gms | German Medical Science

Artificial Vision — The 2nd Bonn Dialogue. The International Symposium on Visual Prosthesis

Retina Implant Foundation

19.09.2009, Bonn

Preliminary Results from the Argus II Study: A 60 Electrode Epiretinal Prosthesis

Meeting Abstract

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  • author Brian Mech - Second Sight® Medical Products, Inc., Sylmar, USA
  • Robert Greenberg - Second Sight® Medical Products, Inc., Sylmar, USA

Artificial Vision – The 2nd Bonn Dialogue. The International Symposium on Visual Prosthesis. Bonn, 19.-19.09.2009. Düsseldorf: German Medical Science GMS Publishing House; 2009. Doc09ri17

DOI: 10.3205/09ri17, URN: urn:nbn:de:0183-09ri178

Veröffentlicht: 30. November 2009

© 2009 Mech et al.
Dieser Artikel ist ein Open Access-Artikel und steht unter den Creative Commons Lizenzbedingungen (http://creativecommons.org/licenses/by-nc-nd/3.0/deed.de). Er darf vervielfältigt, verbreitet und öffentlich zugänglich gemacht werden, vorausgesetzt dass Autor und Quelle genannt werden.


Gliederung

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Purpose: To provide a clinical update on Second Sight Medical Products Inc., (SSMP) Argus II (A-II) epiretinal prosthesis feasibility study.

Methods: As of July 2009, 32 subjects have been implanted at 11 centers. This abstract addresses the first 17 implanted subjects who had reached the six month time point by January 2009. Governmental and institutional approvals were obtained at all centers. All subjects had bare light perception or worse vision due to retinitis pigmentosa (see http://www.clinicaltrials.gov/ for more details). The A-II electronics were sutured episcleraly and then after a vitrectomy the electrode array was inserted through the pars plana and tacked to the retina in the macular region. Data from a glasses-mounted camera and power are transmitted wirelessly in real-time to the implant.

Results: The average age of the subjects has been 60 ± 9 years. The median surgical time has been 3:09 hours. All subjects were able to take the system, which included the glasses and battery-operated video processing unit, home for use outside the clinic. Subjects have been implanted an average of 14 ± 6 months. All subjects have reached the 6 month time point which is the data cutoff for this presentation. As of Janurary 2009, cumulatively, there have been nearly 20 subject-years of experience with the Argus II implant. The safety of the device has been acceptable and as expected for a new implant design. Most of the major adverse events occurred around the time of surgery (within one month post-operative) and all resolved by the six month endpoint. These major events include conjunctival erosion (n=5), hypotony (n=4) and endophthalmitis (n=3). There were no device failures and no explants. On the efficacy side, 100% of the subjects are seeing phosphenes. Significant improvements have also been shown in spatial localization, motion detection, orientation and mobility and other measures.

Conclusions: With six months follow-up on seventeen subjects, to our knowledge, this is the largest study of a visual prosthesis. The results to date confirm previous reports with the Argus I of phosphene production and the ability of the Argus device to provide visual information with a reasonable safety profile and good reliability.