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

Implandata Ophthalmic Products

Status: Completed

Conditions: Primary Open-angle Glaucoma

Treatments: Device: ARGOS-IO Sensor Pressure System

Study type: Interventional

Funder types: Industry

Identifiers

NCT03651336

CIV-18-13-023284 (Other Identifier)

ARGOS-03

Details and patient eligibility

About

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)

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• N/A

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Single-arm longterm follow-up ARGOS-IO Sensor Pressure System

Other group

Description:

The ARGOS-IO sensor was already implanted in a previous study as ARGOS-01 or ARGOS-02.

Treatment:

Device: ARGOS-IO Sensor Pressure System