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

Primary Open-angle Glaucoma Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03651336
• Other study ID #: ARGOS-03
• Secondary ID: CIV-18-13-023284
• Status: Completed
• Phase: N/A
• Start date: August 15, 2018
• Est. completion date: April 27, 2022

Study information

• Verified date: July 2022
• Source: Implandata Ophthalmic Products GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: April 27, 2022
• Est. primary completion date: April 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• N/A

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Primary Open-angle Glaucoma

Intervention

Device:
• ARGOS-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

Locations

Country	Name	City	State
Germany	Klinik für Augenheilkunde, Uniklinik RWTH Aachen	Aachen
Germany	Universitäts-Augenklinik Bochum	Bochum
Germany	Universitätsaugenklinik Magdeburg	Magdeburg
Germany	Universitäts-Augenklinik Tübingen	Tübingen

Sponsors (1)

Lead Sponsor	Collaborator
Implandata Ophthalmic Products GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety measured by Incidence of medical-device related adverse events and serious adverse events	The primary objective of this clinical trial is to evaluate the long-term safety and tolerability of the ARGOS-IO pressure sensor under consideration of incidence, nature, severity and seriousness of observed medical device related adverse and serious adverse events.An AE is considered to be device-related if there is at least a possible relationship to the medical device according to the rating of the investigator.	3 years
Primary	Limits of agreement between IOP measurements made using GAT and the ARGOS-IO system at each study visit.	IOP measured in mmHg	3 years
Primary	Limits of agreement between IOP measurements made using DCT and the ARGOS-IO system at each study visit.	IOP measured in mmHg	3 Years
Primary	Incidence of observed device malfunctions and nature of device malfunction	A device malfunction is e.g. difference of more than 5 mmHg between ARGOS-IO and GAT, readout error of the Mesograph because of measurements outside -2 and +70mmHG.	3 years
Secondary	Patient's compliance in IOP self-monitoring	Daily self-measurements with the ARGOS-IO sensor should be done at least 4 times daily (morning, noon, afternoon, evening)	3 years
Secondary	Impact of IOP self-monitoring on glaucoma progression	Visual field (db), cup/disc ratio, OCT of the optic nerve (µm) and the IOP (mmHg) has to be compared together to evaluate glaucoma progression	3 years
Secondary	Incidence in glaucoma medication change	Number of glaucoma medication	3 years
Secondary	Number of unscheduled visits due to self-measured increased intraocular pressure	The patients decide to come for a visit by their own due to any reason. This will be documented.	3 years