Post Approval Study of the AcrySof® IQ ReSTOR® Toric IOLs
2 other identifiers
interventional
2,449
2 countries
38
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2018
Longer than P75 for not_applicable
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 6, 2018
CompletedFirst Posted
Study publicly available on registry
November 7, 2018
CompletedStudy Start
First participant enrolled
November 27, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 14, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 14, 2022
CompletedResults Posted
Study results publicly available
November 1, 2023
CompletedNovember 1, 2023
October 1, 2023
3.9 years
November 6, 2018
October 12, 2023
October 12, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Rate of Eyes With Post-Surgical Intraocular Inflammation - By Eye - Cohort 2
Post-surgical intraocular inflammation was defined as exacerbated intraocular inflammation within 180 days after IOL implantation, indicated by greater than or equal to 3+ aqueous cell within the first 14 days post-operative, and/or greater than or equal to 2+ aqueous cell greater than 14 days and less than or equal to 60 days post-operative, and/or greater than or equal to 1+ aqueous cell greater than 60 days post-operatively or later. The event rate (per 1000 IOL implants) was calculated as "Total # of reported events / Total # of implants X 1000." No formal safety hypothesis was pre-specified for this outcome measure. This outcome measure was pre-specified for Cohort 2 only.
Day 90 to 180 post implantation, each eye. The second eye was implanted within 20 days of the first eye.
Rate of Eyes With Post-Surgical Intraocular Inflammation - Overall Eyes - Cohort 2
Post-surgical intraocular inflammation was defined as exacerbated intraocular inflammation within 180 days after IOL implantation, indicated by greater than or equal to 3+ aqueous cell within the first 14 days post-operative, and/or greater than or equal to 2+ aqueous cell greater than 14 days and less than or equal to 60 days post-operative, and/or greater than or equal to 1+ aqueous cell greater than 60 days post-operatively or later. The event rate (per 1000 IOL implants) was calculated as "Total # of reported events / Total # of implants X 1000." No formal safety hypothesis was pre-specified for this outcome measure. This outcome measure was pre-specified for Cohort 2 only.
Day 90 to 180 post implantation, each eye. The second eye was implanted within 20 days of the first eye.
Secondary Outcomes (8)
Rate of Eyes With Toxic Anterior Segment Syndrome (TASS) - By Eye - Cohort 2
Day 90 to 180 post implantation, each eye. The second eye was implanted within 20 days of the first eye.
Rate of Eyes With Toxic Anterior Segment Syndrome (TASS) - Overall Eyes - Cohort 2
Day 90 to 180 post second eye implantation, with the second implantation occurring up to 20 days after the first
Rate of Eyes With Acute Postoperative Endophthalmitis - By Eye - Cohort 2
Day 90 to 180 post second eye implantation, with the second implantation occurring up to 20 days after the first
Rate of Eyes With Acute Postoperative Endophthalmitis - Overall Eyes - Cohort 2
Day 90 to 180 post second eye implantation, with the second implantation occurring up to 20 days after the first
Rate of Eyes With Chronic Postoperative Endophthalmitis - By Eye - Cohort 2
Day 90 to 180 post second eye implantation, with the second implantation occurring up to 20 days after the first
- +3 more secondary outcomes
Study Arms (2)
Cohort 1
EXPERIMENTALACRYSOF 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.
Cohort 2
EXPERIMENTALACRYSOF 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.
Interventions
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.
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.
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.
Routine small incision cataract surgery with IOL implantation
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alcon Researchlead
Study Sites (38)
Trinity Research Group
Dothan, Alabama, 36301, United States
Eye Doctors of Arizona
Phoenix, Arizona, 85003, United States
InSight Vision Center
Fresno, California, 93720, United States
Harvard Eye Associates
Laguna Hills, California, 92653, United States
Wolstan Goldberg Eye Associates
Torrance, California, 90505, United States
Eye Center of Northern Colorado, PC
Fort Collins, Colorado, 80528, United States
Rand Eye Institute
Deerfield Beach, Florida, 33064, United States
Central Florida Eye Specialists
DeLand, Florida, 32720, United States
Mid Florida Eye Center
Mt. Dora, Florida, 32757, United States
Newsom Eye and Laser Center
Sebring, Florida, 33870, United States
SightTrust Eye Institute
Sunrise, Florida, 33323, United States
Gainesville Eye Associates
Gainesville, Georgia, 30501, United States
Sabates Eye Center
Leawood, Kansas, 66211, United States
Durrie Vision
Overland Park, Kansas, 66210, United States
Senior Health Services
Louisville, Kentucky, 40220, United States
Willis-Knighton Eye Institute South
Shreveport, Louisiana, 71118, United States
Chu Vision Institute
Bloomington, Minnesota, 55421, United States
Associated Eye Care
Stillwater, Minnesota, 55082, United States
Moyes Eye Center
Kansas City, Missouri, 64154, United States
St. Louis Eye Institute
Town and Country, Missouri, 63017, United States
Raymond Fong Eye Care
New York, New York, 10013, United States
Seeta Eye Center
Poughkeepsie, New York, 12603, United States
Carolina Eye Associates
Southern Pines, North Carolina, 28387, United States
Bergstrom Eye Research
Fargo, North Dakota, 58103, United States
Cincinnati Eye Institute
Cincinnati, Ohio, 45242, United States
Vision for Life
Nashville, Tennessee, 37205, United States
Kleinman Evangelista Eye Center of Texas
Arlington, Texas, 76018, United States
Keystone Research
Austin, Texas, 78731, United States
El Paso Eye Surgeons
El Paso, Texas, 79902, United States
Chu Eye Institute
Fort Worth, Texas, 76107, United States
Houston Eye Associates
Houston, Texas, 77008, United States
Berkeley Eye Center
Houston, Texas, 77027, United States
Baylor College of Medicine Alkek Eye Center
Houston, Texas, 77030, United States
The Eye Institute of Utah
Salt Lake City, Utah, 84107, United States
Piedmont Eye Center
Lynchburg, Virginia, 24501, United States
Vistar Eye Center
Roanoke, Virginia, 24011, United States
Northwest Eye Surgeons
Seattle, Washington, 98133, United States
Centro Oftalmologico Metropolitano
San Juan, 00921, Puerto Rico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sr. Clinical Project Lead, CRD Surgical
- Organization
- Alcon Research, LLC
Study Officials
- STUDY DIRECTOR
Sr. Clinical Trial Lead, CRD Surgical
Alcon Research
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 6, 2018
First Posted
November 7, 2018
Study Start
November 27, 2018
Primary Completion
October 14, 2022
Study Completion
October 14, 2022
Last Updated
November 1, 2023
Results First Posted
November 1, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share