Trial Outcomes & Findings for Long-term Safety and Performance of the ARGOS-SC Suprachoroidal Pressure Sensor System in Patients With Glaucoma Underwent Non-penetrating Glaucoma Surgery (NCT NCT04773106)
NCT ID: NCT04773106
Last Updated: 2025-05-18
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
22 participants
Primary outcome timeframe
Day 360 to Day 1080 (V09 to V13)
Results posted on
2025-05-18
Participant Flow
Recruitment from December 2019 to February 2021 in medical clinics.
Of the ARGOS-SC01 subjects, 22 patients consented to the ARGOS-SC01 follow-up study.
Participant milestones
| Measure |
ARGOS-SC Sensor
ARGOS-SC pressure sensor previously implanted in the ARGOS-SC01 study during routine local intraocular pressure lowering procedures in patients with glaucoma undergoing non-penetrating glaucoma surgery.
ARGOS-SC system: An active implantable intraocular pressure sensor implanted in the suprachoriodal space of the human eye, in combination with non-penetrating glaucoma surgery.
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|---|---|
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Overall Study
STARTED
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22
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Overall Study
COMPLETED
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18
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Overall Study
NOT COMPLETED
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4
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Reasons for withdrawal
| Measure |
ARGOS-SC Sensor
ARGOS-SC pressure sensor previously implanted in the ARGOS-SC01 study during routine local intraocular pressure lowering procedures in patients with glaucoma undergoing non-penetrating glaucoma surgery.
ARGOS-SC system: An active implantable intraocular pressure sensor implanted in the suprachoriodal space of the human eye, in combination with non-penetrating glaucoma surgery.
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Overall Study
Withdrawal by Subject
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3
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Overall Study
Death
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1
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Baseline Characteristics
Long-term Safety and Performance of the ARGOS-SC Suprachoroidal Pressure Sensor System in Patients With Glaucoma Underwent Non-penetrating Glaucoma Surgery
Baseline characteristics by cohort
| Measure |
ARGOS-SC Sensor
n=22 Participants
ARGOS-SC pressure sensor previously implanted in the ARGOS-SC01 study during routine local intraocular pressure lowering procedures in patients with glaucoma undergoing non-penetrating glaucoma surgery.
ARGOS-SC system: An active implantable intraocular pressure sensor implanted in the suprachoriodal space of the human eye, in combination with non-penetrating glaucoma surgery.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=93 Participants
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Age, Categorical
Between 18 and 65 years
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9 Participants
n=93 Participants
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Age, Categorical
>=65 years
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13 Participants
n=93 Participants
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Age, Continuous
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65.0 years
STANDARD_DEVIATION 10.6 • n=93 Participants
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Sex: Female, Male
Female
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12 Participants
n=93 Participants
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Sex: Female, Male
Male
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10 Participants
n=93 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=93 Participants
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Race (NIH/OMB)
Asian
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1 Participants
n=93 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=93 Participants
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Race (NIH/OMB)
Black or African American
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1 Participants
n=93 Participants
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Race (NIH/OMB)
White
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20 Participants
n=93 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=93 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=93 Participants
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Region of Enrollment
Switzerland
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4 participants
n=93 Participants
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Region of Enrollment
Germany
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18 participants
n=93 Participants
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Type of Glaucoma
Primary open-angle glaucoma (POAG)
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15 Participants
n=93 Participants
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Type of Glaucoma
Ocular hypertension (OHT)/Glaucoma suspect
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2 Participants
n=93 Participants
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Type of Glaucoma
Pseudoexfoliative (PEX) glauoma
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2 Participants
n=93 Participants
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Type of Glaucoma
Other
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3 Participants
n=93 Participants
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PRIMARY outcome
Timeframe: Day 360 to Day 1080 (V09 to V13)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=522 measurements
ARGOS-SC pressure sensor previously implanted in the ARGOS-SC01 study during routine local intraocular pressure lowering procedures in patients with glaucoma undergoing non-penetrating glaucoma surgery.
ARGOS-SC system: An active implantable intraocular pressure sensor implanted in the suprachoriodal space of the human eye, in combination with non-penetrating glaucoma surgery.
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|---|---|
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Performance: Level of Agreement Between GAT and the ARGOS-SC System
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-0.3 mmHg
Interval -6.2 to 5.7
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SECONDARY outcome
Timeframe: Day 360 to Day 1080 (V09 to V13)Number of patients experiencing a device-related SAE (SADE)
Outcome measures
| Measure |
ARGOS-SC Sensor
n=22 Participants
ARGOS-SC pressure sensor previously implanted in the ARGOS-SC01 study during routine local intraocular pressure lowering procedures in patients with glaucoma undergoing non-penetrating glaucoma surgery.
ARGOS-SC system: An active implantable intraocular pressure sensor implanted in the suprachoriodal space of the human eye, in combination with non-penetrating glaucoma surgery.
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|---|---|
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Safety: Number of Patients Experiencing a Device-related SAE (SADE)
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0 Participants
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SECONDARY outcome
Timeframe: Day 360 to Day 1080 (V09 to V13)Population: A total of 50 AEs in 16 patients were reported in the ARGOS-SC follow-up study. In overall 15 adverse events were documented in 14 patients affecting the study eye. 12 out of 50 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.
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=50 Total number of AEs
ARGOS-SC pressure sensor previously implanted in the ARGOS-SC01 study during routine local intraocular pressure lowering procedures in patients with glaucoma undergoing non-penetrating glaucoma surgery.
ARGOS-SC system: An active implantable intraocular pressure sensor implanted in the suprachoriodal space of the human eye, in combination with non-penetrating glaucoma surgery.
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Safety: Incidence, Nature, Severity and Seriousness of Observed Adverse Events (AEs) and Adverse Device Events (ADEs)
Overall number of AEs/ADEs
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50 A(D)Es
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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
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15 A(D)Es
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Safety: Incidence, Nature, Severity and Seriousness of Observed Adverse Events (AEs) and Adverse Device Events (ADEs)
AEs related to medical procedure and/or
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1 A(D)Es
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Safety: Incidence, Nature, Severity and Seriousness of Observed Adverse Events (AEs) and Adverse Device Events (ADEs)
AEs related to medical device and/or
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1 A(D)Es
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Safety: Incidence, Nature, Severity and Seriousness of Observed Adverse Events (AEs) and Adverse Device Events (ADEs)
AEs related to other
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7 A(D)Es
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SECONDARY outcome
Timeframe: Day 360 to Day 1080 (V09 to V13)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 65% agreement of the total number of comparisons between +/-5 mmHg.
Outcome measures
| Measure |
ARGOS-SC Sensor
n=86 comparisons
ARGOS-SC pressure sensor previously implanted in the ARGOS-SC01 study during routine local intraocular pressure lowering procedures in patients with glaucoma undergoing non-penetrating glaucoma surgery.
ARGOS-SC system: An active implantable intraocular pressure sensor implanted in the suprachoriodal space of the human eye, in combination with non-penetrating glaucoma surgery.
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|---|---|
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Performance: Percentage of Measurements Within +/- 5 mmHg
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94 percentage of comparisons
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SECONDARY outcome
Timeframe: Day 360 to Day 1080 (V09 to V13)Population: Of the 22 patients, device deficiencies (all related to the Reader device (external handheld device)) have been documented for 10 patients, hence the 10 participants analyzed.
The number of observed device malfunctions / deficiencies (DDs) related to the ARGOS-SC system, consisting of the ARGOS-SC implant and an external handheld reader device for the activation, power supply, and readout of the implanted sensor.
Outcome measures
| Measure |
ARGOS-SC Sensor
n=13 DDs
ARGOS-SC pressure sensor previously implanted in the ARGOS-SC01 study during routine local intraocular pressure lowering procedures in patients with glaucoma undergoing non-penetrating glaucoma surgery.
ARGOS-SC system: An active implantable intraocular pressure sensor implanted in the suprachoriodal space of the human eye, in combination with non-penetrating glaucoma surgery.
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|---|---|
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Performance: Device Malfunctions
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13 DDs
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SECONDARY outcome
Timeframe: Day 1080 (V13)Population: The user acceptance questionnaire for physicians was collected from 8 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 8 physician investigators who completed the User Acceptance Questionnaire. The score 7 represents a greater user acceptance.
Outcome measures
| Measure |
ARGOS-SC Sensor
n=8 Participants
ARGOS-SC pressure sensor previously implanted in the ARGOS-SC01 study during routine local intraocular pressure lowering procedures in patients with glaucoma undergoing non-penetrating glaucoma surgery.
ARGOS-SC system: An active implantable intraocular pressure sensor implanted in the suprachoriodal space of the human eye, in combination with non-penetrating glaucoma surgery.
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|---|---|
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Usability: User Acceptance at the Investigational Site
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4.7 score on a scale
Standard Deviation 3.9
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SECONDARY outcome
Timeframe: Day 1080 (V13)Population: Each patient was asked to provide feedback on the user acceptance of the ARGOS-SC system at home. A total of 15 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=15 Participants
ARGOS-SC pressure sensor previously implanted in the ARGOS-SC01 study during routine local intraocular pressure lowering procedures in patients with glaucoma undergoing non-penetrating glaucoma surgery.
ARGOS-SC system: An active implantable intraocular pressure sensor implanted in the suprachoriodal space of the human eye, in combination with non-penetrating glaucoma surgery.
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|---|---|
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Usability: User Acceptance at Home
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5.6 score on a scale
Standard Deviation 3.6
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Adverse Events
ARGOS-SC Sensor
Serious events: 7 serious events
Other events: 13 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
ARGOS-SC Sensor
n=22 participants at risk
ARGOS-SC pressure sensor previously implanted in the ARGOS-SC01 study during routine local intraocular pressure lowering procedures in patients with glaucoma undergoing non-penetrating glaucoma surgery.
ARGOS-SC system: An active implantable intraocular pressure sensor implanted in the suprachoriodal space of the human eye, in combination with non-penetrating glaucoma surgery.
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Injury, poisoning and procedural complications
Bone fracture, upper arm
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4.5%
1/22 • Number of events 1 • Day 360 to Day 1080 (V09 to V13). 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 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 foetal distress, foetal death or a congenital abnormality or birth defect
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Surgical and medical procedures
Cardiac stent implantation
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4.5%
1/22 • Number of events 1 • Day 360 to Day 1080 (V09 to V13). 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 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 foetal distress, foetal death or a congenital abnormality or birth defect
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General disorders
Death, non-related
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4.5%
1/22 • Number of events 1 • Day 360 to Day 1080 (V09 to V13). 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 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 foetal distress, foetal death or a congenital abnormality or birth defect
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Gastrointestinal disorders
Gastroenterological complaints
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4.5%
1/22 • Number of events 1 • Day 360 to Day 1080 (V09 to V13). 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 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 foetal distress, foetal death or a congenital abnormality or birth defect
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Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hospitalization b/o nose surgery (removal of polyps)
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4.5%
1/22 • Number of events 1 • Day 360 to Day 1080 (V09 to V13). 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 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 foetal distress, foetal death or a congenital abnormality or birth defect
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Infections and infestations
Intestinal inflammation
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4.5%
1/22 • Number of events 1 • Day 360 to Day 1080 (V09 to V13). 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 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 foetal distress, foetal death or a congenital abnormality or birth defect
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Investigations
Intraocular pressure increased
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4.5%
1/22 • Number of events 1 • Day 360 to Day 1080 (V09 to V13). 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 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 foetal distress, foetal death or a congenital abnormality or birth defect
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Gastrointestinal disorders
Pain and fluid accumulation in the abdominal cavity
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4.5%
1/22 • Number of events 4 • Day 360 to Day 1080 (V09 to V13). 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 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 foetal distress, foetal death or a congenital abnormality or birth defect
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Infections and infestations
Pleuritis sicca
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4.5%
1/22 • Number of events 1 • Day 360 to Day 1080 (V09 to V13). 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 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 foetal distress, foetal death or a congenital abnormality or birth defect
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Other adverse events
| Measure |
ARGOS-SC Sensor
n=22 participants at risk
ARGOS-SC pressure sensor previously implanted in the ARGOS-SC01 study during routine local intraocular pressure lowering procedures in patients with glaucoma undergoing non-penetrating glaucoma surgery.
ARGOS-SC system: An active implantable intraocular pressure sensor implanted in the suprachoriodal space of the human eye, in combination with non-penetrating glaucoma surgery.
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|---|---|
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Eye disorders
Cataract
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13.6%
3/22 • Number of events 3 • Day 360 to Day 1080 (V09 to V13). 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 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 foetal distress, foetal death or a congenital abnormality or birth defect
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Infections and infestations
COVID-19 infection
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18.2%
4/22 • Number of events 5 • Day 360 to Day 1080 (V09 to V13). 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 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 foetal distress, foetal death or a congenital abnormality or birth defect
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Investigations
Increased intraocular pressure
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18.2%
4/22 • Number of events 5 • Day 360 to Day 1080 (V09 to V13). 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 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 foetal distress, foetal death or a congenital abnormality or birth defect
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Investigations
Increased intraocular pressure -non-study eye-
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9.1%
2/22 • Number of events 2 • Day 360 to Day 1080 (V09 to V13). 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 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 foetal distress, foetal death or a congenital abnormality or birth defect
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Eye disorders
Visual acuity reduced
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13.6%
3/22 • Number of events 3 • Day 360 to Day 1080 (V09 to V13). 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 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 foetal distress, foetal death or a congenital abnormality or birth defect
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Additional Information
Clinical Study Manager
Implandata Ophthalmic Products GmbH
Phone: +49 (0) 511 - 2204 2580
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place