gms | German Medical Science

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 degenerative diseases, e.g. 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. First, the encircling band of the extraocular portion of the device is fixed similar to a scleral buckle and the case with the electronics is carefully positioned around the eye. Second, a sklerotomy is made parallel to the limbus. Afterwards, the array is inserted through the sclerotomy and is fixed on the central retina by using a retinal tack. Two patch grafts are used to cover the electronic cases in order to reduce the adverse events like infection and conjunctival erosion. At the end of the surgery the complete closure of the conjunctiva is crucial.

Results: Since the study’s beginning surgery-associated adverse events including conjunctival dehiscence, hypotony and endophthalmitis could be reduced because of the refinement of the surgery and the device itself. But conjunctival erosion, retinal detachment and vitreous haemorrhage are still adverse events which appear and could not be reduced. By now the device has been implanted in over 230 patients worldwide, in 37 patients in Germany.

Conclusion: Implantation of the Argus II prosthesis system and the use of the device have delivered promising results and have highlighted new challenges. As the surgery will be optimized and is performed by more and more experienced surgeons, the decrease of surgery-associated adverse events can be estimated.

Acknowledgment: This project was supported by Second Sight.