Researchers have been working towards the development of retinal prostheses, so called “bionic eyes” since the 1960s in an effort to restore functional vision to severely visually impaired patients. Groups from all around the world are involved in this research but in particular, groups from the United States, Germany, France, Japan and Australia have conducted clinical trials of these devices and three of these devices have achieved either FDA HDE (U.S. Food and Drug Administration Humanitarian Device Exception) or CE mark approval for commercial production. Despite this, all three of these devices are now not in commercial production. There are many challenges to overcome to develop devices suitable to implant in human patients and then reach commercial distribution. This is an exacting process and many hurdles need to be overcome to reach this point so that leaving the market after achieving this goal is a significant decision. Ongoing research is exploring the possibility of less complicated surgery with better visual processing algorithms to provide more useful visual information for our patients to provide a commercial alternative.

中文翻译：

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视网膜假体：从何而来？

自 1960 年代以来，研究人员一直致力于开发视网膜假体，即所谓的“仿生眼”，旨在为严重视力受损的患者恢复功能性视力。来自世界各地的团体都参与了这项研究，但特别是来自美国、德国、法国、日本和澳大利亚的团体对这些设备进行了临床试验，其中三个设备已通过 FDA HDE（美国食品药品监督管理局） Administration Humanitarian Device Exception) 或 CE 标志批准用于商业生产。尽管如此，所有这三种设备现在都没有投入商业生产。要开发适合植入人类患者的设备，然后进行商业销售，需要克服许多挑战。这是一个严格的过程，需要克服许多障碍才能达到这一点，因此在实现这一目标后离开市场是一个重要的决定。正在进行的研究正在探索使用更好的视觉处理算法进行不太复杂的手术的可能性，以便为我们的患者提供更有用的视觉信息，从而提供一种商业替代方案。