Implantation and Explantation of a Wireless Epiretinal Retina Implant Device: Observations during the EPIRET3 Prospective Clinical Trial
Implantation and Explantation of a Wireless Epiretinal Retina Implant Device: Observations during the EPIRET3 Prospective Clinical Trial
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DOI：
10.1167/iovs.08-2752
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发表时间：
2009-06-01
影响因子：
4.4
通讯作者：
Walter, Peter
中科院分区：
文献类型：
--
作者：
Roessler, Gernot;Laube, Thomas;Walter, Peter
目的。失明和视网膜变性患者的视觉感觉可以通过植入微电极阵列的视网膜神经元电刺激来恢复。为评价无线眼内视网膜植入物(EPIRET3)在6名失明和RP.患者中的安全性和有效性，启动了一项前瞻性试验。该植入物是一种由接收器和刺激器模块组成的遥控全眼内无线设备。刺激器放置在视网膜表面。数据和能量通过感应链路从眼睛外部传输到植入物。手术包括摘除晶状体，玻璃体切除，以及通过角膜切开植入EPIRET3装置。观察植入术和植入术后的临床效果。根据研究方案，在4周后取出种植体。前部用经巩膜缝线固定，刺激箔置于后极，用视网膜钉固定。植入物耐受性良好，导致暂时性的中度术后炎症，而植入物的位置在手术取出之前保持稳定。在所有病例中，均成功地进行了该装置的移植。不良反应包括1例在硅油植入术中使用激素和抗生素有效治疗的无菌松解，1例发生视网膜破裂。结论：EPIRET3系统可以成功地植入和移植于失明和RP患者。手术步骤是可行的，术后随访揭示了可接受的不良事件范围。(投资眼科VS科学。2009年；50：3003-3008)doi：10.1167/iovs.08-2752
PURPOSE. Visual sensations in patients with blindness and retinal degenerations may be restored by electrical stimulation of retinal neurons with implantable microelectrode arrays. A prospective trial was initiated to evaluate the safety and efficacy of a wireless intraocular retinal implant (EPIRET3) in six volunteers with blindness and RP.METHODS. The implant is a remotely controlled, fully intraocular wireless device consisting of a receiver and a stimulator module. The stimulator is placed on the retinal surface. Data and energy are transmitted via an inductive link from outside the eye to the implant. Surgery included removal of the lens, vitrectomy, and implantation of the EPIRET3 device through a corneal incision. The clinical outcome after implantation and explantation of the device was determined. The implant was removed after 4 weeks, according to the study protocol.RESULTS. Implantation was successful in all six patients. While the anterior part was fixed with transscleral sutures, the stimulating foil was placed onto the posterior pole and fixed with retinal tacks. The implant was well tolerated, causing temporary moderate postoperative inflammation, whereas the position of the implant remained stable until surgical removal. In all cases explantation of the device was performed successfully. Adverse events were a sterile hypopyon effectively treated with steroids and antibiotics in one case and a retinal break in a second case during explantation requiring silicone oil surgery.CONCLUSIONS. The EPIRET3 system can be successfully implanted and explanted in patients with blindness and RP. The surgical steps are feasible, and the postoperative follow-up disclosed an acceptable range of adverse events. (Invest Ophthalmol Vis Sci. 2009; 50: 3003-3008) DOI:10.1167/iovs.08-2752