Trial Outcomes & Findings for Investigation of the Safety and Effectiveness of a Trifocal IOL (NCT NCT04176965)
NCT ID: NCT04176965
Last Updated: 2025-01-29
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
539 participants
Primary outcome timeframe
150-180 days after surgery on the first eyes
Results posted on
2025-01-29
Participant Flow
Subjects were recruited from 20 investigative sites located in the United States.
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).
Unit of analysis: eyes
Participant milestones
| Measure |
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 (Control Group)
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.
|
|---|---|---|
|
Overall Study
STARTED
|
332 661
|
164 328
|
|
Overall Study
COMPLETED
|
315 630
|
159 318
|
|
Overall Study
NOT COMPLETED
|
17 31
|
5 10
|
Reasons for withdrawal
| Measure |
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 (Control Group)
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.
|
|---|---|---|
|
Overall Study
Death
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
10
|
2
|
|
Overall Study
Withdrawal by Subject
|
6
|
1
|
Baseline Characteristics
Investigation of the Safety and Effectiveness of a Trifocal IOL
Baseline characteristics by cohort
| Measure |
FINEVISION HP Trifocal IOL (Test Group)
n=332 Participants
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 (Control Group)
n=164 Participants
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.
|
Total
n=496 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
99 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
137 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
233 Participants
n=5 Participants
|
126 Participants
n=7 Participants
|
359 Participants
n=5 Participants
|
|
Age, Continuous
|
67.1 years
STANDARD_DEVIATION 7.41 • n=5 Participants
|
67.8 years
STANDARD_DEVIATION 6.78 • n=7 Participants
|
67.3 years
STANDARD_DEVIATION 7.21 • n=5 Participants
|
|
Sex: Female, Male
Female
|
211 Participants
n=5 Participants
|
102 Participants
n=7 Participants
|
313 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
121 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
183 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
27 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
305 Participants
n=5 Participants
|
157 Participants
n=7 Participants
|
462 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
13 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
19 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
294 Participants
n=5 Participants
|
148 Participants
n=7 Participants
|
442 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 150-180 days after surgery on the first eyesPopulation: All-Implanted Analysis Set- First Operative Eyes with data available at the visit
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.
Outcome measures
| Measure |
FINEVISION HP
n=332 Participants
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.
|
Control Product
n=164 eyes
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.
|
|---|---|---|
|
Mean Photopic Monocular logMAR Best Corrected Distance Visual Acuity (BCDVA) at 4 Meters in First Operative Eyes
|
0.018 logMAR
Standard Error 0.0050
|
-0.028 logMAR
Standard Error 0.0065
|
PRIMARY outcome
Timeframe: 150-180 days after surgery on the first eyesPopulation: All-Implanted Analysis Set-First Operative Eyes with data at visit
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.
Outcome measures
| Measure |
FINEVISION HP
n=332 Eyes
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.
|
Control Product
n=164 Eyes
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.
|
|---|---|---|
|
Mean Photopic Monocular logMAR Distance Corrected Near Visual Acuity (DCNVA) for the First Operative Eyes.
|
0.160 logMAR
Standard Error 0.0076
|
0.551 logMAR
Standard Error 0.0111
|
PRIMARY outcome
Timeframe: Up to Month 12 (Day 360-420), post first eye implantationPopulation: Safety Set (all eyes with successful IOL implantation) - First Operative Eyes
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.
Outcome measures
| Measure |
FINEVISION HP
n=332 Eyes
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.
|
Control Product
n=164 Eyes
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.
|
|---|---|---|
|
Percentage of 1st Operative Eyes With Secondary Surgical Interventions (SSIs) Related to Optical Properties of IOL for up to Month 12 (Visit 5)
|
1 Eyes
|
0 Eyes
|
PRIMARY outcome
Timeframe: Month 12 (Day 360-420), post-first eye implantationPopulation: Best Case Set - First Operative Eyes
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.
Outcome measures
| Measure |
FINEVISION HP
n=296 Eyes
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.
|
Control Product
n=147 Eyes
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.
|
|---|---|---|
|
Mean Monocular Distance Log Contrast Sensitivity Photopic Without Glare at 2.5 m in 1st Operative Eyes at Month 12 (Visit 5).
3 cycles per degree (cpd)
|
-1.998 log units
Standard Deviation 0.3003
|
-2.158 log units
Standard Deviation 0.2742
|
|
Mean Monocular Distance Log Contrast Sensitivity Photopic Without Glare at 2.5 m in 1st Operative Eyes at Month 12 (Visit 5).
6 cycles per degree (cpd)
|
-1.853 log units
Standard Deviation 0.2996
|
-2.087 log units
Standard Deviation 0.2743
|
|
Mean Monocular Distance Log Contrast Sensitivity Photopic Without Glare at 2.5 m in 1st Operative Eyes at Month 12 (Visit 5).
12 cycles per degree (cpd)
|
-1.419 log units
Standard Deviation 0.3558
|
-1.608 log units
Standard Deviation 0.3723
|
|
Mean Monocular Distance Log Contrast Sensitivity Photopic Without Glare at 2.5 m in 1st Operative Eyes at Month 12 (Visit 5).
18 cycles per degree (cpd)
|
-0.935 log units
Standard Deviation 0.3544
|
-1.149 log units
Standard Deviation 0.3822
|
PRIMARY outcome
Timeframe: Month 12 (Day 360-420), post-first eye implantationPopulation: Best Case Set - First Operative Eyes
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.
Outcome measures
| Measure |
FINEVISION HP
n=296 Eyes
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.
|
Control Product
n=146 Eyes
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.
|
|---|---|---|
|
Mean Monocular Distance Log Contrast Sensitivity Photopic With Glare at 2.5 m in 1st Operative Eyes at Month 12 (Visit 5).
6 cycles per degree (cpd)
|
-1.569 log units
Standard Deviation 0.3381
|
-1.820 log units
Standard Deviation 0.3222
|
|
Mean Monocular Distance Log Contrast Sensitivity Photopic With Glare at 2.5 m in 1st Operative Eyes at Month 12 (Visit 5).
12 cycles per degree (cpd)
|
-1.175 log units
Standard Deviation 0.3928
|
-1.357 log units
Standard Deviation 0.4015
|
|
Mean Monocular Distance Log Contrast Sensitivity Photopic With Glare at 2.5 m in 1st Operative Eyes at Month 12 (Visit 5).
3 cycles per degree (cpd)
|
-1.632 log units
Standard Deviation 0.4171
|
-1.836 log units
Standard Deviation 0.3264
|
|
Mean Monocular Distance Log Contrast Sensitivity Photopic With Glare at 2.5 m in 1st Operative Eyes at Month 12 (Visit 5).
18 cycles per degree (cpd)
|
-0.727 log units
Standard Deviation 0.4454
|
-0.956 log units
Standard Deviation 0.4332
|
PRIMARY outcome
Timeframe: Month 12 (Day 360-420), post-first eye implantationPopulation: Best Case Set - First Operative Eyes
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.
Outcome measures
| Measure |
FINEVISION HP
n=296 Eyes
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.
|
Control Product
n=147 Eyes
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.
|
|---|---|---|
|
Mean Monocular Distance Log Contrast Sensitivity Mesopic Without Glare at 2.5 m in 1st Operative Eyes at Month 12 (Visit 5).
1.5 cycles per degree (cpd)
|
-1.709 log units
Standard Deviation 0.2872
|
-1.769 log units
Standard Deviation 0.3251
|
|
Mean Monocular Distance Log Contrast Sensitivity Mesopic Without Glare at 2.5 m in 1st Operative Eyes at Month 12 (Visit 5).
3 cycles per degree (cpd)
|
-1.735 log units
Standard Deviation 0.2966
|
-1.868 log units
Standard Deviation 0.3196
|
|
Mean Monocular Distance Log Contrast Sensitivity Mesopic Without Glare at 2.5 m in 1st Operative Eyes at Month 12 (Visit 5).
6 cycles per degree (cpd)
|
-1.418 log units
Standard Deviation 0.3054
|
-1.628 log units
Standard Deviation 0.3382
|
|
Mean Monocular Distance Log Contrast Sensitivity Mesopic Without Glare at 2.5 m in 1st Operative Eyes at Month 12 (Visit 5).
12 cycles per degree (cpd)
|
-0.778 log units
Standard Deviation 0.3572
|
-0.945 log units
Standard Deviation 0.3419
|
PRIMARY outcome
Timeframe: Month 12 (Day 360-420), post-first eye implantationPopulation: Best Case Set - First Operative Eyes
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.
Outcome measures
| Measure |
FINEVISION HP
n=296 Eyes
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.
|
Control Product
n=146 Eyes
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.
|
|---|---|---|
|
Mean Monocular Distance Log Contrast Sensitivity Mesopic With Glare at 2.5 m in 1st Operative Eyes at Month 12 (Visit 5).
3 cycles per degree (cpd)
|
-1.453 log units
Standard Deviation 0.3331
|
-1.605 log units
Standard Deviation 0.3278
|
|
Mean Monocular Distance Log Contrast Sensitivity Mesopic With Glare at 2.5 m in 1st Operative Eyes at Month 12 (Visit 5).
1.5 cycles per degree (cpd)
|
-1.355 log units
Standard Deviation 0.3495
|
-1.402 log units
Standard Deviation 0.3706
|
|
Mean Monocular Distance Log Contrast Sensitivity Mesopic With Glare at 2.5 m in 1st Operative Eyes at Month 12 (Visit 5).
6 cycles per degree (cpd)
|
-1.193 log units
Standard Deviation 0.4006
|
-1.407 log units
Standard Deviation 0.3851
|
|
Mean Monocular Distance Log Contrast Sensitivity Mesopic With Glare at 2.5 m in 1st Operative Eyes at Month 12 (Visit 5).
12 cycles per degree (cpd)
|
-0.598 log units
Standard Deviation 0.4356
|
-0.822 log units
Standard Deviation 0.3641
|
SECONDARY outcome
Timeframe: 150-180 days after surgery on the first eyePopulation: All-Implanted Analysis Set- First Operative Eyes with data at visit
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.
Outcome measures
| Measure |
FINEVISION HP
n=332 Eyes
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.
|
Control Product
n=164 Eyes
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.
|
|---|---|---|
|
Mean Photopic Monocular logMAR Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 cm for the First Operative Eyes.
|
0.161 logMAR
Standard Error 0.0063
|
0.342 logMAR
Standard Error 0.0102
|
SECONDARY outcome
Timeframe: Month 12 (Day 360-420), post-first eye implantationPopulation: Safety Set - First Operative Eyes
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.
Outcome measures
| Measure |
FINEVISION HP
n=332 Eyes
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.
|
Control Product
n=164 Eyes
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.
|
|---|---|---|
|
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
Cumulative : Hypopyon
|
0 Eyes
|
0 Eyes
|
|
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
Cumulative : Pupillary block
|
0 Eyes
|
0 Eyes
|
|
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
Cumulative : Retinal detachment
|
3 Eyes
|
0 Eyes
|
|
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
Cumulative : Cystoid macular oedema
|
1 Eyes
|
1 Eyes
|
|
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
Cumulative : Endophthalmitis
|
0 Eyes
|
0 Eyes
|
|
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
Cumulative : Lens dislocated from posterior chamber
|
0 Eyes
|
0 Eyes
|
|
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
Cumulative : Secondary surgical intervention
|
6 Eyes
|
1 Eyes
|
|
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
Persistent: Corneal stroma oedema
|
0 Eyes
|
0 Eyes
|
|
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
Persistent: Cystoid macular oedema
|
0 Eyes
|
1 Eyes
|
|
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
Persistent: Iritis
|
1 Eyes
|
0 Eyes
|
|
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
Persistent: Raised Intraocular Pressure (IOP) requiring treatment
|
0 Eyes
|
0 Eyes
|
SECONDARY outcome
Timeframe: Month 12 (Day 360-420), post-first eye implantationPopulation: Safety Set
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: * Frequency: 0 (Never), 1 (Occasionally), 2 (Quite Often), 3 (Very Often) * Severity: 0 (Not at all), 1 (Mild), 2 (Moderate), 3 (Severe) * 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.
Outcome measures
| Measure |
FINEVISION HP
n=316 Participants
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.
|
Control Product
n=159 Participants
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.
|
|---|---|---|
|
Evaluate Visual Disturbances Using the Quality of Vision (QoV) Questionnaire and QoV Supplemental Questions at Month 12 (Visit 5)
Frequency
|
39.8 score on a scale
Standard Deviation 18.50
|
34.8 score on a scale
Standard Deviation 19.58
|
|
Evaluate Visual Disturbances Using the Quality of Vision (QoV) Questionnaire and QoV Supplemental Questions at Month 12 (Visit 5)
Severity
|
31.8 score on a scale
Standard Deviation 16.25
|
29.3 score on a scale
Standard Deviation 17.40
|
|
Evaluate Visual Disturbances Using the Quality of Vision (QoV) Questionnaire and QoV Supplemental Questions at Month 12 (Visit 5)
Bothersomeness
|
30.1 score on a scale
Standard Deviation 21.22
|
28.8 score on a scale
Standard Deviation 21.45
|
Adverse Events
FINEVISION HP Trifocal IOL-1st Eyes
Serious events: 8 serious events
Other events: 17 other events
Deaths: 0 deaths
FINEVISION HP Trifocal IOL - 2nd Eyes
Serious events: 2 serious events
Other events: 23 other events
Deaths: 0 deaths
Alcon AcrySof SN60AT Monofocal IOL-1st Eyes
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Alcon AcrySof SN60AT Monofocal IOL - 2nd Eyes
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
FINEVISION HP Trifocal IOL-Systemic
Serious events: 11 serious events
Other events: 0 other events
Deaths: 1 deaths
Alcon AcrySof SN60AT Monofocal IOL -Systemic
Serious events: 9 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
FINEVISION HP Trifocal IOL-1st Eyes
n=332 participants at risk
First operated eyes with FINEVISION HP Trifocal IOL.
|
FINEVISION HP Trifocal IOL - 2nd Eyes
n=329 participants at risk
Second operated eyes with FINEVISION HP Trifocal IOL.
|
Alcon AcrySof SN60AT Monofocal IOL-1st Eyes
n=164 participants at risk
First operated eyes with Alcon AcrySof SN60AT Monofocal IOL.
|
Alcon AcrySof SN60AT Monofocal IOL - 2nd Eyes
n=164 participants at risk
Second operated eyes with Alcon AcrySof SN60AT Monofocal IOL.
|
FINEVISION HP Trifocal IOL-Systemic
n=332 participants at risk
All subjects implanted with FINEVISION HP Trifocal IOL.
|
Alcon AcrySof SN60AT Monofocal IOL -Systemic
n=164 participants at risk
All subjects implanted with AcrySof SN60AT Monofocal IOL.
|
|---|---|---|---|---|---|---|
|
Eye disorders
Vitreous detachment
|
0.00%
0/332 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/329 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/164 • Implantation through study completion, an average of 12 months
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).
|
0.61%
1/164 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/332 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/164 • Implantation through study completion, an average of 12 months
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).
|
|
Eye disorders
Retinal detachment
|
0.90%
3/332 • Implantation through study completion, an average of 12 months
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).
|
0.61%
2/329 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/164 • Implantation through study completion, an average of 12 months
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).
|
0.61%
1/164 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/332 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/164 • Implantation through study completion, an average of 12 months
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).
|
|
Eye disorders
Macular hole
|
0.60%
2/332 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/329 • Implantation through study completion, an average of 12 months
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).
|
0.61%
1/164 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/164 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/332 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/164 • Implantation through study completion, an average of 12 months
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).
|
|
Eye disorders
Vitritis
|
0.30%
1/332 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/329 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/164 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/164 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/332 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/164 • Implantation through study completion, an average of 12 months
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).
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/332 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/329 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/164 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/164 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/332 • Implantation through study completion, an average of 12 months
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).
|
0.61%
1/164 • Implantation through study completion, an average of 12 months
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).
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/332 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/329 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/164 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/164 • Implantation through study completion, an average of 12 months
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).
|
0.30%
1/332 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/164 • Implantation through study completion, an average of 12 months
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).
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/332 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/329 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/164 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/164 • Implantation through study completion, an average of 12 months
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).
|
0.30%
1/332 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/164 • Implantation through study completion, an average of 12 months
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).
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/332 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/329 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/164 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/164 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/332 • Implantation through study completion, an average of 12 months
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).
|
0.61%
1/164 • Implantation through study completion, an average of 12 months
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).
|
|
General disorders
Death
|
0.00%
0/332 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/329 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/164 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/164 • Implantation through study completion, an average of 12 months
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).
|
0.30%
1/332 • Implantation through study completion, an average of 12 months
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).
|
0.61%
1/164 • Implantation through study completion, an average of 12 months
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).
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/332 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/329 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/164 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/164 • Implantation through study completion, an average of 12 months
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).
|
0.30%
1/332 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/164 • Implantation through study completion, an average of 12 months
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).
|
|
Infections and infestations
Cellulitis
|
0.00%
0/332 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/329 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/164 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/164 • Implantation through study completion, an average of 12 months
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).
|
0.30%
1/332 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/164 • Implantation through study completion, an average of 12 months
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).
|
|
Infections and infestations
Diabetic gangrene
|
0.00%
0/332 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/329 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/164 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/164 • Implantation through study completion, an average of 12 months
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).
|
0.30%
1/332 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/164 • Implantation through study completion, an average of 12 months
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).
|
|
Infections and infestations
Norovirus infection
|
0.00%
0/332 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/329 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/164 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/164 • Implantation through study completion, an average of 12 months
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).
|
0.30%
1/332 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/164 • Implantation through study completion, an average of 12 months
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).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/332 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/329 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/164 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/164 • Implantation through study completion, an average of 12 months
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).
|
0.30%
1/332 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/164 • Implantation through study completion, an average of 12 months
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).
|
|
Infections and infestations
Sepsis
|
0.00%
0/332 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/329 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/164 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/164 • Implantation through study completion, an average of 12 months
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).
|
0.30%
1/332 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/164 • Implantation through study completion, an average of 12 months
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).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/332 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/329 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/164 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/164 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/332 • Implantation through study completion, an average of 12 months
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).
|
0.61%
1/164 • Implantation through study completion, an average of 12 months
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).
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.00%
0/332 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/329 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/164 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/164 • Implantation through study completion, an average of 12 months
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).
|
0.30%
1/332 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/164 • Implantation through study completion, an average of 12 months
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).
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/332 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/329 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/164 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/164 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/332 • Implantation through study completion, an average of 12 months
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).
|
0.61%
1/164 • Implantation through study completion, an average of 12 months
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).
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/332 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/329 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/164 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/164 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/332 • Implantation through study completion, an average of 12 months
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).
|
0.61%
1/164 • Implantation through study completion, an average of 12 months
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).
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.00%
0/332 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/329 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/164 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/164 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/332 • Implantation through study completion, an average of 12 months
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).
|
0.61%
1/164 • Implantation through study completion, an average of 12 months
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).
|
|
Nervous system disorders
Seizure
|
0.00%
0/332 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/329 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/164 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/164 • Implantation through study completion, an average of 12 months
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).
|
0.30%
1/332 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/164 • Implantation through study completion, an average of 12 months
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).
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.00%
0/332 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/329 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/164 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/164 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/332 • Implantation through study completion, an average of 12 months
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).
|
0.61%
1/164 • Implantation through study completion, an average of 12 months
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).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/332 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/329 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/164 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/164 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/332 • Implantation through study completion, an average of 12 months
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).
|
0.61%
1/164 • Implantation through study completion, an average of 12 months
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).
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.00%
0/332 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/329 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/164 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/164 • Implantation through study completion, an average of 12 months
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).
|
0.30%
1/332 • Implantation through study completion, an average of 12 months
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).
|
0.61%
1/164 • Implantation through study completion, an average of 12 months
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).
|
|
Surgical and medical procedures
Spinal fusion surgery
|
0.00%
0/332 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/329 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/164 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/164 • Implantation through study completion, an average of 12 months
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).
|
0.30%
1/332 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/164 • Implantation through study completion, an average of 12 months
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).
|
|
Eye disorders
Flat anterior chamber of eye
|
0.00%
0/332 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/329 • Implantation through study completion, an average of 12 months
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).
|
0.61%
1/164 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/164 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/332 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/164 • Implantation through study completion, an average of 12 months
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).
|
|
Infections and infestations
Herpes ophthalmic
|
0.30%
1/332 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/329 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/164 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/164 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/332 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/164 • Implantation through study completion, an average of 12 months
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).
|
|
Injury, poisoning and procedural complications
Cataract operation complication
|
0.30%
1/332 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/329 • Implantation through study completion, an average of 12 months
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).
|
0.61%
1/164 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/164 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/332 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/164 • Implantation through study completion, an average of 12 months
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).
|
|
Surgical and medical procedures
Vitrectomy
|
0.90%
3/332 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/329 • Implantation through study completion, an average of 12 months
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).
|
0.61%
1/164 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/164 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/332 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/164 • Implantation through study completion, an average of 12 months
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).
|
|
Surgical and medical procedures
Scleral buckling surgery
|
0.30%
1/332 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/329 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/164 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/164 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/332 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/164 • Implantation through study completion, an average of 12 months
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).
|
|
Surgical and medical procedures
Retinal operation
|
0.00%
0/332 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/329 • Implantation through study completion, an average of 12 months
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).
|
0.61%
1/164 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/164 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/332 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/164 • Implantation through study completion, an average of 12 months
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).
|
Other adverse events
| Measure |
FINEVISION HP Trifocal IOL-1st Eyes
n=332 participants at risk
First operated eyes with FINEVISION HP Trifocal IOL.
|
FINEVISION HP Trifocal IOL - 2nd Eyes
n=329 participants at risk
Second operated eyes with FINEVISION HP Trifocal IOL.
|
Alcon AcrySof SN60AT Monofocal IOL-1st Eyes
n=164 participants at risk
First operated eyes with Alcon AcrySof SN60AT Monofocal IOL.
|
Alcon AcrySof SN60AT Monofocal IOL - 2nd Eyes
n=164 participants at risk
Second operated eyes with Alcon AcrySof SN60AT Monofocal IOL.
|
FINEVISION HP Trifocal IOL-Systemic
n=332 participants at risk
All subjects implanted with FINEVISION HP Trifocal IOL.
|
Alcon AcrySof SN60AT Monofocal IOL -Systemic
n=164 participants at risk
All subjects implanted with AcrySof SN60AT Monofocal IOL.
|
|---|---|---|---|---|---|---|
|
Eye disorders
Vitreous detachment
|
5.1%
17/332 • Implantation through study completion, an average of 12 months
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).
|
7.0%
23/329 • Implantation through study completion, an average of 12 months
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).
|
7.9%
13/164 • Implantation through study completion, an average of 12 months
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).
|
7.3%
12/164 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/332 • Implantation through study completion, an average of 12 months
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).
|
0.00%
0/164 • Implantation through study completion, an average of 12 months
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).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place