本文根据上海鹰瞳医疗科技有限公司的创新产品《糖尿病视网膜病变眼底图像辅助诊断软件》在国家药品监督管理局(NMPA，原CFDA)历时两年半的上市前创新申报与注册申报经历，介绍了人工智能类医疗器械产品的产品研发、注册申报流程及相关重点难点，并且列明了在整个过程中需要遵循和参考的法律法规，为此类产品的上市前注册工作提供参考。

Based on the NMPA premarket application through two and a half years for the computer aided diagnosis software using fundus images of diabetic retinopathy, which is an innovative medical device of Shanghai EagleVision Medical Technology Co., Ltd. (Airdoc), this article introduced the development process, the premarket application, and the key points in the application of this artificial intelligence device, also lists the related regulations and guidelines as references to provide some ideas for the follow-up premarketing application of such kind of products.

眼睛是人体最重要的感觉器官之一，主要由角膜和晶状体构成的屈光系统和视网膜构成的视觉神经系统2个部分构成。眼睛各组织的发育和功能异常都可影响视功能，甚至致盲。现有的致盲眼病的治疗方式均存在各自瓶颈问题，新的诊治方法亟待开发。近年来，得益于干细胞和组织工程学的发展，结合现有眼各组织的发育理论知识，研究者们利用多种来源的干细胞在体外成功诱导出具有组织特异结构和功能的眼类器官。眼类器官研究为利用干细胞研究眼组织发育和眼病发病机制、药物筛选以及替代治疗创造了新机遇，将干细胞治疗眼病的转化研究推向了一个更高平台。本文将对现有眼类器官的技术发展及应用进行综述。

Being one of the most important sensory organs, the eye is composed of the cornea, the lens, which are responsible for refraction, and the retina, which is the neural sensory part of the eye. Various kinds of developmental abnormalities and functional defects could lead to visual dysfunctions, and even blindness. Current treatments for blindness-causing eye diseases all have their own limitations, awaiting new efficient diagnostic and treating methods. Thanks to the development in stem cell biology and bioengineering, taking advantage of the rich knowledge accumulated on the mechanisms governing eye development, researchers have successfully generated various ocular organoids using multiple sources of stem cells in vitro, which resemble their counterparts in vivo on both the structural level and functional level. Ocular organoids provide valuable material and models for studying eye development, pathology, drug screening, and cell replacement therapy, pushing translational studies of ocular stem cell to a new era. Here, the paper reviews the development and application of ocular organoid technologies.

目的：观察盐酸艾司氯胺酮联合丙泊酚在小儿眼睑肿物刮除术中的临床应用效果，评价盐酸艾司氯胺酮联合丙泊酚在小儿眼睑肿物刮除术麻醉中的有效性和安全性。方法：选择2020年11月至2021年7月在佛山市第二人民医院择期行眼睑肿物刮除术的70例患儿，随机分为A组和B组，每组35例。A组采用七氟烷联合丙泊酚复合麻醉，B组采用盐酸艾司氯胺酮联合丙泊酚复合麻醉。记录两组患儿诱导时间、手术时间、苏醒时间、复苏总时间；监测麻醉前、麻醉后5 min、手术开始前、手术结束后患儿血流动力学及呼吸频率变化；记录两组患儿苏醒后即刻、返回病房即刻的东安大略儿童医院疼痛评分量表(Children’s Hospital of Eastern Ontario Pain Scale，CHEOPS)疼痛评分、躁动评分、恶心呕吐评分。结果：两组患儿麻醉诱导时间比较差异无统计学意义(P>0.05)；两组患儿麻醉过程中血流动力学水平、呼吸频率差异无统计学意义(P>0.05)；B组患儿苏醒时间、复苏总时间均明显低于A组(P<0.05)；B组患儿苏醒后即刻及返回病房即刻CHEOPS疼痛评分、躁动评分、恶心呕吐评分均明显低于A组(P<0.05)。另外，B组患儿术后出现恶心呕吐概率低于A组(P<0.05)。结论：盐酸艾司氯胺酮联合丙泊酚应用于小儿眼睑肿物刮除术麻醉，能提供良好麻醉镇痛效果，降低躁动反应和恶心呕吐的发生

Objective: To investigate the anesthetic effect and to evaluate the efficacy and safety of combination application of esketamine and propofol in curettage of eyelid tumors of children. Methods: This study selected 70 children who underwent elective eyelid tumor curettage in Foshan Second People’s Hospital from November 2020 to July 2021. They were randomly divided into group A and group B, with 35 cases in each group. Patients in Group A were anesthetized with sevoflurane combined with propofol. Patients in Group B were anesthetized with esketamine combined with propofol. The anesthetic induction time, operation time, recovery time and total recovery time of the two groups were recorded. The haemodynamics and respiratory frequency changes of patients were being monitored before anesthesia, 5 minutes after anesthesia, before the operation and after the operation. The scores of Children’s Hospital of Eastern Ontario Pain Scale (CHEOPS) pain, agitation and nausea and vomiting were recorded immediately after the patients awakened and were sent back to the ward. Results: There was no significant difference in anesthesia induction time between the two groups (P>0.05). There was also no significant difference in the haemodynamics and respiratory frequency changes during the anaesthetic process between the two groups (P>0.05). The recovery time and total recovery time in group B were significantly lower than those in group A (P<0.05). The scores of CHEOPS pain, agitation and nausea and vomiting in group B were significantly lower than those in group A immediately after the patients awakened and were sent back to the ward (P<0.05). Besides, the probability of nausea and vomiting after curettage of eyelid tumors was lower in group B than in group A (P<0.05). Conclusion: Combination application of esketamine and propofol in curettage of eyelid tumors of children can provide good anesthetic and analgesic effect and reduce the occurrence of restlessness, nausea and vomiting.

近年来人工智能(artificial intelligence，AI)技术在医学领域的应用发展迅猛，尤其在眼科领域，成果显著，极大地提高了相关影像数据的诊断效率，推动了该领域研究的进展。然而，大多数AI的应用都集中于成人眼病，在婴幼儿眼病方向的研究较少。究其原因，可能是婴幼儿眼部影像数据采集配合度低，部分影像设备应用受限，且相关领域专业眼科医生数量匮乏。然而，婴幼儿期是视觉发育最重要的阶段，也是出生缺陷早期筛防诊治的重灾区，对患儿的视觉发展具有长远且重要的影响，亟需AI相关产品提高婴幼儿眼病筛查效率，缓解医疗资源不足的现状。本文将对近年AI在婴幼儿眼病领域的研究应用现状、进展及存在的相关问题进行综述。

In recent years, the application of artificial intelligence (AI) in medicine, especially in ophthalmology, has developed rapidly with remarkable results. This has greatly improved the diagnostic efficiency of relevant imaging data and promoted further research in this field. However, most applications of AI are focused on adult eye diseases, and few studies have addressed infantile eye diseases. This may be because of the non-cooperative nature of infants, the limited availability of imaging equipment in infants, and the lack of pediatric ophthalmologists. Infancy is the most important stage of vision development. Disturbance during this period have a profound and lasting influence on vision development. Hence, early screening, diagnosis, and treatment of birth defects is important. AI-related products, which improves the efficacy of infant eye disease screening, are urgently needed. This paper reviews the current status, progress, and existing problems of recent research related to application of AI in infantile eye diseases.