Long-term Safety and Performance of the ARGOS-SC Suprachoroidal Pressure Sensor System in Patients With Glaucoma Underwent Non-penetrating Glaucoma Surgery

Follow-up of the First in Man, Prospective, Open-label, Single Arm, Multicenter Clinical Investigation to Assess the Long-term Safety and Performance of the ARGOS-SC Suprachoroidal Pressure Sensor System in Patients With Glaucoma Underwent Non-penetrating Glaucoma Surgery (Follow-up Month 12 - Month 36)

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04773106

Enrollment

Registered

2021-02-26

Start date

2020-02-20

Completion date

2023-03-02

Last updated

2025-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma, Open Angle Glaucoma

Keywords

Non-penetrating glaucoma surgery, Open angle glaucoma, Intraocular pressure measurements, Suprachoroidal pressure sensor, ARGOS-SC

Brief summary

The purpose of this study is to evaluate the long-term safety and performance of the ARGOS-SC system.

Detailed description

This study is designed as a prospective, open-label, multicenter, single-arm clinical investigation. This study is a follow-up study to the ARGOS-SC01 study (NCT03756662). Patients who have graduated the ARGOS-SC01 study after 12 month follow-up will be asked to enroll in this study for an additional 24 month follow-up (month 12-36 post implantation). This study will be solely observational, as only patients who had implanted the device within the earlier study will be invited to join this ARGOS-SC01\_FU study. The sensor was always implanted in one eye only which will be the study eye.

Interventions

DEVICEARGOS-SC suprachoroidal pressure sensor

The ARGOS-SC pressure sensor was additionally implanted during routine local intraocular pressure lowering procedures in patients with glaucoma undergoing non-penetrating glaucoma surgery in the earlier ARGOS-SC01 study.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

\- Subjects of the ARGOS-SC01 study with an implanted ARGOS-SC suprachoroidal pressure sensor.

Exclusion criteria

* N/A

Design outcomes

Primary

Measure	Time frame	Description
Performance: Level of Agreement Between GAT and the ARGOS-SC System	Day 360 to Day 1080 (V09 to V13)	Level of Agreement between intraocular pressure (IOP) measurements made using GAT & the ARGOS-SC system (IOP in mmHg) following the Bland-Altman method.

Secondary

Measure	Time frame	Description
Safety: Incidence, Nature, Severity and Seriousness of Observed Adverse Events (AEs) and Adverse Device Events (ADEs)	Day 360 to Day 1080 (V09 to V13)	Safety evaluation based on the incidence, nature, severity and seriousness of observed adverse events and adverse device events.
Performance: Percentage of Measurements Within +/- 5 mmHg	Day 360 to Day 1080 (V09 to V13)	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.
Safety: Number of Patients Experiencing a Device-related SAE (SADE)	Day 360 to Day 1080 (V09 to V13)	Number of patients experiencing a device-related SAE (SADE)
Usability: User Acceptance at the Investigational Site	Day 1080 (V13)	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.
Usability: User Acceptance at Home	Day 1080 (V13)	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.
Performance: Device Malfunctions	Day 360 to Day 1080 (V09 to V13)	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.

Countries

Germany, Switzerland

Participant flow

Recruitment details

Recruitment from December 2019 to February 2021 in medical clinics.

Pre-assignment details

Of the ARGOS-SC01 subjects, 22 patients consented to the ARGOS-SC01 follow-up study.

Participants by arm

Arm	Count
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.	22
Total	22

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Death	1
Overall Study	Withdrawal by Subject	3

Baseline characteristics

Characteristic	ARGOS-SC Sensor
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	13 Participants
Age, Categorical Between 18 and 65 years	9 Participants
Age, Continuous	65.0 years STANDARD_DEVIATION 10.6
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	1 Participants
Race (NIH/OMB) Black or African American	1 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) White	20 Participants
Region of Enrollment Germany	18 participants
Region of Enrollment Switzerland	4 participants
Sex: Female, Male Female	12 Participants
Sex: Female, Male Male	10 Participants
Type of Glaucoma Ocular hypertension (OHT)/Glaucoma suspect	2 Participants
Type of Glaucoma Other	3 Participants
Type of Glaucoma Primary open-angle glaucoma (POAG)	15 Participants
Type of Glaucoma Pseudoexfoliative (PEX) glauoma	2 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	1 / 22
other Total, other adverse events	13 / 22
serious Total, serious adverse events	7 / 22

Outcome results

Primary

Performance: Level of Agreement Between GAT and the ARGOS-SC System

Level of Agreement between intraocular pressure (IOP) measurements made using GAT & the ARGOS-SC system (IOP in mmHg) following the Bland-Altman method.