Trial Outcomes & Findings for Performance and Safety of the ARGOS-SC Suprachoroidal Pressure Sensor in Patients With Glaucoma Undergoing Non-penetrating Glaucoma Surgery (NCT NCT03756662)
NCT ID: NCT03756662
Last Updated: 2025-01-24
Results Overview
Level of Agreement between intraocular pressure (IOP) measurements made using GAT \& the ARGOS-SC system (IOP in mmHg) following the Bland-Altman method.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
24 participants
Primary outcome timeframe
Day 1 to Day 360 (V02 to V09)
Results posted on
2025-01-24
Participant Flow
Recruitment from November 2018 to January 2020 in medical clinics.
Participant milestones
| Measure |
ARGOS-SC Sensor
In this prospective, multicenter, open-label, single-arm, interventional clinical trial, 24 eyes of 24 POAG patients who were due to undergo NPGS (canaloplasty or deep sclerectomy) were enrolled. An ARGOS-SC sensor was implanted during NPGS. Goldmann applanation tonometry(GAT) measures were compared with the sensors' IOP measures and comprehensive ophthalmic examinations at all post-operative visits (V02-V09) through 12 months. Device position and adverse events were recorded throughout the follow-up.
|
|---|---|
|
Overall Study
STARTED
|
24
|
|
Overall Study
COMPLETED
|
23
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
ARGOS-SC Sensor
In this prospective, multicenter, open-label, single-arm, interventional clinical trial, 24 eyes of 24 POAG patients who were due to undergo NPGS (canaloplasty or deep sclerectomy) were enrolled. An ARGOS-SC sensor was implanted during NPGS. Goldmann applanation tonometry(GAT) measures were compared with the sensors' IOP measures and comprehensive ophthalmic examinations at all post-operative visits (V02-V09) through 12 months. Device position and adverse events were recorded throughout the follow-up.
|
|---|---|
|
Overall Study
due to an SAE that was not related to the medical device or medical procedure.
|
1
|
Baseline Characteristics
Performance and Safety of the ARGOS-SC Suprachoroidal Pressure Sensor in Patients With Glaucoma Undergoing Non-penetrating Glaucoma Surgery
Baseline characteristics by cohort
| Measure |
ARGOS-SC Sensor
n=24 Participants
In this prospective, multicenter, open-label, single-arm, interventional clinical trial, 24 eyes of 24 POAG patients who were due to undergo NPGS (canaloplasty or deep sclerectomy) were enrolled. An ARGOS-SC sensor was implanted during NPGS. Goldmann applanation tonometry (GAT) measures were compared with the sensors' IOP measures and comprehensive ophthalmic examinations at all post-operative visits (V02-V09) through 12 months. Device position and adverse events were recorded throughout the follow-up.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=5 Participants
|
|
Age, Continuous
|
65.2 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 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
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
22 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
Switzerland
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
20 participants
n=5 Participants
|
|
Type of Glaucoma
Primary open-angle glaucoma (POAG)
|
17 Participants
n=5 Participants
|
|
Type of Glaucoma
Ocular hypertension (OHT)/Glaucoma suspect
|
2 Participants
n=5 Participants
|
|
Type of Glaucoma
Pseudoexfoliative (PEX) glauoma
|
2 Participants
n=5 Participants
|
|
Type of Glaucoma
Other
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 360 (V02 to V09)Population: All available GAT and ARGOS-SC measurements.
Level of Agreement between intraocular pressure (IOP) measurements made using GAT \& the ARGOS-SC system (IOP in mmHg) following the Bland-Altman method.
Outcome measures
| Measure |
ARGOS-SC Sensor
n=536 comparisons
In this prospective, multicenter, open-label, single-arm, interventional clinical trial, 24 eyes of 24 POAG patients who were due to undergo NPGS (canaloplasty or deep sclerectomy) were enrolled. An ARGOS-SC sensor was implanted during NPGS. Goldmann applanation tonometry(GAT) measures were compared with the sensors' IOP measures and comprehensive ophthalmic examinations at all post-operative visits (V02-V09) through 12 months. Device position and adverse events were recorded throughout the follow-up.
|
ARGOS-SC Sensor After 3 Month Postoperative
Comparisons between ARGOS-SC and GAT at post-operative visits (V05-V09) 3 month through 12 month.
|
|---|---|---|
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Performance: Level of Agreement Between GAT and the ARGOS-SC System
Overall Level of Agreement
|
0.8 mmHg
Interval -5.1 to 6.7
|
—
|
|
Performance: Level of Agreement Between GAT and the ARGOS-SC System
Level of Agreement 3-month post-operatively until the end of the follow-up
|
-0.2 mmHg
Interval -4.6 to 4.2
|
—
|
SECONDARY outcome
Timeframe: Day 0 to Day 360 (V01 [Implantation] to V09)Number of patients experiencing a device-related SAE (SADE).
Outcome measures
| Measure |
ARGOS-SC Sensor
n=24 Participants
In this prospective, multicenter, open-label, single-arm, interventional clinical trial, 24 eyes of 24 POAG patients who were due to undergo NPGS (canaloplasty or deep sclerectomy) were enrolled. An ARGOS-SC sensor was implanted during NPGS. Goldmann applanation tonometry(GAT) measures were compared with the sensors' IOP measures and comprehensive ophthalmic examinations at all post-operative visits (V02-V09) through 12 months. Device position and adverse events were recorded throughout the follow-up.
|
ARGOS-SC Sensor After 3 Month Postoperative
Comparisons between ARGOS-SC and GAT at post-operative visits (V05-V09) 3 month through 12 month.
|
|---|---|---|
|
Safety: Number of Patients Experiencing a Device-related SAE (SADE)
|
0 participants
|
—
|
SECONDARY outcome
Timeframe: Day 0 to Day 360 (V01 [Implantation] to V09)Population: A total of 98 AEs in 22 patients were reported in the ARGOS-SC study. In overall 54 adverse events were documented in 20 patients affecting the study eye. 11 out of 98 AEs in 7 Patients fulfilled at least one criterion for "serious adverse event" (SAE) and were reported as such. All of these SAEs were unrelated to the medical device or implantation procedure.
Safety evaluation based on the incidence, nature, severity and seriousness of observed adverse events and adverse device events.
Outcome measures
| Measure |
ARGOS-SC Sensor
n=98 Total number of AEs
In this prospective, multicenter, open-label, single-arm, interventional clinical trial, 24 eyes of 24 POAG patients who were due to undergo NPGS (canaloplasty or deep sclerectomy) were enrolled. An ARGOS-SC sensor was implanted during NPGS. Goldmann applanation tonometry(GAT) measures were compared with the sensors' IOP measures and comprehensive ophthalmic examinations at all post-operative visits (V02-V09) through 12 months. Device position and adverse events were recorded throughout the follow-up.
|
ARGOS-SC Sensor After 3 Month Postoperative
Comparisons between ARGOS-SC and GAT at post-operative visits (V05-V09) 3 month through 12 month.
|
|---|---|---|
|
Safety: Incidence, Nature, Severity and Seriousness of Observed Adverse Events (AEs) and Adverse Device Events (ADEs)
AEs related to other
|
7 A(D)Es
|
—
|
|
Safety: Incidence, Nature, Severity and Seriousness of Observed Adverse Events (AEs) and Adverse Device Events (ADEs)
Overall number of AEs/ADEs affecting the study eye, of which
|
54 A(D)Es
|
—
|
|
Safety: Incidence, Nature, Severity and Seriousness of Observed Adverse Events (AEs) and Adverse Device Events (ADEs)
AEs related to medical procedure and/or
|
44 A(D)Es
|
—
|
|
Safety: Incidence, Nature, Severity and Seriousness of Observed Adverse Events (AEs) and Adverse Device Events (ADEs)
AEs related to medical device and/or
|
16 A(D)Es
|
—
|
SECONDARY outcome
Timeframe: Day 1 to Day 360 (V02 to V09)Population: All available GAT\<\>ARGOS-SC comparisons.
Concordance of the ARGOS-SC\<\>GAT measurement. Method applied: The probability distribution of the difference in the measurements made using GAT \& the ARGOS-SC system per visit ("paired measurement") grouped within 1 mmHg was compared to the outcome measure of achieving 70% agreement of the total number of comparisons between +/-5 mmHg. The first column presents the overall data and the second column presents data from 3 months postoperatively onwards.
Outcome measures
| Measure |
ARGOS-SC Sensor
n=181 comparisons
In this prospective, multicenter, open-label, single-arm, interventional clinical trial, 24 eyes of 24 POAG patients who were due to undergo NPGS (canaloplasty or deep sclerectomy) were enrolled. An ARGOS-SC sensor was implanted during NPGS. Goldmann applanation tonometry(GAT) measures were compared with the sensors' IOP measures and comprehensive ophthalmic examinations at all post-operative visits (V02-V09) through 12 months. Device position and adverse events were recorded throughout the follow-up.
|
ARGOS-SC Sensor After 3 Month Postoperative
n=87 comparisons
Comparisons between ARGOS-SC and GAT at post-operative visits (V05-V09) 3 month through 12 month.
|
|---|---|---|
|
Performance: Percentage of Measurements Within +/- 5 mmHg
|
91 percentage of measurements
|
98 percentage of measurements
|
SECONDARY outcome
Timeframe: Day 0 to Day 360 (V01 [Implantation] to V09)Population: 24 device deficiencies in 14 patients have been documented and were analyzed. The safety and well-being was not affected (or had the potential to affect) in any patient.
Incidence, nature and seriousness of observed device malfunctions / deficiencies (DDs).
Outcome measures
| Measure |
ARGOS-SC Sensor
n=24 DDs
In this prospective, multicenter, open-label, single-arm, interventional clinical trial, 24 eyes of 24 POAG patients who were due to undergo NPGS (canaloplasty or deep sclerectomy) were enrolled. An ARGOS-SC sensor was implanted during NPGS. Goldmann applanation tonometry(GAT) measures were compared with the sensors' IOP measures and comprehensive ophthalmic examinations at all post-operative visits (V02-V09) through 12 months. Device position and adverse events were recorded throughout the follow-up.
|
ARGOS-SC Sensor After 3 Month Postoperative
Comparisons between ARGOS-SC and GAT at post-operative visits (V05-V09) 3 month through 12 month.
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|---|---|---|
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Performance: Device Malfunctions
Reader device (external handheld device)
|
14 DDs
|
—
|
|
Performance: Device Malfunctions
ARGOS-SC sensor (recalibration of the reader device for compensation, one (1) discontinued use)
|
4 DDs
|
—
|
|
Performance: Device Malfunctions
Both reader device and ARGOS-SC sensor
|
5 DDs
|
—
|
|
Performance: Device Malfunctions
Other
|
1 DDs
|
—
|
SECONDARY outcome
Timeframe: Day 1 (V01 [Implantation])Population: After each implantation procedure, the surgeon performing the implantation procedure was asked to provide feedback on the implantation procedure and the handling of the investigational device. A total of 7 surgeons performed the implantation procedure and provided feedback via a structured questionnaire.
User acceptance of the ARGOS-SC implantation procedure by means of evaluation of implantation procedure questionnaires (surgeons) on a scale of 1 to 7 how strongly they agree to given statements (1 = totally disagree, 7 = totally agree). Overall Number of Participant Analyzed represents the 7 surgeons who provided feedback via a structured questionnaire. The score 7 represents a greater user acceptance.
Outcome measures
| Measure |
ARGOS-SC Sensor
n=7 Participants
In this prospective, multicenter, open-label, single-arm, interventional clinical trial, 24 eyes of 24 POAG patients who were due to undergo NPGS (canaloplasty or deep sclerectomy) were enrolled. An ARGOS-SC sensor was implanted during NPGS. Goldmann applanation tonometry(GAT) measures were compared with the sensors' IOP measures and comprehensive ophthalmic examinations at all post-operative visits (V02-V09) through 12 months. Device position and adverse events were recorded throughout the follow-up.
|
ARGOS-SC Sensor After 3 Month Postoperative
Comparisons between ARGOS-SC and GAT at post-operative visits (V05-V09) 3 month through 12 month.
|
|---|---|---|
|
Usability: Implantation Procedure
|
6.6 score on a scale
Standard Deviation 2.1
|
—
|
SECONDARY outcome
Timeframe: Day 1 to Day 360 (V02 to V09)Population: The user acceptance questionnaire for physicians was collected from 12 investigators.
User acceptance of the ARGOS-SC system at the investigational site by means of evaluation of Investigator's questionnaires on a scale of 1 to 7 how strongly they agree to given statements (1 = totally disagree, 7 = totally agree). Overall Number of Participants Analyzed represents the 12 physician investigators who completed the User Acceptance Questionnaire. The score 7 represents a greater user acceptance.
Outcome measures
| Measure |
ARGOS-SC Sensor
n=12 Participants
In this prospective, multicenter, open-label, single-arm, interventional clinical trial, 24 eyes of 24 POAG patients who were due to undergo NPGS (canaloplasty or deep sclerectomy) were enrolled. An ARGOS-SC sensor was implanted during NPGS. Goldmann applanation tonometry(GAT) measures were compared with the sensors' IOP measures and comprehensive ophthalmic examinations at all post-operative visits (V02-V09) through 12 months. Device position and adverse events were recorded throughout the follow-up.
|
ARGOS-SC Sensor After 3 Month Postoperative
Comparisons between ARGOS-SC and GAT at post-operative visits (V05-V09) 3 month through 12 month.
|
|---|---|---|
|
Usability: User Acceptance at the Investigational Site
|
5.5 score on a scale
Standard Deviation 3.1
|
—
|
SECONDARY outcome
Timeframe: Day 1 to Day 360 (V02 to V09)Population: Each patient was asked to provide feedback on the user acceptance of the ARGOS-SC system at home. A total of 19 patients provided feedback via a structured questionnaire.
User acceptance of the ARGOS-SC system at home by means of evaluation of patient questionnaires on a scale of 1 to 7 how strongly they agree to given statements (1 = totally disagree, 7 = totally agree). The score 7 represents a greater user acceptance.
Outcome measures
| Measure |
ARGOS-SC Sensor
n=19 Participants
In this prospective, multicenter, open-label, single-arm, interventional clinical trial, 24 eyes of 24 POAG patients who were due to undergo NPGS (canaloplasty or deep sclerectomy) were enrolled. An ARGOS-SC sensor was implanted during NPGS. Goldmann applanation tonometry(GAT) measures were compared with the sensors' IOP measures and comprehensive ophthalmic examinations at all post-operative visits (V02-V09) through 12 months. Device position and adverse events were recorded throughout the follow-up.
|
ARGOS-SC Sensor After 3 Month Postoperative
Comparisons between ARGOS-SC and GAT at post-operative visits (V05-V09) 3 month through 12 month.
|
|---|---|---|
|
Usability: User Acceptance at Home
|
5.7 score on a scale
Standard Deviation 3.2
|
—
|
Adverse Events
ARGOS-SC Sensor
Serious events: 7 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ARGOS-SC Sensor
n=24 participants at risk
In this prospective, multicenter, open-label, single-arm, interventional clinical trial, 24 eyes of 24 POAG patients who were due to undergo NPGS (canaloplasty or deep sclerectomy) were enrolled. An ARGOS-SC sensor was implanted during NPGS. Goldmann applanation tonometry(GAT) measures were compared with the sensors' IOP measures and comprehensive ophthalmic examinations at all post-operative visits (V02-V09) through 12 months. Device position and adverse events were recorded throughout the follow-up.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
acute dyspnoe
|
4.2%
1/24 • Number of events 1 • Evaluation over 12 months follow-up period. Within the timeframe of the ARGOS-SC01 Study: In Germany the term SAE is defined according to §2 Section 5 MPSV.
SAE defined as AE that 1. Led to death 2. Led to a serious deterioration in health of a subject that: a Resulted in life-threatening illness or injury b Resulted in permanent impairment of a body-structure or function c Required in-patient hospitalization or prolongation of existing hospitalization d Required medical or surgical intervention to prevent permanent impairment to body-structure or a -function 3. Led to fetal distress, fetal death or a congenital abnormality or birth defect
|
|
Nervous system disorders
Cerebral ischemia, left, suspected
|
4.2%
1/24 • Number of events 1 • Evaluation over 12 months follow-up period. Within the timeframe of the ARGOS-SC01 Study: In Germany the term SAE is defined according to §2 Section 5 MPSV.
SAE defined as AE that 1. Led to death 2. Led to a serious deterioration in health of a subject that: a Resulted in life-threatening illness or injury b Resulted in permanent impairment of a body-structure or function c Required in-patient hospitalization or prolongation of existing hospitalization d Required medical or surgical intervention to prevent permanent impairment to body-structure or a -function 3. Led to fetal distress, fetal death or a congenital abnormality or birth defect
|
|
General disorders
chronic sleep apnoe
|
4.2%
1/24 • Number of events 1 • Evaluation over 12 months follow-up period. Within the timeframe of the ARGOS-SC01 Study: In Germany the term SAE is defined according to §2 Section 5 MPSV.
SAE defined as AE that 1. Led to death 2. Led to a serious deterioration in health of a subject that: a Resulted in life-threatening illness or injury b Resulted in permanent impairment of a body-structure or function c Required in-patient hospitalization or prolongation of existing hospitalization d Required medical or surgical intervention to prevent permanent impairment to body-structure or a -function 3. Led to fetal distress, fetal death or a congenital abnormality or birth defect
|
|
Surgical and medical procedures
Hallux Valux Surgery
|
4.2%
1/24 • Number of events 1 • Evaluation over 12 months follow-up period. Within the timeframe of the ARGOS-SC01 Study: In Germany the term SAE is defined according to §2 Section 5 MPSV.
SAE defined as AE that 1. Led to death 2. Led to a serious deterioration in health of a subject that: a Resulted in life-threatening illness or injury b Resulted in permanent impairment of a body-structure or function c Required in-patient hospitalization or prolongation of existing hospitalization d Required medical or surgical intervention to prevent permanent impairment to body-structure or a -function 3. Led to fetal distress, fetal death or a congenital abnormality or birth defect
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
4.2%
1/24 • Number of events 1 • Evaluation over 12 months follow-up period. Within the timeframe of the ARGOS-SC01 Study: In Germany the term SAE is defined according to §2 Section 5 MPSV.
SAE defined as AE that 1. Led to death 2. Led to a serious deterioration in health of a subject that: a Resulted in life-threatening illness or injury b Resulted in permanent impairment of a body-structure or function c Required in-patient hospitalization or prolongation of existing hospitalization d Required medical or surgical intervention to prevent permanent impairment to body-structure or a -function 3. Led to fetal distress, fetal death or a congenital abnormality or birth defect
|
|
Injury, poisoning and procedural complications
Spinal Fracture
|
4.2%
1/24 • Number of events 1 • Evaluation over 12 months follow-up period. Within the timeframe of the ARGOS-SC01 Study: In Germany the term SAE is defined according to §2 Section 5 MPSV.
SAE defined as AE that 1. Led to death 2. Led to a serious deterioration in health of a subject that: a Resulted in life-threatening illness or injury b Resulted in permanent impairment of a body-structure or function c Required in-patient hospitalization or prolongation of existing hospitalization d Required medical or surgical intervention to prevent permanent impairment to body-structure or a -function 3. Led to fetal distress, fetal death or a congenital abnormality or birth defect
|
|
Gastrointestinal disorders
Stomach ache
|
4.2%
1/24 • Number of events 1 • Evaluation over 12 months follow-up period. Within the timeframe of the ARGOS-SC01 Study: In Germany the term SAE is defined according to §2 Section 5 MPSV.
SAE defined as AE that 1. Led to death 2. Led to a serious deterioration in health of a subject that: a Resulted in life-threatening illness or injury b Resulted in permanent impairment of a body-structure or function c Required in-patient hospitalization or prolongation of existing hospitalization d Required medical or surgical intervention to prevent permanent impairment to body-structure or a -function 3. Led to fetal distress, fetal death or a congenital abnormality or birth defect
|
|
General disorders
Syncope
|
8.3%
2/24 • Number of events 2 • Evaluation over 12 months follow-up period. Within the timeframe of the ARGOS-SC01 Study: In Germany the term SAE is defined according to §2 Section 5 MPSV.
SAE defined as AE that 1. Led to death 2. Led to a serious deterioration in health of a subject that: a Resulted in life-threatening illness or injury b Resulted in permanent impairment of a body-structure or function c Required in-patient hospitalization or prolongation of existing hospitalization d Required medical or surgical intervention to prevent permanent impairment to body-structure or a -function 3. Led to fetal distress, fetal death or a congenital abnormality or birth defect
|
|
General disorders
Syncope, retrograd amnesie and fracture of vertebrae
|
4.2%
1/24 • Number of events 1 • Evaluation over 12 months follow-up period. Within the timeframe of the ARGOS-SC01 Study: In Germany the term SAE is defined according to §2 Section 5 MPSV.
SAE defined as AE that 1. Led to death 2. Led to a serious deterioration in health of a subject that: a Resulted in life-threatening illness or injury b Resulted in permanent impairment of a body-structure or function c Required in-patient hospitalization or prolongation of existing hospitalization d Required medical or surgical intervention to prevent permanent impairment to body-structure or a -function 3. Led to fetal distress, fetal death or a congenital abnormality or birth defect
|
|
Surgical and medical procedures
intestinak surgery (removal of carcinoma)
|
4.2%
1/24 • Number of events 1 • Evaluation over 12 months follow-up period. Within the timeframe of the ARGOS-SC01 Study: In Germany the term SAE is defined according to §2 Section 5 MPSV.
SAE defined as AE that 1. Led to death 2. Led to a serious deterioration in health of a subject that: a Resulted in life-threatening illness or injury b Resulted in permanent impairment of a body-structure or function c Required in-patient hospitalization or prolongation of existing hospitalization d Required medical or surgical intervention to prevent permanent impairment to body-structure or a -function 3. Led to fetal distress, fetal death or a congenital abnormality or birth defect
|
Other adverse events
| Measure |
ARGOS-SC Sensor
n=24 participants at risk
In this prospective, multicenter, open-label, single-arm, interventional clinical trial, 24 eyes of 24 POAG patients who were due to undergo NPGS (canaloplasty or deep sclerectomy) were enrolled. An ARGOS-SC sensor was implanted during NPGS. Goldmann applanation tonometry(GAT) measures were compared with the sensors' IOP measures and comprehensive ophthalmic examinations at all post-operative visits (V02-V09) through 12 months. Device position and adverse events were recorded throughout the follow-up.
|
|---|---|
|
Eye disorders
Conjunctival Wound leak
|
8.3%
2/24 • Number of events 2 • Evaluation over 12 months follow-up period. Within the timeframe of the ARGOS-SC01 Study: In Germany the term SAE is defined according to §2 Section 5 MPSV.
SAE defined as AE that 1. Led to death 2. Led to a serious deterioration in health of a subject that: a Resulted in life-threatening illness or injury b Resulted in permanent impairment of a body-structure or function c Required in-patient hospitalization or prolongation of existing hospitalization d Required medical or surgical intervention to prevent permanent impairment to body-structure or a -function 3. Led to fetal distress, fetal death or a congenital abnormality or birth defect
|
|
Eye disorders
Endothelium, Erythrocytes
|
8.3%
2/24 • Number of events 2 • Evaluation over 12 months follow-up period. Within the timeframe of the ARGOS-SC01 Study: In Germany the term SAE is defined according to §2 Section 5 MPSV.
SAE defined as AE that 1. Led to death 2. Led to a serious deterioration in health of a subject that: a Resulted in life-threatening illness or injury b Resulted in permanent impairment of a body-structure or function c Required in-patient hospitalization or prolongation of existing hospitalization d Required medical or surgical intervention to prevent permanent impairment to body-structure or a -function 3. Led to fetal distress, fetal death or a congenital abnormality or birth defect
|
|
Eye disorders
Eye Pain
|
8.3%
2/24 • Number of events 2 • Evaluation over 12 months follow-up period. Within the timeframe of the ARGOS-SC01 Study: In Germany the term SAE is defined according to §2 Section 5 MPSV.
SAE defined as AE that 1. Led to death 2. Led to a serious deterioration in health of a subject that: a Resulted in life-threatening illness or injury b Resulted in permanent impairment of a body-structure or function c Required in-patient hospitalization or prolongation of existing hospitalization d Required medical or surgical intervention to prevent permanent impairment to body-structure or a -function 3. Led to fetal distress, fetal death or a congenital abnormality or birth defect
|
|
Eye disorders
Hyphema
|
37.5%
9/24 • Number of events 9 • Evaluation over 12 months follow-up period. Within the timeframe of the ARGOS-SC01 Study: In Germany the term SAE is defined according to §2 Section 5 MPSV.
SAE defined as AE that 1. Led to death 2. Led to a serious deterioration in health of a subject that: a Resulted in life-threatening illness or injury b Resulted in permanent impairment of a body-structure or function c Required in-patient hospitalization or prolongation of existing hospitalization d Required medical or surgical intervention to prevent permanent impairment to body-structure or a -function 3. Led to fetal distress, fetal death or a congenital abnormality or birth defect
|
|
Eye disorders
Hyposphagma
|
12.5%
3/24 • Number of events 3 • Evaluation over 12 months follow-up period. Within the timeframe of the ARGOS-SC01 Study: In Germany the term SAE is defined according to §2 Section 5 MPSV.
SAE defined as AE that 1. Led to death 2. Led to a serious deterioration in health of a subject that: a Resulted in life-threatening illness or injury b Resulted in permanent impairment of a body-structure or function c Required in-patient hospitalization or prolongation of existing hospitalization d Required medical or surgical intervention to prevent permanent impairment to body-structure or a -function 3. Led to fetal distress, fetal death or a congenital abnormality or birth defect
|
|
Eye disorders
Reduction of retinal nerve fibre thickness
|
8.3%
2/24 • Number of events 2 • Evaluation over 12 months follow-up period. Within the timeframe of the ARGOS-SC01 Study: In Germany the term SAE is defined according to §2 Section 5 MPSV.
SAE defined as AE that 1. Led to death 2. Led to a serious deterioration in health of a subject that: a Resulted in life-threatening illness or injury b Resulted in permanent impairment of a body-structure or function c Required in-patient hospitalization or prolongation of existing hospitalization d Required medical or surgical intervention to prevent permanent impairment to body-structure or a -function 3. Led to fetal distress, fetal death or a congenital abnormality or birth defect
|
|
Eye disorders
Secondary Cataract
|
12.5%
3/24 • Number of events 3 • Evaluation over 12 months follow-up period. Within the timeframe of the ARGOS-SC01 Study: In Germany the term SAE is defined according to §2 Section 5 MPSV.
SAE defined as AE that 1. Led to death 2. Led to a serious deterioration in health of a subject that: a Resulted in life-threatening illness or injury b Resulted in permanent impairment of a body-structure or function c Required in-patient hospitalization or prolongation of existing hospitalization d Required medical or surgical intervention to prevent permanent impairment to body-structure or a -function 3. Led to fetal distress, fetal death or a congenital abnormality or birth defect
|
|
Eye disorders
Thygeson's superficial punctate keratooathy
|
8.3%
2/24 • Number of events 2 • Evaluation over 12 months follow-up period. Within the timeframe of the ARGOS-SC01 Study: In Germany the term SAE is defined according to §2 Section 5 MPSV.
SAE defined as AE that 1. Led to death 2. Led to a serious deterioration in health of a subject that: a Resulted in life-threatening illness or injury b Resulted in permanent impairment of a body-structure or function c Required in-patient hospitalization or prolongation of existing hospitalization d Required medical or surgical intervention to prevent permanent impairment to body-structure or a -function 3. Led to fetal distress, fetal death or a congenital abnormality or birth defect
|
|
Eye disorders
Touch sensitivity of the eye
|
12.5%
3/24 • Number of events 3 • Evaluation over 12 months follow-up period. Within the timeframe of the ARGOS-SC01 Study: In Germany the term SAE is defined according to §2 Section 5 MPSV.
SAE defined as AE that 1. Led to death 2. Led to a serious deterioration in health of a subject that: a Resulted in life-threatening illness or injury b Resulted in permanent impairment of a body-structure or function c Required in-patient hospitalization or prolongation of existing hospitalization d Required medical or surgical intervention to prevent permanent impairment to body-structure or a -function 3. Led to fetal distress, fetal death or a congenital abnormality or birth defect
|
|
Eye disorders
Intraocular pressure increased non-study eye
|
12.5%
3/24 • Number of events 3 • Evaluation over 12 months follow-up period. Within the timeframe of the ARGOS-SC01 Study: In Germany the term SAE is defined according to §2 Section 5 MPSV.
SAE defined as AE that 1. Led to death 2. Led to a serious deterioration in health of a subject that: a Resulted in life-threatening illness or injury b Resulted in permanent impairment of a body-structure or function c Required in-patient hospitalization or prolongation of existing hospitalization d Required medical or surgical intervention to prevent permanent impairment to body-structure or a -function 3. Led to fetal distress, fetal death or a congenital abnormality or birth defect
|
|
Eye disorders
surgical intervention non-study eye
|
12.5%
3/24 • Number of events 3 • Evaluation over 12 months follow-up period. Within the timeframe of the ARGOS-SC01 Study: In Germany the term SAE is defined according to §2 Section 5 MPSV.
SAE defined as AE that 1. Led to death 2. Led to a serious deterioration in health of a subject that: a Resulted in life-threatening illness or injury b Resulted in permanent impairment of a body-structure or function c Required in-patient hospitalization or prolongation of existing hospitalization d Required medical or surgical intervention to prevent permanent impairment to body-structure or a -function 3. Led to fetal distress, fetal death or a congenital abnormality or birth defect
|
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