Department of Ophthalmology, University of Duisburg-Essen, Hufelandstr. 55, 45147 Essen, Germany.
Graefes Arch Clin Exp Ophthalmol. 2012 Jan;250(1):51-9. doi: 10.1007/s00417-011-1756-z. Epub 2011 Aug 23.
The aim of this study was to develop surgical methods for the implantation of a wireless intraocular epiretinal retina implant (EPI RET3) in Göttingen minipigs. This animal model resembles closely the anatomical conditions in humans, and is thus suitable for investigating the EPI RET3 implant as designed for the application in humans.
Phacoemulsification and vitrectomy was performed on the right eye of 16 Göttingen minipigs under general anesthesia. The implants, consisting of a receiver module and an electrode array connected via a flexible micro cable, were inserted through a corneoscleral incision. The receiver module was placed into the sulcus ciliaris and the electrode array was fixed onto the retina temporal to the optic disc with a retinal tack. Minipigs were monitored for intra- and postoperative ocular complications. Follow-up times were 3 (seven minipigs) and 12 weeks (nine minipigs).
Implantation was successfully performed in all 16 minipigs. The complete implantation surgery required on average 2 hours. Intraoperative findings were a minor hemorrhage of the anterior chamber angle in two eyes, one minor iris hemorrhage, and one minor punctiform retinal hemorrhage, which were all reversible. Postoperatively, the corneoscleral incision showed good wound healing in all eyes. Intraocular reactions included mainly fibrin exudation (six eyes) and formation of iris synechiae with the receiver module of the implants (three eyes).
The performed implantation procedures of the intraocular EPI RET3 implant are feasible and reproducible within an acceptable surgical time. The development of inflammatory responses is a specific predisposition of the minipig following any intraocular intervention; nevertheless, the surgical techniques should be further improved to minimize procedure-related reactions. Our results provide a step towards the application of the EPI RET3 system in clinical studies.
本研究旨在为哥廷根小型猪开发一种无线眼内视网膜上植入物（EPI RET3）的手术方法。该动物模型与人类的解剖条件非常相似，因此适合研究 EPI RET3 植入物，因为它是为在人类中应用而设计的。
在全身麻醉下对 16 只哥廷根小型猪的右眼进行超声乳化术和玻璃体切除术。植入物由接收器模块和通过柔性微电缆连接的电极阵列组成，通过角膜巩膜切口插入。接收器模块放置在睫状沟内，电极阵列通过视网膜钉固定在视盘颞侧的视网膜上。监测小型猪的眼内和术后眼部并发症。随访时间为 3 周（7 只小型猪）和 12 周（9 只小型猪）。
所有 16 只小型猪均成功植入。完整的植入手术平均需要 2 小时。术中发现 2 只眼前房角有轻微出血，1 只眼虹膜有轻微出血，1 只眼视网膜有轻微点状出血，均为可逆性的。术后所有眼的角膜巩膜切口均愈合良好。眼内反应主要包括纤维蛋白渗出（6 只眼）和植入物接收器模块与虹膜粘连（3 只眼）。
眼内 EPI RET3 植入物的植入程序是可行的，并且在可接受的手术时间内可重复进行。炎症反应的发生是小型猪在任何眼内干预后的一种特定倾向；然而，手术技术应进一步改进，以尽量减少与手术相关的反应。我们的结果为 EPI RET3 系统在临床研究中的应用迈出了一步。
