Original articleThe Argus II Retinal Prosthesis: 12-Month Outcomes from a Single-Study Center
Section snippets
Methods
This study was an interventional case series. The local ethics committee of the Azienda Ospedaliero-Universitaria Pisana waived the need for ethics committee approval of this research. This was done because a postmarketing study on the Argus II Retinal Prosthesis implant had already been approved. Although our study population was different from that of the approved study, the same surgery and visual function tests were performed. Informed consent for prosthesis implant was obtained from the
Patients
A total of 6 patients (5 men, 1 woman) were included in this study (Table), and all surgeries were performed between October 2011 and May 2012. Subjects' ages averaged 45.0 ± 10.9 years (range, 30–59 years), and all patients had visual acuities no better than light perception. One patient was phakic and 5 patients were pseudophakic at the time of surgery. Additionally, 1 patient had cellophane maculopathy in both eyes.
Surgery
In general, surgery was uneventful. Mean operation time was 174.1 ± 36.9 min
Discussion
Surgery was safely performed in all patients. Only minor surgical complications occurred and no patient required additional surgery. Of the 6 patients, 5 (83%) were followed for the full 12 months, with 1 patient lost to follow-up 1 month after surgery. Using a sutureless 23-gauge vitrectomy system did not complicate surgery. Because the insertion of the electrode array required a large sclerotomy, this wound was covered with human pericardium that had been prepared by a tissue bank. This was
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