Post Approval Study of the AcrySof® IQ ReSTOR® Toric IOLs
NCT ID: NCT03733730
Last Updated: 2023-11-01
Study Results
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View full resultsBasic Information
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COMPLETED
NA
2449 participants
INTERVENTIONAL
2018-11-27
2022-10-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort 1
ACRYSOF IQ RESTOR Multifocal Toric IOL (+3.0 D or +2.5 D) implanted in at least one eye during cataract surgery, with implantation occurring from November 2018 through July 2020.
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.
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.
Cataract Surgery
Routine small incision cataract surgery with IOL implantation
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, with implantation occurring after July 2020.
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.
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.
Cataract Surgery
Routine small incision cataract surgery with IOL implantation
Interventions
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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.
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.
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.
Cataract Surgery
Routine small incision cataract surgery with IOL implantation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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)
22 Years
ALL
No
Sponsors
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Alcon Research
INDUSTRY
Responsible Party
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Principal Investigators
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Sr. Clinical Trial Lead, CRD Surgical
Role: STUDY_DIRECTOR
Alcon Research
Locations
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Trinity Research Group
Dothan, Alabama, United States
Eye Doctors of Arizona
Phoenix, Arizona, United States
InSight Vision Center
Fresno, California, United States
Harvard Eye Associates
Laguna Hills, California, United States
Wolstan Goldberg Eye Associates
Torrance, California, United States
Eye Center of Northern Colorado, PC
Fort Collins, Colorado, United States
Rand Eye Institute
Deerfield Beach, Florida, United States
Central Florida Eye Specialists
DeLand, Florida, United States
Mid Florida Eye Center
Mt. Dora, Florida, United States
Newsom Eye and Laser Center
Sebring, Florida, United States
SightTrust Eye Institute
Sunrise, Florida, United States
Gainesville Eye Associates
Gainesville, Georgia, United States
Sabates Eye Center
Leawood, Kansas, United States
Durrie Vision
Overland Park, Kansas, United States
Senior Health Services
Louisville, Kentucky, United States
Willis-Knighton Eye Institute South
Shreveport, Louisiana, United States
Chu Vision Institute
Bloomington, Minnesota, United States
Associated Eye Care
Stillwater, Minnesota, United States
Moyes Eye Center
Kansas City, Missouri, United States
St. Louis Eye Institute
Town and Country, Missouri, United States
Raymond Fong Eye Care
New York, New York, United States
Seeta Eye Center
Poughkeepsie, New York, United States
Carolina Eye Associates
Southern Pines, North Carolina, United States
Bergstrom Eye Research
Fargo, North Dakota, United States
Cincinnati Eye Institute
Cincinnati, Ohio, United States
Vision for Life
Nashville, Tennessee, United States
Kleinman Evangelista Eye Center of Texas
Arlington, Texas, United States
Keystone Research
Austin, Texas, United States
El Paso Eye Surgeons
El Paso, Texas, United States
Chu Eye Institute
Fort Worth, Texas, United States
Houston Eye Associates
Houston, Texas, United States
Berkeley Eye Center
Houston, Texas, United States
Baylor College of Medicine Alkek Eye Center
Houston, Texas, United States
The Eye Institute of Utah
Salt Lake City, Utah, United States
Piedmont Eye Center
Lynchburg, Virginia, United States
Vistar Eye Center
Roanoke, Virginia, United States
Northwest Eye Surgeons
Seattle, Washington, United States
Centro Oftalmologico Metropolitano
San Juan, , Puerto Rico
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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P040020
Identifier Type: OTHER
Identifier Source: secondary_id
ILR431b-P001
Identifier Type: -
Identifier Source: org_study_id
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