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

Implandata Ophthalmic Products GmbH16 enrolled

Overview

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)

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Primary Open-angle Glaucoma

Interventions

ARGOS-IO Sensor Pressure SystemDEVICE

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

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects of the ARGOS-01 and ARGOS-02 study with an implanted ARGOS-IO pressure sensor. Exclusion Criteria: * N/A

Locations (4)

Klinik für Augenheilkunde, Uniklinik RWTH Aachen

Aachen, Germany

Universitäts-Augenklinik Bochum

Bochum, Germany

Universitätsaugenklinik Magdeburg

Magdeburg, Germany

Universitäts-Augenklinik Tübingen

Tübingen, Germany

Outcomes

Primary Outcomes

Safety: Number of Patients Experiencing a Device Related Serious Adverse Events (SADE) and Device Related Adverse Events (ADE)

Number of patients experiencing a device related SAE (SADE) and device related complications (ADE) over the 36-months' clinical follow-up time.