A Clinical Study of the ACRYSOF® IQ EDF Intraocular Lens... | NCT03010254 | Trialant
NCT03010254
Sponsor
Alcon Research
Status
Completed
Last Update Posted
Apr 7, 2020Actual
Enrollment
322Actual
Phase
Not Applicable
Conditions
Cataract
Interventions
ACRYSOF® IQ Extended Depth of Focus IOL
ACRYSOF® IQ Monofocal IOL
Cataract surgery
Countries
Australia
Canada
Spain
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT03010254
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
ILI875-C001
Secondary IDs
Not provided
Brief Title
A Clinical Study of the ACRYSOF® IQ EDF Intraocular Lens (IOL)
Official Title
A Prospective, Randomized, Controlled, Multi-Center Clinical Study of the ACRYSOF® IQ Extended Depth of Focus (EDF) IOL
Acronym
Not provided
Organization
Alcon ResearchINDUSTRY
Status Module
Record Verification Date
Mar 2020
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
Mar 21, 2017Actual
Primary Completion Date
Aug 17, 2018Actual
Completion Date
Oct 31, 2018Actual
First Submitted Date
Jan 3, 2017
First Submission Date that Met QC Criteria
Jan 3, 2017
First Posted Date
Jan 5, 2017Estimated
Results Waived
Not provided
Results First Submitted Date
Mar 10, 2020
Results First Submitted that Met QC Criteria
Mar 25, 2020
Results First Posted Date
Apr 7, 2020Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Aug 12, 2019
Certification/Extension First Submitted that Passed QC Review
Mar 25, 2020
Certification/Extension First Posted Date
Apr 7, 2020Actual
Last Update Submitted Date
Mar 25, 2020
Last Update Posted Date
Apr 7, 2020Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Alcon ResearchINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
No
Is FDA Regulated Device
Yes
Is Unapproved Device
Yes
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Yes
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of the study is to demonstrate the safety and performance of the ACRYSOF® IQ EDF IOL.
Detailed Description
Both eyes will be implanted. The second eye implantation will occur a minimum of 7 calendar days and a maximum of 28 calendar days from the first eye implantation.
Conditions Module
Conditions
Cataract
Keywords
Not provided
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
322Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
DFT015
Experimental
ACRYSOF® IQ Extended Depth of Focus Intraocular lens (IOL), bilateral implantation
Device: ACRYSOF® IQ Extended Depth of Focus IOL
Procedure: Cataract surgery
SN60WF
Active Comparator
ACRYSOF® IQ Monofocal IOL, bilateral implantation
Device: ACRYSOF® IQ Monofocal IOL
Procedure: Cataract surgery
Interventions
Name
Type
Description
Arm Group Labels
Other Names
ACRYSOF® IQ Extended Depth of Focus IOL
Device
Implantable IOL intending to extend the depth of focus and provide continuous functional vision from distance to near while maintaining distance vision and a visual disturbance profile comparable to a monofocal IOL; intended for long-term use over the lifetime of the pseudophakic subject
Visual Acuity (VA) was assessed monocularly (each eye separately) under photopic (well-lit) conditions using best distance correction (distance refraction) and high contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart at 66 cm from spectacle plane. It was measured in logarithm of the minimum angle of resolution (logMAR), with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. This analysis was prespecified for the first operative eye.
Month 3 (70-100 days post second eye implantation)
Percentage of Subjects With Ocular Adverse Events
An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device (test article). Ocular AEs are events localized to the eye. Cumulative and persistent serious adverse events as defined by ISO 11979-7:2014 were collected for Model DFT015 first and second eyes. No formal statistical hypothesis testing was planned.
Day 0 (first operative eye visit) up to Month 6 (120-180 days post second eye implantation)
Secondary Outcomes
Measure
Description
Time Frame
Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA) at 4 Meters (m)
VA was tested monocularly under photopic conditions using the correction obtained from the manual manifest refraction and 100% contrast, ETDRS charts at a distance of 4 m from the spectacle plane. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. This analysis was prespecified for the first operative eye.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Able to understand and sign an Independent Ethics Committee (IEC)/ Institutional Review Board (IRB) approved Informed Consent Form;
Diagnosed with cataract in both eyes;
Planned cataract removal by routine small incision surgery;
Calculated IOL power is within the clinical study supply range (18.0-25.0 diopter (D) in 0.5 D steps);
Preoperative regular astigmatism of less than 1.0 D.
Exclusion Criteria:
Pregnancy or lactation current or planned during the course of the study;
History of anterior segment (corneal, anterior chamber, sulcus) or posterior segment (uveal, vitreo-retinal) pathology including retinal vascular occlusive disease, retinal detachment or peripheral retinal laser photocoagulation, age-related macular degeneration (ARMD), glaucoma (uncontrolled or controlled with medication) or ocular hypertension, diabetic retinopathy, retinitis pigmentosa and any optic nerve pathology.
Bala C, Poyales F, Guarro M, Mesa RR, Mearza A, Varma DK, Jasti S, Lemp-Hull J. Multicountry clinical outcomes of a new nondiffractive presbyopia-correcting IOL. J Cataract Refract Surg. 2022 Feb 1;48(2):136-143. doi: 10.1097/j.jcrs.0000000000000712.
See Also Links
Not provided
Available IPD Information
Not provided
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
A total of 322 subjects were enrolled in the study, out of which 39 subjects exited due to screen failure and 1 subject discontinued due to site being closed before actual screening visit and randomization. This reporting group includes all randomized subjects.
Recruitment Details
Subjects were recruited from 21 investigative sites located in Australia, Canada, Spain and the United Kingdom.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
DFT015
ACRYSOF® IQ Extended Depth of Focus Intraocular lens (IOL), bilateral implantation
FG001
SN60WF
ACRYSOF® IQ Monofocal IOL, bilateral implantation
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
All randomized subjects
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
May 23, 2018
Oct 2, 2019
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantOutcomes Assessor
DFT015
Model DFT015
ACRYSOF® IQ Monofocal IOL
Device
Monofocal IOL implanted for long-term use over the lifetime of the pseudophakic subject
SN60WF
Model SN60WF
Cataract surgery
Procedure
IOL bilateral implantation
DFT015
SN60WF
Month 3 (70-100 days post second eye implantation)
Monocular Photopic Distance Corrected Near Visual Acuity (DCNVA) at 40 cm
VA was tested monocularly under photopic conditions using best distance correction (distance refraction) and high contrast, ETDRS chart set at 40 cm from the spectacle plane using the near point rod. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. This analysis was prespecified for the first operative eye.
Month 3 (70-100 days post second eye implantation)
Monocular Photopic Distance Corrected Depth of Focus Assessed by the Mean Defocus Curve
Depth of focus was assessed at 4 meters under photopic (well-lit) conditions using best corrected distance refraction, added defocus and 100% contrast ETDRS charts. VA was measured between +1.50 Diopter (D) and -2.50 D in 0.5 D defocus steps, except in the region from +0.50 D through -0.50 D, which was assessed in 0.25 D steps. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. The depth of focus was estimated as the dioptric range between zero defocus and the first point on the negative lens induced mean defocus curve that crosses the 0.2 logMAR using a linear interpolation. A lower numeric value represents better VA. This analysis was pre-specified for the first operative eye. No formal statistical hypothesis testing was planned.
Month 3 (70-100 days post second eye implantation)
Monocular Mesopic Contrast Sensitivity at 12 Cycles Per Degree (Cpd)
Contrast sensitivity (i.e., the ability to detect objects by distinguishing them from their background) was assessed monocularly with the subject's best spectacle correction under mesopic (low, but not quite dark) conditions at a distance of 8 feet (2.45 m) from the eye at a spatial frequency of 12 cpd using the Vector Vision CSV 1000-HGT with and without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. A higher numeric value represented better contrast sensitivity. This analysis was prespecified for the first operative eye.
Month 6 (120-180 days post second eye implantation)
Percentage of Subjects Who Respond "Never" to Question 1 of the Spectacle Use Questionnaire: "How Often Do You Wear Eyeglasses for Any Purpose?"
Proportion of subjects was reported as a percentage. No formal statistical hypothesis testing was planned.
Month 6 (120-180 days post second eye implantation)
Percentage of Subjects Who Respond "Never" to Question 3 of the Spectacle Use Questionnaire: "How Often Do You Wear Eyeglasses for Intermediate Tasks (e.g., Computer)?"
No formal statistical hypothesis testing was planned.
Month 6 (120-180 days post second eye implantation)
Southport
Queensland
4215
Australia
Alcon Investigative Site
Footscray
Victoria
3011
Australia
Alcon Investigative Site
Hawthorn East
Victoria
3123
Australia
Alcon Investigative Site
Vancouver
British Columbia
V5Z 3N9
Canada
Alcon Investigative Site
Mississauga
Ontario
L5L1W8
Canada
Alcon Investigative Site
Toronto
Ontario
M3N 2V7
Canada
Alcon Investigative Site
Toronto
Ontario
M5T 3A9
Canada
Alcon Investigative Site
Boisbriand
QU
J7H 186
Canada
Alcon Investigative Site
Québec
QU
G1S 4L8
Canada
Alcon Investigative Site
Sant Cugat del Vallès
BCN
08195
Spain
Alcon Investigative Site
Jerez de la Frontera
Cadiz
11408
Spain
Alcon Investigative Site
Barcelona
08008
Spain
Alcon Investigative Site
Barcelona
08021
Spain
Alcon Investigative Site
Barcelona
08022
Spain
Alcon Investigative Site
Madrid
28003
Spain
Alcon Investigative Site
Valencia
46015
Spain
Alcon Investigative Site
Dartford
Kent
DA2 8DA
United Kingdom
Alcon Investigative Site
Essex
SS0 9AG
United Kingdom
Alcon Investigative Site
London
NW1 5QH
United Kingdom
Alcon Investigative Site
Manchester
M13 9WL
United Kingdom
FG000159 subjects
FG001123 subjects
Attempted Implantation
FG000156 subjects
FG001120 subjects
Successful Implantation
FG000156 subjects
FG001120 subjects
COMPLETED
FG000152 subjects
FG001118 subjects
NOT COMPLETED
FG0007 subjects
FG0015 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0011 subjects
Lost to Follow-up
FG0004 subjects
FG0010 subjects
Withdrawal by Subject
FG0001 subjects
FG0011 subjects
Other
FG0002 subjects
FG0013 subjects
This analysis population included all randomized eyes with successful IOL implantation (All-Implanted Analysis Set).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
DFT015
ACRYSOF® IQ Extended Depth of Focus IOL, bilateral implantation
Visual Acuity (VA) was assessed monocularly (each eye separately) under photopic (well-lit) conditions using best distance correction (distance refraction) and high contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart at 66 cm from spectacle plane. It was measured in logarithm of the minimum angle of resolution (logMAR), with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. This analysis was prespecified for the first operative eye.
All-Implanted Analysis Set
Posted
Least Squares Mean
Standard Error
logMAR
Month 3 (70-100 days post second eye implantation)
Eyes
Eyes
ID
Title
Description
OG000
DFT015
ACRYSOF® IQ Extended Depth of Focus IOL, bilateral implantation
OG001
SN60WF
ACRYSOF® IQ Monofocal IOL, bilateral implantation
Units
Counts
Participants
OG000153
OG001115
Eyes
OG000153
OG001
Title
Denominators
Categories
Title
Measurements
OG0000.175± 0.0137
OG0010.313± 0.0158
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
t-test, 2 sided
<0.001
2-sided p-value reported. A hypothesis test was based on a two sample t-test, with a type I error rate of 0.025, 1-sided.
Least Squares Mean Difference
-0.138
Standard Error of the Mean
0.0210
2-Sided
95
-0.180
-0.097
Least squares mean difference (DFT015 - SN60WF)
Superiority
Primary
Percentage of Subjects With Ocular Adverse Events
An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device (test article). Ocular AEs are events localized to the eye. Cumulative and persistent serious adverse events as defined by ISO 11979-7:2014 were collected for Model DFT015 first and second eyes. No formal statistical hypothesis testing was planned.
This analysis population included all eyes with attempted IOL implantation (successful or aborted after contact with the eye) (Safety Analysis Set). This outcome measure was pre-specified for the ACRYSOF® IQ Extended Depth of Focus IOL DTF015 only.
Posted
Number
percentage of subjects
Day 0 (first operative eye visit) up to Month 6 (120-180 days post second eye implantation)
Eyes
Eyes
ID
Title
Description
OG000
DFT015 First Eye
All eyes with attempted test article implantation (successful or aborted after contact with the eye) in the first implanted eye
OG001
DFT015 Second Eye
All eyes with attempted test article implantation (successful or aborted after contact with the eye) in the second implanted eye
Secondary
Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA) at 4 Meters (m)
VA was tested monocularly under photopic conditions using the correction obtained from the manual manifest refraction and 100% contrast, ETDRS charts at a distance of 4 m from the spectacle plane. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. This analysis was prespecified for the first operative eye.
All-Implanted Analysis Set
Posted
Least Squares Mean
Standard Error
logMAR
Month 3 (70-100 days post second eye implantation)
Eyes
Eyes
ID
Title
Description
OG000
DFT015
ACRYSOF® IQ Extended Depth of Focus IOL, bilateral implantation
OG001
SN60WF
ACRYSOF® IQ Monofocal IOL, bilateral implantation
Units
Counts
Participants
OG000
Secondary
Monocular Photopic Distance Corrected Near Visual Acuity (DCNVA) at 40 cm
VA was tested monocularly under photopic conditions using best distance correction (distance refraction) and high contrast, ETDRS chart set at 40 cm from the spectacle plane using the near point rod. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. This analysis was prespecified for the first operative eye.
All-Implanted Analysis Set
Posted
Least Squares Mean
Standard Error
logMAR
Month 3 (70-100 days post second eye implantation)
Eyes
Eyes
ID
Title
Description
OG000
DFT015
ACRYSOF® IQ Extended Depth of Focus IOL, bilateral implantation
OG001
SN60WF
ACRYSOF® IQ Monofocal IOL, bilateral implantation
Units
Counts
Participants
OG000
Secondary
Monocular Photopic Distance Corrected Depth of Focus Assessed by the Mean Defocus Curve
Depth of focus was assessed at 4 meters under photopic (well-lit) conditions using best corrected distance refraction, added defocus and 100% contrast ETDRS charts. VA was measured between +1.50 Diopter (D) and -2.50 D in 0.5 D defocus steps, except in the region from +0.50 D through -0.50 D, which was assessed in 0.25 D steps. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. The depth of focus was estimated as the dioptric range between zero defocus and the first point on the negative lens induced mean defocus curve that crosses the 0.2 logMAR using a linear interpolation. A lower numeric value represents better VA. This analysis was pre-specified for the first operative eye. No formal statistical hypothesis testing was planned.
This analysis population included all eyes successfully implanted that had at least 1 postoperative visit, no macular degeneration at any time, and no major protocol violations (Best-case Analysis Set). Number analyzed is the number of subjects/eyes with data available for analysis at specified defocus.
Posted
Number
diopter
Month 3 (70-100 days post second eye implantation)
Eyes
Eyes
ID
Title
Description
OG000
DFT015
ACRYSOF® IQ Extended Depth of Focus IOL, bilateral implantation
OG001
SN60WF
Secondary
Monocular Mesopic Contrast Sensitivity at 12 Cycles Per Degree (Cpd)
Contrast sensitivity (i.e., the ability to detect objects by distinguishing them from their background) was assessed monocularly with the subject's best spectacle correction under mesopic (low, but not quite dark) conditions at a distance of 8 feet (2.45 m) from the eye at a spatial frequency of 12 cpd using the Vector Vision CSV 1000-HGT with and without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. A higher numeric value represented better contrast sensitivity. This analysis was prespecified for the first operative eye.
All-Implanted Analysis Set. Number analyzed is the number of subjects/eyes with data available for analysis at without glare and with glare assessments.
Posted
Least Squares Mean
Standard Error
log unit
Month 6 (120-180 days post second eye implantation)
Eyes
Eyes
ID
Title
Description
OG000
DFT015
ACRYSOF® IQ Extended Depth of Focus IOL, bilateral implantation
OG001
SN60WF
ACRYSOF® IQ Monofocal IOL, bilateral implantation
Units
Counts
Participants
Secondary
Percentage of Subjects Who Respond "Never" to Question 1 of the Spectacle Use Questionnaire: "How Often Do You Wear Eyeglasses for Any Purpose?"
Proportion of subjects was reported as a percentage. No formal statistical hypothesis testing was planned.
All-Implanted Analysis Set
Posted
Number
percentage of subjects
Month 6 (120-180 days post second eye implantation)
ID
Title
Description
OG000
DFT015
ACRYSOF® IQ Extended Depth of Focus IOL, bilateral implantation
OG001
SN60WF
ACRYSOF® IQ Monofocal IOL, bilateral implantation
Units
Counts
Participants
OG000
Secondary
Percentage of Subjects Who Respond "Never" to Question 3 of the Spectacle Use Questionnaire: "How Often Do You Wear Eyeglasses for Intermediate Tasks (e.g., Computer)?"
No formal statistical hypothesis testing was planned.
All-Implanted Analysis Set
Posted
Number
percentage of subjects
Month 6 (120-180 days post second eye implantation)
ID
Title
Description
OG000
DFT015
ACRYSOF® IQ Extended Depth of Focus IOL, bilateral implantation
OG001
SN60WF
ACRYSOF® IQ Monofocal IOL, bilateral implantation
Units
Counts
Participants
OG000
Time Frame
Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
Description
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
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
Preoperative
All subjects in the safety analysis set prior to initiation of treatment
0
276
1
276
0
276
EG001
DFT015 First Eye
All eyes with attempted test article implantation (successful or aborted after contact with the eye) in the first implanted eye
0
156
2
156
0
156
EG002
DFT015 Second Eye
All eyes with attempted test article implantation (successful or aborted after contact with the eye) in the second implanted eye
0
154
2
154
0
154
EG003
DFT015 Systemic
All subjects with attempted test article implantation (successful or aborted after contact with the eye)
0
156
3
156
0
156
EG004
SN60WF First Eye
All eyes with attempted control article implantation (successful or aborted after contact with the eye) in the first implanted eye
0
120
2
120
0
120
EG005
SN60WF Second Eye
All eyes with attempted control article implantation (successful or aborted after contact with the eye) in the second implanted eye
0
119
0
119
0
119
EG006
SN60WF Systemic
All subjects with attempted control article implantation (successful or aborted after contact with the eye)
0
120
9
120
0
120
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Acute myocardial infarction
Cardiac disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected276 at risk
EG0010 affected156 at risk
EG0020 affected154 at risk
EG0030 affected156 at risk
EG0040 affected120 at risk
EG0050 affected119 at risk
EG0061 affected120 at risk
Cystoid macular oedema
Eye disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected276 at risk
EG0011 affected156 at risk
EG0020 affected154 at risk
EG003
Posterior capsule rupture
Eye disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected276 at risk
EG0010 affected156 at risk
EG0021 affected154 at risk
EG003
Refraction disorder
Eye disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected276 at risk
EG0010 affected156 at risk
EG0021 affected154 at risk
EG003
Vitreous loss
Eye disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected276 at risk
EG0010 affected156 at risk
EG0021 affected154 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected276 at risk
EG0010 affected156 at risk
EG0020 affected154 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected276 at risk
EG0010 affected156 at risk
EG0020 affected154 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected276 at risk
EG0010 affected156 at risk
EG0020 affected154 at risk
EG003
Cholecystitis infective
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0000 affected276 at risk
EG0010 affected156 at risk
EG0020 affected154 at risk
EG003
Influenza
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0000 affected276 at risk
EG0010 affected156 at risk
EG0020 affected154 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0001 affected276 at risk
EG0010 affected156 at risk
EG0020 affected154 at risk
EG003
Craniocerebral injury
Injury, poisoning and procedural complications
MedDRA (19.0)
Systematic Assessment
EG0000 affected276 at risk
EG0010 affected156 at risk
EG0020 affected154 at risk
EG003
Breast cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (19.0)
Systematic Assessment
EG0000 affected276 at risk
EG0010 affected156 at risk
EG0020 affected154 at risk
EG003
Cerebral infarction
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected276 at risk
EG0010 affected156 at risk
EG0020 affected154 at risk
EG003
Syncope
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected276 at risk
EG0010 affected156 at risk
EG0020 affected154 at risk
EG003
Device dislocation
Product Issues
MedDRA (19.0)
Systematic Assessment
EG0000 affected276 at risk
EG0011 affected156 at risk
EG0020 affected154 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected276 at risk
EG0010 affected156 at risk
EG0020 affected154 at risk
EG003
Hip arthroplasty
Surgical and medical procedures
MedDRA (19.0)
Systematic Assessment
EG0000 affected276 at risk
EG0010 affected156 at risk
EG0020 affected154 at risk
EG003
Intraocular lens repositioning
Surgical and medical procedures
MedDRA (19.0)
Systematic Assessment
EG0000 affected276 at risk
EG0011 affected156 at risk
EG0020 affected154 at risk
EG003
Keratomileusis
Surgical and medical procedures
MedDRA (19.0)
Systematic Assessment
EG0000 affected276 at risk
EG0010 affected156 at risk
EG0021 affected154 at risk
EG003
Vitrectomy
Surgical and medical procedures
MedDRA (19.0)
Systematic Assessment
EG0000 affected276 at risk
EG0010 affected156 at risk
EG0021 affected154 at risk
EG003
Other Adverse Events
Not provided
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.