Safety evaluation of "retina implant alpha IMS"aEuro"a prospective clinical trial
Safety evaluation of "retina implant alpha IMS"aEuro"a prospective clinical trial
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DOI：
10.1007/s00417-014-2797-x
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发表时间：
2015-03-01
影响因子：
2.7
通讯作者：
Zrenner, Eberhart
中科院分区：
文献类型：
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作者：
Kitiratschky, Veronique B. D.;Stingl, Katarina;Zrenner, Eberhart
为了恢复视网膜色素变性患者的视力，已经开发了几种类型的电子设备来刺激视觉通路上沿着不同水平的神经元。已经证明用Retina Implant Alpha IMS（Retina Implant AG，罗伊特林根，德国）对视网膜进行视网膜下刺激可在日常生活中提供有用的视力。在此，我们对该器械的安全性进行了评估。在视网膜色素变性患者中进行了一项介入性、前瞻性、多中心、单组研究。报告了单中心前9例患者的器械安全性结果。记录和评价与试验器械相关或无关的任何不良医疗事件。在Tubingen研究中心，9名成年受试者被纳入研究。总共发生了75起不良事件，其中53起影响眼睛及其附属器。31例眼部不良事件与植入物相关，被归类为“确定”，19例可能或可能相关; 3例与植入物无关。39例眼部不良事件消退无后遗症，2例消退有后遗症，11例仍未消退，1例状态未知。大多数病例（n = 45）的眼部不良事件强度为轻度，6例为中度，2例为重度。未发生与器械有一定关系的非眼部不良事件。一名受试者的研究眼失去了光感（无光定位）。总之，这项前瞻性研究“视网膜下植入物用于盲人患者部分视力恢复的安全性和有效性”表明，视网膜植入物Alpha IMS是使用视网膜下刺激装置恢复视力的一种选择，具有临床可接受的安全性。
To restore vision in patients with retinitis pigmentosa, several types of electronic devices have been developed to stimulate neurons at different levels along the visual pathway. Subretinal stimulation of the retina with the Retina Implant Alpha IMS (Retina Implant AG, Reutlingen, Germany) has been demonstrated to provide useful vision in daily life. Here we evaluated the safety of this device.An interventional, prospective, multi-center, single-arm study was conducted in patients with retinitis pigmentosa with the Retina Implant Alpha IMS. The results from the first nine patients of a single center regarding safety of the device are reported. Any untoward medical occurrence related or unrelated to the tested device was documented and evaluated.Nine adult subjects were included in the study at the Tubingen site. Seventy-five adverse events occurred in total, and 53 affected the eye and its adnexa. Thirty-one ocular adverse events had a relationship to the implant that was classified as "certain" while 19 had a probable or possible relationship; three had no relationship to the implant. Thirty-nine ocular adverse events resolved without sequelae, two resolved with sequelae, 11 remained unresolved, and in one the status was unknown. The intensity of ocular adverse events was mild in the majority of cases (n = 45), while six were of moderate and two of severe intensity. There was no non-ocular adverse event with certain relationship to the device. One subject lost light perception (without light localization) in her study eye.In conclusion, this prospective study, "Safety and Efficacy of Subretinal Implants for Partial Restoration of Vision in Blind Patients," shows that the Retina Implant Alpha IMS is an option for restoring vision using a subretinal stimulation device with a clinically acceptable safety profile.