Long-term Safety and Performance of the ARGOS-IO Intraocular Pressure Sensor System in Subjects With Primary Open Angle Glaucoma (POAG)

A Prospective, Open-label, Multicenter Clinical Follow-up Investigation of the ARGOS-01 and ARGOS-02 Patients to Assess the Long-term Safety and Performance of the ARGOS-IO Intraocular Pressure Sensor System in Subjects With Primary Open Angle Glaucoma (POAG)

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03651336

Enrollment

Registered

2018-08-29

Start date

2018-08-15

Completion date

2022-04-27

Last updated

2025-05-09

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

Conditions

Primary Open-angle Glaucoma

Keywords

POAG, Primary Open Angle Glaucoma, Cataract, Intraocular Pressure, Intraocular Pressure Sensor System, IOP, Self-monitoring of intraocular pressure

Brief summary

The purpose of this study is to evaluate the long-term safety and performance of the ARGOS-IO system in patients with Primary Open Angle Glaucoma (POAG)

Detailed description

This study is a prospective open-label, multicenter study for clinical follow-up of the ARGOS-01 and ARGOS-02 patients. From the ARGOS-01 to the ARGOS-02 study, some modifications were made to the form of the ARGOS-IO implant in consequence of the outcomes of the ARGOS-01 study. Maximal 5 patients of the ARGOS-01 study and maximal 21 patients of the ARGOS-02 study will take part in this study. The sensor was always implanted in one eye only which will be the study eye.

Interventions

DEVICEARGOS-IO Sensor Pressure System

The ARGOS-IO Pressure sensor have been additionally implanted during local routine working procedures for cataract surgery in Patients with Primary Open Angle Glaucoma (POAG) and indicated cataract surgery in previous studies ARGOS-01 and ARGOS-02

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

Inclusion criteria

* Subjects of the ARGOS-01 and ARGOS-02 study with an implanted ARGOS-IO pressure sensor.

Exclusion criteria

* N/A

Design outcomes

Primary

Measure	Time frame	Description
Safety: Number of Patients Experiencing a Device Related Serious Adverse Events (SADE) and Device Related Adverse Events (ADE)	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.
Performance: Level of Agreement Between GAT and the ARGOS-IO System	Baseline visit to Day 1080 (V01 [Baseline visit] to V07)	Level of Agreement between intraocular pressure (IOP) measurements made using GAT & the ARGOS-IO system (IOP in mmHg) following the Bland-Altman method.
Performance: Device Malfunctions	Baseline visit to Day 1080 (V01 [Baseline visit] to V07)	Incidence, nature and seriousness of observed device malfunctions / deficiencies (DDs)

Secondary

Measure	Time frame	Description
Patient's Compliance in IOP Self-monitoring (Daily Self-measurements)	Baseline visit to Day 1080 (V01 [Baseline visit] to V07)	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).
Patient's Compliance in IOP Self-monitoring (Self-measurement Sequences / Day)	Baseline visit to Day 1080 (V01 [Baseline visit] to V07)	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).

Countries

Germany

Participant flow

Recruitment details

Recruitment from August 2018 to May 2019 in medical clinics.

Participants by arm

Arm	Count
ARGOS-IO System 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.	16
Total	16

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Withdrawal by Subject	4

Baseline characteristics

Characteristic	ARGOS-IO System
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	14 Participants
Age, Categorical Between 18 and 65 years	2 Participants
Age, Continuous	72.4 years STANDARD_DEVIATION 5.7
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	0 Participants
Race (NIH/OMB) Black or African American	0 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	16 Participants
Region of Enrollment Germany	16 participants
Sex: Female, Male Female	6 Participants
Sex: Female, Male Male	10 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 16
other Total, other adverse events	8 / 16
serious Total, serious adverse events	10 / 16