Clinical Evaluation of a Small Aperture Extended Depth of... | NCT03633695 | Trialant
NCT03633695
Sponsor
AcuFocus, Inc.
Status
Completed
Last Update Posted
Oct 24, 2022Actual
Enrollment
453Actual
Phase
Not Applicable
Conditions
Cataract
Presbyopia
Interventions
IC-8 IOL Group
Control Group
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT03633695
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
SAIL-101-UNI
Secondary IDs
Not provided
Brief Title
Clinical Evaluation of a Small Aperture Extended Depth of Focus Intraocular Lens
Official Title
Clinical Evaluation of a Small Aperture Extended Depth of Focus Intraocular Lens
Acronym
Not provided
Organization
AcuFocus, Inc.INDUSTRY
Status Module
Record Verification Date
Sep 2022
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
Dec 4, 2018Actual
Primary Completion Date
Oct 15, 2020Actual
Completion Date
Oct 15, 2020Actual
First Submitted Date
Aug 14, 2018
First Submission Date that Met QC Criteria
Aug 14, 2018
First Posted Date
Aug 16, 2018Actual
Results Waived
Not provided
Results First Submitted Date
Aug 21, 2022
Results First Submitted that Met QC Criteria
Sep 23, 2022
Results First Posted Date
Oct 24, 2022Actual
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
Sep 23, 2022
Last Update Posted Date
Oct 24, 2022Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
AcuFocus, Inc.INDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
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
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to determine the safety and effectiveness of the IC-8 IOL implanted in one eye and a monofocal or monofocal toric IOL implanted in the fellow eye in accordance with the indication.
Detailed Description
Eligible patients will complete up to 12 study visits over a 12-month period. All subjects will complete a preoperative examination of both eyes to assess study eligibility: operative visit (each eye) and up to 9 postoperative visits (Day 1 - each eye, Week 1 - each eye, Month 1 - each eye or combined, Month 3 - both eyes, Month 6 - both eyes, and Month 12 - both eyes). The first eye must meet specific qualification criteria in order to proceed with IOL implantation in the second eye. The second eye should be implanted within 45 days of the first eye.
Conditions Module
Conditions
Cataract
Presbyopia
Keywords
Cataract
Intraocular lens
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
453Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
IC-8 IOL Group
Experimental
A monofocal IOL (TECNIS ZCB00, ZCT150 or ZCT225 or AcrySof IQ SA60WF, SA6AT3 or SA6AT4) implanted in the first eye. The AcuFocus IC-8 IOL implanted in the second eye.
Device: IC-8 IOL Group
Control Group
Active Comparator
A monofocal IOL (TECNIS ZCB00, ZCT150 or ZCT225 or AcrySof IQ SA60WF, SA6AT3 or SA6AT4) bilaterally implanted.
Device: Control Group
Interventions
Name
Type
Description
Arm Group Labels
Other Names
IC-8 IOL Group
Device
A monofocal IOL (TECNIS ZCB00, ZCT150 or ZCT225 or AcrySof IQ SA60WF, SA6AT3 or SA6AT4) implanted in the first eye for use over the lifetime of the patient. The IC-8 IOL implanted in the second eye for use over the lifetime of the patient.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Mean Binocular Photopic Uncorrected Intermediate (66 cm) Visual Acuity (UCIVA)
Visual acuity (VA) was tested binocularly (both eyes) at a distance of 66 cm, without manifest refraction, using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart presenting on a self-calibrating monitor in a computerized testing system. Visual acuity was measured in logarithm of the minimum angle of resolution (logMAR), with a 0.02 logMAR increment corresponding to a single letter on the ETDRS chart.
6 Months (160-210 days post second eye operative visit)
Mean Binocular Photopic Uncorrected Near (40 cm) Visual Acuity (UCNVA)
Visual acuity (VA) was tested binocularly (both eyes) at a distance of 40 cm, without manifest refraction, using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart presenting on a self-calibrating monitor in a computerized testing system. Visual acuity was measured in logarithm of the minimum angle of resolution (logMAR), with a 0.02 logMAR increment corresponding to a single letter on the ETDRS chart.
6 Months (160-210 days post second eye operative visit)
Mean Binocular Photopic Uncorrected Distance (4 m) Visual Acuity (UCDVA)
Visual acuity (VA) was tested binocularly (both eyes) at a distance of 4 m, with +0.25 D infinity adjustment lens in front of the eyes, using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart presenting on a self-calibrating monitor in a computerized testing system. Visual acuity was measured in logarithm of the minimum angle of resolution (logMAR), with a 0.02 logMAR increment corresponding to a single letter on the ETDRS chart.
6 Months (160-210 days post second eye operative visit)
Mean Monocular Photopic Distance-Corrected Intermediate (66 cm) Visual Acuity (DCIVA) in IC-8â„¢ IOL Eyes
Visual acuity (VA) was tested monocularly (each eye) at a distance of 66 cm, with the distance manifest refraction (with infinity adjustment) in place for that eye, using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart presenting on a self-calibrating monitor in a computerized testing system. Visual acuity was measured in logarithm of the minimum angle of resolution (logMAR), with a 0.02 logMAR increment corresponding to a single letter on the ETDRS chart.
Secondary Outcomes
Measure
Description
Time Frame
Tolerance to Preoperative Corneal Astigmatism in IC-8â„¢ IOL Eyes With BCDVA 20/25 at 3 Months
Uncorrected-distance visual acuity (UCDVA) in IC-8â„¢ IOL eyes achieving best-corrected distance visual acuity (BCDVA) of 20/25 or better was compared between eyes with preoperative corneal astigmatism < 1.0 D to eyes with 1.0 D to 1.5 D of preoperative corneal astigmatism.
3 Months (60-110 days post second eye operative visit)
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Minimum 22 years of age;
Able to comprehend and have signed a statement of informed consent;
Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visits;
Planned crystalline lens removal by phacoemulsification, with or without femtosecond laser-assisted extraction, and posterior chamber IOL implantation in both eyes;
Cataractous lens changes as demonstrated by best-corrected visual acuity (BCDVA) of 20/40 or worse either with or without a glare source present;
Potential for postoperative BCDVA of 20/25 or better in each eye
Clear intraocular media, other than cataract.
Exclusion Criteria:
Requiring an IC-8 intraocular lens outside the available spherical power range
Pharmacologically dilated pupil size less than 6 mm in either eye;
Inability to achieve stable keratometric readings for contact lens wearers
Irregular astigmatism in either eye;
Preoperative corneal astigmatism > 1.50 diopters in either eye
Active or recurrent anterior segment pathology
Presence of ocular abnormalities other than cataract as specified in the protocol
Diagnosis of dry eye in which patients are unable to maintain eye comfort or adequate vision even with dry eye medication;
Congenital cataracts;
Previous corneal or intraocular surgery
History of ocular trauma or ocular conditions expected to require retinal laser treatment or other surgical intervention;
Systemic conditions as specified in the protocol;
Patient is pregnant, plans to become pregnant, or is lactating
Concurrent participation or participation in any clinical trial up to 30 days prior to preoperative visit.
Accepts Healthy Volunteers
Yes
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
Magda Michna, PhD
AcuFocus, Inc.
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Fishkind, Bakewell, Maltzman, Hunter & Associates Eye Care & Surgery Center
Vukich J, Thompson V, Yeu E, Wiley WF, Bafna S, Koch DD, Lin L, Michna M. Evaluating the small aperture intraocular lens: depth of focus and the role of refraction and preoperative corneal astigmatism in visual performance. J Cataract Refract Surg. 2024 Nov 1;50(11):1165-1172. doi: 10.1097/j.jcrs.0000000000001524.
A total of 548 subjects signed the informed consent form, 79 of whom did not meet inclusion/exclusion criteria and were considered screen failures; leaving 469 subjects who were considered provisionally enrolled in the study. A total of 16 subjects were disqualified or discontinued from the study prior to second eye implantation. There were 453 subjects who were successfully bilaterally implanted in the study (reporting group).
Recruitment Details
Subjects were recruited from 21 investigative sites within the United States from 04 December 2018 to 21 August 2019. The investigative sites were comprised of similar clinic, surgical center, and equipment requirements necessary for the intended use of the IC-8â„¢ IOL.
Type of Units Analyzed
Eyes
Arm/Group Information
ID
Title
Description
FG000
IC-8â„¢ IOL Group
Subjects implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225) in the first eye and the IC-8™ Intraocular Lens (IOL) in the second eye.
Subjects in this Group were assigned to Astigmatism Group 1 (<1.0 D) or Astigmatism Group 2 (1.0 D - 1.5 D), as determined by preoperative corneal astigmatism in the 2nd eye (study eye).
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
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_SAP
Yes
Yes
No
Study Protocol and Statistical Analysis Plan
Oct 23, 2018
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
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Single
Masking Description
Examiner masked
Who Masked
Outcomes Assessor
IC-8 IOL Group
Intraocular Lens
Control Group
Device
A monofocal IOL (TECNIS ZCB00, ZCT150 or ZCT225 or AcrySof IQ SA60WF, SA6AT3 or SA6AT4) bilaterally implanted for lifetime use of the patient.
Control Group
Intraocular lens
6 Months (160-210 days post second eye operative visit)
Mean Monocular Photopic Depth of Focus (DOF) in IC-8â„¢ IOL Eyes
Depth of focus was performed monocularly in the IC-8â„¢ IOL Group at the far to near range of vision (+2.00 to -5.00 D), using 100% contrast ETDRS charts in a computerized testing system calibrated for a 4 m test distance, with manifest refraction (no infinity adjustment) in place for the eye(s) being tested. The defocus power was progressively introduced in 0.50 D increments from +2.00 D to +0.50 D and from -0.50 D to -5.00 D, then in 0.25 D increments from +0.50 D to -0.50 D, while visual acuity was measured at each successive defocus step. The depth of focus was estimated as the defocus 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.
3 Months (60-110 days post second eye operative visit)
Mean Monocular Best-corrected Distance (4 m) Visual Acuity (BCDVA)
Visual acuity (VA) was tested monocularly (each eye) at a distance of 4 m, in photopic conditions, with manifest refraction in place (no infinity adjustment) using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart presenting on a self-calibrating monitor in a computerized testing system. Visual acuity was measured in logarithm of the minimum angle of resolution (logMAR), with a 0.02 logMAR increment corresponding to a single letter on the ETDRS chart.
12 Months (300-420 days post second eye operative visit)
Proportion of IC-8â„¢ IOL Eyes Achieving Best-corrected Distance Visual Acuity (BCDVA) 0.3 logMAR or Better Compared to the Safety and Performance Endpoints (SPE) Rates
Visual acuity (VA) was tested monocularly (each eye) at a distance of 4 m, in photopic conditions, with manifest refraction in place (no infinity adjustment) using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart presenting on a self-calibrating monitor in a computerized testing system. Visual acuity was measured in logarithm of the minimum angle of resolution (logMAR), with a 0.02 logMAR increment corresponding to a single letter on the ETDRS chart.
12 Months (300-420 days post second eye operative visit)
Proportion of Best-Case IC-8â„¢ IOL Eyes Achieving Best-corrected Distance Visual Acuity (BCDVA) 0.3 logMAR or Better Compared to the Safety and Performance Endpoints (SPE) Rates
Visual acuity (VA) was tested monocularly (each eye) at a distance of 4 m, in photopic conditions, with manifest refraction in place (no infinity adjustment) using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart presenting on a self-calibrating monitor in a computerized testing system. Visual acuity was measured in logarithm of the minimum angle of resolution (logMAR), with a 0.02 logMAR increment corresponding to a single letter on the ETDRS chart. Monocular BCDVA for the IC-8â„¢ IOL eyes of subjects in the Best-Case population was compared to the safety and performance endpoints (SPE) rate for posterior chamber IOLs.
12 Months (300-420 days post second eye operative visit)
Rates of IC-8â„¢ IOL Eyes With Cumulative Ocular Serious Adverse Events
The rates of cumulative ocular serious adverse events (SAEs) for IC-8â„¢ IOL eyes were calculated from the time of second eye (IC-8â„¢ IOL eye) implantation through Month 12.
Through 12 Months (300-420 days post second eye operative visit)
Rates of IC-8â„¢ IOL Eyes With Cumulative Postoperative Ocular Adverse Events (Secondary Surgical Interventions)
The rates of cumulative ocular adverse events for IC-8â„¢ IOL eyes were calculated from the time of second eye (IC-8â„¢ IOL eye) implantation through Month 12.
Through 12 Months (300-420 days post second eye operative visit)
Rates of IC-8â„¢ IOL Eyes With Persistent Ocular Serious Adverse Events
The rates of persistent (defined as being unresolved at final scheduled visit) ocular adverse events (AEs) for IC-8â„¢ IOL eyes were calculated from the time of second eye (IC-8â„¢ IOL eye) implantation through Month 12.
Through 12 Months (300-420 days post second eye operative visit)
Rates of IC-8â„¢ IOL Eyes With IC-8â„¢ IOL Removals
The rates of cumulative ocular adverse events for IC-8â„¢ IOL eyes were calculated from the time of second eye (IC-8â„¢ IOL eye) implantation through Month 12.
Through 12 Months (300-420 days post second eye operative visit)
Rates of Eyes With Postoperative Ocular Adverse Events (Other Than Secondary Surgical Intervention), Related to Device (Serious and Non-Serious Combined)
The rates of cumulative ocular adverse events (AEs) for IC-8â„¢ IOL eyes were calculated from the time of second eye (IC-8â„¢ IOL eye) implantation through Month 12.
Through 12 Months (300-420 days post second eye operative visit)
Mean Monocular Photopic Contrast Sensitivity Without Glare
Contrast sensitivity (the ability to distinguish between an object and it's background) was evaluated in a subgroup of subjects and was tested monocularly (each eye) in photopic (well-lit) conditions, without a glare source, using sine waving gratings in a computerized testing system. The photopic spatial frequencies tested were 3, 6, 12, 18 cycles per degree (cpd). When a subject was unable to see the highest contrast grating, the highest contrast score was assigned. Raw scores (0 to 9) from contrast sensitivity testing were transformed to log units. Better contrast sensitivity results are reflected by a higher numeric value.
6 Months (160-210 days post second eye operative visit)
Mean Monocular Photopic Contrast Sensitivity With Glare
Contrast sensitivity (the ability to distinguish between an object and it's background) was evaluated in a subgroup of subjects, and was tested monocularly (each eye) in photopic (well-lit) conditions, with a glare source, using sine waving gratings in a computerized testing system. The photopic spatial frequencies tested were 3, 6, 12, 18 cycles per degree (cpd). When a subject was unable to see the highest contrast grating, the highest contrast score was assigned. Raw scores (0 to 9) from contrast sensitivity testing were transformed to log units. Better results are reflected by a higher numeric value.
6 Months (160-210 days post second eye operative visit)
Mean Monocular Mesopic Contrast Sensitivity Without Glare
Contrast sensitivity (the ability to distinguish between an object and it's background) was evaluated in a subgroup of subjects and was tested monocularly (each eye) in mesopic (low-light) conditions, without a glare source, using sine waving gratings in a computerized testing system. The mesopic spatial frequencies tested were 1.5, 3, 6, 12 cycles per degree (cpd). When a subject was unable to see the highest contrast grating, the highest contrast score was assigned. Raw scores (0 to 9) from contrast sensitivity testing were transformed to log units. Better results are reflected by a higher numeric value.
6 Months (160-210 days post second eye operative visit)
Mean Monocular Mesopic Contrast Sensitivity With Glare
Contrast sensitivity (the ability to distinguish between an object and it's background) was evaluated in a subgroup of subjects and was tested monocularly (each eye) in mesopic (low-light) conditions, with a glare source, using sine waving gratings in a computerized testing system. The mesopic spatial frequencies tested were 1.5, 3, 6, 12 cycles per degree (cpd). When a subject was unable to see the highest contrast grating, the highest contrast score was assigned. Raw scores (0 to 9) from contrast sensitivity testing were transformed to log units. Better results are reflected by a higher numeric value.
6 Months (160-210 days post second eye operative visit)
Mean Binocular Photopic Contrast Sensitivity Without Glare
Contrast sensitivity (the ability to distinguish between an object and it's background) was evaluated in a subgroup of subjects and was tested binocularly (both eyes) in photopic (well-lit) conditions, without a glare source, using sine waving gratings in a computerized testing system. The photopic spatial frequencies tested were 3, 6, 12, 18 cycles per degree (cpd). When a subject was unable to see the highest contrast grating, the highest contrast score was assigned. Raw scores (0 to 9) from contrast sensitivity testing were transformed to log units. Better results are reflected by a higher numeric value.
6 Months (160-210 days post second eye operative visit)
Mean Binocular Photopic Contrast Sensitivity With Glare
Contrast sensitivity (the ability to distinguish between an object and it's background) was evaluated in a subgroup of subjects and was tested binocularly (both eyes) in photopic (well-lit) conditions, with a glare source, using sine waving gratings in a computerized testing system. The photopic spatial frequencies tested were 3, 6, 12, 18 cycles per degree (cpd). When a subject was unable to see the highest contrast grating, the highest contrast score was assigned. Raw scores (0 to 9) from contrast sensitivity testing were transformed to log units. Better results are reflected by a higher numeric value.
6 Months (160-210 days post second eye operative visit)
Mean Binocular Mesopic Contrast Sensitivity Without Glare
Contrast sensitivity (the ability to distinguish between an object and it's background) was evaluated in a subgroup of subjects and was tested binocularly (both eyes) in mesopic (low-light) conditions, without a glare source, using sine waving gratings in a computerized testing system. The mesopic spatial frequencies tested were 1.5, 3, 6, 12 cycles per degree (cpd). When a subject was unable to see the highest contrast, the highest contrast grating, the highest contrast score was assigned. Raw scores (0 to 9) from contrast sensitivity testing were transformed to log units. Better results are reflected by a higher numeric value.
6 Months (160-210 days post second eye operative visit)
Mean Binocular Mesopic Contrast Sensitivity With Glare
Contrast sensitivity (the ability to distinguish between an object and it's background) was evaluated in a subgroup of subjects and was tested binocularly (both eyes) in mesopic (low-light) conditions, with a glare source, using sine waving gratings in a computerized testing system. The mesopic spatial frequencies tested were 1.5, 3, 6, 12 cycles per degree (cpd). When a subject was unable to see the highest contrast grating, the highest contrast score was assigned. Raw scores (0 to 9) from contrast sensitivity testing were transformed to log units. Better results are reflected by a higher numeric value.
6 Months (160-210 days post second eye operative visit)
Empire Eye & Laser Center
Bakersfield
California
93309
United States
Harvard Eye Associates
Laguna Hills
California
92653
United States
Altos Eye Physicians
Los Altos
California
94024
United States
Advanced Vision Care
Los Angeles
California
90067
United States
Eye Center of Northern Colorado
Fort Collins
Colorado
80525
United States
Eye Center of North Florida
Panama City
Florida
32405
United States
Chu Vision Institute
Bloomington
Minnesota
55420
United States
Pepose Vision Institute
St Louis
Missouri
63128
United States
Kugler Vision
Omaha
Nebraska
68118
United States
Alterman, Modi & Wolter
Poughkeepsie
New York
12603
United States
Physicians Protocol
Greensboro
North Carolina
27408
United States
Cleveland Eye Clinic
Brecksville
Ohio
44141
United States
Philadelphia Eye Associates
Philadelphia
Pennsylvania
19148
United States
Bucci Laser Vision
Wilkes-Barre
Pennsylvania
18702
United States
Vance Thompson Vision
Sioux Falls
South Dakota
57108
United States
Baylor College of Medicine
Houston
Texas
77030
United States
Parkhurst NuVision
San Antonio
Texas
78229
United States
Hoopes Vision
Draper
Utah
84021
United States
Utah Eye Centers
Ogden
Utah
84403
United States
Virginia Eye Consultants
Norfolk
Virginia
23502
United States
FG001
Control Group
Subjects bilaterally implanted with monofocal IOLs (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
Subjects in this Group were assigned to Astigmatism Group 1 (<1.0 D) or Astigmatism Group 2 (1.0 D - 1.5 D), as determined by preoperative corneal astigmatism in the 2nd eye (fellow eye).
FG000343 subjects686 units
FG001110 subjects220 units
Astigmatism Group 1 (IC-8â„¢ IOL Group)
FG000273 subjects546 units
FG0010 subjects0 units
Astigmatism Group 2 (IC-8â„¢ IOL Group)
FG00070 subjects140 units
FG0010 subjects0 units
Astigmatism Group 1 (Control Group)
FG0000 subjects0 units
FG00191 subjects182 units
Astigmatism Group 2 (Control Group)
FG0000 subjects0 units
FG00119 subjects38 units
COMPLETED
FG000331 subjects662 units
FG001101 subjects202 units
NOT COMPLETED
FG00012 subjects24 units
FG0019 subjects18 units
Type
Comment
Reasons
Lost to Follow-up
FG0004 subjects
FG0015 subjects
Discontinued
FG0008 subjects
FG0014 subjects
The analysis population includes all eyes with successful bilateral implantation (Intent-to-Treat analysis population). Baseline characteristics were analyzed by subject.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
IC-8â„¢ IOL Group
Subjects implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225) in the first eye and the IC-8™ Intraocular Lens (IOL) in the second eye.
BG001
Control Group
Subjects bilaterally implanted with monofocal IOLs (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
BG002
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000343
BG001110
BG002453
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00066.1± 7.96
BG00169.1± 8.63
BG00266.8± 8.22
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000211
BG00176
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00022
BG00110
BG002
Race (NIH/OMB)
Entries of 'Unknown' or 'Not Reported' represent race reported as 'Other'. During the clinical study there were no participants with 'Unknown' or 'Not Reported' race.
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0001
BG001
Preoperative Corneal Astigmatism
Each study group (IC-8â„¢ IOL Group, Control Group) included two astigmatism groups, Astigmatism Group 1 (<1.0 D) and Astigmatism Group 2 (1.0 D - 1.5 D). The enrollment ratio was approximately 5:1 for Astigmatism Group 1 vs. Astigmatism Group 2. Subject assignment to Astigmatism Group 1 or Astigmatism Group 2 was determined by preoperative corneal astigmatism in the second eye as measured by optical biometry.
Count of Participants
Participants
Title
Denominators
Categories
Astigmatism Group 1 (<1.0 D)
Title
Measurements
BG000273
BG001
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
Mean Binocular Photopic Uncorrected Intermediate (66 cm) Visual Acuity (UCIVA)
Visual acuity (VA) was tested binocularly (both eyes) at a distance of 66 cm, without manifest refraction, using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart presenting on a self-calibrating monitor in a computerized testing system. Visual acuity was measured in logarithm of the minimum angle of resolution (logMAR), with a 0.02 logMAR increment corresponding to a single letter on the ETDRS chart.
For this outcome measure, the number of participants/eyes from the Intent-to-Treat (ITT) population (all subjects who were fully enrolled and were binocularly implanted in the study) that were available for analysis at 6 Months was used. It was pre-specified that results were not separated by Astigmatism Groups for this measure.
Posted
Mean
Standard Deviation
logMAR
6 Months (160-210 days post second eye operative visit)
Eyes
Eyes
ID
Title
Description
OG000
IC-8â„¢ IOL Group
Subjects implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225) in the first eye and the IC-8™ Intraocular Lens (IOL) in the second eye.
OG001
Control Group
Subjects bilaterally implanted with monofocal IOLs (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
Units
Counts
Participants
OG000335
OG001100
Eyes
OG000670
OG001
Title
Denominators
Categories
Title
Measurements
OG0000.051± 0.1629
OG0010.228± 0.1646
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
The null hypothesis was that the mean acuity for the IC-8 Group was greater (i.e. worse) than or equal to that for the Control Group. The alternative hypothesis was that the mean for the IC-8 Group less (i.e., better) than that for the Control Group.
t-test, 2 sided
<.0001
The threshold for statistical significance was p=0.05.
Mean Difference (Final Values)
-0.177
2-Sided
95
-0.214
-0.140
Acuity Difference = IC-8 Group - Control Group
Superiority
Primary
Mean Binocular Photopic Uncorrected Near (40 cm) Visual Acuity (UCNVA)
Visual acuity (VA) was tested binocularly (both eyes) at a distance of 40 cm, without manifest refraction, using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart presenting on a self-calibrating monitor in a computerized testing system. Visual acuity was measured in logarithm of the minimum angle of resolution (logMAR), with a 0.02 logMAR increment corresponding to a single letter on the ETDRS chart.
For this outcome measure, the number of participants/eyes from the Intent-to-Treat (ITT) population (all subjects who were fully enrolled and were binocularly implanted in the study) that were available for analysis at 6 Months was used. It was pre-specified that results were not separated by Astigmatism Groups for this measure.
Posted
Mean
Standard Deviation
logMAR
6 Months (160-210 days post second eye operative visit)
Eyes
Eyes
ID
Title
Description
OG000
IC-8â„¢ IOL Group
Subjects implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225) in the first eye and the IC-8™ Intraocular Lens (IOL) in the second eye.
OG001
Control Group
Subjects bilaterally implanted with monofocal IOLs (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
Primary
Mean Binocular Photopic Uncorrected Distance (4 m) Visual Acuity (UCDVA)
Visual acuity (VA) was tested binocularly (both eyes) at a distance of 4 m, with +0.25 D infinity adjustment lens in front of the eyes, using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart presenting on a self-calibrating monitor in a computerized testing system. Visual acuity was measured in logarithm of the minimum angle of resolution (logMAR), with a 0.02 logMAR increment corresponding to a single letter on the ETDRS chart.
For this outcome measure, the number of participants/eyes from the Intent-to-Treat (ITT) population (all subjects who were fully enrolled and were binocularly implanted in the study) that were available for analysis at 6 Months was used. It was pre-specified that results were not separated by Astigmatism Groups for this measure.
Posted
Mean
Standard Deviation
logMAR
6 Months (160-210 days post second eye operative visit)
Eyes
Eyes
ID
Title
Description
OG000
IC-8â„¢ IOL Group
Subjects implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225) in the first eye and the IC-8™ Intraocular Lens (IOL) in the second eye.
OG001
Control Group
Subjects bilaterally implanted with monofocal IOLs (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
Primary
Mean Monocular Photopic Distance-Corrected Intermediate (66 cm) Visual Acuity (DCIVA) in IC-8â„¢ IOL Eyes
Visual acuity (VA) was tested monocularly (each eye) at a distance of 66 cm, with the distance manifest refraction (with infinity adjustment) in place for that eye, using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart presenting on a self-calibrating monitor in a computerized testing system. Visual acuity was measured in logarithm of the minimum angle of resolution (logMAR), with a 0.02 logMAR increment corresponding to a single letter on the ETDRS chart.
For this outcome measure, the number of participants/eyes from the Intent-to-Treat (ITT) population (all subjects who were fully enrolled and were binocularly implanted in the study) that were available for analysis at 6 Months was used. It was pre-specified that results were not separated by Astigmatism Groups for this measure.
Posted
Mean
Standard Deviation
logMAR
6 Months (160-210 days post second eye operative visit)
Eyes
Eyes
ID
Title
Description
OG000
IC-8â„¢ IOL Eyes (IC-8â„¢ IOL Group)
Eyes implanted with the IC-8â„¢ Intraocular Lens (IOL).
OG001
Fellow Eyes (IC-8â„¢ IOL Group)
Eyes implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
Primary
Mean Monocular Photopic Depth of Focus (DOF) in IC-8â„¢ IOL Eyes
Depth of focus was performed monocularly in the IC-8â„¢ IOL Group at the far to near range of vision (+2.00 to -5.00 D), using 100% contrast ETDRS charts in a computerized testing system calibrated for a 4 m test distance, with manifest refraction (no infinity adjustment) in place for the eye(s) being tested. The defocus power was progressively introduced in 0.50 D increments from +2.00 D to +0.50 D and from -0.50 D to -5.00 D, then in 0.25 D increments from +0.50 D to -0.50 D, while visual acuity was measured at each successive defocus step. The depth of focus was estimated as the defocus 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.
For this outcome measure, the number of participants/eyes from the Intent-to-Treat (ITT) population (all subjects who were fully enrolled and were binocularly implanted in the study) that were available for analysis at 3 Months was used. It was pre-specified that results were not separated by Astigmatism Groups for this measure.
Posted
Mean
Standard Deviation
Diopter
3 Months (60-110 days post second eye operative visit)
Eyes
Eyes
ID
Title
Description
OG000
IC-8â„¢ IOL Eyes (IC-8â„¢ IOL Group)
Eyes implanted with the IC-8â„¢ Intraocular Lens (IOL).
OG001
Fellow Eyes (IC-8â„¢ IOL Group)
Eyes implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
Primary
Mean Monocular Best-corrected Distance (4 m) Visual Acuity (BCDVA)
Visual acuity (VA) was tested monocularly (each eye) at a distance of 4 m, in photopic conditions, with manifest refraction in place (no infinity adjustment) using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart presenting on a self-calibrating monitor in a computerized testing system. Visual acuity was measured in logarithm of the minimum angle of resolution (logMAR), with a 0.02 logMAR increment corresponding to a single letter on the ETDRS chart.
For this outcome measure, the safety analysis set was used, which, included available data from all eyes that were bilaterally implanted, or for whom implantation of an IC-8â„¢ IOL was attempted (the IC-8 IOL touched the eye during surgery). The Safety and ITT populations were identical in this study. Data from participants/eyes available for analysis at 12 Months was used. It was pre-specified that results were not separated by Astigmatism Groups for this outcome measure.
Posted
Mean
Standard Deviation
logMAR
12 Months (300-420 days post second eye operative visit)
Eyes
Eyes
ID
Title
Description
OG000
IC-8â„¢ IOL Eyes (IC-8â„¢ IOL Group)
Eyes implanted with the IC-8â„¢ Intraocular Lens (IOL).
OG001
Fellow Eyes (IC-8â„¢ IOL Group)
Eyes implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
Primary
Proportion of IC-8â„¢ IOL Eyes Achieving Best-corrected Distance Visual Acuity (BCDVA) 0.3 logMAR or Better Compared to the Safety and Performance Endpoints (SPE) Rates
Visual acuity (VA) was tested monocularly (each eye) at a distance of 4 m, in photopic conditions, with manifest refraction in place (no infinity adjustment) using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart presenting on a self-calibrating monitor in a computerized testing system. Visual acuity was measured in logarithm of the minimum angle of resolution (logMAR), with a 0.02 logMAR increment corresponding to a single letter on the ETDRS chart.
For this outcome measure, the safety analysis set was used, which, included available data from all eyes that were bilaterally implanted, or for whom implantation of an IC-8â„¢ IOL was attempted (the IC-8 IOL touched the eye during surgery). The Safety and ITT populations were identical in this study. Data from participants/eyes available for analysis at 12 Months was used. It was pre-specified that results were not separated by Astigmatism Groups for this outcome measure.
Posted
Count of Units
Eyes
12 Months (300-420 days post second eye operative visit)
Eyes
Eyes
ID
Title
Description
OG000
IC-8â„¢ IOL Eyes (IC-8â„¢ IOL Group)
Eyes implanted with the IC-8â„¢ Intraocular Lens (IOL).
OG001
Fellow Eyes (IC-8â„¢ IOL Group)
Eyes implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
Primary
Proportion of Best-Case IC-8â„¢ IOL Eyes Achieving Best-corrected Distance Visual Acuity (BCDVA) 0.3 logMAR or Better Compared to the Safety and Performance Endpoints (SPE) Rates
Visual acuity (VA) was tested monocularly (each eye) at a distance of 4 m, in photopic conditions, with manifest refraction in place (no infinity adjustment) using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart presenting on a self-calibrating monitor in a computerized testing system. Visual acuity was measured in logarithm of the minimum angle of resolution (logMAR), with a 0.02 logMAR increment corresponding to a single letter on the ETDRS chart. Monocular BCDVA for the IC-8â„¢ IOL eyes of subjects in the Best-Case population was compared to the safety and performance endpoints (SPE) rate for posterior chamber IOLs.
For this outcome measure, the Best-Case analysis was used, which, included subjects with no preoperative ocular pathology, no macular degeneration detected at any time, and no previous surgery for the correction of refractive errors (as defined by ISO 11979-1:2012), as well as no significant macular pathology at any time. Data from participants/eyes available for analysis at 12 Months was used. It was pre-specified that results were not separated by Astigmatism Groups for this outcome measure.
Posted
Count of Units
Eyes
12 Months (300-420 days post second eye operative visit)
Eyes
Eyes
ID
Title
Description
OG000
IC-8â„¢ IOL Eyes (IC-8â„¢ IOL Group)
Eyes implanted with the IC-8â„¢ Intraocular Lens (IOL).
OG001
Fellow Eyes (IC-8â„¢ IOL Group)
Primary
Rates of IC-8â„¢ IOL Eyes With Cumulative Ocular Serious Adverse Events
The rates of cumulative ocular serious adverse events (SAEs) for IC-8â„¢ IOL eyes were calculated from the time of second eye (IC-8â„¢ IOL eye) implantation through Month 12.
For this outcome measure, the safety analysis set was used, which, included available data from all eyes that were bilaterally implanted, or for whom implantation of an IC-8â„¢ IOL was attempted (the IC-8 IOL touched the eye during surgery). The Safety and ITT populations were identical in this study. Data from participants/eyes available for analysis at 12 Months was used. It was pre-specified that results were not separated by Astigmatism Groups for this outcome measure.
Posted
Count of Units
Eyes
Through 12 Months (300-420 days post second eye operative visit)
Eyes
Eyes
ID
Title
Description
OG000
IC-8â„¢ IOL Eyes (IC-8â„¢ IOL Group)
Eyes implanted with the IC-8â„¢ Intraocular Lens (IOL).
OG001
Fellow Eyes (IC-8â„¢ IOL Group)
Eyes implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
Units
Counts
Primary
Rates of IC-8â„¢ IOL Eyes With Cumulative Postoperative Ocular Adverse Events (Secondary Surgical Interventions)
The rates of cumulative ocular adverse events for IC-8â„¢ IOL eyes were calculated from the time of second eye (IC-8â„¢ IOL eye) implantation through Month 12.
For this outcome measure, the safety analysis set was used, which, included available data from all eyes that were bilaterally implanted, or for whom implantation of an IC-8â„¢ IOL was attempted (the IC-8 IOL touched the eye during surgery). The Safety and ITT populations were identical in this study. Data from participants/eyes available for analysis at 12 Months was used. It was pre-specified that results were not separated by Astigmatism Groups for this outcome measure.
Posted
Count of Units
Eyes
Through 12 Months (300-420 days post second eye operative visit)
Eyes
Eyes
ID
Title
Description
OG000
IC-8 IOL Eyes (IC-8â„¢ IOL Group)
Eyes implanted with the IC-8â„¢ Intraocular Lens (IOL).
OG001
Fellow Eyes (IC-8â„¢ IOL Group)
Eyes implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
OG002
Second Eyes (Control Group)
Primary
Rates of IC-8â„¢ IOL Eyes With Persistent Ocular Serious Adverse Events
The rates of persistent (defined as being unresolved at final scheduled visit) ocular adverse events (AEs) for IC-8â„¢ IOL eyes were calculated from the time of second eye (IC-8â„¢ IOL eye) implantation through Month 12.
For this outcome measure, the safety analysis set was used, which, included available data from all eyes that were bilaterally implanted, or for whom implantation of an IC-8â„¢ IOL was attempted (the IC-8 IOL touched the eye during surgery). The Safety and ITT populations were identical in this study. Data from participants/eyes available for analysis at 12 Months was used. It was pre-specified that results were not separated by Astigmatism Groups for this outcome measure.
Posted
Count of Units
Eyes
Through 12 Months (300-420 days post second eye operative visit)
Eyes
Eyes
ID
Title
Description
OG000
IC-8â„¢ IOL Eyes (IC-8â„¢ IOL Group)
Eyes implanted with the IC-8â„¢ Intraocular Lens (IOL).
OG001
Fellow Eyes (IC-8â„¢ IOL Group)
Eyes implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
Units
Primary
Rates of IC-8â„¢ IOL Eyes With IC-8â„¢ IOL Removals
The rates of cumulative ocular adverse events for IC-8â„¢ IOL eyes were calculated from the time of second eye (IC-8â„¢ IOL eye) implantation through Month 12.
For this outcome measure, the safety analysis set was used, which, included available data from all eyes that were bilaterally implanted, or for whom implantation of an IC-8â„¢ IOL was attempted (the IC-8 IOL touched the eye during surgery). The Safety and ITT populations were identical in this study. Data from participants/eyes available for analysis at 12 Months was used. It was pre-specified that results were not separated by Astigmatism Groups for this outcome measure.
Posted
Count of Units
Eyes
Through 12 Months (300-420 days post second eye operative visit)
Eyes
Eyes
ID
Title
Description
OG000
IC-8â„¢ IOL Eyes (IC-8â„¢ IOL Group)
Eyes implanted with the IC-8â„¢ Intraocular Lens (IOL).
OG001
Fellow Eyes (IC-8â„¢ IOL Group)
Eyes implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
OG002
Second Eye (Control Group)
Eyes implanted with an AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00, or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225) in the Control Group.
Primary
Rates of Eyes With Postoperative Ocular Adverse Events (Other Than Secondary Surgical Intervention), Related to Device (Serious and Non-Serious Combined)
The rates of cumulative ocular adverse events (AEs) for IC-8â„¢ IOL eyes were calculated from the time of second eye (IC-8â„¢ IOL eye) implantation through Month 12.
For this outcome measure, the safety analysis set was used, which, included available data from all eyes that were bilaterally implanted, or for whom implantation of an IC-8â„¢ IOL was attempted (the IC-8 IOL touched the eye during surgery). The Safety and ITT populations were identical in this study. Data from participants/eyes available for analysis at 12 Months was used. It was pre-specified that results were not separated by Astigmatism Groups for this outcome measure.
Posted
Count of Units
Eyes
Through 12 Months (300-420 days post second eye operative visit)
Eyes
Eyes
ID
Title
Description
OG000
IC-8 IOL Eyes (IC-8â„¢ IOL Group
Eyes implanted with the IC-8â„¢ Intraocular Lens (IOL).
OG001
Fellow Eyes (IC-8â„¢ IOL Group
Eyes implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
OG002
Second Eyes (Control Group)
Secondary
Tolerance to Preoperative Corneal Astigmatism in IC-8â„¢ IOL Eyes With BCDVA 20/25 at 3 Months
Uncorrected-distance visual acuity (UCDVA) in IC-8â„¢ IOL eyes achieving best-corrected distance visual acuity (BCDVA) of 20/25 or better was compared between eyes with preoperative corneal astigmatism < 1.0 D to eyes with 1.0 D to 1.5 D of preoperative corneal astigmatism.
For this outcome measure, the number of participants/eyes from the modified Intent-to-Treat (mITT) population (subjects from the intent to treat population that achieved BCDVA 20/25 or better) that were available for analysis at 3 Months was used. It was pre-specified that results were not separated by Astigmatism Groups for this measure.
Posted
Mean
Standard Deviation
logMAR
3 Months (60-110 days post second eye operative visit)
Eyes
Eyes
ID
Title
Description
OG000
IC-8â„¢ IOL Eyes With Astigmatism <1.0 D (IC-8â„¢ IOL Group)
Eyes with <1.0 D preoperative corneal astigmatism implanted with the IC-8â„¢ Intraocular Lens (IOL).
OG001
IC-8â„¢ IOL Eyes With Astigmatism 1.0 D - 1.5 D (IC-8â„¢ IOL Group)
Eyes with 1.0 D - 1.5 D preoperative corneal astigmatism implanted with the IC-8â„¢ Intraocular Lens (IOL).
Units
Counts
Secondary
Mean Monocular Photopic Contrast Sensitivity Without Glare
Contrast sensitivity (the ability to distinguish between an object and it's background) was evaluated in a subgroup of subjects and was tested monocularly (each eye) in photopic (well-lit) conditions, without a glare source, using sine waving gratings in a computerized testing system. The photopic spatial frequencies tested were 3, 6, 12, 18 cycles per degree (cpd). When a subject was unable to see the highest contrast grating, the highest contrast score was assigned. Raw scores (0 to 9) from contrast sensitivity testing were transformed to log units. Better contrast sensitivity results are reflected by a higher numeric value.
A subgroup of subjects from the IC-8â„¢ IOL Group (262 enrolled) and Control Group (68 enrolled) available for analysis at 6 Months. It was pre-specified that results were not separated by Astigmatism Groups for this outcome measure.
Posted
Mean
Standard Deviation
log units on a scale
6 Months (160-210 days post second eye operative visit)
log units
log units
ID
Title
Description
OG000
IC-8â„¢ IOL Eyes (IC-8â„¢ IOL Group)
Eyes implanted with the IC-8â„¢ Intraocular Lens (IOL).
OG001
Fellow Eyes (IC-8â„¢ IOL Group)
Eyes implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
Secondary
Mean Monocular Photopic Contrast Sensitivity With Glare
Contrast sensitivity (the ability to distinguish between an object and it's background) was evaluated in a subgroup of subjects, and was tested monocularly (each eye) in photopic (well-lit) conditions, with a glare source, using sine waving gratings in a computerized testing system. The photopic spatial frequencies tested were 3, 6, 12, 18 cycles per degree (cpd). When a subject was unable to see the highest contrast grating, the highest contrast score was assigned. Raw scores (0 to 9) from contrast sensitivity testing were transformed to log units. Better results are reflected by a higher numeric value.
A subgroup of subjects from the IC-8â„¢ IOL Group (262 enrolled) and Control Group (68 enrolled) available for analysis at 6 Months. It was pre-specified that results were not separated by Astigmatism Groups for this outcome measure.
Posted
Mean
Standard Deviation
log units on a scale
6 Months (160-210 days post second eye operative visit)
ID
Title
Description
OG000
IC-8â„¢ IOL Eyes (IC-8â„¢ IOL Group)
Eyes implanted with the IC-8â„¢ Intraocular Lens (IOL).
OG001
Fellow Eyes (IC-8â„¢ IOL Group)
Eyes implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
Secondary
Mean Monocular Mesopic Contrast Sensitivity Without Glare
Contrast sensitivity (the ability to distinguish between an object and it's background) was evaluated in a subgroup of subjects and was tested monocularly (each eye) in mesopic (low-light) conditions, without a glare source, using sine waving gratings in a computerized testing system. The mesopic spatial frequencies tested were 1.5, 3, 6, 12 cycles per degree (cpd). When a subject was unable to see the highest contrast grating, the highest contrast score was assigned. Raw scores (0 to 9) from contrast sensitivity testing were transformed to log units. Better results are reflected by a higher numeric value.
A subgroup of subjects from the IC-8â„¢ IOL Group (262 enrolled) and Control Group (68 enrolled) available for analysis at 6 Months. It was pre-specified that results were not separated by Astigmatism Groups for this outcome measure.
Posted
Mean
Standard Deviation
log units on a scale
6 Months (160-210 days post second eye operative visit)
log units
log units
ID
Title
Description
OG000
IC-8â„¢ IOL Eyes (IC-8â„¢ IOL Group)
Eyes implanted with the IC-8â„¢ Intraocular Lens (IOL).
OG001
Fellow Eyes (IC-8â„¢ IOL Group)
Eyes implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
Secondary
Mean Monocular Mesopic Contrast Sensitivity With Glare
Contrast sensitivity (the ability to distinguish between an object and it's background) was evaluated in a subgroup of subjects and was tested monocularly (each eye) in mesopic (low-light) conditions, with a glare source, using sine waving gratings in a computerized testing system. The mesopic spatial frequencies tested were 1.5, 3, 6, 12 cycles per degree (cpd). When a subject was unable to see the highest contrast grating, the highest contrast score was assigned. Raw scores (0 to 9) from contrast sensitivity testing were transformed to log units. Better results are reflected by a higher numeric value.
A subgroup of subjects from the IC-8â„¢ IOL Group (262 enrolled) and Control Group (68 enrolled) available for analysis at 6 Months. It was pre-specified that results were not separated by Astigmatism Groups for this outcome measure.
Posted
Mean
Standard Deviation
log units on a scale
6 Months (160-210 days post second eye operative visit)
log units
log units
ID
Title
Description
OG000
IC-8â„¢ IOL Eyes (IC-8â„¢ IOL Group)
Eyes implanted with the IC-8â„¢ Intraocular Lens (IOL).
OG001
Fellow Eyes (IC-8â„¢ IOL Group)
Eyes implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
Secondary
Mean Binocular Photopic Contrast Sensitivity Without Glare
Contrast sensitivity (the ability to distinguish between an object and it's background) was evaluated in a subgroup of subjects and was tested binocularly (both eyes) in photopic (well-lit) conditions, without a glare source, using sine waving gratings in a computerized testing system. The photopic spatial frequencies tested were 3, 6, 12, 18 cycles per degree (cpd). When a subject was unable to see the highest contrast grating, the highest contrast score was assigned. Raw scores (0 to 9) from contrast sensitivity testing were transformed to log units. Better results are reflected by a higher numeric value.
A subgroup of subjects from the IC-8â„¢ IOL Group (262 enrolled) and Control Group (68 enrolled) available for analysis at 6 Months. It was pre-specified that results were not separated by Astigmatism Groups for this outcome measure.
Posted
Mean
Standard Deviation
log units on a scale
6 Months (160-210 days post second eye operative visit)
log units
log units
ID
Title
Description
OG000
IC-8â„¢ IOL Group
Subjects implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225) in the first eye and the IC-8™ Intraocular Lens (IOL) in the second eye.
OG001
Control Group
Subjects bilaterally implanted with monofocal IOLs (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
Secondary
Mean Binocular Photopic Contrast Sensitivity With Glare
Contrast sensitivity (the ability to distinguish between an object and it's background) was evaluated in a subgroup of subjects and was tested binocularly (both eyes) in photopic (well-lit) conditions, with a glare source, using sine waving gratings in a computerized testing system. The photopic spatial frequencies tested were 3, 6, 12, 18 cycles per degree (cpd). When a subject was unable to see the highest contrast grating, the highest contrast score was assigned. Raw scores (0 to 9) from contrast sensitivity testing were transformed to log units. Better results are reflected by a higher numeric value.
A subgroup of subjects from the IC-8â„¢ IOL Group (262 enrolled) and Control Group (68 enrolled) available for analysis at 6 Months. It was pre-specified that results were not separated by Astigmatism Groups for this outcome measure.
Posted
Mean
Standard Deviation
log units on a scale
6 Months (160-210 days post second eye operative visit)
log units
log units
ID
Title
Description
OG000
IC-8â„¢ IOL Group
Subjects implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225) in the first eye and the IC-8™ Intraocular Lens (IOL) in the second eye.
OG001
Control Group
Subjects bilaterally implanted with monofocal IOLs (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
Secondary
Mean Binocular Mesopic Contrast Sensitivity Without Glare
Contrast sensitivity (the ability to distinguish between an object and it's background) was evaluated in a subgroup of subjects and was tested binocularly (both eyes) in mesopic (low-light) conditions, without a glare source, using sine waving gratings in a computerized testing system. The mesopic spatial frequencies tested were 1.5, 3, 6, 12 cycles per degree (cpd). When a subject was unable to see the highest contrast, the highest contrast grating, the highest contrast score was assigned. Raw scores (0 to 9) from contrast sensitivity testing were transformed to log units. Better results are reflected by a higher numeric value.
A subgroup of subjects from the IC-8â„¢ IOL Group (262 enrolled) and Control Group (68 enrolled) available for analysis at 6 Months. It was pre-specified that results were not separated by Astigmatism Groups for this outcome measure.
Posted
Mean
Standard Deviation
log units on a scale
6 Months (160-210 days post second eye operative visit)
log units
log units
ID
Title
Description
OG000
IC-8â„¢ IOL Group
Subjects implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225) in the first eye and the IC-8™ Intraocular Lens (IOL) in the second eye.
OG001
Control Group
Subjects bilaterally implanted with monofocal IOLs (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
Secondary
Mean Binocular Mesopic Contrast Sensitivity With Glare
Contrast sensitivity (the ability to distinguish between an object and it's background) was evaluated in a subgroup of subjects and was tested binocularly (both eyes) in mesopic (low-light) conditions, with a glare source, using sine waving gratings in a computerized testing system. The mesopic spatial frequencies tested were 1.5, 3, 6, 12 cycles per degree (cpd). When a subject was unable to see the highest contrast grating, the highest contrast score was assigned. Raw scores (0 to 9) from contrast sensitivity testing were transformed to log units. Better results are reflected by a higher numeric value.
A subgroup of subjects from the IC-8â„¢ IOL Group (262 enrolled) and Control Group (68 enrolled) available for analysis at 6 Months. It was pre-specified that results were not separated by Astigmatism Groups for this outcome measure.
Posted
Mean
Standard Deviation
log units on a scale
6 Months (160-210 days post second eye operative visit)
log units
log units
ID
Title
Description
OG000
IC-8â„¢ IOL Group
Subjects implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225) in the first eye and the IC-8™ Intraocular Lens (IOL) in the second eye.
OG001
Control Group
Subjects bilaterally implanted with monofocal IOLs (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
Time Frame
Second eye implantation through study completion; approximately 1-year (12 months).
Description
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8â„¢ IOL but for whom the IC-8â„¢ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
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 population (Intent-to-Treat population) prior to second eye implantation.
0
453
0
453
0
453
EG001
IC-8â„¢ IOL Group - 2nd Eye
All second eyes (study eyes) implanted with IC-8â„¢ IOL in the IC-8â„¢ IOL Group.
0
343
6
343
264
343
EG002
IC-8â„¢ IOL Group - 1st Eye
All first eyes (fellow eyes) implanted with an AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00, or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225) in the IC-8™ IOL Group.
0
343
2
343
148
343
EG003
IC-8â„¢ IOL Group - Systemic
All subjects implanted with the IC-8â„¢ IOL in the IC-8â„¢ IOL Group.
0
343
22
343
114
343
EG004
Control Group - 2nd Eye
All second eyes implanted with an AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00, or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225) in the Control Group.
0
110
1
110
56
110
EG005
Control Group - 1st Eye
All first eyes implanted with an AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00, or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225) in the Control Group.
0
110
1
110
55
110
EG006
Control Group - Systemic
All subjects implanted with an AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00, or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225) in the Control Group.
0
110
5
110
50
110
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abscess
Infections and infestations
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG0031 events1 affected343 at risk
EG0040 events0 affected110 at risk
EG0050 events0 affected110 at risk
EG0060 events0 affected110 at risk
Aneursysm
Blood and lymphatic system disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Arrhythmia
Vascular disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Electrolyte imbalance
Metabolism and nutrition disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Heart failure/Congestive heart failure
Vascular disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Hemorrhage/Bleeding
Blood and lymphatic system disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Ischemic heart disease
Vascular disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Pneumonia
Respiratory, thoracic and mediastinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Pulmonary embolism
Vascular disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Sepsis
Infections and infestations
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Solid tumour
Immune system disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Spinal column injury
Musculoskeletal and connective tissue disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Suicidal ideation
Psychiatric disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Transient ischemic attack
Vascular disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Vomiting
General disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Cystoid Macular Edema
Eye disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0013 events3 affected343 at risk
EG0022 events2 affected343 at risk
EG003
Endophthalmitis
Eye disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Intraocular Pressure Increased
Eye disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Iris Injury
Eye disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Retinal Vein Occlusion
Eye disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal pain
General disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG0031 events1 affected343 at risk
EG0040 events0 affected110 at risk
EG0050 events0 affected110 at risk
EG0060 events0 affected110 at risk
Abscess
Infections and infestations
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Acute liver failure
Hepatobiliary disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Altered Visual Depth Perception
Eye disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0011 events1 affected343 at risk
EG0021 events1 affected343 at risk
EG003
Anemia
Blood and lymphatic system disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Angioedema
Musculoskeletal and connective tissue disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Anterior Capsular Phimosis
Eye disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Anxiety
General disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Arrhythmia
Vascular disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Arteriosclerosis/Atherosclerosis
Blood and lymphatic system disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Arthralgia/Myalgia
Musculoskeletal and connective tissue disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Atrial fibrillation
Vascular disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Bradycardia
Surgical and medical procedures
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Breast cancer
Immune system disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Bronchitis
Respiratory, thoracic and mediastinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Bronchospasm/Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Brow, Eyelid Ptosis
Eye disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0012 events2 affected343 at risk
EG0022 events2 affected343 at risk
EG003
Cancer
Immune system disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Cataract Fragments in Eye Following Cataract Surgery
Eye disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0012 events2 affected343 at risk
EG0021 events1 affected343 at risk
EG003
Cataract Operation Complication, Lens Dislocation
Eye disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0011 events1 affected343 at risk
EG0021 events1 affected343 at risk
EG003
Cataract Subcapsular
Eye disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Catheterization arterial normal
Vascular disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Ciliary Zonular Dehiscence, Vitreous Prolapse
Eye disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Cold sores
Immune system disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Common cold syndrome
General disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Conjunctival Edema
Eye disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0021 events1 affected343 at risk
EG003
Conjunctival Hemorrhage
Eye disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0023 events3 affected343 at risk
EG003
Conjunctival abrasion
Eye disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Conjunctivitis
Eye disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0017 events7 affected343 at risk
EG0024 events4 affected343 at risk
EG003
Convulsion/Seizure
Nervous system disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Corneal Abrasion
Eye disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Corneal Deposits, Cornea Verticillata
Eye disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0011 events1 affected343 at risk
EG0021 events1 affected343 at risk
EG003
Corneal Dystrophy
Eye disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0013 events3 affected343 at risk
EG0023 events3 affected343 at risk
EG003
Corneal Epithelial Defect
Eye disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Corneal Epithelial Microcysts
Eye disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0011 events1 affected343 at risk
EG0021 events1 affected343 at risk
EG003
Corneal stromal edema
Eye disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Cramp(s)/Muscle spasm(s)
Musculoskeletal and connective tissue disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Cystoid Macular Edema
Eye disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0012 events2 affected343 at risk
EG0023 events3 affected343 at risk
EG003
Dacryostenosis acquired
Eye disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0011 events1 affected343 at risk
EG0021 events1 affected343 at risk
EG003
Damage to ligament(s)
Musculoskeletal and connective tissue disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Depression
General disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Detached Descemet's membrane
Eye disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0012 events2 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Detachment of retinal pigment epithelium, Retinal depigmentation
Eye disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Device Damage
Eye disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0012 events2 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Diplopia
Eye disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0011 events1 affected343 at risk
EG0022 events2 affected343 at risk
EG003
Dizziness
General disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Dry Eye
Eye disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG00132 events32 affected343 at risk
EG00226 events26 affected343 at risk
EG003
Dysphotopsia
Eye disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0015 events5 affected343 at risk
EG0023 events3 affected343 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Electrolyte Imbalance
Metabolism and nutrition disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Encephalopathy
Infections and infestations
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Eye Irritation
Eye disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0011 events1 affected343 at risk
EG0021 events1 affected343 at risk
EG003
Eye Pain
Eye disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0015 events5 affected343 at risk
EG0021 events1 affected343 at risk
EG003
Eye Pruritus
Eye disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0012 events2 affected343 at risk
EG0022 events2 affected343 at risk
EG003
Eyelid infection
Eye disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0016 events6 affected343 at risk
EG0022 events2 affected343 at risk
EG003
Eyelid tumor
Eye disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Facial pain
General disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Fasciitis
Musculoskeletal and connective tissue disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Flu
General disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Foreign body in eye
Eye disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Fracture
Injury, poisoning and procedural complications
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Fungal infection
Infections and infestations
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Gastrointestinal hemorrhage
Gastrointestinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Gastrointestinal regurgitation
Gastrointestinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Giant cell arteritis
Vascular disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Halo Vision
Eye disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0012 events2 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Headache
General disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Heart failure/Congestive heart failure
Vascular disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Hepatitis, unspecified
Endocrine disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
High blood pressure/Hypertension
General disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
High pulmonary arterial wedge pressure
Vascular disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Hypercholesterolemia
General disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Hyperglycemia
Blood and lymphatic system disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Hypersensitivity/Allergic reaction
Skin and subcutaneous tissue disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Hypertension worsened
Vascular disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Hyponatremia
Metabolism and nutrition disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Hypotension
Vascular disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Intervertebral disc compression or protrusion
Musculoskeletal and connective tissue disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Intraocular pressure increased
Eye disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG00119 events19 affected343 at risk
EG00216 events16 affected343 at risk
EG003
Iris transillumination defect
Eye disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Iritis
Eye disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG00115 events15 affected343 at risk
EG0027 events7 affected343 at risk
EG003
Keratic precipitates
Eye disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0011 events1 affected343 at risk
EG0021 events1 affected343 at risk
EG003
Low blood pressure/Hypotension
Vascular disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Lyme disease
Immune system disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Metabolic acidosis
Metabolism and nutrition disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Muscle/Tendon damage
General disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Ocular Discomfort
Eye disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0021 events1 affected343 at risk
EG003
Oral bacterial infection
Infections and infestations
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Pain
General disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Peripheral vascular disease NOS
Vascular disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Phlebitis
Vascular disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Photophobia
Eye disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0011 events1 affected343 at risk
EG0021 events1 affected343 at risk
EG003
Pleural effusion
Vascular disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Pneumonia
Respiratory, thoracic and mediastinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Polyp of nasal cavity
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Posterior Vitreous Detachment
Eye disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG00119 events19 affected343 at risk
EG0028 events8 affected343 at risk
EG003
Posterior capsule opacification
Eye disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG001111 events111 affected343 at risk
EG00248 events48 affected343 at risk
EG003
Posterior capsule tear
Eye disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Prostatic hyperplasia
Reproductive system and breast disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Punctate Keratitis
Eye disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0014 events4 affected343 at risk
EG0021 events1 affected343 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Renal impairment
Renal and urinary disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Respiratory tract infection
Respiratory, thoracic and mediastinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Restless legs syndrome
Musculoskeletal and connective tissue disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Retinal Drusen
Eye disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Retinal Tear
Eye disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0021 events1 affected343 at risk
EG003
Retinal Vein Occlusion
Eye disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0021 events1 affected343 at risk
EG003
Suicidal ideation
Psychiatric disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Swollen lymph nodes/glands
Endocrine disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Thrombocytopenia
Vascular disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Thrombosis/Thrombus
Vascular disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Thrombus
Vascular disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Transient ischemic attack
Vascular disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Trichiasis
Eye disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0011 events1 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Unspecified infection
Infections and infestations
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Unspecified mental, emotional or behavioural problem
Psychiatric disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Unspecified musculoskeletal problem
Musculoskeletal and connective tissue disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Unspecified nervous system problem
Nervous system disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Urolithiasis
Renal and urinary disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Uveitis (intermediate)
Eye disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0011 events1 affected343 at risk
EG0021 events1 affected343 at risk
EG003
Vertigo
General disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Viral infection
Infections and infestations
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Vision Blurred
Eye disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0012 events2 affected343 at risk
EG0023 events3 affected343 at risk
EG003
Visual Acuity Reduced
Eye disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0014 events4 affected343 at risk
EG0021 events1 affected343 at risk
EG003
Vitreoretinal Traction Syndrome
Eye disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Vomiting
General disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 at risk
EG003
Whiplash injury to neck
Injury, poisoning and procedural complications
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected453 at risk
EG0010 events0 affected343 at risk
EG0020 events0 affected343 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
The only disclosure restriction on the PI is that the PI must provide sponsor a manuscript of such submission(s) for review, comment and approval at least 90 days prior to a planned submission for publication or presentation and that sponsor is permitted to delay any publication or presentation in specific circumstances.
Point of Contact
Title
Organization
Phone
Extension
Email
Magda Michna, PhD., Chief Global Clinical, Medical and Regulatory Affairs Officer
The null hypothesis was that the mean acuity for the IC-8 Group was greater (i.e. worse) than or equal to that for the Control Group. The alternative hypothesis was that the mean for the IC-8 Group less (i.e., better) than that for the Control Group.
t-test, 2 sided
<.0001
The threshold for statistical significance was p=0.05.
Mean Difference (Final Values)
-0.191
2-Sided
95
-0.223
-0.158
Acuity Difference = IC-8 Group - Control Group
Superiority
Units
Counts
Participants
OG000335
OG001100
Eyes
OG000670
OG001200
Title
Denominators
Categories
Title
Measurements
OG000-0.010± 0.1063
OG0010.002± 0.0992
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
The null hypothesis was that the mean acuity for the IC-8 IOL Group is inferior to the Control Group by 0.1 logMAR or more. The alternative hypothesis was that the mean acuity for the IC-8 IOL group is inferior to the Control Group by less than 0.1 logMAR.
t-test, 1 sided
<.0001
The threshold for statistical significance was p=0.05.
Mean Difference (Final Values)
-0.012
1-Sided
95
0.007
Acuity Difference = IC-8 IOL Group - Control Group
Non-Inferiority
Non-inferiority margin was 0.1 logMAR.
Units
Counts
Participants
OG000335
OG001335
Eyes
OG000335
OG001335
Title
Denominators
Categories
Title
Measurements
OG0000.144± 0.1709
OG0010.325± 0.1687
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
The null hypothesis was that the mean acuity for the IC-8 IOL eyes is greater (i.e., worse) than or equal to that for the fellow eyes. The alternative hypothesis was that the mean for the IC-8 IOL eyes is less (i.e., better) than that for the fellow eyes.
t-test, 2 sided
<.0001
The threshold for statistical significance was p=0.05.
OG000-1.99± NAThe negative intercept (outcome measure) was calculated from the means of the two defocus steps where the defocus curve crosses the 0.2 logMAR threshold.
OG001-1.08± NAThe negative intercept (outcome measure) was calculated from the means of the two defocus steps where the defocus curve crosses the 0.2 logMAR threshold.
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
Difference in depth of focus
0.91
2-Sided
Difference in depth of focus [IC-8â„¢ IOL Eyes (IC-8â„¢ IOL Group) - Fellow Eyes (IC-8â„¢ IOL Group)]
Other
Units
Counts
Participants
OG000331
OG001331
Eyes
OG000331
OG001331
Title
Denominators
Categories
Title
Measurements
OG0000.009± 0.1131
OG001-0.059± 0.0928
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
The null hypothesis was that the mean acuity for the IC-8 IOL eyes was inferior to the fellow eyes by 0.1 logMAR or more. The alternative hypothesis was that the mean acuity for the IC-8 eyes was inferior to the fellow eyes by less than 0.1 logMAR.
t-test, 1 sided
<.0001
The threshold for statistical significance was p=0.05.
Eyes implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
Units
Counts
Participants
OG000319
OG001319
Eyes
OG000319
OG001319
Title
Denominators
Categories
Title
Measurements
OG000315
OG001318
Participants
OG000343
OG001343
Eyes
OG000343
OG001343
Title
Denominators
Categories
Cystoid Macular Edema
Title
Measurements
OG0005
OG0014
Hypopyon
Title
Measurements
OG0000
OG0010
Endophthalmitis
Title
Measurements
OG0001
OG0010
Lens Dislocated from Posterior Chamber
Title
Measurements
OG0000
OG0010
Pupillary Block
Title
Measurements
OG0000
OG0010
Retinal Detachment
Title
Measurements
OG0000
OG0010
Modified Paracentesis
Title
Measurements
OG0004
OG0013
Intravitreal Injection
Title
Measurements
OG0001
OG0011
Laser Retinopexy
Title
Measurements
OG0000
OG0011
Other: Retinal Vein Occlusion
Title
Measurements
OG0001
OG0010
Vitrectomy
Title
Measurements
OG0004
OG0011
Removal of retained cortex
Title
Measurements
OG0002
OG0010
IOL repositioning
Title
Measurements
OG0001
OG0011
Eyes implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
OG003
First Eyes (Control Group)
Eyes implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
Units
Counts
Participants
OG000343
OG001343
OG002110
OG003110
Eyes
OG000343
OG001343
OG002110
OG003110
Title
Denominators
Categories
Intravitreal Injection
Title
Measurements
OG0001
OG0011
OG0020
OG0031
IOL Exchange
Title
Measurements
OG0000
OG0010
OG0021
OG003
IOL Repositioning
Title
Measurements
OG0001
OG0011
OG0020
OG003
Iris Reposition
Title
Measurements
OG0000
OG0010
OG0020
OG003
Laser Retinopexy
Title
Measurements
OG0000
OG0011
OG0020
OG003
Laser Vitreolysis
Title
Measurements
OG0000
OG0010
OG0021
OG003
Modified Paracentesis
Title
Measurements
OG0004
OG0013
OG0020
OG003
Removal of Retained Cortex
Title
Measurements
OG0002
OG0010
OG0020
OG003
Vitrectomy
Title
Measurements
OG0004
OG0011
OG0020
OG003
Counts
Participants
OG000331
OG001331
Eyes
OG000331
OG001331
Title
Denominators
Categories
Corneal Stromal Edema
Title
Measurements
OG0000
OG0010
Cystoid Macular Edema
Title
Measurements
OG0001
OG0011
Iritis
Title
Measurements
OG0002
OG0011
Raised IOP Requiring Treatment
Title
Measurements
OG0000
OG0010
Other: Retinal Vein Occlusion
Title
Measurements
OG0001
OG0010
OG003
First Eye (Control Group)
Eyes implanted with an AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00, or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225) in the Control Group.
Units
Counts
Participants
OG000343
OG001343
OG002110
OG003110
Eyes
OG000343
OG001343
OG002110
OG003110
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0021
OG0031
Eyes implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
OG003
First Eyes (Control Group)
Eyes implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
Units
Counts
Participants
OG000343
OG001343
OG002110
OG003110
Eyes
OG000343
OG001343
OG002110
OG003110
Title
Denominators
Categories
Device Damage
Title
Measurements
OG0001
OG0010
OG0020
OG0030
Posterior Capsule Opacification
Title
Measurements
OG0003
OG0011
OG0020
OG003
Altered Visual Depth Perception
Title
Measurements
OG0001
OG0011
OG0020
OG003
Dysphotopsia
Title
Measurements
OG0005
OG0013
OG0020
OG003
Halo Vision
Title
Measurements
OG0002
OG0010
OG0020
OG003
Vision Blurred
Title
Measurements
OG0002
OG0011
OG0020
OG003
Participants
OG000244
OG00165
Eyes
OG000244
OG00165
Title
Denominators
Categories
Title
Measurements
OG0000.085± 0.1269
OG0010.108± 0.1208
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
The null hypothesis was that the mean acuity in Astigmatism Group 2 was inferior to the Astigmatism Group 1 by 0.12 logMAR or more. The alternative hypothesis was that the mean acuity in Astigmatism Group 2 was inferior to Astigmatism Group 1 by less than 0.12 logMAR.
t-test, 1 sided
<.0001
The threshold for statistical significance was p=0.05.