Health ·
脑机接口设备帮助晚期黄斑变性患者恢复阅读视力
Science Corp公司的PRIMA脑机接口现已在欧洲全面商业化上市,在一项已发表的临床试验中,84%的患者在因地图样萎缩失去中心视力后重新获得了阅读能力。
本文由AI根据下方引用的来源综合生成。
Science Corp公司已在欧洲30个国家正式商业推出其PRIMA脑机接口,这是首个获批、能够为地图样萎缩患者恢复功能性中心视力的治疗方法。地图样萎缩是年龄相关性黄斑变性的一种晚期、此前无法治疗的形式。
在一项覆盖17个中心、38名患者的临床试验中(发表于《新英格兰医学杂志》),患者在标准视力表上平均提高了25.5个字母的视力,84%的患者重新获得了识读字母、数字和文字的能力。这枚微小的植入物被置于视网膜下方,并配合一副向其投射近红外光的眼镜使用;芯片将这些光转化为电信号,刺激眼睛中残存的细胞,绕过导致视力丧失的受损感光细胞。
PRIMA是首个在欧洲获得用于视力恢复的CE认证的脑机接口,并已获得美国食品药品监督管理局(FDA)的突破性医疗器械认定和人道主义医疗器械豁免认定,该公司目前正致力于在美国获批。地图样萎缩是老年人失明的主要原因之一,此前一直没有办法逆转已经丧失的视力。
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