Centre for Ophthalmology, University of Tübingen, Tübingen, Germany.
Jpn J Ophthalmol. 2010 Sep;54(5):467-75. doi: 10.1007/s10384-010-0851-8. Epub 2010 Nov 5.
For human trials with retinal prostheses it is mandatory to develop procedures to safely explant and possibly reimplant the devices. This prompted us to investigate in a small exploratory study the safety of repeated transchoroidal implantation and explantation procedures of complex subretinal devices in laboratory animals.
Repeated transchoroidal surgery was performed in four rabbits. The rabbits were examined by clinical examination and funduscopy. Function was assessed by electroretinography and cortical recordings following light and subretinal electrical stimulation. Sections of the retina and of the implantation channel were examined by light microscopy.
Using the same access route, repeated transchoroidal subretinal implantation surgery was successfully performed in all cases. Fixation of implants was stable for up to 13 months; retinas remained attached at all examination dates. Electroretinograms and visual evoked cortical potential proved retinal and visual pathway integrity. Subretinal electrical stimulation elicited retinal and cortical responses. While retinal morphology at earlier stages was found to be essentially unaltered, atrophic disorganization in the region of the subretinal channel was observed after 10 months and after subretinal electrical stimulation.
Repeated transchoroidal surgery can be safely performed for implantation, explantation, and reimplantation of subretinal devices in rabbits. With modifications, we believe the technique can be applied in human surgery.
对于视网膜假体的人体试验,必须开发出安全地取出和可能重新植入设备的程序。这促使我们在一项小型探索性研究中,研究在实验室动物中重复经脉络膜植入和取出复杂的眼内设备的安全性。
对四只兔子进行了重复经脉络膜手术。通过临床检查和眼底检查来检查兔子。通过光和视网膜下电刺激后的视网膜电图和皮质记录来评估功能。用光显微镜检查视网膜和植入通道的切片。
使用相同的进入途径,所有病例均成功地进行了重复经脉络膜下视网膜下植入手术。植入物的固定可稳定长达 13 个月;在所有检查日期,视网膜均保持附着。视网膜电图和视觉诱发电位证明了视网膜和视觉通路的完整性。视网膜下电刺激引起视网膜和皮质反应。虽然早期视网膜形态基本未改变,但在 10 个月后和视网膜下电刺激后,观察到视网膜下通道区域的萎缩性紊乱。
重复经脉络膜手术可安全地用于植入、取出和重新植入兔子的眼内设备。我们相信,经过修改后,该技术可应用于人类手术。