Trial Outcomes & Findings for Clinical Investigation of Visual Function After Bilateral Implantation of Two Presbyopia-Correcting Trifocal Intraocular Lenses (IOL) (NCT NCT02691741)
NCT ID: NCT02691741
Last Updated: 2019-09-27
Results Overview
VA was tested binocularly (both eyes together) with no refractive correction in place using an early treatment diabetic retinopathy study (ETDRS) chart set at 60 cm. VA was measured in "logarithm of the minimum angle of resolution" (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
215 participants
Primary outcome timeframe
Day 120-180 from second eye implantation
Results posted on
2019-09-27
Participant Flow
Subjects were recruited from 15 study centers located in Australia (3), Brazil (3), Spain (3), Denmark (2), Colombia (2), United Kingdom (1), and the Netherlands (1).
Of the 215 enrolled, 26 subjects were exited as screen failures and 1 subject died prior to randomization. This reporting group includes all randomized subjects (188).
Participant milestones
| Measure |
TFNT00
AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL, bilateral implantation
|
839MP
AT LISA® tri IOL, bilateral implantation
|
|---|---|---|
|
Overall Study
STARTED
|
94
|
94
|
|
Overall Study
All-Implanted Analysis Set
|
93
|
89
|
|
Overall Study
Best-Case Analysis Set
|
86
|
85
|
|
Overall Study
Safety Analysis Set
|
93
|
89
|
|
Overall Study
COMPLETED
|
93
|
87
|
|
Overall Study
NOT COMPLETED
|
1
|
7
|
Reasons for withdrawal
| Measure |
TFNT00
AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL, bilateral implantation
|
839MP
AT LISA® tri IOL, bilateral implantation
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
4
|
Baseline Characteristics
Clinical Investigation of Visual Function After Bilateral Implantation of Two Presbyopia-Correcting Trifocal Intraocular Lenses (IOL)
Baseline characteristics by cohort
| Measure |
TFNT00
n=93 Participants
AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL, bilateral implantation
|
839MP
n=89 Participants
AT LISA® tri IOL, bilateral implantation
|
Total
n=182 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.1 years
STANDARD_DEVIATION 9.29 • n=5 Participants
|
65.6 years
STANDARD_DEVIATION 9.56 • n=7 Participants
|
65.9 years
STANDARD_DEVIATION 9.40 • n=5 Participants
|
|
Sex: Female, Male
Female
|
57 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White or Caucasian
|
42 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Asian
|
3 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · American Indian or Native American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Multi-Racial
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Other
|
44 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 120-180 from second eye implantationPopulation: All-Implanted Analysis Set
VA was tested binocularly (both eyes together) with no refractive correction in place using an early treatment diabetic retinopathy study (ETDRS) chart set at 60 cm. VA was measured in "logarithm of the minimum angle of resolution" (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity.
Outcome measures
| Measure |
TFNT00
n=93 Participants
AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL, bilateral implantation
|
839MP
n=89 Participants
AT LISA® tri IOL, bilateral implantation
|
|---|---|---|
|
Least Squares Mean Binocular Uncorrected Intermediate Visual Acuity (UCIVA) (60cm) at Day 120-180
|
0.053 logMAR
Standard Error 0.0134
|
0.115 logMAR
Standard Error 0.0139
|
SECONDARY outcome
Timeframe: Day 120-180 from second eye implantationPopulation: All-Implanted Analysis Set
VA was tested binocularly with no refractive correction in place using an ETDRS chart set at 60 cm. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity.
Outcome measures
| Measure |
TFNT00
n=93 Participants
AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL, bilateral implantation
|
839MP
n=89 Participants
AT LISA® tri IOL, bilateral implantation
|
|---|---|---|
|
Least Squares Mean Binocular UCIVA (60cm) at Day 120-180
|
0.053 logMAR
Standard Error 0.0134
|
0.115 logMAR
Standard Error 0.0139
|
SECONDARY outcome
Timeframe: Day 120-180 from second eye implantationPopulation: All-Implanted Analysis Set
VA was tested binocularly with no refractive correction in place using an ETDRS chart set at 4 meters. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity.
Outcome measures
| Measure |
TFNT00
n=93 Participants
AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL, bilateral implantation
|
839MP
n=89 Participants
AT LISA® tri IOL, bilateral implantation
|
|---|---|---|
|
Least Squares Mean Binocular Uncorrected Distance VA (4m) at Day 120-180
|
0.015 logMAR
Standard Error 0.0109
|
0.004 logMAR
Standard Error 0.0113
|
SECONDARY outcome
Timeframe: Day 120-180 from second eye implantationPopulation: All-Implanted Analysis Set
VA was tested binocularly with no refractive correction in place using an ETDRS chart set at 40 cm. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity.
Outcome measures
| Measure |
TFNT00
n=93 Participants
AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL, bilateral implantation
|
839MP
n=89 Participants
AT LISA® tri IOL, bilateral implantation
|
|---|---|---|
|
Least Squares Mean Binocular Uncorrected Near VA (40cm) at Day 120-180
|
0.083 logMAR
Standard Error 0.0116
|
0.133 logMAR
Standard Error 0.0121
|
SECONDARY outcome
Timeframe: Day 120-180 from second eye implantationPopulation: This analysis population includes all subjects with eyes successfully implanted with the test or control article that had at least one postoperative visit, and with no macular degeneration at any time, and no major protocol deviations (Best-Case Analysis Set), with data available.
A defocus curve is created by multiple measurements of one's visual acuity (VA) at different spherical powers. VA was measured in logMAR. A lower logMAR value indicates better visual acuity. No statistical test was performed.
Outcome measures
| Measure |
TFNT00
n=86 Participants
AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL, bilateral implantation
|
839MP
n=81 Participants
AT LISA® tri IOL, bilateral implantation
|
|---|---|---|
|
Mean Photopic Binocular Defocus Curve at Day 120-180
-1.0D
|
0.093 logMAR
Standard Deviation 0.0993
|
0.048 logMAR
Standard Deviation 0.1207
|
|
Mean Photopic Binocular Defocus Curve at Day 120-180
-2.5D
|
0.027 logMAR
Standard Deviation 0.1013
|
0.063 logMAR
Standard Deviation 0.1399
|
|
Mean Photopic Binocular Defocus Curve at Day 120-180
-3.0D
|
0.118 logMAR
Standard Deviation 0.1297
|
0.077 logMAR
Standard Deviation 0.1241
|
|
Mean Photopic Binocular Defocus Curve at Day 120-180
-3.5D
|
0.231 logMAR
Standard Deviation 0.1252
|
0.206 logMAR
Standard Deviation 0.1415
|
|
Mean Photopic Binocular Defocus Curve at Day 120-180
-4.0D
|
0.338 logMAR
Standard Deviation 0.1319
|
0.364 logMAR
Standard Deviation 0.1302
|
|
Mean Photopic Binocular Defocus Curve at Day 120-180
0.0 Diopter (D)
|
-0.048 logMAR
Standard Deviation 0.0811
|
-0.069 logMAR
Standard Deviation 0.0831
|
|
Mean Photopic Binocular Defocus Curve at Day 120-180
-0.5D
|
0.016 logMAR
Standard Deviation 0.0835
|
-0.018 logMAR
Standard Deviation 0.0951
|
|
Mean Photopic Binocular Defocus Curve at Day 120-180
-1.5D
|
0.038 logMAR
Standard Deviation 0.0983
|
0.084 logMAR
Standard Deviation 0.1111
|
|
Mean Photopic Binocular Defocus Curve at Day 120-180
-2.0D
|
0.011 logMAR
Standard Deviation 0.0859
|
0.117 logMAR
Standard Deviation 0.1039
|
|
Mean Photopic Binocular Defocus Curve at Day 120-180
-4.5D
|
0.469 logMAR
Standard Deviation 0.1417
|
0.532 logMAR
Standard Deviation 0.1240
|
|
Mean Photopic Binocular Defocus Curve at Day 120-180
-5.0D
|
0.586 logMAR
Standard Deviation 0.1292
|
0.644 logMAR
Standard Deviation 0.1048
|
SECONDARY outcome
Timeframe: Day 120-180 from second eye implantationPopulation: Best-Case Analysis Set, with available data
Contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly in lighted conditions with distance manifest correction in place and uncorrected, with no glare source illumination. Contrast sensitivity was assessed at spatial frequencies of 3, 6, 12, and 18 cycles per degree (CPD) and reported in log units. A higher numeric value represents better contrast sensitivity. No statistical test was performed.
Outcome measures
| Measure |
TFNT00
n=86 Participants
AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL, bilateral implantation
|
839MP
n=81 Participants
AT LISA® tri IOL, bilateral implantation
|
|---|---|---|
|
Mean Photopic Without Glare Binocular Distance Contrast Sensitivity at Day 120-180
6 CPD
|
1.860 log units
Standard Deviation 0.2635
|
1.831 log units
Standard Deviation 0.2699
|
|
Mean Photopic Without Glare Binocular Distance Contrast Sensitivity at Day 120-180
12 CPD
|
1.482 log units
Standard Deviation 0.3853
|
1.496 log units
Standard Deviation 0.4328
|
|
Mean Photopic Without Glare Binocular Distance Contrast Sensitivity at Day 120-180
3 CPD
|
1.720 log units
Standard Deviation 0.2025
|
1.735 log units
Standard Deviation 0.1894
|
|
Mean Photopic Without Glare Binocular Distance Contrast Sensitivity at Day 120-180
18 CPD
|
1.021 log units
Standard Deviation 0.3778
|
1.022 log units
Standard Deviation 0.4197
|
SECONDARY outcome
Timeframe: Day 120-180 from second eye implantationPopulation: Best-Case Analysis Set, with data available
Contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly in lighted conditions with distance manifest correction in place and uncorrected, with glare source illumination. Contrast sensitivity was assessed at spatial frequencies of 3, 6, 12, and 18 CPDs and reported in log units. A higher numeric value represents better contrast sensitivity. No statistical test was performed.
Outcome measures
| Measure |
TFNT00
n=86 Participants
AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL, bilateral implantation
|
839MP
n=81 Participants
AT LISA® tri IOL, bilateral implantation
|
|---|---|---|
|
Mean Photopic With Glare Binocular Distance Contrast Sensitivity at Day 120-180
3 CPD
|
1.721 log units
Standard Deviation 0.2041
|
1.754 log units
Standard Deviation 0.2225
|
|
Mean Photopic With Glare Binocular Distance Contrast Sensitivity at Day 120-180
12 CPD
|
1.434 log units
Standard Deviation 0.4616
|
1.426 log units
Standard Deviation 0.4570
|
|
Mean Photopic With Glare Binocular Distance Contrast Sensitivity at Day 120-180
6 CPD
|
1.790 log units
Standard Deviation 0.3282
|
1.797 log units
Standard Deviation 0.3538
|
|
Mean Photopic With Glare Binocular Distance Contrast Sensitivity at Day 120-180
18 CPD
|
1.007 log units
Standard Deviation 0.3769
|
1.033 log units
Standard Deviation 0.4316
|
SECONDARY outcome
Timeframe: Day 120-180 from second eye implantationPopulation: Best-Case Analysis Set with data available
Contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly in dim to dark conditions with distance manifest correction in place and uncorrected, with no glare source illumination. Contrast sensitivity was assessed at spatial frequencies of 1.5, 3, 6, and 12 CPDs and reported in log units. A higher numeric value represents better contrast sensitivity. No statistical test was performed.
Outcome measures
| Measure |
TFNT00
n=86 Participants
AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL, bilateral implantation
|
839MP
n=81 Participants
AT LISA® tri IOL, bilateral implantation
|
|---|---|---|
|
Mean Mesopic Without Glare Binocular Distance Contrast Sensitivity at Day 120-180
1.5 CPD
|
1.611 log units
Standard Deviation 0.2293
|
1.600 log units
Standard Deviation 0.2226
|
|
Mean Mesopic Without Glare Binocular Distance Contrast Sensitivity at Day 120-180
3 CPD
|
1.648 log units
Standard Deviation 0.3115
|
1.682 log units
Standard Deviation 0.2639
|
|
Mean Mesopic Without Glare Binocular Distance Contrast Sensitivity at Day 120-180
6 CPD
|
1.667 log units
Standard Deviation 0.4284
|
1.676 log units
Standard Deviation 0.4243
|
|
Mean Mesopic Without Glare Binocular Distance Contrast Sensitivity at Day 120-180
12 CPD
|
1.208 log units
Standard Deviation 0.5262
|
1.227 log units
Standard Deviation 0.5307
|
SECONDARY outcome
Timeframe: Day 120-180 from second eye implantationPopulation: Best-Case Analysis Set, with data available
Contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly with distance manifest correction in place and uncorrected, with glare source illumination. Contrast sensitivity was assessed at spatial frequencies of 1.5, 3, 6, and 12 CPDs and reported in log units. A higher numeric value represents better contrast sensitivity. No statistical test was performed.
Outcome measures
| Measure |
TFNT00
n=86 Participants
AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL, bilateral implantation
|
839MP
n=81 Participants
AT LISA® tri IOL, bilateral implantation
|
|---|---|---|
|
Mean Mesopic With Glare Binocular Distance Contrast Sensitivity at Day 120-180
1.5 CPD
|
1.579 log units
Standard Deviation 0.2581
|
1.538 log units
Standard Deviation 0.2568
|
|
Mean Mesopic With Glare Binocular Distance Contrast Sensitivity at Day 120-180
3 CPD
|
1.642 log units
Standard Deviation 0.2696
|
1.682 log units
Standard Deviation 0.2642
|
|
Mean Mesopic With Glare Binocular Distance Contrast Sensitivity at Day 120-180
6 CPD
|
1.550 log units
Standard Deviation 0.4791
|
1.607 log units
Standard Deviation 0.4898
|
|
Mean Mesopic With Glare Binocular Distance Contrast Sensitivity at Day 120-180
12 CPD
|
1.146 log units
Standard Deviation 0.5623
|
1.175 log units
Standard Deviation 0.6062
|
SECONDARY outcome
Timeframe: Day 120-180 from second eye implantationPopulation: All-Implanted Analysis Set with data available
At the Month 6 Visit, subjects responded to the question: "Given your current postoperative vision, if you had to do it all over would you have the same lens implanted again?". Responses were reported as a percentage of subjects. No statistical test was performed.
Outcome measures
| Measure |
TFNT00
n=93 Participants
AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL, bilateral implantation
|
839MP
n=87 Participants
AT LISA® tri IOL, bilateral implantation
|
|---|---|---|
|
Subject Satisfaction Recorded at Day 120-180
No
|
3.2 percentage of subjects
|
2.3 percentage of subjects
|
|
Subject Satisfaction Recorded at Day 120-180
Missing
|
1.1 percentage of subjects
|
1.1 percentage of subjects
|
|
Subject Satisfaction Recorded at Day 120-180
Yes
|
95.7 percentage of subjects
|
96.6 percentage of subjects
|
Adverse Events
TFNT00 - 1st Eye
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
TFNT00 - 2nd Eye
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
TFNT00 - Systemic
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
839MP - 1st Eye
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
839MP - 2nd Eye
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
839MP - Non-Study Eye
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
839MP - Systemic
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TFNT00 - 1st Eye
n=93 participants at risk
First eye implanted with AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL
|
TFNT00 - 2nd Eye
n=93 participants at risk
Second eye implanted with AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL
|
TFNT00 - Systemic
n=93 participants at risk
Subjects implanted with AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL in at least one eye
|
839MP - 1st Eye
n=89 participants at risk
First eye implanted with AT LISA® tri IOL
|
839MP - 2nd Eye
n=87 participants at risk
Second eye implanted with AT LISA® tri IOL
|
839MP - Non-Study Eye
n=2 participants at risk
Eyes not meeting study inclusion/exclusion criteria
|
839MP - Systemic
n=89 participants at risk
Subjects implanted with AT LISA® tri IOL in at least one eye
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/93 • IOL implantation through study completion, an average of 7 months
An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. AEs were obtained through solicited comments from subjects by the Investigators. Safety Analysis Set. "At risk" population for ocular AEs is reported in units of eyes.
|
0.00%
0/93 • IOL implantation through study completion, an average of 7 months
An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. AEs were obtained through solicited comments from subjects by the Investigators. Safety Analysis Set. "At risk" population for ocular AEs is reported in units of eyes.
|
1.1%
1/93 • IOL implantation through study completion, an average of 7 months
An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. AEs were obtained through solicited comments from subjects by the Investigators. Safety Analysis Set. "At risk" population for ocular AEs is reported in units of eyes.
|
0.00%
0/89 • IOL implantation through study completion, an average of 7 months
An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. AEs were obtained through solicited comments from subjects by the Investigators. Safety Analysis Set. "At risk" population for ocular AEs is reported in units of eyes.
|
0.00%
0/87 • IOL implantation through study completion, an average of 7 months
An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. AEs were obtained through solicited comments from subjects by the Investigators. Safety Analysis Set. "At risk" population for ocular AEs is reported in units of eyes.
|
0.00%
0/2 • IOL implantation through study completion, an average of 7 months
An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. AEs were obtained through solicited comments from subjects by the Investigators. Safety Analysis Set. "At risk" population for ocular AEs is reported in units of eyes.
|
0.00%
0/89 • IOL implantation through study completion, an average of 7 months
An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. AEs were obtained through solicited comments from subjects by the Investigators. Safety Analysis Set. "At risk" population for ocular AEs is reported in units of eyes.
|
|
Eye disorders
Cystoid macular oedema
|
0.00%
0/93 • IOL implantation through study completion, an average of 7 months
An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. AEs were obtained through solicited comments from subjects by the Investigators. Safety Analysis Set. "At risk" population for ocular AEs is reported in units of eyes.
|
0.00%
0/93 • IOL implantation through study completion, an average of 7 months
An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. AEs were obtained through solicited comments from subjects by the Investigators. Safety Analysis Set. "At risk" population for ocular AEs is reported in units of eyes.
|
0.00%
0/93 • IOL implantation through study completion, an average of 7 months
An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. AEs were obtained through solicited comments from subjects by the Investigators. Safety Analysis Set. "At risk" population for ocular AEs is reported in units of eyes.
|
2.2%
2/89 • IOL implantation through study completion, an average of 7 months
An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. AEs were obtained through solicited comments from subjects by the Investigators. Safety Analysis Set. "At risk" population for ocular AEs is reported in units of eyes.
|
2.3%
2/87 • IOL implantation through study completion, an average of 7 months
An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. AEs were obtained through solicited comments from subjects by the Investigators. Safety Analysis Set. "At risk" population for ocular AEs is reported in units of eyes.
|
0.00%
0/2 • IOL implantation through study completion, an average of 7 months
An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. AEs were obtained through solicited comments from subjects by the Investigators. Safety Analysis Set. "At risk" population for ocular AEs is reported in units of eyes.
|
0.00%
0/89 • IOL implantation through study completion, an average of 7 months
An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. AEs were obtained through solicited comments from subjects by the Investigators. Safety Analysis Set. "At risk" population for ocular AEs is reported in units of eyes.
|
|
Product Issues
Device dislocation
|
0.00%
0/93 • IOL implantation through study completion, an average of 7 months
An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. AEs were obtained through solicited comments from subjects by the Investigators. Safety Analysis Set. "At risk" population for ocular AEs is reported in units of eyes.
|
0.00%
0/93 • IOL implantation through study completion, an average of 7 months
An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. AEs were obtained through solicited comments from subjects by the Investigators. Safety Analysis Set. "At risk" population for ocular AEs is reported in units of eyes.
|
0.00%
0/93 • IOL implantation through study completion, an average of 7 months
An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. AEs were obtained through solicited comments from subjects by the Investigators. Safety Analysis Set. "At risk" population for ocular AEs is reported in units of eyes.
|
1.1%
1/89 • IOL implantation through study completion, an average of 7 months
An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. AEs were obtained through solicited comments from subjects by the Investigators. Safety Analysis Set. "At risk" population for ocular AEs is reported in units of eyes.
|
0.00%
0/87 • IOL implantation through study completion, an average of 7 months
An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. AEs were obtained through solicited comments from subjects by the Investigators. Safety Analysis Set. "At risk" population for ocular AEs is reported in units of eyes.
|
0.00%
0/2 • IOL implantation through study completion, an average of 7 months
An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. AEs were obtained through solicited comments from subjects by the Investigators. Safety Analysis Set. "At risk" population for ocular AEs is reported in units of eyes.
|
0.00%
0/89 • IOL implantation through study completion, an average of 7 months
An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. AEs were obtained through solicited comments from subjects by the Investigators. Safety Analysis Set. "At risk" population for ocular AEs is reported in units of eyes.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/93 • IOL implantation through study completion, an average of 7 months
An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. AEs were obtained through solicited comments from subjects by the Investigators. Safety Analysis Set. "At risk" population for ocular AEs is reported in units of eyes.
|
0.00%
0/93 • IOL implantation through study completion, an average of 7 months
An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. AEs were obtained through solicited comments from subjects by the Investigators. Safety Analysis Set. "At risk" population for ocular AEs is reported in units of eyes.
|
1.1%
1/93 • IOL implantation through study completion, an average of 7 months
An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. AEs were obtained through solicited comments from subjects by the Investigators. Safety Analysis Set. "At risk" population for ocular AEs is reported in units of eyes.
|
0.00%
0/89 • IOL implantation through study completion, an average of 7 months
An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. AEs were obtained through solicited comments from subjects by the Investigators. Safety Analysis Set. "At risk" population for ocular AEs is reported in units of eyes.
|
0.00%
0/87 • IOL implantation through study completion, an average of 7 months
An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. AEs were obtained through solicited comments from subjects by the Investigators. Safety Analysis Set. "At risk" population for ocular AEs is reported in units of eyes.
|
0.00%
0/2 • IOL implantation through study completion, an average of 7 months
An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. AEs were obtained through solicited comments from subjects by the Investigators. Safety Analysis Set. "At risk" population for ocular AEs is reported in units of eyes.
|
0.00%
0/89 • IOL implantation through study completion, an average of 7 months
An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. AEs were obtained through solicited comments from subjects by the Investigators. Safety Analysis Set. "At risk" population for ocular AEs is reported in units of eyes.
|
|
Surgical and medical procedures
Intra-ocular injection
|
0.00%
0/93 • IOL implantation through study completion, an average of 7 months
An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. AEs were obtained through solicited comments from subjects by the Investigators. Safety Analysis Set. "At risk" population for ocular AEs is reported in units of eyes.
|
0.00%
0/93 • IOL implantation through study completion, an average of 7 months
An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. AEs were obtained through solicited comments from subjects by the Investigators. Safety Analysis Set. "At risk" population for ocular AEs is reported in units of eyes.
|
0.00%
0/93 • IOL implantation through study completion, an average of 7 months
An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. AEs were obtained through solicited comments from subjects by the Investigators. Safety Analysis Set. "At risk" population for ocular AEs is reported in units of eyes.
|
1.1%
1/89 • IOL implantation through study completion, an average of 7 months
An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. AEs were obtained through solicited comments from subjects by the Investigators. Safety Analysis Set. "At risk" population for ocular AEs is reported in units of eyes.
|
1.1%
1/87 • IOL implantation through study completion, an average of 7 months
An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. AEs were obtained through solicited comments from subjects by the Investigators. Safety Analysis Set. "At risk" population for ocular AEs is reported in units of eyes.
|
0.00%
0/2 • IOL implantation through study completion, an average of 7 months
An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. AEs were obtained through solicited comments from subjects by the Investigators. Safety Analysis Set. "At risk" population for ocular AEs is reported in units of eyes.
|
0.00%
0/89 • IOL implantation through study completion, an average of 7 months
An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. AEs were obtained through solicited comments from subjects by the Investigators. Safety Analysis Set. "At risk" population for ocular AEs is reported in units of eyes.
|
|
Surgical and medical procedures
Intraocular lens implant
|
0.00%
0/93 • IOL implantation through study completion, an average of 7 months
An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. AEs were obtained through solicited comments from subjects by the Investigators. Safety Analysis Set. "At risk" population for ocular AEs is reported in units of eyes.
|
0.00%
0/93 • IOL implantation through study completion, an average of 7 months
An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. AEs were obtained through solicited comments from subjects by the Investigators. Safety Analysis Set. "At risk" population for ocular AEs is reported in units of eyes.
|
0.00%
0/93 • IOL implantation through study completion, an average of 7 months
An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. AEs were obtained through solicited comments from subjects by the Investigators. Safety Analysis Set. "At risk" population for ocular AEs is reported in units of eyes.
|
1.1%
1/89 • IOL implantation through study completion, an average of 7 months
An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. AEs were obtained through solicited comments from subjects by the Investigators. Safety Analysis Set. "At risk" population for ocular AEs is reported in units of eyes.
|
0.00%
0/87 • IOL implantation through study completion, an average of 7 months
An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. AEs were obtained through solicited comments from subjects by the Investigators. Safety Analysis Set. "At risk" population for ocular AEs is reported in units of eyes.
|
0.00%
0/2 • IOL implantation through study completion, an average of 7 months
An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. AEs were obtained through solicited comments from subjects by the Investigators. Safety Analysis Set. "At risk" population for ocular AEs is reported in units of eyes.
|
0.00%
0/89 • IOL implantation through study completion, an average of 7 months
An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. AEs were obtained through solicited comments from subjects by the Investigators. Safety Analysis Set. "At risk" population for ocular AEs is reported in units of eyes.
|
Other adverse events
| Measure |
TFNT00 - 1st Eye
n=93 participants at risk
First eye implanted with AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL
|
TFNT00 - 2nd Eye
n=93 participants at risk
Second eye implanted with AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL
|
TFNT00 - Systemic
n=93 participants at risk
Subjects implanted with AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL in at least one eye
|
839MP - 1st Eye
n=89 participants at risk
First eye implanted with AT LISA® tri IOL
|
839MP - 2nd Eye
n=87 participants at risk
Second eye implanted with AT LISA® tri IOL
|
839MP - Non-Study Eye
n=2 participants at risk
Eyes not meeting study inclusion/exclusion criteria
|
839MP - Systemic
n=89 participants at risk
Subjects implanted with AT LISA® tri IOL in at least one eye
|
|---|---|---|---|---|---|---|---|
|
Eye disorders
Halo vision
|
5.4%
5/93 • IOL implantation through study completion, an average of 7 months
An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. AEs were obtained through solicited comments from subjects by the Investigators. Safety Analysis Set. "At risk" population for ocular AEs is reported in units of eyes.
|
5.4%
5/93 • IOL implantation through study completion, an average of 7 months
An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. AEs were obtained through solicited comments from subjects by the Investigators. Safety Analysis Set. "At risk" population for ocular AEs is reported in units of eyes.
|
0.00%
0/93 • IOL implantation through study completion, an average of 7 months
An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. AEs were obtained through solicited comments from subjects by the Investigators. Safety Analysis Set. "At risk" population for ocular AEs is reported in units of eyes.
|
2.2%
2/89 • IOL implantation through study completion, an average of 7 months
An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. AEs were obtained through solicited comments from subjects by the Investigators. Safety Analysis Set. "At risk" population for ocular AEs is reported in units of eyes.
|
2.3%
2/87 • IOL implantation through study completion, an average of 7 months
An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. AEs were obtained through solicited comments from subjects by the Investigators. Safety Analysis Set. "At risk" population for ocular AEs is reported in units of eyes.
|
0.00%
0/2 • IOL implantation through study completion, an average of 7 months
An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. AEs were obtained through solicited comments from subjects by the Investigators. Safety Analysis Set. "At risk" population for ocular AEs is reported in units of eyes.
|
0.00%
0/89 • IOL implantation through study completion, an average of 7 months
An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. AEs were obtained through solicited comments from subjects by the Investigators. Safety Analysis Set. "At risk" population for ocular AEs is reported in units of eyes.
|
|
Eye disorders
Posterior capsule opacification
|
3.2%
3/93 • IOL implantation through study completion, an average of 7 months
An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. AEs were obtained through solicited comments from subjects by the Investigators. Safety Analysis Set. "At risk" population for ocular AEs is reported in units of eyes.
|
3.2%
3/93 • IOL implantation through study completion, an average of 7 months
An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. AEs were obtained through solicited comments from subjects by the Investigators. Safety Analysis Set. "At risk" population for ocular AEs is reported in units of eyes.
|
0.00%
0/93 • IOL implantation through study completion, an average of 7 months
An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. AEs were obtained through solicited comments from subjects by the Investigators. Safety Analysis Set. "At risk" population for ocular AEs is reported in units of eyes.
|
5.6%
5/89 • IOL implantation through study completion, an average of 7 months
An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. AEs were obtained through solicited comments from subjects by the Investigators. Safety Analysis Set. "At risk" population for ocular AEs is reported in units of eyes.
|
1.1%
1/87 • IOL implantation through study completion, an average of 7 months
An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. AEs were obtained through solicited comments from subjects by the Investigators. Safety Analysis Set. "At risk" population for ocular AEs is reported in units of eyes.
|
0.00%
0/2 • IOL implantation through study completion, an average of 7 months
An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. AEs were obtained through solicited comments from subjects by the Investigators. Safety Analysis Set. "At risk" population for ocular AEs is reported in units of eyes.
|
0.00%
0/89 • IOL implantation through study completion, an average of 7 months
An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. AEs were obtained through solicited comments from subjects by the Investigators. Safety Analysis Set. "At risk" population for ocular AEs is reported in units of eyes.
|
Additional Information
Sr. Global Brand Medical Affairs Lead, CDMA Surgical
Alcon, A Novartis Division
Phone: 1-888-451-3937
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
- Publication restrictions are in place
Restriction type: OTHER