Artikel
The Intelligent Retinal Implant System IRIS V1: technology, surgical technique, first study results
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Autoren
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Michaela Velikay-Parel
- Medical University Graz, Graz, Austria
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Y. LeMer
- Fondation Ophtalmologique A. De Rothschild, Paris, France
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G. Richard
- Klinik und Poliklinik für Augenheilkunde Hamburg-Eppendorf, Hamburg, Germany
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M. Keserü
- Klinik und Poliklinik für Augenheilkunde Hamburg-Eppendorf, Hamburg, Germany
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R. Hornig
- Pixium Vision SA, Paris, France
| Veröffentlicht: | 7. März 2016 |
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Gliederung
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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.
