Trial Outcomes & Findings for Long-term Safety and Performance of the ARGOS-IO Intraocular Pressure Sensor System in Subjects With Primary Open Angle Glaucoma (POAG) (NCT NCT03651336)
NCT ID: NCT03651336
Last Updated: 2025-05-09
Results Overview
Number of patients experiencing a device related SAE (SADE) and device related complications (ADE) over the 36-months' clinical follow-up time.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
16 participants
Primary outcome timeframe
Baseline visit to Day 1080 (V01 [Baseline visit] to V07)
Results posted on
2025-05-09
Participant Flow
Recruitment from August 2018 to May 2019 in medical clinics.
Participant milestones
| Measure |
ARGOS-IO System
ARGOS-IO Pressure sensor previously implanted during local routine working procedures for cataract surgery in Patients with Primary Open Angle Glaucoma (POAG) and indicated cataract surgery in the ARGOS-01 and ARGOS-02 studies.
ARGOS-IO system: An active implantable intraocular pressure sensor to be implanted in the ciliary sulcus of the human eye, in combination with cataract surgery.
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|---|---|
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Overall Study
STARTED
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16
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Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
ARGOS-IO System
ARGOS-IO Pressure sensor previously implanted during local routine working procedures for cataract surgery in Patients with Primary Open Angle Glaucoma (POAG) and indicated cataract surgery in the ARGOS-01 and ARGOS-02 studies.
ARGOS-IO system: An active implantable intraocular pressure sensor to be implanted in the ciliary sulcus of the human eye, in combination with cataract surgery.
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|---|---|
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Overall Study
Withdrawal by Subject
|
4
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Baseline Characteristics
Long-term Safety and Performance of the ARGOS-IO Intraocular Pressure Sensor System in Subjects With Primary Open Angle Glaucoma (POAG)
Baseline characteristics by cohort
| Measure |
ARGOS-IO System
n=16 Participants
In this prospective open-label, multicenter study for clinical follow-up of the ARGOS-01 and ARGOS-02 patients, 16 patients were enrolled. Goldmann applanation tonometry (GAT) measurements were compared with the sensors' IOP measurements and comprehensive ophthalmic examinations were performed at all follow-up visits (V01-V07) through 36 months.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
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|
Age, Categorical
Between 18 and 65 years
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2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
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14 Participants
n=5 Participants
|
|
Age, Continuous
|
72.4 years
STANDARD_DEVIATION 5.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
16 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline visit to Day 1080 (V01 [Baseline visit] to V07)Number of patients experiencing a device related SAE (SADE) and device related complications (ADE) over the 36-months' clinical follow-up time.
Outcome measures
| Measure |
ARGOS-IO System
n=16 Participants
In this prospective open-label, multicenter study for clinical follow-up of the ARGOS-01 and ARGOS-02 patients, 16 patients were enrolled. Goldmann applanation tonometry (GAT) measurements were compared with the sensors' IOP measurements and comprehensive ophthalmic examinations were performed at all follow-up visits (V01-V07) through 36 months.
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|---|---|
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Safety: Number of Patients Experiencing a Device Related Serious Adverse Events (SADE) and Device Related Adverse Events (ADE)
SADEs
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0 Participants
|
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Safety: Number of Patients Experiencing a Device Related Serious Adverse Events (SADE) and Device Related Adverse Events (ADE)
ADEs
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0 Participants
|
PRIMARY outcome
Timeframe: Baseline visit to Day 1080 (V01 [Baseline visit] to V07)Population: All available pairs of GAT and the ARGOS-IO System IOP measurements.
Level of Agreement between intraocular pressure (IOP) measurements made using GAT \& the ARGOS-IO system (IOP in mmHg) following the Bland-Altman method.
Outcome measures
| Measure |
ARGOS-IO System
n=212 IOP measurement pairs
In this prospective open-label, multicenter study for clinical follow-up of the ARGOS-01 and ARGOS-02 patients, 16 patients were enrolled. Goldmann applanation tonometry (GAT) measurements were compared with the sensors' IOP measurements and comprehensive ophthalmic examinations were performed at all follow-up visits (V01-V07) through 36 months.
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|---|---|
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Performance: Level of Agreement Between GAT and the ARGOS-IO System
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1.4 mmHg
Interval -5.2 to 7.9
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PRIMARY outcome
Timeframe: Baseline visit to Day 1080 (V01 [Baseline visit] to V07)Population: All device deficiencies.
Incidence, nature and seriousness of observed device malfunctions / deficiencies (DDs)
Outcome measures
| Measure |
ARGOS-IO System
n=8 DDs
In this prospective open-label, multicenter study for clinical follow-up of the ARGOS-01 and ARGOS-02 patients, 16 patients were enrolled. Goldmann applanation tonometry (GAT) measurements were compared with the sensors' IOP measurements and comprehensive ophthalmic examinations were performed at all follow-up visits (V01-V07) through 36 months.
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|---|---|
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Performance: Device Malfunctions
Reader device (external handheld device)
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8 DDs
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Performance: Device Malfunctions
ARGOS-IO sensor
|
0 DDs
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SECONDARY outcome
Timeframe: Baseline visit to Day 1080 (V01 [Baseline visit] to V07)Population: All available ARGOS-IO measurements. Of the 16 patients, 3 patients were not included in the summarizing analysis for reasons related to early withdrawal from the study and dementia, hence the 13 participants analyzed.
The patients' compliance in IOP self-monitoring throughout the clinical follow-up study. Daily self-measurements with the ARGOS-IO sensor were to be done at least 4 times daily (morning, noon, afternoon, evening).
Outcome measures
| Measure |
ARGOS-IO System
n=13 Participants
In this prospective open-label, multicenter study for clinical follow-up of the ARGOS-01 and ARGOS-02 patients, 16 patients were enrolled. Goldmann applanation tonometry (GAT) measurements were compared with the sensors' IOP measurements and comprehensive ophthalmic examinations were performed at all follow-up visits (V01-V07) through 36 months.
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|---|---|
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Patient's Compliance in IOP Self-monitoring (Daily Self-measurements)
|
79 percentage of daily self-measurements
Standard Deviation 29
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SECONDARY outcome
Timeframe: Baseline visit to Day 1080 (V01 [Baseline visit] to V07)Population: All available ARGOS-IO measurements. Of the 16 patients, 3 patients were not included in the summarizing analysis for reasons related to early withdrawal from the study and dementia, hence the 13 participants analyzed.
The patients' compliance in IOP self-monitoring throughout the clinical follow-up study. Daily self-measurements with the ARGOS-IO sensor were to be done at least 4 times daily (morning, noon, afternoon, evening).
Outcome measures
| Measure |
ARGOS-IO System
n=13 Participants
In this prospective open-label, multicenter study for clinical follow-up of the ARGOS-01 and ARGOS-02 patients, 16 patients were enrolled. Goldmann applanation tonometry (GAT) measurements were compared with the sensors' IOP measurements and comprehensive ophthalmic examinations were performed at all follow-up visits (V01-V07) through 36 months.
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|---|---|
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Patient's Compliance in IOP Self-monitoring (Self-measurement Sequences / Day)
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3.4 number of self-measurement sequences/day
Standard Deviation 0.9
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Adverse Events
ARGOS-IO System
Serious events: 10 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ARGOS-IO System
n=16 participants at risk
A total of 16 patients from the ARGOS-01 and ARGOS-02 studies were enrolled in this open-label, multicenter study for clinical follow-up. Throughout the 36 months' clinical follow-up, the patients returned for 8 follow-up visits (V01-V07) consisting of comprehensive ophthalmic examinations as well as IOP measurements with the ARGOS-IO system and GAT.
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|---|---|
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Cardiac disorders
Myocardial infarction
|
12.5%
2/16 • Number of events 2 • Evaluation over 36 months' follow-up period.
SAE Definition That meets any of the following criteria of a serious adverse event: * Resulted in death, permanent damage or disability or a congenital anomaly * Was life threatening * Required hospitalization
|
|
Infections and infestations
Urinary tract infection
|
6.2%
1/16 • Number of events 1 • Evaluation over 36 months' follow-up period.
SAE Definition That meets any of the following criteria of a serious adverse event: * Resulted in death, permanent damage or disability or a congenital anomaly * Was life threatening * Required hospitalization
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
6.2%
1/16 • Number of events 1 • Evaluation over 36 months' follow-up period.
SAE Definition That meets any of the following criteria of a serious adverse event: * Resulted in death, permanent damage or disability or a congenital anomaly * Was life threatening * Required hospitalization
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
6.2%
1/16 • Number of events 1 • Evaluation over 36 months' follow-up period.
SAE Definition That meets any of the following criteria of a serious adverse event: * Resulted in death, permanent damage or disability or a congenital anomaly * Was life threatening * Required hospitalization
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
6.2%
1/16 • Number of events 1 • Evaluation over 36 months' follow-up period.
SAE Definition That meets any of the following criteria of a serious adverse event: * Resulted in death, permanent damage or disability or a congenital anomaly * Was life threatening * Required hospitalization
|
|
Investigations
Increased intraocular pressure
|
12.5%
2/16 • Number of events 2 • Evaluation over 36 months' follow-up period.
SAE Definition That meets any of the following criteria of a serious adverse event: * Resulted in death, permanent damage or disability or a congenital anomaly * Was life threatening * Required hospitalization
|
|
Investigations
Increased intraocular pressure -non-study eye-
|
6.2%
1/16 • Number of events 1 • Evaluation over 36 months' follow-up period.
SAE Definition That meets any of the following criteria of a serious adverse event: * Resulted in death, permanent damage or disability or a congenital anomaly * Was life threatening * Required hospitalization
|
|
Musculoskeletal and connective tissue disorders
Arthralgia -shoulder-
|
6.2%
1/16 • Number of events 1 • Evaluation over 36 months' follow-up period.
SAE Definition That meets any of the following criteria of a serious adverse event: * Resulted in death, permanent damage or disability or a congenital anomaly * Was life threatening * Required hospitalization
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
6.2%
1/16 • Number of events 1 • Evaluation over 36 months' follow-up period.
SAE Definition That meets any of the following criteria of a serious adverse event: * Resulted in death, permanent damage or disability or a congenital anomaly * Was life threatening * Required hospitalization
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
6.2%
1/16 • Number of events 1 • Evaluation over 36 months' follow-up period.
SAE Definition That meets any of the following criteria of a serious adverse event: * Resulted in death, permanent damage or disability or a congenital anomaly * Was life threatening * Required hospitalization
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma in remission
|
6.2%
1/16 • Number of events 1 • Evaluation over 36 months' follow-up period.
SAE Definition That meets any of the following criteria of a serious adverse event: * Resulted in death, permanent damage or disability or a congenital anomaly * Was life threatening * Required hospitalization
|
|
Nervous system disorders
Dementia
|
6.2%
1/16 • Number of events 1 • Evaluation over 36 months' follow-up period.
SAE Definition That meets any of the following criteria of a serious adverse event: * Resulted in death, permanent damage or disability or a congenital anomaly * Was life threatening * Required hospitalization
|
|
Product Issues
Loosening of shoulder joint prothesis
|
6.2%
1/16 • Number of events 1 • Evaluation over 36 months' follow-up period.
SAE Definition That meets any of the following criteria of a serious adverse event: * Resulted in death, permanent damage or disability or a congenital anomaly * Was life threatening * Required hospitalization
|
|
Renal and urinary disorders
Haematuria
|
6.2%
1/16 • Number of events 1 • Evaluation over 36 months' follow-up period.
SAE Definition That meets any of the following criteria of a serious adverse event: * Resulted in death, permanent damage or disability or a congenital anomaly * Was life threatening * Required hospitalization
|
|
Surgical and medical procedures
Hip arthroplasty
|
6.2%
1/16 • Number of events 1 • Evaluation over 36 months' follow-up period.
SAE Definition That meets any of the following criteria of a serious adverse event: * Resulted in death, permanent damage or disability or a congenital anomaly * Was life threatening * Required hospitalization
|
|
Surgical and medical procedures
Joint arthroplasty
|
6.2%
1/16 • Number of events 1 • Evaluation over 36 months' follow-up period.
SAE Definition That meets any of the following criteria of a serious adverse event: * Resulted in death, permanent damage or disability or a congenital anomaly * Was life threatening * Required hospitalization
|
Other adverse events
| Measure |
ARGOS-IO System
n=16 participants at risk
A total of 16 patients from the ARGOS-01 and ARGOS-02 studies were enrolled in this open-label, multicenter study for clinical follow-up. Throughout the 36 months' clinical follow-up, the patients returned for 8 follow-up visits (V01-V07) consisting of comprehensive ophthalmic examinations as well as IOP measurements with the ARGOS-IO system and GAT.
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|---|---|
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Eye disorders
Visual acuity reduced
|
18.8%
3/16 • Number of events 3 • Evaluation over 36 months' follow-up period.
SAE Definition That meets any of the following criteria of a serious adverse event: * Resulted in death, permanent damage or disability or a congenital anomaly * Was life threatening * Required hospitalization
|
|
Eye disorders
Visual acuity reduced -non-study eye-
|
12.5%
2/16 • Number of events 2 • Evaluation over 36 months' follow-up period.
SAE Definition That meets any of the following criteria of a serious adverse event: * Resulted in death, permanent damage or disability or a congenital anomaly * Was life threatening * Required hospitalization
|
|
General disorders
Reduced general health
|
12.5%
2/16 • Number of events 2 • Evaluation over 36 months' follow-up period.
SAE Definition That meets any of the following criteria of a serious adverse event: * Resulted in death, permanent damage or disability or a congenital anomaly * Was life threatening * Required hospitalization
|
|
Investigations
Intraocular pressure increased
|
12.5%
2/16 • Number of events 2 • Evaluation over 36 months' follow-up period.
SAE Definition That meets any of the following criteria of a serious adverse event: * Resulted in death, permanent damage or disability or a congenital anomaly * Was life threatening * Required hospitalization
|
|
Eye disorders
Anterior chamber inflammation
|
6.2%
1/16 • Number of events 1 • Evaluation over 36 months' follow-up period.
SAE Definition That meets any of the following criteria of a serious adverse event: * Resulted in death, permanent damage or disability or a congenital anomaly * Was life threatening * Required hospitalization
|
|
Musculoskeletal and connective tissue disorders
Arthralgia -knee-
|
6.2%
1/16 • Number of events 1 • Evaluation over 36 months' follow-up period.
SAE Definition That meets any of the following criteria of a serious adverse event: * Resulted in death, permanent damage or disability or a congenital anomaly * Was life threatening * Required hospitalization
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.2%
1/16 • Number of events 1 • Evaluation over 36 months' follow-up period.
SAE Definition That meets any of the following criteria of a serious adverse event: * Resulted in death, permanent damage or disability or a congenital anomaly * Was life threatening * Required hospitalization
|
|
Eye disorders
Blepharitis
|
6.2%
1/16 • Number of events 1 • Evaluation over 36 months' follow-up period.
SAE Definition That meets any of the following criteria of a serious adverse event: * Resulted in death, permanent damage or disability or a congenital anomaly * Was life threatening * Required hospitalization
|
|
Cardiac disorders
Cardiovascular decompensation
|
6.2%
1/16 • Number of events 1 • Evaluation over 36 months' follow-up period.
SAE Definition That meets any of the following criteria of a serious adverse event: * Resulted in death, permanent damage or disability or a congenital anomaly * Was life threatening * Required hospitalization
|
|
Surgical and medical procedures
Cataract surgery
|
6.2%
1/16 • Number of events 1 • Evaluation over 36 months' follow-up period.
SAE Definition That meets any of the following criteria of a serious adverse event: * Resulted in death, permanent damage or disability or a congenital anomaly * Was life threatening * Required hospitalization
|
|
Eye disorders
Conjunctival irritation b/o allergy to preservatives
|
6.2%
1/16 • Number of events 1 • Evaluation over 36 months' follow-up period.
SAE Definition That meets any of the following criteria of a serious adverse event: * Resulted in death, permanent damage or disability or a congenital anomaly * Was life threatening * Required hospitalization
|
|
Eye disorders
Conjunctivitis allergic OU
|
6.2%
1/16 • Number of events 1 • Evaluation over 36 months' follow-up period.
SAE Definition That meets any of the following criteria of a serious adverse event: * Resulted in death, permanent damage or disability or a congenital anomaly * Was life threatening * Required hospitalization
|
|
Infections and infestations
Conjunctivitis OU
|
6.2%
1/16 • Number of events 1 • Evaluation over 36 months' follow-up period.
SAE Definition That meets any of the following criteria of a serious adverse event: * Resulted in death, permanent damage or disability or a congenital anomaly * Was life threatening * Required hospitalization
|
|
Injury, poisoning and procedural complications
Contusion -wrist-
|
6.2%
1/16 • Number of events 1 • Evaluation over 36 months' follow-up period.
SAE Definition That meets any of the following criteria of a serious adverse event: * Resulted in death, permanent damage or disability or a congenital anomaly * Was life threatening * Required hospitalization
|
|
Eye disorders
Corneal dystrophy OU
|
6.2%
1/16 • Number of events 1 • Evaluation over 36 months' follow-up period.
SAE Definition That meets any of the following criteria of a serious adverse event: * Resulted in death, permanent damage or disability or a congenital anomaly * Was life threatening * Required hospitalization
|
|
Eye disorders
Corneal endothelial cell loss
|
6.2%
1/16 • Number of events 1 • Evaluation over 36 months' follow-up period.
SAE Definition That meets any of the following criteria of a serious adverse event: * Resulted in death, permanent damage or disability or a congenital anomaly * Was life threatening * Required hospitalization
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic -periocular skin-
|
6.2%
1/16 • Number of events 1 • Evaluation over 36 months' follow-up period.
SAE Definition That meets any of the following criteria of a serious adverse event: * Resulted in death, permanent damage or disability or a congenital anomaly * Was life threatening * Required hospitalization
|
|
Eye disorders
Epiretinal membrane
|
6.2%
1/16 • Number of events 1 • Evaluation over 36 months' follow-up period.
SAE Definition That meets any of the following criteria of a serious adverse event: * Resulted in death, permanent damage or disability or a congenital anomaly * Was life threatening * Required hospitalization
|
|
Eye disorders
Eye heamatoma
|
6.2%
1/16 • Number of events 1 • Evaluation over 36 months' follow-up period.
SAE Definition That meets any of the following criteria of a serious adverse event: * Resulted in death, permanent damage or disability or a congenital anomaly * Was life threatening * Required hospitalization
|
|
General disorders
Fatigue (b/o suspected side effects of medications)
|
6.2%
1/16 • Number of events 1 • Evaluation over 36 months' follow-up period.
SAE Definition That meets any of the following criteria of a serious adverse event: * Resulted in death, permanent damage or disability or a congenital anomaly * Was life threatening * Required hospitalization
|
|
General disorders
Gait disturbance
|
6.2%
1/16 • Number of events 1 • Evaluation over 36 months' follow-up period.
SAE Definition That meets any of the following criteria of a serious adverse event: * Resulted in death, permanent damage or disability or a congenital anomaly * Was life threatening * Required hospitalization
|
|
Surgical and medical procedures
Glaucoma surgery
|
6.2%
1/16 • Number of events 1 • Evaluation over 36 months' follow-up period.
SAE Definition That meets any of the following criteria of a serious adverse event: * Resulted in death, permanent damage or disability or a congenital anomaly * Was life threatening * Required hospitalization
|
|
Infections and infestations
Herpes Keratitis OU
|
6.2%
1/16 • Number of events 1 • Evaluation over 36 months' follow-up period.
SAE Definition That meets any of the following criteria of a serious adverse event: * Resulted in death, permanent damage or disability or a congenital anomaly * Was life threatening * Required hospitalization
|
|
Eye disorders
Increased intraocular pressure -non-study eye-
|
6.2%
1/16 • Number of events 1 • Evaluation over 36 months' follow-up period.
SAE Definition That meets any of the following criteria of a serious adverse event: * Resulted in death, permanent damage or disability or a congenital anomaly * Was life threatening * Required hospitalization
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
6.2%
1/16 • Number of events 1 • Evaluation over 36 months' follow-up period.
SAE Definition That meets any of the following criteria of a serious adverse event: * Resulted in death, permanent damage or disability or a congenital anomaly * Was life threatening * Required hospitalization
|
|
Eye disorders
Lentodonesis -non-study eye-
|
6.2%
1/16 • Number of events 1 • Evaluation over 36 months' follow-up period.
SAE Definition That meets any of the following criteria of a serious adverse event: * Resulted in death, permanent damage or disability or a congenital anomaly * Was life threatening * Required hospitalization
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
6.2%
1/16 • Number of events 1 • Evaluation over 36 months' follow-up period.
SAE Definition That meets any of the following criteria of a serious adverse event: * Resulted in death, permanent damage or disability or a congenital anomaly * Was life threatening * Required hospitalization
|
|
Renal and urinary disorders
Nephrolithiasis
|
6.2%
1/16 • Number of events 1 • Evaluation over 36 months' follow-up period.
SAE Definition That meets any of the following criteria of a serious adverse event: * Resulted in death, permanent damage or disability or a congenital anomaly * Was life threatening * Required hospitalization
|
|
General disorders
Oedema peripheral -leg-
|
6.2%
1/16 • Number of events 1 • Evaluation over 36 months' follow-up period.
SAE Definition That meets any of the following criteria of a serious adverse event: * Resulted in death, permanent damage or disability or a congenital anomaly * Was life threatening * Required hospitalization
|
|
Eye disorders
Optic disk haemorrhage
|
6.2%
1/16 • Number of events 1 • Evaluation over 36 months' follow-up period.
SAE Definition That meets any of the following criteria of a serious adverse event: * Resulted in death, permanent damage or disability or a congenital anomaly * Was life threatening * Required hospitalization
|
|
Congenital, familial and genetic disorders
Phimosis
|
6.2%
1/16 • Number of events 1 • Evaluation over 36 months' follow-up period.
SAE Definition That meets any of the following criteria of a serious adverse event: * Resulted in death, permanent damage or disability or a congenital anomaly * Was life threatening * Required hospitalization
|
|
Eye disorders
Posterior capsule opacification
|
6.2%
1/16 • Number of events 1 • Evaluation over 36 months' follow-up period.
SAE Definition That meets any of the following criteria of a serious adverse event: * Resulted in death, permanent damage or disability or a congenital anomaly * Was life threatening * Required hospitalization
|
|
Eye disorders
Posterior capsule opacification -non-study eye-
|
6.2%
1/16 • Number of events 1 • Evaluation over 36 months' follow-up period.
SAE Definition That meets any of the following criteria of a serious adverse event: * Resulted in death, permanent damage or disability or a congenital anomaly * Was life threatening * Required hospitalization
|
|
Injury, poisoning and procedural complications
Procedural dizziness
|
6.2%
1/16 • Number of events 1 • Evaluation over 36 months' follow-up period.
SAE Definition That meets any of the following criteria of a serious adverse event: * Resulted in death, permanent damage or disability or a congenital anomaly * Was life threatening * Required hospitalization
|
|
Eye disorders
Retinal haemorrhage
|
6.2%
1/16 • Number of events 1 • Evaluation over 36 months' follow-up period.
SAE Definition That meets any of the following criteria of a serious adverse event: * Resulted in death, permanent damage or disability or a congenital anomaly * Was life threatening * Required hospitalization
|
|
Eye disorders
Retinal tear
|
6.2%
1/16 • Number of events 1 • Evaluation over 36 months' follow-up period.
SAE Definition That meets any of the following criteria of a serious adverse event: * Resulted in death, permanent damage or disability or a congenital anomaly * Was life threatening * Required hospitalization
|
|
Skin and subcutaneous tissue disorders
Skin lesion -wrists and forearms-
|
6.2%
1/16 • Number of events 1 • Evaluation over 36 months' follow-up period.
SAE Definition That meets any of the following criteria of a serious adverse event: * Resulted in death, permanent damage or disability or a congenital anomaly * Was life threatening * Required hospitalization
|
|
Vascular disorders
Thrombophlebitis
|
6.2%
1/16 • Number of events 1 • Evaluation over 36 months' follow-up period.
SAE Definition That meets any of the following criteria of a serious adverse event: * Resulted in death, permanent damage or disability or a congenital anomaly * Was life threatening * Required hospitalization
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
6.2%
1/16 • Number of events 1 • Evaluation over 36 months' follow-up period.
SAE Definition That meets any of the following criteria of a serious adverse event: * Resulted in death, permanent damage or disability or a congenital anomaly * Was life threatening * Required hospitalization
|
|
Eye disorders
Visual acuity reduced OU
|
6.2%
1/16 • Number of events 1 • Evaluation over 36 months' follow-up period.
SAE Definition That meets any of the following criteria of a serious adverse event: * Resulted in death, permanent damage or disability or a congenital anomaly * Was life threatening * Required hospitalization
|
|
Immune system disorders
Worsening of allergic reaction to eye drops
|
6.2%
1/16 • Number of events 1 • Evaluation over 36 months' follow-up period.
SAE Definition That meets any of the following criteria of a serious adverse event: * Resulted in death, permanent damage or disability or a congenital anomaly * Was life threatening * Required hospitalization
|
|
Eye disorders
Worsening of glaucoma
|
6.2%
1/16 • Number of events 1 • Evaluation over 36 months' follow-up period.
SAE Definition That meets any of the following criteria of a serious adverse event: * Resulted in death, permanent damage or disability or a congenital anomaly * Was life threatening * Required hospitalization
|
|
Eye disorders
Worsening of glaucoma OU
|
6.2%
1/16 • Number of events 1 • Evaluation over 36 months' follow-up period.
SAE Definition That meets any of the following criteria of a serious adverse event: * Resulted in death, permanent damage or disability or a congenital anomaly * Was life threatening * Required hospitalization
|
|
Injury, poisoning and procedural complications
Wound dehiscence -knee-
|
6.2%
1/16 • Number of events 1 • Evaluation over 36 months' follow-up period.
SAE Definition That meets any of the following criteria of a serious adverse event: * Resulted in death, permanent damage or disability or a congenital anomaly * Was life threatening * Required hospitalization
|
Additional Information
Clinical Study Manager
Implandata Ophthalmic Products
Phone: +49 (0) 511 - 2204 2580
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place