Department of Ophthalmology, Harvard Medical School and the Massachusetts Eye and Ear Infirmary, Boston, Massachusetts 02458, USA.
J Neuroophthalmol. 2011 Jun;31(2):160-8. doi: 10.1097/WNO.0b013e31821eb79e.
The field of retinal prosthetic research, now more than 20 years old, has produced many high-quality technical options that have the potential to restore vision to patients with acquired disease of the outer retina. Five companies have performed Phase I clinical trials demonstrating that blind patients can reliably report basic elements of visual percepts induced by electrical stimulation. However, at present patients and observers generally do not consider the results to be useful enough in the performance of tasks of daily living to justify the risks of surgery and chronic implantation or the costs. Having developed a wireless device implanted in the subretinal space, the Boston Retinal Implant Project has focused its efforts on developing scalable technologies to create a hermetic device that can deliver individually controlled pulses of electrical stimulation to each of hundreds of electrodes. An advanced device with such attributes will be needed to justify the risks of implantation. An assessment of long-term biocompatibility for all devices remains to be done.
视网膜假体研究领域已有 20 多年的历史,已经产生了许多高质量的技术选择,这些技术选择有可能使患有外视网膜获得性疾病的患者恢复视力。五家公司已经进行了 I 期临床试验,证明了盲人可以可靠地报告电刺激引起的视觉感知的基本元素。然而,目前患者和观察者通常认为这些结果在日常生活任务的表现中还不够有用,无法证明手术和慢性植入或成本的风险是合理的。波士顿视网膜植入项目开发了一种植入于视网膜下腔的无线设备,其工作重点是开发可扩展技术,以创建一种可以向数百个电极中的每个电极提供单独控制的电刺激脉冲的密封设备。只有具有这种属性的先进设备才能证明植入的风险是合理的。还需要对所有设备的长期生物相容性进行评估。