Artikel
Clinical Study of Retinal Prosthesis by 49 Channel Suprachoroidal-Transretinal Stimulation (STS) in Patients with Advanced Retinitis Pigmentosa
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Veröffentlicht: | 7. März 2016 |
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Gliederung
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Objective: To report the results of clinical trial to evaluate the safety and effectiveness of 49-channel STS retinal prosthesis.
Material and Methods: Three patients with advanced retinitis pigmentosa (RP) with vision equal or less than hand motion were enrolled. Forty nine-channel STS prosthesis system was implanted chronically for 1 year. Safety of surgery, postoperative side effects, and the efficacy of artificial vision was investigated.
Results: Implantation surgery was performed without complications in all cases. The electrode array was implanted in the scleral pocket located under the parafoveal inferio-temporal retinal area. Postoperative side effects were observed in patient 2 and 3 in which iridocyclitis were observed 2 and 5 months after surgery, which were successfully treated by eye drops. The implanted devises were functioning during the follow-up period in all cases. The number of electrodes which elicited phosphene with a current less than 1 mA and without evoking somatosensory sensation was 36, 34, and 18. The results of localization test were significantly (P<0.05) better with the devise switch ON compared with switch OFF in patient 3, in which the electrode array was inserted in the scleral pocket created closer to the fovea centralis.
Conclusion: The 49-channel STS-Japan retinal prosthesis was able to be implanted without major complications and can elicit phosphene in patients with advanced retinitis pigmentosa. A more effective vision could be obtained in eyes with electrode array implanted closer to the fovea centralis.
Acknowledgement: This work was supported by the Translational Research Network Program (B03) from the Ministry of Education, Culture, Sports, Science and Technology, Japan.