Trial Outcomes & Findings for Extension Study of NT-501 Ciliary Neurotrophic Factor (CNTF) Implant for Macular Telangiectasia (MacTel) (NCT NCT03071965)
NCT ID: NCT03071965
Last Updated: 2025-05-09
Results Overview
Change from baseline to 72, 84, 96 and 108 months post-surgery (based on participants' original implant date during precursor study) by SD-OCT for Cohort 1
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
70 participants
Primary outcome timeframe
72, 84, 96, and 108 months (based on participants' original implant date during precursor study)
Results posted on
2025-05-09
Participant Flow
Cohort 1: Six subjects consented to the extension study, totaling six study eyes and six fellow eyes. Cohort 2: In NTMT-02, 64 subjects joined the extension study: NT-501 group: 15 subjects (15 study eyes, 15 fellow eyes). Sham group: 19 subjects (19 study eyes, 19 fellow eyes). Sham+NT-501 group: 30 subjects (1 implanted, 1 sham eye each). Cohort 2 included 128 eyes: 94 study eyes (45 NT-501, 49 sham) and 34 fellow eyes.
Unit of analysis: eyes
Participant milestones
| Measure |
Cohort 1 - Implant Only
Participants who completed protocol NTMT-01 and had one NT-501 implant.
|
Cohort 2 - Sham Only
Participants who completed protocol NTMT-02 and only had a sham surgery. Note, there is a subset of these participants who opted to receive an actual NT-501 implant during the extension study.
|
Cohort 2 - NT-501 Implant
Participants who completed protocol NTMT-02 and had one NT-501 implant..
|
Cohort 2 - Sham + NT-501 Implant
Participants who completed protocol NTMT-02 and had one NT-501 implant in one eye and sham surgery in the other.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6 6
|
19 19
|
15 15
|
30 60
|
|
Overall Study
Switched to NT-501
|
0 0
|
16 16
|
0 0
|
0 0
|
|
Overall Study
Retained NT-501 Throughout the Study
|
6 0
|
16 16
|
14 14
|
30 60
|
|
Overall Study
COMPLETED
|
6 0
|
18 18
|
13 13
|
27 54
|
|
Overall Study
NOT COMPLETED
|
0 6
|
1 1
|
2 2
|
3 6
|
Reasons for withdrawal
| Measure |
Cohort 1 - Implant Only
Participants who completed protocol NTMT-01 and had one NT-501 implant.
|
Cohort 2 - Sham Only
Participants who completed protocol NTMT-02 and only had a sham surgery. Note, there is a subset of these participants who opted to receive an actual NT-501 implant during the extension study.
|
Cohort 2 - NT-501 Implant
Participants who completed protocol NTMT-02 and had one NT-501 implant..
|
Cohort 2 - Sham + NT-501 Implant
Participants who completed protocol NTMT-02 and had one NT-501 implant in one eye and sham surgery in the other.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
0
|
|
Overall Study
Death
|
0
|
0
|
1
|
1
|
|
Overall Study
COVID-19
|
0
|
1
|
0
|
1
|
|
Overall Study
Other Health Reason
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Extension Study of NT-501 Ciliary Neurotrophic Factor (CNTF) Implant for Macular Telangiectasia (MacTel)
Baseline characteristics by cohort
| Measure |
Cohort 1 - Implant Only
n=6 Participants
Participants who completed protocol NTMT-01 and had one NT-501 implant.
|
Cohort 2 - Sham Only
n=19 Participants
Participants who completed protocol NTMT-02 and only had a sham surgery. Note, there is a subset of these participants who opted to receive an actual NT-501 implant during the extension study.
|
Cohort 2 - NT-501 Implant
n=15 Participants
Participants who completed protocol NTMT-02 and had one NT-501 implant..
|
Cohort 2 - Sham + NT-501 Implant
n=30 Participants
Participants who completed protocol NTMT-02 and had one NT-501 implant in one eye and sham surgery in the other.
|
Total
n=70 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
48 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
|
Age, Continuous
|
53.8 years
STANDARD_DEVIATION 5.12 • n=5 Participants
|
59.4 years
STANDARD_DEVIATION 7.61 • n=7 Participants
|
59.5 years
STANDARD_DEVIATION 10.82 • n=5 Participants
|
63.6 years
STANDARD_DEVIATION 8.59 • n=4 Participants
|
61.4 years
STANDARD_DEVIATION 8.99 • n=21 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
44 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
67 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
59 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 72, 84, 96, and 108 months (based on participants' original implant date during precursor study)Population: All enrolled participants by eye
Change from baseline to 72, 84, 96 and 108 months post-surgery (based on participants' original implant date during precursor study) by SD-OCT for Cohort 1
Outcome measures
| Measure |
Cohort 1 - Fellow Eye
n=6 eyes
Cohort 1 - Previous NTMT-01 participant's fellow untreated eye
|
Cohort 1 - NT-501 Implant
n=6 eyes
Cohort 1 - Previous NTMT-01 participant's NT-501 implant eye
|
|---|---|---|
|
Ellipsoid Zone (Area of IS/OS Loss) - Cohort 1
Baseline
|
0.697 mm2
Standard Deviation 0.8334
|
0.629 mm2
Standard Deviation 0.08135
|
|
Ellipsoid Zone (Area of IS/OS Loss) - Cohort 1
72 Months Post-Surgery Actual
|
1.37 mm2
Standard Deviation 1.4648
|
1.137 mm2
Standard Deviation 1.2905
|
|
Ellipsoid Zone (Area of IS/OS Loss) - Cohort 1
72 Months Post-Surgery Change from Baseline
|
0.620 mm2
Standard Deviation 0.7526
|
0.508 mm2
Standard Deviation 0.6348
|
|
Ellipsoid Zone (Area of IS/OS Loss) - Cohort 1
84 Months Post-Surgery Actual
|
1.241 mm2
Standard Deviation 1.4691
|
1.132 mm2
Standard Deviation 1.1194
|
|
Ellipsoid Zone (Area of IS/OS Loss) - Cohort 1
84 Months Post-Surgery Change from Baseline
|
0.705 mm2
Standard Deviation 0.7474
|
0.503 mm2
Standard Deviation 0.5001
|
|
Ellipsoid Zone (Area of IS/OS Loss) - Cohort 1
96 Months Post-Surgery Actual
|
1.338 mm2
Standard Deviation 1.3264
|
1.169 mm2
Standard Deviation 1.0987
|
|
Ellipsoid Zone (Area of IS/OS Loss) - Cohort 1
96 Months Post-Surgery Change from Baseline
|
0.642 mm2
Standard Deviation 0.6922
|
0.540 mm2
Standard Deviation 0.5159
|
|
Ellipsoid Zone (Area of IS/OS Loss) - Cohort 1
108 Months Post-Surgery Actual
|
0.394 mm2
Standard Deviation 0.5156
|
0.301 mm2
Standard Deviation 0.4909
|
|
Ellipsoid Zone (Area of IS/OS Loss) - Cohort 1
108 Months Post-Surgery Change from Baseline
|
0.165 mm2
Standard Deviation 0.1558
|
0.277 mm2
Standard Deviation 0.4605
|
PRIMARY outcome
Timeframe: Baseline to 36, 48, 60 and 72 Months post-surgery (based on participants' original implant date during precursor study)Population: Intent to treat population by eye
Change in EZ from baseline to 36, 48, 60 and 72 Months post-surgery (based on participants' original implant date during precursor study). Cohort 2 sham surgery arm includes 16 participants (16 eyes) that received an NT-501 following their Month 36 follow-up
Outcome measures
| Measure |
Cohort 1 - Fellow Eye
n=45 eyes
Cohort 1 - Previous NTMT-01 participant's fellow untreated eye
|
Cohort 1 - NT-501 Implant
n=49 eyes
Cohort 1 - Previous NTMT-01 participant's NT-501 implant eye
|
|---|---|---|
|
Ellipsoid Zone (Area of IS/OS Loss) - Cohort 2
Baseline
|
0.684 mm2
Standard Error 0.0707
|
0.766 mm2
Standard Error 0.0687
|
|
Ellipsoid Zone (Area of IS/OS Loss) - Cohort 2
Change at 36 Months Post-Surgery
|
0.259 mm2
Standard Error 0.0609
|
0.279 mm2
Standard Error 0.0585
|
|
Ellipsoid Zone (Area of IS/OS Loss) - Cohort 2
Change at 48 Months Post-Surgery
|
0.360 mm2
Standard Error 0.0609
|
0.282 mm2
Standard Error 0.0589
|
|
Ellipsoid Zone (Area of IS/OS Loss) - Cohort 2
Change at 60 Months Post-Surgery
|
0.450 mm2
Standard Error 0.0644
|
0.105 mm2
Standard Error 0.0760
|
|
Ellipsoid Zone (Area of IS/OS Loss) - Cohort 2
Change at 72 Months Post-Surgery
|
0.443 mm2
Standard Error 0.0728
|
0.497 mm2
Standard Error 0.0680
|
SECONDARY outcome
Timeframe: Baseline to 72 Months (based on participants' original implant date)Population: Intent to Treat population by eye
Baseline to 72 Months - analyses also presented for additional times: 36, 48, and 60 Months post-surgery (based on participants' original implant date during precursor study) . Cohort 2 sham surgery arm includes 16 participants (16 eyes) that received an NT-501 following their Month 36 follow-up in this study.
Outcome measures
| Measure |
Cohort 1 - Fellow Eye
n=45 eyes
Cohort 1 - Previous NTMT-01 participant's fellow untreated eye
|
Cohort 1 - NT-501 Implant
n=49 eyes
Cohort 1 - Previous NTMT-01 participant's NT-501 implant eye
|
|---|---|---|
|
Change in Retinal Sensitivity (dB) From Baseline - Cohort 2 Only
Baseline
|
25.688 dB
Standard Error 0.3377
|
25.672 dB
Standard Error 0.3317
|
|
Change in Retinal Sensitivity (dB) From Baseline - Cohort 2 Only
Retinal Sensitivity Change at 36 Months Post-Surgery
|
-1.391 dB
Standard Error 0.3377
|
-1.054 dB
Standard Error 0.3320
|
|
Change in Retinal Sensitivity (dB) From Baseline - Cohort 2 Only
Retinal Sensitivity Change at 48 Months Post-Surgery
|
-2.312 dB
Standard Error 0.3376
|
-1.965 dB
Standard Error 0.3319
|
|
Change in Retinal Sensitivity (dB) From Baseline - Cohort 2 Only
Retinal Sensitivity Change at 60 Months Post-Surgery
|
-2.912 dB
Standard Error 0.3562
|
-2.369 dB
Standard Error 0.3347
|
|
Change in Retinal Sensitivity (dB) From Baseline - Cohort 2 Only
Retinal Sensitivity Change at 72 Months Post-Surgery
|
-3.047 dB
Standard Error 0.3674
|
-2.909 dB
Standard Error 0.3595
|
SECONDARY outcome
Timeframe: Baseline to 108 Months (based on participants' original implant date)Population: Intent to Treat population by eye
Baseline to 108 Months - analyses also presented for additional times: 84, 96 and 108 Months (based on participants' original implant date)
Outcome measures
| Measure |
Cohort 1 - Fellow Eye
n=6 eyes
Cohort 1 - Previous NTMT-01 participant's fellow untreated eye
|
Cohort 1 - NT-501 Implant
n=6 eyes
Cohort 1 - Previous NTMT-01 participant's NT-501 implant eye
|
|---|---|---|
|
Change in BCVA From Baseline for Cohort 1
Baseline Actual
|
80.5 letters
Standard Deviation 7.34
|
75.0 letters
Standard Deviation 7.92
|
|
Change in BCVA From Baseline for Cohort 1
72 Months Post-Surgery Actual
|
72.8 letters
Standard Deviation 11.91
|
71.8 letters
Standard Deviation 7.76
|
|
Change in BCVA From Baseline for Cohort 1
72 Months Post-Surgery Change from Baseline
|
-7.7 letters
Standard Deviation 7.23
|
-3.2 letters
Standard Deviation 2.48
|
|
Change in BCVA From Baseline for Cohort 1
84 Months Post-Surgery Actual
|
72.7 letters
Standard Deviation 9.37
|
72.3 letters
Standard Deviation 6.65
|
|
Change in BCVA From Baseline for Cohort 1
84 Months Post-Surgery Change from Baseline
|
-7.8 letters
Standard Deviation 4.83
|
-2.7 letters
Standard Deviation 2.80
|
|
Change in BCVA From Baseline for Cohort 1
96 Months Post-Surgery Actual
|
72.7 letters
Standard Deviation 8.82
|
72.3 letters
Standard Deviation 6.22
|
|
Change in BCVA From Baseline for Cohort 1
96 Months Post-Surgery Change from Baseline
|
-7.8 letters
Standard Deviation 3.43
|
-2.7 letters
Standard Deviation 3.20
|
|
Change in BCVA From Baseline for Cohort 1
108 Months Post-Surgery Actual
|
72.5 letters
Standard Deviation 8.31
|
68.8 letters
Standard Deviation 10.30
|
|
Change in BCVA From Baseline for Cohort 1
108 Months Post-Surgery Change from Baseline
|
-8.0 letters
Standard Deviation 3.74
|
-6.2 letters
Standard Deviation 3.37
|
SECONDARY outcome
Timeframe: Baseline to 72 Months (based on participants' original implant date)Population: Intent to Treat population by eye
Baseline to 72 Months - analyses also presented for additional times: 36, 48, and 60 Months (based on participants' original implant date during precursor study) . Cohort 2 sham surgery arm includes 16 participants (16 eyes) that received an NT-501 following their Month 36 follow-up
Outcome measures
| Measure |
Cohort 1 - Fellow Eye
n=45 eyes
Cohort 1 - Previous NTMT-01 participant's fellow untreated eye
|
Cohort 1 - NT-501 Implant
n=49 eyes
Cohort 1 - Previous NTMT-01 participant's NT-501 implant eye
|
|---|---|---|
|
Change in BCVA From Baseline for Cohort 2
Baseline
|
77.2 letters
Standard Error 0.97
|
77.0 letters
Standard Error 0.93
|
|
Change in BCVA From Baseline for Cohort 2
Change at 36 Months Post-Surgery
|
-4.8 letters
Standard Error 0.80
|
-3.2 letters
Standard Error 0.77
|
|
Change in BCVA From Baseline for Cohort 2
Change at 48 Months Post-Surgery
|
-5.7 letters
Standard Error 0.81
|
-3.9 letters
Standard Error 0.78
|
|
Change in BCVA From Baseline for Cohort 2
Change at 60 Months Post-Surgery
|
-8.5 letters
Standard Error 0.82
|
-3.9 letters
Standard Error 0.79
|
|
Change in BCVA From Baseline for Cohort 2
Change at 72 Months Post-Surgery
|
-10.1 letters
Standard Error 0.87
|
-6.9 letters
Standard Error 0.83
|
SECONDARY outcome
Timeframe: Baseline to 72 Months (based on participants' original implant date)Population: Intent to Treat population by eye and based on participants who completed the reading speed assessment each timepoint
Baseline to 72 Months - analyses also presented for additional times: 36, 48, and 60 Months (based on participants' original implant date during precursor study) . Cohort 2 sham surgery arm includes 16 participants (16 eyes) that received an NT-501 following their Month 36 follow-up. Note: there were
Outcome measures
| Measure |
Cohort 1 - Fellow Eye
n=44 eyes
Cohort 1 - Previous NTMT-01 participant's fellow untreated eye
|
Cohort 1 - NT-501 Implant
n=47 eyes
Cohort 1 - Previous NTMT-01 participant's NT-501 implant eye
|
|---|---|---|
|
Change in Reading Speed From Baseline - Cohort 2 Only
Baseline
|
94.740 words per minute
Standard Error 6.4973
|
107.222 words per minute
Standard Error 6.2866
|
|
Change in Reading Speed From Baseline - Cohort 2 Only
Reading Speed Change at 36 Months Post-Surgery
|
-8.838 words per minute
Standard Error 5.4428
|
-17.798 words per minute
Standard Error 5.2686
|
|
Change in Reading Speed From Baseline - Cohort 2 Only
Reading Speed Change at 48 Months Post-Surgery
|
-18.931 words per minute
Standard Error 5.5846
|
-25.488 words per minute
Standard Error 5.3072
|
|
Change in Reading Speed From Baseline - Cohort 2 Only
Reading Speed Change at 60 Months Post-Surgery
|
-28.627 words per minute
Standard Error 5.6369
|
-18.324 words per minute
Standard Error 5.4825
|
|
Change in Reading Speed From Baseline - Cohort 2 Only
Reading Speed Change at 72 Months Post-Surgery
|
-24.713 words per minute
Standard Error 5.9294
|
-34.478 words per minute
Standard Error 5.6311
|
Adverse Events
Cohort 1 - Implant Only
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort 2 - Sham Only
Serious events: 3 serious events
Other events: 18 other events
Deaths: 0 deaths
Cohort 2 - NT-501 Implant
Serious events: 4 serious events
Other events: 14 other events
Deaths: 1 deaths
Cohort 2 - Sham + NT-501 Implant
Serious events: 7 serious events
Other events: 20 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Cohort 1 - Implant Only
n=6 participants at risk
Participants who completed protocol NTMT-01 and had one NT-501 implant.
|
Cohort 2 - Sham Only
n=19 participants at risk
Participants who completed protocol NTMT-02 and only had a sham surgery. Note, there is a subset of these participants who opted to receive an actual NT-501 implant during the extension study.
|
Cohort 2 - NT-501 Implant
n=15 participants at risk
Participants who completed protocol NTMT-02 and had one NT-501 implant..
|
Cohort 2 - Sham + NT-501 Implant
n=30 participants at risk
Participants who completed protocol NTMT-02 and had one NT-501 implant in one eye and sham surgery in the other.
|
|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant peritoneal neoplasm
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
3.3%
1/30 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
6.7%
1/15 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
5.3%
1/19 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Cardiac disorders
Prinzmetal angina
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
3.3%
1/30 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
3.3%
1/30 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
6.7%
1/15 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Infections and infestations
Sinusitis
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
3.3%
1/30 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Eye disorders
Non-infectious endophthalmitis
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
6.7%
1/15 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
3.3%
1/30 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Gastrointestinal disorders
Duodenal ulcer perforation
|
16.7%
1/6 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
General disorders
Pain
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
6.7%
1/15 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
General disorders
Incarcerated hernia
|
16.7%
1/6 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
3.3%
1/30 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
16.7%
1/6 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
5.3%
1/19 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Nervous system disorders
Syncope
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
5.3%
1/19 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Product Issues
Device expulsion
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
6.7%
1/15 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
3.3%
1/30 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
Other adverse events
| Measure |
Cohort 1 - Implant Only
n=6 participants at risk
Participants who completed protocol NTMT-01 and had one NT-501 implant.
|
Cohort 2 - Sham Only
n=19 participants at risk
Participants who completed protocol NTMT-02 and only had a sham surgery. Note, there is a subset of these participants who opted to receive an actual NT-501 implant during the extension study.
|
Cohort 2 - NT-501 Implant
n=15 participants at risk
Participants who completed protocol NTMT-02 and had one NT-501 implant..
|
Cohort 2 - Sham + NT-501 Implant
n=30 participants at risk
Participants who completed protocol NTMT-02 and had one NT-501 implant in one eye and sham surgery in the other.
|
|---|---|---|---|---|
|
Eye disorders
Retinal cyst
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
6.7%
1/15 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Eye disorders
Retinal degeneration
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
6.7%
1/15 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Eye disorders
Retinal oedema
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
5.3%
1/19 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Eye disorders
Subretinal fluid
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
6.7%
1/15 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Eye disorders
Swelling of eyelid
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
6.7%
1/15 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Eye disorders
Uveitis
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
6.7%
1/15 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Eye disorders
Visual field defect
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
5.3%
1/19 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Eye disorders
Visual impairment
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
6.7%
1/15 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Eye disorders
Cataract cortical
|
16.7%
1/6 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Eye disorders
Conjunctivitis allergic
|
16.7%
1/6 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Eye disorders
Dacryostenosis acquired
|
16.7%
1/6 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Eye disorders
Eye allergy
|
16.7%
1/6 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Eye disorders
Periorbital dermatitis
|
16.7%
1/6 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
10.5%
2/19 • Number of events 2 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
6.7%
1/15 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
6.7%
2/30 • Number of events 2 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Infections and infestations
Influenza
|
16.7%
1/6 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
5.3%
1/19 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
6.7%
1/15 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
3.3%
1/30 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
5.3%
1/19 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
6.7%
1/15 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Eye disorders
Cataract
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
21.1%
4/19 • Number of events 4 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
13.3%
2/15 • Number of events 2 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Eye disorders
Delayed dark adaptation
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
15.8%
3/19 • Number of events 3 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Eye disorders
Eye pain
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
15.8%
3/19 • Number of events 3 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Eye disorders
Eye pruritus
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
15.8%
3/19 • Number of events 3 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
20.0%
3/15 • Number of events 3 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Eye disorders
Conjunctival cyst
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
5.3%
1/19 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
6.7%
1/15 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Eye disorders
Dry eye
|
16.7%
1/6 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
13.3%
2/15 • Number of events 2 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Eye disorders
Eye irritation
|
16.7%
1/6 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
5.3%
1/19 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
6.7%
1/15 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Eye disorders
Foreign body sensation in eyes
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
10.5%
2/19 • Number of events 2 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Eye disorders
Miosis
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
5.3%
1/19 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
6.7%
1/15 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
5.3%
1/19 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
6.7%
1/15 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Eye disorders
Vitreoretinal traction syndrome
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
13.3%
2/15 • Number of events 2 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
10.5%
2/19 • Number of events 2 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Eye disorders
Blindness transient
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
6.7%
1/15 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Eye disorders
Cataract nuclear
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
5.3%
1/19 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Eye disorders
Cataract subcapsular
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
5.3%
1/19 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Eye disorders
Diabetic retinal oedema
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
5.3%
1/19 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Eye disorders
Diabetic retinopathy
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
5.3%
1/19 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Eye disorders
Eyelids pruritus
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
6.7%
1/15 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Eye disorders
Iris adhesions
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
6.7%
1/15 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Eye disorders
Keratitis
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
6.7%
1/15 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Eye disorders
Macular oedema
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
6.7%
1/15 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
5.3%
1/19 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Eye disorders
Optic atrophy
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
6.7%
1/15 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Eye disorders
Photopsia
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
5.3%
1/19 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Eye disorders
Posterior capsule opacification
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
5.3%
1/19 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Eye disorders
Retinal artery embolism
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
6.7%
1/15 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Infections and infestations
Covid-19
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
3.3%
1/30 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Infections and infestations
Conjunctivitis bacterial
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
6.7%
1/15 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Infections and infestations
Dysentery
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
6.7%
1/15 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Infections and infestations
Labyrinthitis
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
5.3%
1/19 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
3.3%
1/30 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
5.3%
1/19 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Infections and infestations
Pneumonia
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
3.3%
1/30 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Infections and infestations
Respiratory tract infection bacterial
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
6.7%
1/15 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Infections and infestations
Sinusitis
|
16.7%
1/6 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
5.3%
1/19 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
5.3%
1/19 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Infections and infestations
Tooth infection
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
3.3%
1/30 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
5.3%
1/19 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
10.5%
2/19 • Number of events 2 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
5.3%
1/19 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
6.7%
1/15 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
6.7%
2/30 • Number of events 2 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.7%
1/6 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
13.3%
2/15 • Number of events 2 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
5.3%
1/19 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
6.7%
1/15 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
3.3%
1/30 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
6.7%
1/15 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Musculoskeletal and connective tissue disorders
Plantar fascitis
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
3.3%
1/30 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Injury, poisoning and procedural complications
Contusion
|
16.7%
1/6 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
5.3%
1/19 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Injury, poisoning and procedural complications
Iliotibial band syndrome
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
3.3%
1/30 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
5.3%
1/19 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
3.3%
1/30 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Injury, poisoning and procedural complications
Suture related complication
|
16.7%
1/6 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
6.7%
1/15 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
6.7%
1/15 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Injury, poisoning and procedural complications
Tooth injury
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
3.3%
1/30 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
3.3%
1/30 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
16.7%
1/6 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Injury, poisoning and procedural complications
Procedural pain
|
16.7%
1/6 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Injury, poisoning and procedural complications
Seroma
|
16.7%
1/6 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
16.7%
1/6 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
10.5%
2/19 • Number of events 2 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
6.7%
1/15 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
3.3%
1/30 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
5.3%
1/19 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
3.3%
1/30 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Metabolism and nutrition disorders
Oligodipsia
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
5.3%
1/19 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
5.3%
1/19 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Metabolism and nutrition disorders
Gout
|
16.7%
1/6 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
16.7%
1/6 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Surgical and medical procedures
Artificial crown procedure
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
3.3%
1/30 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Surgical and medical procedures
Cancer surgery
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
5.3%
1/19 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Surgical and medical procedures
Cyst removal
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
3.3%
1/30 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Surgical and medical procedures
Endodontic procedure
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
3.3%
1/30 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Surgical and medical procedures
Hysterectomy
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
3.3%
1/30 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Surgical and medical procedures
Joint arthroplasty
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
3.3%
1/30 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Surgical and medical procedures
Scar excision
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
6.7%
1/15 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Surgical and medical procedures
Urinary bladder suspension
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
5.3%
1/19 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Vascular disorders
Hypertension
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
5.3%
1/19 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
13.3%
2/15 • Number of events 2 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
10.0%
3/30 • Number of events 3 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Vascular disorders
Peripheral venous disease
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
3.3%
1/30 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Vascular disorders
Hypotension
|
16.7%
1/6 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
6.7%
1/15 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Investigations
Blood glucose increased
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
5.3%
1/19 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Investigations
Blood pressure increased
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
6.7%
1/15 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Investigations
Colonoscopy
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
5.3%
1/19 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Investigations
Heart rate irregular
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
6.7%
1/15 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Investigations
Platelet count decreased
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
3.3%
1/30 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
3.3%
1/30 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Investigations
Computerised tomogram abnormal
|
16.7%
1/6 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
10.5%
2/19 • Number of events 2 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
3.3%
1/30 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
10.5%
2/19 • Number of events 2 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
3.3%
1/30 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
5.3%
1/19 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
3.3%
1/30 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Gastrointestinal disorders
Duodenal ulcer
|
16.7%
1/6 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
6.7%
1/15 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Nervous system disorders
Cervical radiculopathy
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
5.3%
1/19 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Nervous system disorders
Migraine
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
6.7%
1/15 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
3.3%
1/30 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Nervous system disorders
Peroneal nerve palsy
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
3.3%
1/30 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Nervous system disorders
Nerve compression
|
16.7%
1/6 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Nervous system disorders
Neuropathy peripheral
|
16.7%
1/6 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
6.7%
1/15 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
3.3%
1/30 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
5.3%
1/19 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
6.7%
1/15 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
5.3%
1/19 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
6.7%
2/30 • Number of events 2 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
16.7%
1/6 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
5.3%
1/19 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
6.7%
2/30 • Number of events 2 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Psychiatric disorders
Depression
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
5.3%
1/19 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Cardiac disorders
Cardiovascular disorder
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
3.3%
1/30 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
5.3%
1/19 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
3.3%
1/30 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
General disorders
Fibrosis
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
5.3%
1/19 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
General disorders
Pain
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
3.3%
1/30 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
General disorders
Injection site haemorrhage
|
16.7%
1/6 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
6.7%
2/30 • Number of events 2 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
5.3%
1/19 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
5.3%
1/19 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Respiratory, thoracic and mediastinal disorders
Nasal cyst
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
3.3%
1/30 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive sleep apnoea syndrome
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
3.3%
1/30 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
3.3%
1/30 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
16.7%
1/6 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Skin and subcutaneous tissue disorders
Diabetic ulcer
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
3.3%
1/30 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
3.3%
1/30 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
1/6 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
3.3%
1/30 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
|
Product Issues
Device expulsion
|
16.7%
1/6 • Number of events 1 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/19 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/15 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
0.00%
0/30 • Any serious AE occurring after surgery through study completion, up to 108 months based on participants original implant date
Safety Population, Serious non-ocular AEs and serious ocular AEs in the study eye
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place