视网膜疾病大多以周边视网膜病变为首要表现,后者的早期诊断、监测对于视网膜疾病的治疗及预防起着至关重要的作用。以往传统眼底成像技术仅能提供20°视网膜的可视范围,即便使用蒙太奇拍摄技术,也只能采集部分眼底范围。目前眼底成像技术已步入最新的超广角时代,其所提供的眼底视野至少可达200°,并且基于该技术的超广角眼底彩色照相、荧光素血管造影、光学相干断层扫描及其血管造影等已广泛应用于临床实践中,对于诊断及评估视网膜疾病发挥重要作用,如糖尿病性视网膜病变、视网膜静脉阻塞、早产儿视网膜病变、视网膜色素变性及视网膜脱离等。本文将从超广角成像技术的产生、发展及其国内外的临床应用现状作一综述,旨在为临床工作及研究提供指导意义。
Retinal diseases primarily feature with peripheral retinopathy, and its early diagnosis as well as the later following up both play a vital role in the treatment and prevention of retinal diseases. In the past, traditional fundus imaging technology can only provide the visual range of 20 degrees. Even if montage photography technology is used, it can only partially reveal the fundus field. At present, fundus imaging technology has entered the latest era of ultra-wide-field, which provides at least 200-degree fundus field of vision. Ultra-wide-field fundus photochromy, fluorescein angiography, optical coherence tomography and angiography based on this technology have been widely used in clinical practice, and play an important role in the diagnosis and evaluation of retinal diseases, such as diabetes retinopathy, retinal vein occlusion, retinopathy of prematurity, retinitis pigmentosa and retinal detachment. This article aims to review the occurrence and development of ultra-wide-field fundus imaging technology and its clinical applications up to now to provide a relative guideline for clinic and research.
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.
眼缺血综合征(ocular ischemia syndrome,OIS)是由一系列诱因引发的以慢性眼部低灌注为主要临床表现的眼部疾病。临床相对少见,但对视力的影响较大,其症状主要包括一过性黑朦、缺血性眼痛、永久性视力丧失等。近年来医疗美容行业逐步兴起,自体脂肪填充技术使用逐渐增多,其所引起的OIS不可忽视。本文分析1例自体脂肪填充患者术后致OIS病例,研究该类疾病眼底影像学特征。
Ocular ischemia syndrome (OIS), featuring as chronic ocular hypoperfusion, is an eye disease caused by a series of incentives. It is relatively rare in clinical practice, but has a great impact on vision. The symptoms of OIS mainly include transient amaurosis, ischemic eye pain, permanent vision loss, etc. In recent years, with the rise of the Aesthetic Medicine industry, the technology of autologous fat filling has been increasingly adopted. The OIS caused by the surgery of autologous fat filling is nonnegligible. In this paper, by means of analyzing a case that an autologous fat filling surgery resulted in the OIS, discusses features of fundus angiography of OIS.
目的:观察喉罩通气吸入七氟醚麻醉在小儿眼底荧光素造影检查(fundus fluorescein angiography,FFA)期间眼位情况、眼球运动的发生率和丙泊酚调整眼位的有效率。方法:回顾性分析2018年6月至2019年12月七氟醚麻醉下接受FFA的儿童的病例资料,记录检查开始时眼位分级、检查中眼球运动发生率、丙泊酚调整眼位的有效率、麻醉后恢复自主活动时间以及不良事件。结果:纳入1~9岁患儿54例,检查开始时42.6%(23/54)的患者眼位1级,51.9%(28/54)的患者眼位2级,5.6%(3/54)的患者眼位3级,检查中眼球运动发生率为61.1%(33/54)。13%(7/54)的患儿需丙泊酚干预,丙泊酚1 mg/kg纠正眼位的有效率为100%。患儿麻醉后恢复正常活动的平均时间为24.4 min,未发生不良事件。结论:喉罩复合七氟醚的麻醉可为门诊小儿眼底荧光造影提供相对满意的麻醉质量,患者在麻醉后可迅速恢复日常活动,丙泊酚可迅速纠正检查中眼位不正。
Objective: To observe the eye position, the incidence of eye movement and the efficacy of propofol on correcting eccentric eyeball position in children undergoing examination of outpatient fundus fluorescein angiography (FFA) with inhaled sevoflurane via laryngeal mask airway. Methods: Children undergoing FFA with sevoflurane anesthesia from June 2018 to December 2019 were retrospectively reviewed. Eye position at the beginning of examination, incidence of eye movement during examination, the efficiency of propofol on correcting eccentric eyeball position during procedure, the time to resume normal activities, and adverse events were recorded. Results: Fifty-four children aged 1–9 years were included in this study. The rates of eye position from grade one to grade three at the beginning of examination were 42.6% (23/54), 51.9% (28/54), and 5.6% (3/54), respectively. The incidence of eye movement during examination was 61.1% (33/54). 13% (7/54) of children with unsatisfactory eye-position needed intervention with propofol. The efficacy of propofol (1 mg/kg) in correcting eye position was 100%. The mean time to return normal activities was 24.4 min. There were no any adverse events during the peri-anesthetic period. Conclusion: Inhaled sevoflurane via LMA can provide appropriate anesthesia for outpatient FFA in children. Children can resume daily activities soon after anesthesia. Propofol can return the incorrect eye position during examination