gms | German Medical Science

27th International Congress of German Ophthalmic Surgeons

15. to 17.05.2014, Nürnberg

Results from the European post-market surveillance study of the Argus II retinal prosthesis system (P2, I)

Meeting Abstract

  • Maura Arsiero - Second Sight Medical Products, Lausanne, Switzerland
  • Stanislao Rizzo - Azienda Ospedaliero-Universitaria Pisana, Pisa, Italien
  • Peter Walter - Klinik und Poliklinik für Augenheilkunde, Aachen
  • Bernd Kirchhof - Univ.-Augenklinik, Köln
  • Albert Augustin - Städt.Klinikum Karlsruhe, Karlsruhe
  • Salvatore Grisanti - Universitätsklinikum Schleswig-Holstein, Lübeck
  • Gisbert Richard - Universitätsklinikum Hamburg-Eppendorf, Hamburg

27. Internationaler Kongress der Deutschen Ophthalmochirurgen. Nürnberg, 15.-17.05.2014. Düsseldorf: German Medical Science GMS Publishing House; 2014. DocWK 5.13

doi: 10.3205/14doc149, urn:nbn:de:0183-14doc1490

Published: May 5, 2014

© 2014 Arsiero et al.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( You are free: to Share – to copy, distribute and transmit the work, provided the original author and source are credited.



Purpose: The Argus II Retinal Prosthesis System (Argus II) received the CE mark in 2011 and FDA approval in 2013. This makes it the first artificial retina approved for market use in Europe and the only retinal prosthesis available in the United States. A European post-market surveillance study is taking place in order to follow Safety and performance results. As of February 20, 2014, 40 commercial patients with severe to profound retinitis pigmentosa have been implanted with the Argus II in Italy, Germany, France, the Netherlands, the UK, and Saudi Arabia.

Methods: From the day of surgery to the present, safety data – number, type, and severity of adverse events – have been collected. All significant safety related events in all implanted patients, independently from their participation in the post-market study have been carefully captured as per Vigilance requirements. Here safety data for all commercial patients will be reported.

In the post-market study performance is measured by comparing subjects’ abilities to locate a high-contrast square on a black screen, determine the direction of a moving white bar, and determines the orientation of black and white bars shown for only 5 seconds.

Results: Of the 40 patients implanted, 27 enrolled in the post-market study; 4 of these later withdrew. Of the study subjects, 17 were male and 10 were female. The average age at implant was 54 years (range 31–75).

3 patients (out of 40 implanted) have experienced serious adverse events that required surgical intervention(s) to treat: 1 patient had recurrent conjunctival erosion; the 2nd had recurrent hypotony and associated retinal detachment; and the 3rd had hypotony. There were also 29 non-serious adverse events (AEs) among 11 subjects. 29 subjects had no adverse events. These results represent an improvement in the safety profile of the Argus II, compared with that observed in the clinical trial.

Results from 2 of the 3 tests show that, as a group, subjects perform better with the System ON than with it OFF at most time points, with no performance decline over time (up to 12 months post-implant). The most difficult of the tests shows no major change in the implanted eye with the System ON vs. OFF.

Conclusions: Results on performance from the first group of Argus II patients using the commercially available device show an improvement with the System ON compared to System OFF. Moreover, they also display a good safety profile.