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Safety and Performance Study of the ARGOS-IO System in Patients Undergoing Boston Keratoprosthesis Implantation

2016-10-27 05:38:23 | BioPortfolio

Summary

The ARGOS-IO pressure sensor is intended to be implanted in the human eye in combination with Boston Keratoprosthesis (BKPro) surgery and to remain in place indefinitely. It is intended to be used together with the hand-held Mesograph reading device to telemetrically measure the intraocular pressure (IOP) of patients with a BKPro.

The purpose of this study is to evaluate the safety and performance of the ARGOS-IO system in patients undergoing concomitant implantation of a BKPro and an ARGOS-IO sensor over the 12 month period beginning at implantation.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Conditions

Graft vs Host Disease

Intervention

ARGOS-IO system

Location

Zentrum für Augenheilkunde der Universität zu Köln
Cologne
Germany
50924

Status

Active, not recruiting

Source

Implandata Ophthalmic Products GmbH

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-10-27T05:38:23-0400

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