Investigation of the Safety and Effectiveness of a Trifoc... | NCT04176965 | Trialant
NCT04176965
Sponsor
Beaver-Visitec International, Inc.
Status
Completed
Last Update Posted
Jan 29, 2025Actual
Enrollment
539Actual
Phase
Not Applicable
Conditions
Eye Diseases
Postcataract Aphakia
Cataract
Lens Opacities
Interventions
FINEVISION HP IOL
Alcon AcrySof SN60AT
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT04176965
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
PHY1903
Secondary IDs
Not provided
Brief Title
Investigation of the Safety and Effectiveness of a Trifocal IOL
Official Title
Clinical Investigation of the Safety and Effectiveness of FINEVISION HP Trifocal IOL
Acronym
Not provided
Organization
Beaver-Visitec International, Inc.INDUSTRY
Status Module
Record Verification Date
Jan 2025
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
Apr 28, 2022Actual
Primary Completion Date
May 13, 2024Actual
Completion Date
May 13, 2024Actual
First Submitted Date
Nov 20, 2019
First Submission Date that Met QC Criteria
Nov 22, 2019
First Posted Date
Nov 26, 2019Actual
Results Waived
Not provided
Results First Submitted Date
Sep 27, 2024
Results First Submitted that Met QC Criteria
Jan 3, 2025
Results First Posted Date
Jan 29, 2025Actual
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
Jan 3, 2025
Last Update Posted Date
Jan 29, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Beaver-Visitec International, Inc.INDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Not provided
Is FDA Regulated Drug
No
Is FDA Regulated Device
Yes
Is Unapproved Device
Yes
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This study is a prospective, multicenter, randomized, double masked confirmatory trial comparing an investigational trifocal intraocular lens (IOL) and a commercially available monofocal IOL.
Detailed Description
The study will include adult subjects with operable cataracts in both eyes who are eligible for phacoemulsification cataract surgery followed by IOL implantation.
Conditions Module
Conditions
Eye Diseases
Postcataract Aphakia
Cataract
Lens Opacities
Keywords
Intraocular Lens
Multifocal
Hydrophobic
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
539Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
FINEVISION HP
Experimental
Trifocal FINEVISION HP. Cataractous lens will be removed in the study eyes and the FINEVISION HP will be implanted in the capsular bag.
Device: FINEVISION HP IOL
Control Product
Active Comparator
Cataractous lens will be removed in the study eyes and the Alcon AcrySof® SN60AT IOL will be implanted in the capsular bag.
Device: Alcon AcrySof SN60AT
Interventions
Name
Type
Description
Arm Group Labels
Other Names
FINEVISION HP IOL
Device
Cataractous lens will be removed in the study eyes and the FINEVISION HP IOL will be implanted in the capsular bag.
FINEVISION HP
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Mean Photopic Monocular logMAR Best Corrected Distance Visual Acuity (BCDVA) at 4 Meters in First Operative Eyes
Visual acuity (VA) was tested monocularly (each eye separately) under photopic (well-lit) conditions using the correction obtained from the manifest refraction and electronic Early Treatment Diabetic Retinopathy Study (ETDRS) charts on a CTS (Clinical Trial Suite, M&S Technologies) device at a distance of 4 meters (m) from the eye. VA was measured in logarithm of the minimum angle of resolution (logMAR), with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A lower or negative value represents better visual acuity. The mean logMAR values of the two groups were compared to demonstrate non-inferiority of FINEVISION HP trifocal IOL to the control IOL in mean photopic monocular logMAR BCDVA (best corrected distance visual acuity) for the first operative eyes.
150-180 days after surgery on the first eyes
Mean Photopic Monocular logMAR Distance Corrected Near Visual Acuity (DCNVA) for the First Operative Eyes.
VA was tested monocularly under photopic (well-lit) conditions using the manifest refraction adjusted for optical infinity and electronic ETDRS charts at a distance of 40 centimeters (cm) from the eye. Distance corrected visual acuity at near was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A lower value represents better visual acuity. The mean logMAR values of the two groups were compared to demonstrate superiority of FINEVISION HP trifocal IOL to the control in mean photopic monocular logMAR DCNVA for the first operative eyes.
150-180 days after surgery on the first eyes
Percentage of 1st Operative Eyes With Secondary Surgical Interventions (SSIs) Related to Optical Properties of IOL for up to Month 12 (Visit 5)
The number of SSI's related to the optical properties of the IOL was calculated from the time of implantation up to Month 12. The percentage of SSIs was calculated as (# of first operative eyes with an SSI related to the optical properties of the IOL) divided by (# of first operative eyes with successful IOL implantation) times 100. The percentages were compared in the two groups to demonstrate noninferiority of FINEVISION HP IOL compared to AcrySof SN60AT IOL.
Secondary Outcomes
Measure
Description
Time Frame
Mean Photopic Monocular logMAR Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 cm for the First Operative Eyes.
VA was tested monocularly under photopic(well-lit) conditions using the manifest refraction adjusted for optical infinity and electronic ETDRS charts at a distance of 66 centimeters (cm) from the eye. DCIVA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A lower value represents better visual acuity. The mean logMAR values of the two groups were compared to demonstrate superiority of FINEVISION HP trifocal IOL to the control in mean photopic monocular logMAR DCIVA for the first operative eyes.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Male or female adults, age 22 years or older at the Preoperative Visit.
Visually significant cataracts in both eyes that are eligible for phacoemulsification cataract surgery.
Willing to undergo cataract surgery in the second operative eye within 7 - 30 days after surgery in the first eye.
Projected Best Corrected Distance Visual Acuity (BCDVA) of 0.2 logMAR (20/32 Snellen) or better in each eye after cataract surgery/IOL implantation, as determined by the medical judgement of the Investigator
Eligible for receipt of an IOL power within the range of the investigational IOL (+10.0 D to +30.0 D, in 0.50 D increments) in each eye
Contact lens users must be willing to discontinue wear of their lenses in accordance with the following requirements:
Rigid gas permeable lenses for ≥ 7 days prior to the Preoperative Visit
Soft contact lenses for ≥ 3 days prior to the Preoperative Visit Contact lens wearers must demonstrate a stable refraction (within ±0.50 D for both sphere and cylinder) in each eye, as determined by manifest refraction on two consecutive examination dates at least one week apart after discontinuation of contact lens wear.
Provide signed written consent prior to participation in any study-related procedures.
Ability, comprehension, and willingness to follow study instructions, and likely to complete all study visits.
Female subjects must be 1-year postmenopausal, surgically sterilized, or, if of childbearing potential, have a negative urine pregnancy test at the Preoperative Visit. Women of childbearing potential must use an acceptable form of contraception throughout the study. Acceptable methods include at least one of the following: intrauterine (intrauterine device), hormonal (oral, injection, patch, implant, ring), barrier with spermicide (condom, diaphragm), or abstinence.
Exclusion Criteria:
History or presence of, or predisposition to, degenerative visual disorders (e.g., macular degeneration, retinal detachment, proliferative diabetic retinopathy, or other retinal disorders) predicted to result in BCDVA worse than 0.2 LogMAR (20/32 Snellen) in either eye during the study participation period.
Significant anterior segment pathology in either eye that might increase intraoperative risk or compromise IOL stability (e.g., pseudoexfoliation syndrome)
Reasonably expected to require secondary ocular surgical intervention or laser treatment other than YAG capsulotomy in either eye during the study participation period.
Presence of one or more clinically significant corneal abnormalities in either eye, including corneal dystrophy, irregularity, or edema per the Investigator's medical opinion.
Previous intraocular, corneal, or retinal detachment surgery, including corneal transplant, LASIK, astigmatic keratotomy and limbal relaxing incisions in either eye
Rubella, congenital, traumatic or complicated cataract in either eye
Preoperative keratometric astigmatism > 1.0 D or irregular corneal astigmatism in either eye (Note: corneal incisions intended to reduce astigmatism are not permitted)
Clinically significant ocular inflammation or infection present ≤ 30 days in either eye prior to the Preoperative Visit.
Presence or history of one or more severe/serious ocular conditions (e.g., glaucoma, uveitis, ocular infection, severe dry eye) in either eye, or any other unstable medical condition (e.g., uncontrolled diabetes) that in the opinion of the Investigator would put the subject's health at risk, confound the results of the study and/or prevent the subject from completing all study visits.
Use of medications known to interfere with visual performance, pupil dilation, or iris structure ≤ 30 days prior to the Preoperative Visit.
Participation in any study of an investigational, interventional product within 30 days prior to the Preoperative Visit or at any time during the study period.
Pregnant or nursing females.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
22 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Not provided
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Mitchell C Shultz MD/Shultz Chang Vision
Northridge
California
91325
United States
Coastal Vision Medical Group
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
Of the 539 enrolled, 27 exited as screen failures prior to randomization. A total of 512 Participants were randomized in a ratio of 2:1 to receive either the FINEVISION HP Trifocal Intraocular lens (IOL) or the AcrySof SN60AT Monofocal IOL (control) IOL in both eyes. 16 participants discontinued after randomization but before implantation. A total of 496 participants were implanted with either FINEVISION HP Trifocal IOL or the control IOL (3 subjects unilaterally, 493 subjects bilaterally).
Recruitment Details
Subjects were recruited from 20 investigative sites located in the United States.
Type of Units Analyzed
eyes
Arm/Group Information
ID
Title
Description
FG000
FINEVISION HP Trifocal IOL (Test Group)
FINEVISION HP Trifocal IOL implanted in the capsular bag after removal of cataractous lens by phacoemulsification in both eyes on 2 separate operative visits.
Approximately 501 subjects will be screened across up to 24 study sites to complete 300 subjects implanted bilaterally with the FINEVISION HP and 150 subjects implanted bilaterally with the control monofocal Alcon AcrySof SN60AT.
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
In order to minimize bias, site personnel performing postoperative study assessments of visual performance will be masked to subject treatment assignment until after the final database lock ("masked assessors").
Who Masked
ParticipantOutcomes Assessor
Alcon AcrySof SN60AT
Device
Cataractous lens will be removed in the study eyes and the Alcon AcrySof SN60AT IOL will be implanted in the capsular bag.
Control Product
Up to Month 12 (Day 360-420), post first eye implantation
Mean Monocular Distance Log Contrast Sensitivity Photopic Without Glare at 2.5 m in 1st Operative Eyes at Month 12 (Visit 5).
Contrast sensitivity (the ability to detect objects by distinguishing them from their background) was measured monocularly under photopic (well-lit) conditions without glare source in log units using the Clinical Trial Suite (M&S Technologies) for sine-wave gratings 3, 6, 12, and 18 cycles per degree (CPD) at a test distance of 2.5 meters with best-corrected manifest refraction at 4 meters in place with an adjustment of +0.12 D for the 2.5-meter test distance. A more negative numeric log value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure.
Mean Monocular Distance Log Contrast Sensitivity Photopic With Glare at 2.5 m in 1st Operative Eyes at Month 12 (Visit 5).
Contrast sensitivity (the ability to detect objects by distinguishing them from their background) was measured monocularly under photopic (well-lit) conditions with a glare source in log units using the Clinical Trial Suite (M&S Technologies) for sine-wave gratings 3, 6, 12, and 18 cycles per degree (CPD) at a test distance of 2.5 meters with best-corrected manifest refraction at 4 meters in place with an adjustment of +0.12 D for the 2.5-meter test distance. A more negative numeric log value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure.
Mean Monocular Distance Log Contrast Sensitivity Mesopic Without Glare at 2.5 m in 1st Operative Eyes at Month 12 (Visit 5).
Contrast sensitivity (the ability to detect objects by distinguishing them from their background) was measured monocularly under mesopic (dim-lit) conditions without glare source in log units using the Clinical Trial Suite (M&S Technologies) for sine-wave gratings 1.5, 3, 6, and 12 cycles per degree (CPD) at a test distance of 2.5 meters with best-corrected manifest refraction at 4 meters in place with an adjustment of +0.12 D for the 2.5-meter test distance. A more negative numeric log value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure.
Mean Monocular Distance Log Contrast Sensitivity Mesopic With Glare at 2.5 m in 1st Operative Eyes at Month 12 (Visit 5).
Contrast sensitivity (the ability to detect objects by distinguishing them from their background) was measured monocularly under mesopic (dim-lit) conditions with a glare source in log units using the Clinical Trial Suite (M&S Technologies) for sine-wave gratings 1.5, 3, 6, and12 cycles per degree (CPD) at a test distance of 2.5 meters with best-corrected manifest refraction at 4 meters in place with an adjustment of +0.12 D for the 2.5-meter test distance. A more negative numeric log value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure.
Number and Percentage of First Operative Eyes With Cumulative and Persistent Adverse Events at Month 12 (Visit 5) in Comparison to the ISO Safety and Performance Endpoint (SPE) Rates as Described in ISO 11979-7
The number and percentage of the first operative eyes with cumulative and persistent adverse events as noted in ISO 11979-7 were calculated for the two IOL groups and compared with the ISO Safety and Performance Endpoint (SPE) rates from ISO 11979-7 Table E.2. A p-value was calculated for each adverse event for each IOL group to determine the statistical significance of the difference in the percentages.
Evaluate Visual Disturbances Using the Quality of Vision (QoV) Questionnaire and QoV Supplemental Questions at Month 12 (Visit 5)
The Quality of Vision (QoV) questionnaire was used to assess subjective visual disturbances reported by subjects receiving IOLs. The QoV asked the subject to rate the frequency, severity, and degree of bothersomeness for 10 items/visual disturbances in their everyday life based on the past week. The rating scales for frequency, severity, and degree of bothersomeness were:
Bothersome: 0 (Not at all), 1 (A little), 2 (Quite), 3 (Very)
Scores for each subscale (frequency, severity, degree of bothersomeness) ranging from 0 to 100, with higher scores indicating a higher degree of visual disturbances, were computed using a Rasch scoring algorithm which utilized data from the original validation of the QoV. Hypothesis testing was not planned for this outcome measure.
Alcon AcrySof SN60AT Monofocal IOL implanted in the capsular bag after removal of cataractous lens by phacoemulsification in both eyes on 2 separate operative visits.
FG000332 subjects661 units
FG001164 subjects328 units
COMPLETED
FG000315 subjects630 units
FG001159 subjects318 units
NOT COMPLETED
FG00017 subjects31 units
FG0015 subjects10 units
Type
Comment
Reasons
Death
FG0001 subjects
FG0012 subjects
Lost to Follow-up
FG00010 subjects
FG0012 subjects
Withdrawal by Subject
FG0006 subjects
FG0011 subjects
This analysis population includes all participants with successful IOL implantation with at least 1 post-operative visit (All-Implanted Analysis Set).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
FINEVISION HP Trifocal IOL (Test Group)
FINEVISION HP Trifocal IOL implanted in the capsular bag after removal of cataractous lens by phacoemulsification in both eyes on 2 separate operative visits.
Alcon AcrySof SN60AT Monofocal IOL implanted in the capsular bag after removal of cataractous lens by phacoemulsification in both eyes on 2 separate operative visits.
BG002
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000332
BG001164
BG002496
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
Between 18 and 65 years
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00067.1± 7.41
BG00167.8± 6.78
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000211
BG001102
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00027
BG0017
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0001
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Mean Photopic Monocular logMAR Best Corrected Distance Visual Acuity (BCDVA) at 4 Meters in First Operative Eyes
Visual acuity (VA) was tested monocularly (each eye separately) under photopic (well-lit) conditions using the correction obtained from the manifest refraction and electronic Early Treatment Diabetic Retinopathy Study (ETDRS) charts on a CTS (Clinical Trial Suite, M&S Technologies) device at a distance of 4 meters (m) from the eye. VA was measured in logarithm of the minimum angle of resolution (logMAR), with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A lower or negative value represents better visual acuity. The mean logMAR values of the two groups were compared to demonstrate non-inferiority of FINEVISION HP trifocal IOL to the control IOL in mean photopic monocular logMAR BCDVA (best corrected distance visual acuity) for the first operative eyes.
All-Implanted Analysis Set- First Operative Eyes with data available at the visit
Posted
Mean
Standard Error
logMAR
150-180 days after surgery on the first eyes
eyes
eyes
ID
Title
Description
OG000
FINEVISION HP
Trifocal FINEVISION HP. Cataractous lens will be removed in the study eyes and the FINEVISION HP will be implanted in the capsular bag.
FINEVISION HP IOL: Cataractous lens will be removed in the study eyes and the FINEVISION HP IOL will be implanted in the capsular bag.
OG001
Control Product
Cataractous lens will be removed in the study eyes and the Alcon AcrySof® SN60AT IOL will be implanted in the capsular bag.
Alcon AcrySof SN60AT: Cataractous lens will be removed in the study eyes and the Alcon AcrySof SN60AT IOL will be implanted in the capsular bag.
Units
Counts
Participants
OG000332
OG001164
eyes
OG000332
OG001
Title
Denominators
Categories
Title
Measurements
OG0000.018± 0.0050
OG001-0.028± 0.0065
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
t-test, 1 sided
<0.0001
Mean difference
0.045
Standard Error of the Mean
0.0084
2-Sided
90
0.0316
0.0592
Non-Inferiority
Non-inferiority based on the observed 95% Upper Confidence Limit of the difference in means between the 2 groups (FINEVISION HP - AcrySof SN60AT). Non-inferiority margin = 0.10 logMAR.
Primary
Mean Photopic Monocular logMAR Distance Corrected Near Visual Acuity (DCNVA) for the First Operative Eyes.
VA was tested monocularly under photopic (well-lit) conditions using the manifest refraction adjusted for optical infinity and electronic ETDRS charts at a distance of 40 centimeters (cm) from the eye. Distance corrected visual acuity at near was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A lower value represents better visual acuity. The mean logMAR values of the two groups were compared to demonstrate superiority of FINEVISION HP trifocal IOL to the control in mean photopic monocular logMAR DCNVA for the first operative eyes.
All-Implanted Analysis Set-First Operative Eyes with data at visit
Posted
Mean
Standard Error
logMAR
150-180 days after surgery on the first eyes
Eyes
Eyes
ID
Title
Description
OG000
FINEVISION HP Trifocal IOL (Test Group)
FINEVISION HP Trifocal IOL implanted in the capsular bag after removal of cataractous lens by phacoemulsification in both eyes on 2 separate operative visits.
Alcon AcrySof SN60AT Monofocal IOL implanted in the capsular bag after removal of cataractous lens by phacoemulsification in both eyes on 2 separate operative visits.
Primary
Percentage of 1st Operative Eyes With Secondary Surgical Interventions (SSIs) Related to Optical Properties of IOL for up to Month 12 (Visit 5)
The number of SSI's related to the optical properties of the IOL was calculated from the time of implantation up to Month 12. The percentage of SSIs was calculated as (# of first operative eyes with an SSI related to the optical properties of the IOL) divided by (# of first operative eyes with successful IOL implantation) times 100. The percentages were compared in the two groups to demonstrate noninferiority of FINEVISION HP IOL compared to AcrySof SN60AT IOL.
Safety Set (all eyes with successful IOL implantation) - First Operative Eyes
Posted
Count of Units
Eyes
Up to Month 12 (Day 360-420), post first eye implantation
Eyes
Eyes
ID
Title
Description
OG000
FINEVISION HP Trifocal IOL (Test Group)
FINEVISION HP Trifocal IOL implanted in the capsular bag after removal of cataractous lens by phacoemulsification in both eyes on 2 separate operative visits.
Alcon AcrySof SN60AT Monofocal IOL implanted in the capsular bag after removal of cataractous lens by phacoemulsification in both eyes on 2 separate operative visits.
Primary
Mean Monocular Distance Log Contrast Sensitivity Photopic Without Glare at 2.5 m in 1st Operative Eyes at Month 12 (Visit 5).
Contrast sensitivity (the ability to detect objects by distinguishing them from their background) was measured monocularly under photopic (well-lit) conditions without glare source in log units using the Clinical Trial Suite (M&S Technologies) for sine-wave gratings 3, 6, 12, and 18 cycles per degree (CPD) at a test distance of 2.5 meters with best-corrected manifest refraction at 4 meters in place with an adjustment of +0.12 D for the 2.5-meter test distance. A more negative numeric log value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure.
FINEVISION HP Trifocal IOL implanted in the capsular bag after removal of cataractous lens by phacoemulsification in both eyes on 2 separate operative visits.
Alcon AcrySof SN60AT Monofocal IOL implanted in the capsular bag after removal of cataractous lens by phacoemulsification in both eyes on 2 separate operative visits.
Primary
Mean Monocular Distance Log Contrast Sensitivity Photopic With Glare at 2.5 m in 1st Operative Eyes at Month 12 (Visit 5).
Contrast sensitivity (the ability to detect objects by distinguishing them from their background) was measured monocularly under photopic (well-lit) conditions with a glare source in log units using the Clinical Trial Suite (M&S Technologies) for sine-wave gratings 3, 6, 12, and 18 cycles per degree (CPD) at a test distance of 2.5 meters with best-corrected manifest refraction at 4 meters in place with an adjustment of +0.12 D for the 2.5-meter test distance. A more negative numeric log value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure.
FINEVISION HP Trifocal IOL implanted in the capsular bag after removal of cataractous lens by phacoemulsification in both eyes on 2 separate operative visits.
Alcon AcrySof SN60AT Monofocal IOL implanted in the capsular bag after removal of cataractous lens by phacoemulsification in both eyes on 2 separate operative visits.
Primary
Mean Monocular Distance Log Contrast Sensitivity Mesopic Without Glare at 2.5 m in 1st Operative Eyes at Month 12 (Visit 5).
Contrast sensitivity (the ability to detect objects by distinguishing them from their background) was measured monocularly under mesopic (dim-lit) conditions without glare source in log units using the Clinical Trial Suite (M&S Technologies) for sine-wave gratings 1.5, 3, 6, and 12 cycles per degree (CPD) at a test distance of 2.5 meters with best-corrected manifest refraction at 4 meters in place with an adjustment of +0.12 D for the 2.5-meter test distance. A more negative numeric log value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure.
FINEVISION HP Trifocal IOL implanted in the capsular bag after removal of cataractous lens by phacoemulsification in both eyes on 2 separate operative visits.
Alcon AcrySof SN60AT Monofocal IOL implanted in the capsular bag after removal of cataractous lens by phacoemulsification in both eyes on 2 separate operative visits.
Primary
Mean Monocular Distance Log Contrast Sensitivity Mesopic With Glare at 2.5 m in 1st Operative Eyes at Month 12 (Visit 5).
Contrast sensitivity (the ability to detect objects by distinguishing them from their background) was measured monocularly under mesopic (dim-lit) conditions with a glare source in log units using the Clinical Trial Suite (M&S Technologies) for sine-wave gratings 1.5, 3, 6, and12 cycles per degree (CPD) at a test distance of 2.5 meters with best-corrected manifest refraction at 4 meters in place with an adjustment of +0.12 D for the 2.5-meter test distance. A more negative numeric log value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure.
FINEVISION HP Trifocal IOL implanted in the capsular bag after removal of cataractous lens by phacoemulsification in both eyes on 2 separate operative visits.
Alcon AcrySof SN60AT Monofocal IOL implanted in the capsular bag after removal of cataractous lens by phacoemulsification in both eyes on 2 separate operative visits.
Secondary
Mean Photopic Monocular logMAR Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 cm for the First Operative Eyes.
VA was tested monocularly under photopic(well-lit) conditions using the manifest refraction adjusted for optical infinity and electronic ETDRS charts at a distance of 66 centimeters (cm) from the eye. DCIVA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A lower value represents better visual acuity. The mean logMAR values of the two groups were compared to demonstrate superiority of FINEVISION HP trifocal IOL to the control in mean photopic monocular logMAR DCIVA for the first operative eyes.
All-Implanted Analysis Set- First Operative Eyes with data at visit
Posted
Mean
Standard Error
logMAR
150-180 days after surgery on the first eye
Eyes
Eyes
ID
Title
Description
OG000
FINEVISION HP
Trifocal FINEVISION HP. Cataractous lens will be removed in the study eyes and the FINEVISION HP will be implanted in the capsular bag.
FINEVISION HP IOL: Cataractous lens will be removed in the study eyes and the FINEVISION HP IOL will be implanted in the capsular bag.
OG001
Control Product
Cataractous lens will be removed in the study eyes and the Alcon AcrySof® SN60AT IOL will be implanted in the capsular bag.
Alcon AcrySof SN60AT: Cataractous lens will be removed in the study eyes and the Alcon AcrySof SN60AT IOL will be implanted in the capsular bag.
Secondary
Number and Percentage of First Operative Eyes With Cumulative and Persistent Adverse Events at Month 12 (Visit 5) in Comparison to the ISO Safety and Performance Endpoint (SPE) Rates as Described in ISO 11979-7
The number and percentage of the first operative eyes with cumulative and persistent adverse events as noted in ISO 11979-7 were calculated for the two IOL groups and compared with the ISO Safety and Performance Endpoint (SPE) rates from ISO 11979-7 Table E.2. A p-value was calculated for each adverse event for each IOL group to determine the statistical significance of the difference in the percentages.
FINEVISION HP Trifocal IOL implanted in the capsular bag after removal of cataractous lens by phacoemulsification in both eyes on 2 separate operative visits.
Alcon AcrySof SN60AT Monofocal IOL implanted in the capsular bag after removal of cataractous lens by phacoemulsification in both eyes on 2 separate operative visits.
Units
Secondary
Evaluate Visual Disturbances Using the Quality of Vision (QoV) Questionnaire and QoV Supplemental Questions at Month 12 (Visit 5)
The Quality of Vision (QoV) questionnaire was used to assess subjective visual disturbances reported by subjects receiving IOLs. The QoV asked the subject to rate the frequency, severity, and degree of bothersomeness for 10 items/visual disturbances in their everyday life based on the past week. The rating scales for frequency, severity, and degree of bothersomeness were:
Bothersome: 0 (Not at all), 1 (A little), 2 (Quite), 3 (Very)
Scores for each subscale (frequency, severity, degree of bothersomeness) ranging from 0 to 100, with higher scores indicating a higher degree of visual disturbances, were computed using a Rasch scoring algorithm which utilized data from the original validation of the QoV. Hypothesis testing was not planned for this outcome measure.
FINEVISION HP Trifocal IOL implanted in the capsular bag after removal of cataractous lens by phacoemulsification in both eyes on 2 separate operative visits.
Alcon AcrySof SN60AT Monofocal IOL implanted in the capsular bag after removal of cataractous lens by phacoemulsification in both eyes on 2 separate operative visits.
Time Frame
Implantation through study completion, an average of 12 months
Description
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with successful IOL implantation (Safety Analysis Set).
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
FINEVISION HP Trifocal IOL-1st Eyes
First operated eyes with FINEVISION HP Trifocal IOL.
0
332
8
332
17
332
EG001
FINEVISION HP Trifocal IOL - 2nd Eyes
Second operated eyes with FINEVISION HP Trifocal IOL.
0
329
2
329
23
329
EG002
Alcon AcrySof SN60AT Monofocal IOL-1st Eyes
First operated eyes with Alcon AcrySof SN60AT Monofocal IOL.
0
164
2
164
13
164
EG003
Alcon AcrySof SN60AT Monofocal IOL - 2nd Eyes
Second operated eyes with Alcon AcrySof SN60AT Monofocal IOL.
0
164
1
164
12
164
EG004
FINEVISION HP Trifocal IOL-Systemic
All subjects implanted with FINEVISION HP Trifocal IOL.
1
332
11
332
0
332
EG005
Alcon AcrySof SN60AT Monofocal IOL -Systemic
All subjects implanted with AcrySof SN60AT Monofocal IOL.
Noninferiority of FINEVISION HP compared to control in percentages of first operative eyes with secondary surgical interventions related to the optical properties of the IOL was evaluated using two-sided 90% Farrington method confidence intervals around the difference in percentages between the 2 groups. If the upper limit of the confidence interval is less than 1.4%, the FINEVISION HP IOL will be considered statistically non-inferior to the control IOL.
Units
Counts
Participants
OG000296
OG001147
Eyes
OG000296
OG001147
Title
Denominators
Categories
3 cycles per degree (cpd)
Title
Measurements
OG000-1.998± 0.3003
OG001-2.158± 0.2742
6 cycles per degree (cpd)
Title
Measurements
OG000-1.853± 0.2996
OG001-2.087± 0.2743
12 cycles per degree (cpd)
Title
Measurements
OG000-1.419± 0.3558
OG001-1.608± 0.3723
18 cycles per degree (cpd)
Title
Measurements
OG000-0.935± 0.3544
OG001-1.149± 0.3822
Units
Counts
Participants
OG000296
OG001146
Eyes
OG000296
OG001146
Title
Denominators
Categories
3 cycles per degree (cpd)
Title
Measurements
OG000-1.632± 0.4171
OG001-1.836± 0.3264
6 cycles per degree (cpd)
Title
Measurements
OG000-1.569± 0.3381
OG001-1.820± 0.3222
12 cycles per degree (cpd)
Title
Measurements
OG000-1.175± 0.3928
OG001-1.357± 0.4015
18 cycles per degree (cpd)
Title
Measurements
OG000-0.727± 0.4454
OG001-0.956± 0.4332
Units
Counts
Participants
OG000296
OG001147
Eyes
OG000296
OG001147
Title
Denominators
Categories
1.5 cycles per degree (cpd)
Title
Measurements
OG000-1.709± 0.2872
OG001-1.769± 0.3251
3 cycles per degree (cpd)
Title
Measurements
OG000-1.735± 0.2966
OG001-1.868± 0.3196
6 cycles per degree (cpd)
Title
Measurements
OG000-1.418± 0.3054
OG001-1.628± 0.3382
12 cycles per degree (cpd)
Title
Measurements
OG000-0.778± 0.3572
OG001-0.945± 0.3419
Units
Counts
Participants
OG000296
OG001146
Eyes
OG000296
OG001146
Title
Denominators
Categories
1.5 cycles per degree (cpd)
Title
Measurements
OG000-1.355± 0.3495
OG001-1.402± 0.3706
3 cycles per degree (cpd)
Title
Measurements
OG000-1.453± 0.3331
OG001-1.605± 0.3278
6 cycles per degree (cpd)
Title
Measurements
OG000-1.193± 0.4006
OG001-1.407± 0.3851
12 cycles per degree (cpd)
Title
Measurements
OG000-0.598± 0.4356
OG001-0.822± 0.3641
Units
Counts
Participants
OG000332
OG001164
Eyes
OG000332
OG001164
Title
Denominators
Categories
Title
Measurements
OG0000.161± 0.0063
OG0010.342± 0.0102
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
t-test, 2 sided
<0.0001
Superiority
Counts
Participants
OG000332
OG001164
Eyes
OG000332
OG001164
Title
Denominators
Categories
Cumulative : Cystoid macular oedema
Title
Measurements
OG0001
OG0011
Cumulative : Hypopyon
Title
Measurements
OG0000
OG0010
Cumulative : Endophthalmitis
Title
Measurements
OG0000
OG0010
Cumulative : Lens dislocated from posterior chamber
Cumulative: Cystoid macular oedema. The observed AE rates in the FINEVISION HP group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of >0.05 indicates that the rates were statistically not significant when compared to SPE rates.
OG001
One-sided exact binomial test
>0.05
Non-Inferiority
Cumulative: Cystoid macular oedema. The observed AE rates in the control group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of >0.05 indicates that the rates were statistically not significant when compared to SPE rates.
OG000
One-sided exact binomial test
>0.05
Non-Inferiority
Cumulative: Hypopyon. The observed AE rates in the FINEVISION HP group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of >0.05 indicates that the rates were statistically not significant when compared to SPE rates.
OG001
One-sided exact binomial test
>0.05
Non-Inferiority
Cumulative: Hypopyon. The observed AE rates in the control group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of >0.05 indicates that the rates were statistically not significant when compared to SPE rates.
OG000
One-sided exact binomial test
>0.05
Non-Inferiority
Cumulative: Endophthalmitis. The observed AE rates in the FINEVISION HP group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of >0.05 indicates that the rates were statistically not significant when compared to SPE rates.
OG001
One-sided exact binomial test
>0.05
Non-Inferiority
Cumulative: Endophthalmitis. The observed AE rates in the control group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of >0.05 indicates that the rates were statistically not significant when compared to SPE rates.
OG000
One-sided exact binomial test
>0.05
Non-Inferiority
Cumulative: Lens dislocated from posterior chamber. The observed AE rates in the FINEVISION HP group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of >0.05 indicates that the rates were statistically not significant when compared to SPE rates.
OG001
One-sided exact binomial test
>0.05
Non-Inferiority
Cumulative: Lens dislocated from posterior chamber. The observed AE rates in the control group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of >0.05 indicates that the rates were statistically not significant when compared to SPE rates.
OG000
One-sided exact binomial test
>0.05
Non-Inferiority
Cumulative: Pupillary block.The observed AE rates in the FINEVISION HP group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of >0.05 indicates that the rates were statistically not significant when compared to SPE rates.
OG001
One-sided exact binomial test
>0.05
Non-Inferiority
Cumulative: Pupillary block.The observed AE rates in the control group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of >0.05 indicates that the rates were statistically not significant when compared to SPE rates.
OG000
One-sided exact binomial test
>0.05
Non-Inferiority
Cumulative: Retinal detachment.The observed AE rates in the FINEVISION HP group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of >0.05 indicates that the rates were statistically not significant when compared to SPE rates.
OG001
One-sided exact binomial test
>0.05
Non-Inferiority
Cumulative: Retinal detachment.The observed AE rates in the control group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of >0.05 indicates that the rates were statistically not significant when compared to SPE rates.
OG000
One-sided exact binomial test
>0.05
Non-Inferiority
Cumulative: Secondary surgical intervention.The observed AE rates in the FINEVISION HP group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of >0.05 indicates that the rates were statistically not significant when compared to SPE rates.
OG001
One-sided exact binomial test
>0.05
Non-Inferiority
Cumulative: Secondary surgical intervention.The observed AE rates in the control group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of >0.05 indicates that the rates were statistically not significant when compared to SPE rates.
OG000
One-sided exact binomial test
>0.05
Non-Inferiority
Persistent: Corneal stroma oedema.The observed AE rates in the FINEVISION HP group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of >0.05 indicates that the rates were statistically not significant when compared to SPE rates.
OG001
One-sided exact binomial test
>0.05
Non-Inferiority
Persistent: Corneal stroma oedema.The observed AE rates in the control group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of >0.05 indicates that the rates were statistically not significant when compared to SPE rates.
OG000
One-sided exact binomial test
>0.05
Non-Inferiority
Persistent: Cystoid macular oedema.The observed AE rates in the FINEVISION HP group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of >0.05 indicates that the rates were statistically not significant when compared to SPE rates.
OG001
One-sided exact binomial test
>0.05
Non-Inferiority
Persistent: Cystoid macular oedema.The observed AE rates in the control group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of >0.05 indicates that the rates were statistically not significant when compared to SPE rates.
OG000
One-sided exact binomial test
>0.05
Non-Inferiority
Persistent: Iritis.The observed AE rates in the FINEVISION HP group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of >0.05 indicates that the rates were statistically not significant when compared to SPE rates.
OG001
One-sided exact binomial test
>0.05
Non-Inferiority
Persistent: Iritis.The observed AE rates in the control group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of >0.05 indicates that the rates were statistically not significant when compared to SPE rates.
OG000
One-sided exact binomial test
>0.05
Non-Inferiority
Persistent: Raised Intraocular Pressure (IOP) requiring treatment.The observed AE rates in the FINEVISION HP group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of >0.05 indicates that the rates were statistically not significant when compared to SPE rates.
OG001
One-sided exact binomial test
>0.05
Non-Inferiority
Persistent: Raised Intraocular Pressure (IOP) requiring treatment.The observed AE rates in the control group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of >0.05 indicates that the rates were statistically not significant when compared to SPE rates.