Bae So Hyun, Jeong Joonsoo, Kim Sung June, Chung Hum, Seo Jong-Mo
Department of Ophthalmology, Kangnam Sacred Heart Hospital, College of Medicine, Hallym University, Seoul, Republic of Korea.
Interdisciplinary Program for Bioengineering, Seoul National University, Seoul, Republic of Korea.
Transl Vis Sci Technol. 2018 Aug 24;7(4):17. doi: 10.1167/tvst.7.4.17. eCollection 2018 Aug.
To investigate reproducible surgical techniques to optimize the long-term safety of liquid crystal polymer (LCP)-based retinal prosthesis implantation.
An LCP-based retinal prosthesis is fabricated monolithically on a single-body LCP substrate with all components, including the package and electrode array. We implanted the electrode array into the suprachoroidal space and anchored the package and transition part to the sclera in rabbits ( = 11). The safety profile was assessed upon the completion of the surgery and postoperatively.
The surgical procedures for implantation of the entire system were easily performed in nine eyes (81.8%) without any intraoperative complications. In the other two eyes (18.2%), surgical complications related to electrode insertion, including optic nerve damage and retinal tear, arose. In 10 eyes (90.9%), the devices were well tolerated for at least 3 months. However, in most eyes (nine; 81.8%), two complications began to appear after 3 months, postoperatively, including conjunctival erosion or dehiscence over the package or transition part. The electrode arrays were maintained safely in the suprachoroidal space after surgery without any complications, regardless of the status of the extraocular components in all cases except two intraoperative complications.
We established safe and reproducible surgical techniques for implantation of our LCP-based retinal prosthesis into the suprachoroidal space. Although issues related to surgical technique or device configuration were identified, further technical solutions would improve the long-term safety of device implantation.
This study presents successful implantation of LCP-based retinal prosthesis. The technical solutions will permit an optimization of surgical techniques.
研究可重复的手术技术,以优化基于液晶聚合物(LCP)的视网膜假体植入的长期安全性。
基于LCP的视网膜假体在包含封装和电极阵列等所有组件的一体式LCP基板上整体制造。我们将电极阵列植入兔眼(n = 11)的脉络膜上腔,并将封装和过渡部分固定于巩膜。在手术完成时及术后评估安全性。
9只眼(81.8%)中整个系统的植入手术操作简便,无任何术中并发症。另外2只眼(18.2%)出现与电极插入相关的手术并发症,包括视神经损伤和视网膜裂孔。10只眼(90.9%)中,装置至少耐受3个月。然而,在大多数眼(9只;81.8%)中,术后3个月后开始出现两种并发症,包括封装或过渡部分上方的结膜糜烂或裂开。除了2例术中并发症外,无论眼外组件的状态如何,术后电极阵列均安全地保留在脉络膜上腔,无任何并发症。
我们建立了将基于LCP的视网膜假体安全且可重复地植入脉络膜上腔的手术技术。尽管发现了与手术技术或装置配置相关的问题,但进一步的技术解决方案将提高装置植入的长期安全性。
本研究展示了基于LCP的视网膜假体的成功植入。这些技术解决方案将有助于优化手术技术。