frame

Up to Day 180 post implantation, each eye

Title

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

Description

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.

Time Frame

Up to Day 180 post implantation, each eye

Title

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

Description

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.

Time Frame

Up to Day 180 post implantation, each eye

10. Eligibility

Sex

All

Minimum Age & Unit of Time

22 Years

Accepts Healthy Volunteers

No

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sr. Clinical Trial Lead, CDMA Surgical

Organizational Affiliation

Alcon Research

Official's Role

Study Director

Facility Information:

Facility Name

Alcon Investigative Site

City

Dothan

State/Province

Alabama

ZIP/Postal Code

36301

Country

United States

Facility Name

Alcon Investigative Site

City

Fresno

State/Province

California

ZIP/Postal Code

93720

Country

United States

Facility Name

Alcon Investigative Site

City

Laguna Hills

State/Province

California

ZIP/Postal Code

92653

Country

United States

Facility Name

Alcon Investigative Site

City

Deerfield Beach

State/Province

Florida

ZIP/Postal Code

33064

Country

United States

Facility Name

Alcon Investigative Site

City

DeLand

State/Province

Florida

ZIP/Postal Code

32720

Country

United States

Facility Name

Alcon Investigative Site

City

Mount Dora

State/Province

Florida

ZIP/Postal Code

32757

Country

United States

Facility Name

Alcon Investigative Site

City

Sunrise

State/Province

Florida

ZIP/Postal Code

33323

Country

United States

Facility Name

Alcon Investigative Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33618

Country

United States

Facility Name

Alcon Investigative Site

City

Leawood

State/Province

Kansas

ZIP/Postal Code

66211

Country

United States

Facility Name

Alcon Investigative Site

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40220

Country

United States

Facility Name

Alcon Investigative Site

City

Shreveport

State/Province

Louisiana

ZIP/Postal Code

71105

Country

United States

Facility Name

Alcon Investigative Site

City

Shreveport

State/Province

Louisiana

ZIP/Postal Code

71118

Country

United States

Facility Name

Alcon Investigative Site

City

Town And Country

State/Province

Missouri

ZIP/Postal Code

63017

Country

United States

Facility Name

Alcon Investigative Site

City

New York

State/Province

New York

ZIP/Postal Code

10013

Country

United States

Facility Name

Alcon Investigative Site

City

Poughkeepsie

State/Province

New York

ZIP/Postal Code

12603

Country

United States

Facility Name

Alcon Investigative Site

City

Southern Pines

State/Province

North Carolina

ZIP/Postal Code

28387

Country

United States

Facility Name

Alcon Investigative Site

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45242

Country

United States

Facility Name

Alcon Investigative Site

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37205

Country

United States

Facility Name

Alcon Investigative Site

City

Arlington

State/Province

Texas

ZIP/Postal Code

76018

Country

United States

Facility Name

Alcon Investigative Site

City

El Paso

State/Province

Texas

ZIP/Postal Code

79902

Country

United States

Facility Name

Alcon Investigative Site

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76107

Country

United States

Facility Name

Alcon Investigative Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77008

Country

United States

Facility Name

Alcon Investigative Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77027

Country

United States

Facility Name

Alcon Investigative Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Alcon Investigative Site

City

San Juan

ZIP/Postal Code

00921

Country

Puerto Rico

12. IPD Sharing Statement

Plan to Share IPD

No

Aphakia, Presbyopia, Astigmatism

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial