gms | German Medical Science

Artificial Vision 2015

The International Symposium on Visual Prosthetics

27.11. - 28.11.2015, Aachen

The Intelligent Retinal Implant System IRIS V1: technology, surgical technique, first study results

Meeting Abstract

  • Michaela Velikay-Parel - Medical University Graz, Graz, Austria
  • Y. LeMer - Fondation Ophtalmologique A. De Rothschild, Paris, France
  • G. Richard - Klinik und Poliklinik für Augenheilkunde Hamburg-Eppendorf, Hamburg, Germany
  • M. Keserü - Klinik und Poliklinik für Augenheilkunde Hamburg-Eppendorf, Hamburg, Germany
  • R. Hornig - Pixium Vision SA, Paris, France

Artificial Vision 2015. Aachen, 27.-28.11.2015. Düsseldorf: German Medical Science GMS Publishing House; 2016. Doc15artvis26

doi: 10.3205/15artvis26, urn:nbn:de:0183-15artvis262

Veröffentlicht: 7. März 2016

© 2016 Velikay-Parel et al.
Dieser Artikel ist ein Open-Access-Artikel und steht unter den Lizenzbedingungen der Creative Commons Attribution 4.0 License (Namensnennung). Lizenz-Angaben siehe http://creativecommons.org/licenses/by/4.0/.


Gliederung

Text

Objective: To present the IRIS V1 technology, surgical technique and first experience of the clinical trial (NCT01864486).

Methods: The system is composed of external parts (Visual Interface with camera and infrared data transmitters mounted on spectacles linked to a pocket processor) and an implantable part (hermetic housing with microelectronics sutured on the sclera and a flexible polymer carrier implanted on the retina through a scleral opening protected by a scleral flap). The surgical method allows explantability and potentially changeability, if required. The open-label, multicenter, prospective, safety and performance trial was initiated in July 2013, using the IRIS V1 system.

Results: The implantation procedure takes 2-3 hours. Retinitis pigmentosa patients who had bare light perception (logmar VA >2.7) in both eyes were implanted in study centers in France, Germany and Austria. After a short training period of recognition of shapes, such as doors and table top objects on a black background was achieved.

Discussion: Our results confirm proof of concept of the IRIS V1 system, supported by a safe and short operation procedure with the option of exchangeability. A relatively short training period is needed to accomplish first meaningful visual perception.