Post Approval Study of the AcrySof® IQ ReSTOR® Toric IOLs | NCT03733730 | Trialant
NCT03733730
Sponsor
Alcon Research
Status
Completed
Last Update Posted
Nov 1, 2023Actual
Enrollment
2,449Actual
Phase
Not Applicable
Conditions
Aphakia
Presbyopia
Astigmatism
Interventions
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
Countries
United States
Puerto Rico
Protocol Section
Identification Module
NCT ID
NCT03733730
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
ILR431b-P001
Secondary IDs
ID
Type
Description
Link
P040020
Other Identifier
FDA
Brief Title
Post Approval Study of the AcrySof® IQ ReSTOR® Toric IOLs
Official Title
Post Approval Study of the AcrySof® IQ ReSTOR® Toric IOLs
Acronym
Not provided
Organization
Alcon ResearchINDUSTRY
Status Module
Record Verification Date
Oct 2023
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Nov 27, 2018Actual
Primary Completion Date
Oct 14, 2022Actual
Completion Date
Oct 14, 2022Actual
First Submitted Date
Nov 6, 2018
First Submission Date that Met QC Criteria
Nov 6, 2018
First Posted Date
Nov 7, 2018Actual
Results Waived
Not provided
Results First Submitted Date
Oct 12, 2023
Results First Submitted that Met QC Criteria
Oct 12, 2023
Results First Posted Date
Nov 1, 2023Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Oct 12, 2023
Last Update Posted Date
Nov 1, 2023Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Alcon ResearchINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Not provided
Is FDA Regulated Drug
No
Is FDA Regulated Device
Yes
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Yes
FDAAA801 Violation
Not provided
Description Module
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 20 days of the first eye surgery. 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.
Conditions Module
Conditions
Aphakia
Presbyopia
Astigmatism
Keywords
cataract
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Not Applicable
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
2,449Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Cohort 1
Experimental
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.
Device: ACRYSOF IQ RESTOR +3.0 Multifocal Toric IOL
Device: ACRYSOF IQ RESTOR +2.5 D Multifocal Toric IOL
Procedure: Cataract Surgery
Cohort 2
Experimental
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.
Device: ACRYSOF IQ RESTOR +3.0 Multifocal Toric IOL
Device: ACRYSOF IQ RESTOR +2.5 D Multifocal IOL
Procedure: Cataract Surgery
Interventions
Name
Type
Description
Arm Group Labels
Other Names
ACRYSOF IQ RESTOR +3.0 Multifocal Toric IOL
Device
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.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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
Measure
Description
Time Frame
Rate of Eyes With Toxic Anterior Segment Syndrome (TASS) - By Eye - Cohort 2
TASS was defined as exacerbated intraocular inflammation within 180 days after IOL implantation associated with the following findings: Greater than or equal to 3+ aqueous cell, non-infectious etiology, and rapid onset (up to and including 2 days post-operatively). 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.
Other Outcomes
Not provided
Eligibility Module
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.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
22 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Sr. Clinical Trial Lead, CRD Surgical
Alcon Research
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Trinity Research Group
Dothan
Alabama
36301
United States
Eye Doctors of Arizona
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
Cohort 1: Of the 478 enrolled, 25 subjects discontinued prior to attempted implantation. Cohort 2: Of the 1971 enrolled, 144 subjects discontinued prior to attempted implantation. This reporting group includes all enrolled subjects/eyes with attempted implantation (453/706 in Cohort 1) (1827/3417 in Cohort 2).
Recruitment Details
Subjects were enrolled at 37 investigative sites located in the United States and 1 investigative site located in Puerto Rico.
Type of Units Analyzed
eyes
Arm/Group Information
ID
Title
Description
FG000
Cohort 1
ACRYSOF IQ RESTOR Multifocal Toric IOL (+3.0 D or +2.5 D) implanted in at least one eye during cataract surgery.
FG001
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.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
All subjects/eyes with attempted implantation
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Sep 2, 2020
Sep 28, 2023
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
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.
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Cohort 1
Cohort 2
Models SND1T3, SND1T4, SND1T5, and SND1T6
ACRYSOF IQ RESTOR +2.5 D Multifocal Toric IOL
Device
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.
Cohort 1
Models SV25T3, SV25T4, SV25T5, and SV25T6
ACRYSOF IQ RESTOR +2.5 D Multifocal IOL
Device
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.
Cohort 2
Model SV25T0
Cataract Surgery
Procedure
Routine small incision cataract surgery with IOL implantation
Cohort 1
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
TASS was defined as exacerbated intraocular inflammation within 180 days after IOL implantation associated with the following findings: Greater than or equal to 3+ aqueous cell, non-infectious etiology, and rapid onset (up to and including 2 days post-operatively). 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 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
Acute postoperative endophthalmitis was defined as exacerbated intraocular inflammation within 180 days after IOL implantation associated with the following findings: Greater or equal to 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). 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 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
Acute postoperative endophthalmitis was defined as exacerbated intraocular inflammation within 180 days after IOL implantation associated with the following findings: Greater or equal to 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). 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 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
Chronic postoperative endophthalmitis was defined as exacerbated intraocular inflammation within 180 days after IOL implantation associated with the following findings: Greater than or equal to 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 (greater than 14 days post-operatively). 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 second eye implantation, with the second implantation occurring up to 20 days after the first
Rate of Eyes With Chronic Postoperative Endophthalmitis - Overall Eyes - Cohort 2
Chronic postoperative endophthalmitis was defined as exacerbated intraocular inflammation within 180 days after IOL implantation associated with the following findings: Greater than or equal to 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 (greater than 14 days post-operatively). 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 second eye implantation, with the second implantation occurring up to 20 days after the first
Rate of Eyes With Uncategorized Cases of Post-Surgical Intraocular Inflammation - By Eye - Cohort 2
Uncategorized post-surgical intraocular inflammation was defined as signs of exacerbated intraocular inflammation within 180 days after IOL implantation associated with the following findings that do not fall in the given category of TASS, Acute Postoperative Endophthalmitis, or Chronic Postoperative Endophthalmitis: Greater than or equal to 3+ aqueous cell within the first 14 days post-op, and/or greater than or equal to 2+ aqueous cell greater than 14 days and less than or equal to 60 days post-op, 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 second eye implantation, with the second implantation occurring up to 20 days after the first
Rate of Eyes With Uncategorized Cases of Post-Surgical Intraocular Inflammation - Overall Eyes - Cohort 2
Uncategorized post-surgical intraocular inflammation was defined as signs of exacerbated intraocular inflammation within 180 days after IOL implantation associated with the following findings that do not fall in the given category of TASS, Acute Postoperative Endophthalmitis, or Chronic Postoperative Endophthalmitis: Greater than or equal to 3+ aqueous cell within the first 14 days post-op, and/or greater than or equal to 2+ aqueous cell greater than 14 days and less than or equal to 60 days post-op, 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 second eye implantation, with the second implantation occurring up to 20 days after the first
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
FG000453 subjects706 units
FG0011827 subjects3417 units
First Eye Attempted Implantation
FG000453 subjects453 units
FG0011827 subjects1827 units
First Eye Successful Implantation
FG000453 subjects453 units
FG0011827 subjects1827 units
Second Eye Attempted Implantation
FG000453 subjects253 units
FG0011827 subjects1590 units
Second Eye Successful Implantation
FG000453 subjects253 units
FG0011827 subjects1589 units
Safety Analysis Set
FG000453 subjects706 units
FG0011827 subjects3417 units
COMPLETED
FG000451 subjects703 units
FG0011778 subjects3334 units
NOT COMPLETED
FG0002 subjects3 units
FG00149 subjects83 units
Type
Comment
Reasons
Lost to Follow-up
FG0001 subjects
FG00132 subjects
Other
FG0001 subjects
FG0010 subjects
Adverse Event
FG0000 subjects
FG0014 subjects
Death
FG0000 subjects
FG0015 subjects
Withdrawal by Subject
FG0000 subjects
FG0018 subjects
Safety Analysis Set. Cohort 2 excluded one site (35 subjects/60 eyes) due to noncompliance with GCP as previously communicated with the FDA.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Cohort 1
ACRYSOF IQ RESTOR Multifocal Toric IOL (+3.0 D or +2.5 D) implanted in at least one eye during cataract surgery.
BG001
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.
BG002
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000453
BG0011792
BG0022245
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Number
participants
Title
Denominators
Categories
Less that 65 years
Title
Measurements
BG000148
BG001432
BG002580
Equal to or greater than 65 years
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG000274
BG0011150
BG002
Race/Ethnicity, Customized
Number
participants
Title
Denominators
Categories
White
Title
Measurements
BG000336
BG0011387
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
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.
Safety Analysis Set, minus one site (35 subjects/60 eyes) due to noncompliance with GCP as previously communicated with the FDA.
Posted
Number
event rate per 1000 implants
Day 90 to 180 post implantation, each eye. The second eye was implanted within 20 days of the first eye.
eyes
eyes
ID
Title
Description
OG000
First Eye
ACRYSOF IQ RESTOR +3.0 D Multifocal Toric IOL or ACRYSOF IQ RESTOR +2.5 D Multifocal IOL implanted in first eye during cataract surgery.
OG001
Second Eye
ACRYSOF IQ RESTOR +3.0 D Multifocal Toric IOL or ACRYSOF IQ RESTOR +2.5 D Multifocal IOL implanted in second eye during cataract surgery.
Units
Counts
Participants
OG0001792
OG0011565
eyes
OG0001792
OG001
Title
Denominators
Categories
Title
Measurements
OG0005.6
OG0014.5
Primary
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.
Safety Analysis Set, minus one site (35 subjects/60 eyes) due to noncompliance with GCP as previously communicated with the FDA.
Posted
Number
95% Confidence Interval
event rate per 1000 implants
Day 90 to 180 post implantation, each eye. The second eye was implanted within 20 days of the first eye.
eyes
eyes
ID
Title
Description
OG000
Overall Eyes
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.
Units
Counts
Participants
Secondary
Rate of Eyes With Toxic Anterior Segment Syndrome (TASS) - By Eye - Cohort 2
TASS was defined as exacerbated intraocular inflammation within 180 days after IOL implantation associated with the following findings: Greater than or equal to 3+ aqueous cell, non-infectious etiology, and rapid onset (up to and including 2 days post-operatively). 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.
Safety Analysis Set, minus one site (35 subjects/60 eyes) due to noncompliance with GCP as previously communicated with the FDA.
Posted
Number
event rate per 1000 implants
Day 90 to 180 post implantation, each eye. The second eye was implanted within 20 days of the first eye.
eyes
eyes
ID
Title
Description
OG000
First Eye
ACRYSOF IQ RESTOR +3.0 D Multifocal Toric IOL or ACRYSOF IQ RESTOR +2.5 D Multifocal IOL implanted in first eye during cataract surgery.
OG001
Second Eye
ACRYSOF IQ RESTOR +3.0 D Multifocal Toric IOL or ACRYSOF IQ RESTOR +2.5 D Multifocal IOL implanted in second eye during cataract surgery.
Secondary
Rate of Eyes With Toxic Anterior Segment Syndrome (TASS) - Overall Eyes - Cohort 2
TASS was defined as exacerbated intraocular inflammation within 180 days after IOL implantation associated with the following findings: Greater than or equal to 3+ aqueous cell, non-infectious etiology, and rapid onset (up to and including 2 days post-operatively). 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.
Safety Analysis Set, minus one site (35 subjects/60 eyes) due to noncompliance with GCP as previously communicated with the FDA.
Posted
Number
95% Confidence Interval
event rate per 1000 implants
Day 90 to 180 post second eye implantation, with the second implantation occurring up to 20 days after the first
eyes
eyes
ID
Title
Description
OG000
Overall Eyes
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.
Units
Counts
Participants
OG000
Secondary
Rate of Eyes With Acute Postoperative Endophthalmitis - By Eye - Cohort 2
Acute postoperative endophthalmitis was defined as exacerbated intraocular inflammation within 180 days after IOL implantation associated with the following findings: Greater or equal to 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). 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.
Safety Analysis Set, minus one site (35 subjects/60 eyes) due to noncompliance with GCP as previously communicated with the FDA.
Posted
Number
event rate per 1000 implants
Day 90 to 180 post second eye implantation, with the second implantation occurring up to 20 days after the first
eyes
eyes
ID
Title
Description
OG000
First Eye
ACRYSOF IQ RESTOR +3.0 D Multifocal Toric IOL or ACRYSOF IQ RESTOR +2.5 D Multifocal IOL implanted in first eye during cataract surgery.
OG001
Second Eye
ACRYSOF IQ RESTOR +3.0 D Multifocal Toric IOL or ACRYSOF IQ RESTOR +2.5 D Multifocal IOL implanted in second eye during cataract surgery.
Secondary
Rate of Eyes With Acute Postoperative Endophthalmitis - Overall Eyes - Cohort 2
Acute postoperative endophthalmitis was defined as exacerbated intraocular inflammation within 180 days after IOL implantation associated with the following findings: Greater or equal to 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). 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.
Safety Analysis Set, minus one site (35 subjects/60 eyes) due to noncompliance with GCP as previously communicated with the FDA.
Posted
Number
95% Confidence Interval
event rate per 1000 implants
Day 90 to 180 post second eye implantation, with the second implantation occurring up to 20 days after the first
eyes
eyes
ID
Title
Description
OG000
Overall Eyes
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.
Units
Counts
Participants
Secondary
Rate of Eyes With Chronic Postoperative Endophthalmitis - By Eye - Cohort 2
Chronic postoperative endophthalmitis was defined as exacerbated intraocular inflammation within 180 days after IOL implantation associated with the following findings: Greater than or equal to 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 (greater than 14 days post-operatively). 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.
Safety Analysis Set, minus one site (35 subjects/60 eyes) due to noncompliance with GCP as previously communicated with the FDA.
Posted
Number
event rate per 1000 implants
Day 90 to 180 post second eye implantation, with the second implantation occurring up to 20 days after the first
eyes
eyes
ID
Title
Description
OG000
First Eye
ACRYSOF IQ RESTOR +3.0 D Multifocal Toric IOL or ACRYSOF IQ RESTOR +2.5 D Multifocal IOL implanted in first eye during cataract surgery.
OG001
Second Eye
ACRYSOF IQ RESTOR +3.0 D Multifocal Toric IOL or ACRYSOF IQ RESTOR +2.5 D Multifocal IOL implanted in second eye during cataract surgery.
Secondary
Rate of Eyes With Chronic Postoperative Endophthalmitis - Overall Eyes - Cohort 2
Chronic postoperative endophthalmitis was defined as exacerbated intraocular inflammation within 180 days after IOL implantation associated with the following findings: Greater than or equal to 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 (greater than 14 days post-operatively). 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.
Safety Analysis Set, minus one site (35 subjects/60 eyes) due to noncompliance with GCP as previously communicated with the FDA.
Posted
Number
95% Confidence Interval
event rate per 1000 implants
Day 90 to 180 post second eye implantation, with the second implantation occurring up to 20 days after the first
eyes
eyes
ID
Title
Description
OG000
Overall Eyes
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.
Units
Counts
Participants
Secondary
Rate of Eyes With Uncategorized Cases of Post-Surgical Intraocular Inflammation - By Eye - Cohort 2
Uncategorized post-surgical intraocular inflammation was defined as signs of exacerbated intraocular inflammation within 180 days after IOL implantation associated with the following findings that do not fall in the given category of TASS, Acute Postoperative Endophthalmitis, or Chronic Postoperative Endophthalmitis: Greater than or equal to 3+ aqueous cell within the first 14 days post-op, and/or greater than or equal to 2+ aqueous cell greater than 14 days and less than or equal to 60 days post-op, 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.
Safety Analysis Set, minus one site (35 subjects/60 eyes) due to noncompliance with GCP as previously communicated with the FDA.
Posted
Number
event rate per 1000 implants
Day 90 to 180 post second eye implantation, with the second implantation occurring up to 20 days after the first
eyes
eyes
ID
Title
Description
OG000
First Eye
ACRYSOF IQ RESTOR +3.0 D Multifocal Toric IOL or ACRYSOF IQ RESTOR +2.5 D Multifocal IOL implanted in first eye during cataract surgery.
OG001
Second Eye
ACRYSOF IQ RESTOR +3.0 D Multifocal Toric IOL or ACRYSOF IQ RESTOR +2.5 D Multifocal IOL implanted in second eye during cataract surgery.
Secondary
Rate of Eyes With Uncategorized Cases of Post-Surgical Intraocular Inflammation - Overall Eyes - Cohort 2
Uncategorized post-surgical intraocular inflammation was defined as signs of exacerbated intraocular inflammation within 180 days after IOL implantation associated with the following findings that do not fall in the given category of TASS, Acute Postoperative Endophthalmitis, or Chronic Postoperative Endophthalmitis: Greater than or equal to 3+ aqueous cell within the first 14 days post-op, and/or greater than or equal to 2+ aqueous cell greater than 14 days and less than or equal to 60 days post-op, 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.
Safety Analysis Set, minus one site (35 subjects/60 eyes) due to noncompliance with GCP as previously communicated with the FDA.
Posted
Number
95% Confidence Interval
event rate per 1000 implants
Day 90 to 180 post second eye implantation, with the second implantation occurring up to 20 days after the first
eyes
eyes
ID
Title
Description
OG000
Overall
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.
Units
Time Frame
Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Description
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Cohort 1 Pretreatment
Events reported in this group occurred prior to attempted implantation with the ACRYSOF IQ RESTOR Multifocal IOL
0
453
0
453
2
453
EG001
Cohort 1 Ocular - First Eye
Events reported in this group occurred after attempted implantation with the ACRYSOF IQ RESTOR Multifocal IOL and include ocular events in the first implanted eye
0
453
4
453
71
453
EG002
Cohort 1 Ocular - Second Eye
Events reported in this group occurred after attempted implantation with the ACRYSOF IQ RESTOR Multifocal IOL and include ocular events in the second implanted eye
0
253
6
253
31
253
EG003
Cohort 1 Systemic
Events reported in this group occurred after attempted implantation with the ACRYSOF IQ RESTOR Multifocal IOL
0
453
8
453
0
453
EG004
Cohort 2 Pretreatment
Events reported in this group occurred prior to attempted implantation with the ACRYSOF IQ RESTOR Multifocal IOL
0
1,827
5
1,827
0
1,827
EG005
Cohort 2 Ocular - First Eye
Events reported in this group occurred after attempted implantation with the ACRYSOF IQ RESTOR Multifocal IOL and include ocular events in the first implanted eye
0
1,827
27
1,827
0
1,827
EG006
Cohort 2 Ocular - Second Eye
Events reported in this group occurred after attempted implantation with the ACRYSOF IQ RESTOR Multifocal IOL and include ocular events in the second implanted eye
0
1,590
17
1,590
0
1,590
EG007
Cohort 2 Systemic
Events reported in this group occurred after attempted implantation with the ACRYSOF IQ RESTOR Multifocal IOL
7
1,827
28
1,827
0
1,827
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Atrial fibrillation
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected453 at risk
EG0010 affected453 at risk
EG0020 affected253 at risk
EG0030 affected453 at risk
EG0040 affected1,827 at risk
EG0050 affected1,827 at risk
EG0060 affected1,590 at risk
EG0071 affected1,827 at risk
Myocardial infarction
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected453 at risk
EG0010 affected453 at risk
EG0020 affected253 at risk
EG003
Anterior capsule contraction
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected453 at risk
EG0011 affected453 at risk
EG0020 affected253 at risk
EG003
Corneal infiltrates
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected453 at risk
EG0010 affected453 at risk
EG0020 affected253 at risk
EG003
Cystoid macular oedema
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected453 at risk
EG0011 affected453 at risk
EG0021 affected253 at risk
EG003
Diabetic retinopathy
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected453 at risk
EG0010 affected453 at risk
EG0020 affected253 at risk
EG003
Eye inflammation
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected453 at risk
EG0010 affected453 at risk
EG0020 affected253 at risk
EG003
Glare
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected453 at risk
EG0010 affected453 at risk
EG0020 affected253 at risk
EG003
Macular fibrosis
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected453 at risk
EG0010 affected453 at risk
EG0020 affected253 at risk
EG003
Macular hole
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected453 at risk
EG0010 affected453 at risk
EG0020 affected253 at risk
EG003
Punctate keratitis
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected453 at risk
EG0012 affected453 at risk
EG0021 affected253 at risk
EG003
Refraction disorder
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected453 at risk
EG0010 affected453 at risk
EG0020 affected253 at risk
EG003
Retinal detachment
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected453 at risk
EG0010 affected453 at risk
EG0021 affected253 at risk
EG003
Retinal tear
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected453 at risk
EG0010 affected453 at risk
EG0021 affected253 at risk
EG003
Retinal vein occlusion
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected453 at risk
EG0010 affected453 at risk
EG0020 affected253 at risk
EG003
Visual acuity reduced
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected453 at risk
EG0010 affected453 at risk
EG0020 affected253 at risk
EG003
Vitreoretinal traction syndrome
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected453 at risk
EG0010 affected453 at risk
EG0021 affected253 at risk
EG003
Vitreous floaters
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected453 at risk
EG0010 affected453 at risk
EG0020 affected253 at risk
EG003
Vitreous haemorrhage
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected453 at risk
EG0010 affected453 at risk
EG0020 affected253 at risk
EG003
Vitreous prolapse
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected453 at risk
EG0010 affected453 at risk
EG0020 affected253 at risk
EG003
Colitis ischaemic
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected453 at risk
EG0010 affected453 at risk
EG0020 affected253 at risk
EG003
Intestinal perforation
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected453 at risk
EG0010 affected453 at risk
EG0020 affected253 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected453 at risk
EG0010 affected453 at risk
EG0020 affected253 at risk
EG003
Death
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected453 at risk
EG0010 affected453 at risk
EG0020 affected253 at risk
EG003
Endophthalmitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected453 at risk
EG0010 affected453 at risk
EG0020 affected253 at risk
EG003
Eye complication associated with device
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected453 at risk
EG0010 affected453 at risk
EG0020 affected253 at risk
EG003
COVID-19
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected453 at risk
EG0010 affected453 at risk
EG0020 affected253 at risk
EG003
COVID-19 pneumonia
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected453 at risk
EG0010 affected453 at risk
EG0020 affected253 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected453 at risk
EG0010 affected453 at risk
EG0020 affected253 at risk
EG003
Influenza
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected453 at risk
EG0010 affected453 at risk
EG0020 affected253 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected453 at risk
EG0010 affected453 at risk
EG0020 affected253 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected453 at risk
EG0010 affected453 at risk
EG0020 affected253 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 affected453 at risk
EG0010 affected453 at risk
EG0020 affected253 at risk
EG003
Cardiac procedure complication
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 affected453 at risk
EG0010 affected453 at risk
EG0020 affected253 at risk
EG003
Cataract operation complication
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 affected453 at risk
EG0010 affected453 at risk
EG0021 affected253 at risk
EG003
Posterior capsule rupture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 affected453 at risk
EG0010 affected453 at risk
EG0020 affected253 at risk
EG003
Blood urine present
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 affected453 at risk
EG0010 affected453 at risk
EG0020 affected253 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected453 at risk
EG0010 affected453 at risk
EG0020 affected253 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 affected453 at risk
EG0010 affected453 at risk
EG0020 affected253 at risk
EG003
Lung neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 affected453 at risk
EG0010 affected453 at risk
EG0020 affected253 at risk
EG003
Lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 affected453 at risk
EG0010 affected453 at risk
EG0020 affected253 at risk
EG003
Neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 affected453 at risk
EG0010 affected453 at risk
EG0020 affected253 at risk
EG003
Non-Hodgkin's lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 affected453 at risk
EG0010 affected453 at risk
EG0020 affected253 at risk
EG003
Renal cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 affected453 at risk
EG0010 affected453 at risk
EG0020 affected253 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected453 at risk
EG0010 affected453 at risk
EG0020 affected253 at risk
EG003
Subarachnoid haemorrhage
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected453 at risk
EG0010 affected453 at risk
EG0020 affected253 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected453 at risk
EG0010 affected453 at risk
EG0020 affected253 at risk
EG003
Visual field defect
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected453 at risk
EG0010 affected453 at risk
EG0021 affected253 at risk
EG003
Device dislocation
Product Issues
MedDRA 23.1
Systematic Assessment
EG0000 affected453 at risk
EG0010 affected453 at risk
EG0021 affected253 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected453 at risk
EG0010 affected453 at risk
EG0020 affected253 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected453 at risk
EG0010 affected453 at risk
EG0020 affected253 at risk
EG003
Pulmonary mass
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected453 at risk
EG0010 affected453 at risk
EG0020 affected253 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected453 at risk
EG0010 affected453 at risk
EG0020 affected253 at risk
EG003
Cerebral endovascular aneurysm repair
Surgical and medical procedures
MedDRA 23.1
Systematic Assessment
EG0000 affected453 at risk
EG0010 affected453 at risk
EG0020 affected253 at risk
EG003
Cholecystectomy
Surgical and medical procedures
MedDRA 23.1
Systematic Assessment
EG0000 affected453 at risk
EG0010 affected453 at risk
EG0020 affected253 at risk
EG003
Corneal operation
Surgical and medical procedures
MedDRA 23.1
Systematic Assessment
EG0000 affected453 at risk
EG0012 affected453 at risk
EG0021 affected253 at risk
EG003
Hysterectomy
Surgical and medical procedures
MedDRA 23.1
Systematic Assessment
EG0000 affected453 at risk
EG0010 affected453 at risk
EG0020 affected253 at risk
EG003
Injection
Surgical and medical procedures
MedDRA 23.1
Systematic Assessment
EG0000 affected453 at risk
EG0010 affected453 at risk
EG0020 affected253 at risk
EG003
Intra-ocular injection
Surgical and medical procedures
MedDRA 23.1
Systematic Assessment
EG0000 affected453 at risk
EG0011 affected453 at risk
EG0020 affected253 at risk
EG003
Intraocular lens repositioning
Surgical and medical procedures
MedDRA 23.1
Systematic Assessment
EG0000 affected453 at risk
EG0011 affected453 at risk
EG0021 affected253 at risk
EG003
Lens extraction
Surgical and medical procedures
MedDRA 23.1
Systematic Assessment
EG0000 affected453 at risk
EG0010 affected453 at risk
EG0020 affected253 at risk
EG003
Lung lobectomy
Surgical and medical procedures
MedDRA 23.1
Systematic Assessment
EG0000 affected453 at risk
EG0010 affected453 at risk
EG0020 affected253 at risk
EG003
Mastectomy
Surgical and medical procedures
MedDRA 23.1
Systematic Assessment
EG0000 affected453 at risk
EG0010 affected453 at risk
EG0020 affected253 at risk
EG003
Nephrostomy
Surgical and medical procedures
MedDRA 23.1
Systematic Assessment
EG0000 affected453 at risk
EG0010 affected453 at risk
EG0020 affected253 at risk
EG003
Retinal laser coagulation
Surgical and medical procedures
MedDRA 23.1
Systematic Assessment
EG0000 affected453 at risk
EG0010 affected453 at risk
EG0020 affected253 at risk
EG003
Retinal operation
Surgical and medical procedures
MedDRA 23.1
Systematic Assessment
EG0000 affected453 at risk
EG0010 affected453 at risk
EG0021 affected253 at risk
EG003
Retinopexy
Surgical and medical procedures
MedDRA 23.1
Systematic Assessment
EG0000 affected453 at risk
EG0010 affected453 at risk
EG0020 affected253 at risk
EG003
Spinal Operation
Surgical and medical procedures
MedDRA 23.1
Systematic Assessment
EG0000 affected453 at risk
EG0010 affected453 at risk
EG0020 affected253 at risk
EG003
Vitrectomy
Surgical and medical procedures
MedDRA 23.1
Systematic Assessment
EG0000 affected453 at risk
EG0010 affected453 at risk
EG0020 affected253 at risk
EG003
Hypertension
Vascular disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected453 at risk
EG0010 affected453 at risk
EG0020 affected253 at risk
EG003
Shock
Vascular disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected453 at risk
EG0010 affected453 at risk
EG0020 affected253 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Dry eye
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected453 at risk
EG00123 affected453 at risk
EG00211 affected253 at risk
EG0030 affected453 at risk
EG0040 affected1,827 at risk
EG0050 affected1,827 at risk
EG0060 affected1,590 at risk
EG0070 affected1,827 at risk
Posterior capsule opacification
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected453 at risk
EG00131 affected453 at risk
EG00213 affected253 at risk
EG003
Intraocular pressure increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 affected453 at risk
EG00127 affected453 at risk
EG00211 affected253 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.