Artikel
Surgery-associated adverse events of Argus II retinal prosthesis system
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Autoren
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Hannah Schimitzek
- Department of Ophthalmology, RWTH Aachen, University Hospital Aachen, Germany
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P. Walter
- Department of Ophthalmology, RWTH Aachen, University Hospital Aachen, Germany
| Veröffentlicht: | 7. März 2016 |
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Gliederung
Text
Background: The Argus II Retinal Prosthesis System (Second Sight Medical Products Inc., Sylmar, CA, USA) is an implantable device designed to improve vision in patients with Retinitis pigmentosa. The device has received commercial approval by the European Union (CE Mark) in March 2011 and by the Food and Drug Administration (FDA) in February 2013.
Methods: Implanting the Argus II retinal prosthesis represents a new aspect in vitreoretinal surgery bringing along new challenges in surgical procedures. The encircling band of the extraocular portion of the device is secured similar to a scleral buckle. The electronics case is carefully positioned around the eye. The array is inserted through a sclerotomy and fixed on the retina using a retinal tack. A patch graft is used to cover the scleral-attached portion of the device and complete closure of the conjunctiva is critical.
Results: Surgery-associated adverse events including conjunctival erosion, hypotony, and endophthalmitis were noted in 9 of 30 patients in the original clinical pre-market trial. So far the device has been implanted in over 100 patients worldwide. An improved adverse event profile has been reported following refinement of the procedure and device itself.
Conclusion: Early experiences with the Argus II implant have delivered promising results and have highlighted new challenges. With optimizing surgery strategies and optimizing the extraocular portion of the device, surgery-associated adverse events should decrease.
