传统的眼底手术要求眼科医生具备精细的操作技术,但即便拥有再精湛的操作技术,眼底手术还是存在很大的风险性。因此,为了减少手术风险,提高手术质量,对传统眼底手术进行改进是十分必要的。近年来,在我国对于人工智能产业的大力支持之下,应用于各类行业的机器人随之诞生。机器人辅助系统(robot auxiliary system,RAS)在医学领域,特别是眼科学中应用广泛。对近几年RAS应用于眼底手术的案例进行整理总结,并将RAS参与的眼底手术以及传统的眼底手术进行对比,可以发现RAS在眼底手术中的应用可以显著提高手术效率,并降低手术风险。未来RAS的发展趋势可能着重聚焦于与深度学习算法的紧密结合。通过算法对手术中的视野图像进行预测、优化,从而让高精度的眼底手术更加高效、安全。
Traditional fundus surgery requires ophthalmologists to be equipped with sophisticated operating techniques, but even with the most sophisticated operating techniques, fundus surgery still has great risks. Therefore, in order to reduce the risk of surgery and improve the quality of surgery, it is very necessary to improve the traditional fundus surgery. In recent years, with China’s strong support for the artificial intelligence industry, robots used in various industries have been born. Robot auxiliary system (RAS) is widely used in the medical field, especially in ophthalmology. By summarizing the cases of fundus surgery with RAS in recent years and comparing the fundus surgery involving RAS with traditional fundus surgery, it can be found that the application of RAS in fundus surgery can significantly improve the efficiency of surgery and reduce the risk of surgery. The future development trend of RAS may focus on the close integration with deep learning algorithms, which can predict and optimize the field of view images during surgery so that high-precision fundus surgery can be more efficient and safer.
房角镜辅助的内路360°小梁切开术(Gonioscopy-Assisted Transluminal Trabeculotomy,GATT)是近年来国内外开展的新型微创青光眼手术,是一种改良的小梁切开术。GATT将微导管(iTrack)环穿Schlemm's管后,利用微导管张力全周切开小梁网及Schlemm's管内壁,重建生理性房水流出通道,避免小梁网阻力,实现房水从前房直接进入集液管,通过增加房水流出机制降低眼压。GATT适应证广泛,主要应用于开角型青光眼,包括原发型开角型青光眼和继发性开角型青光眼,同时可运用于闭角型青光眼。GATT微创、不依赖滤过泡、能明显减少降眼压药物的使用、中远期疗效稳定、安全性高、较少发生威胁视力的并发症,可作为开角型青光眼的首选手术方式。本文将对GATT在青光眼中的应用、手术步骤、作用机制、有效性、并发症及影响疗效的因素等进行综述,以期为其临床运用提供参考。
As a modifed trabeculotomy, Gonioscopy-Assisted Transluminal Trabeculotomy (GAT) is a new type of minimally invasive glaucoma surgery developed at home and abroad in recent years. GAT inserts a microcatheter (iTrack) into the Schlemm's canal and advance the catheter through the canal circumferentially 360°, then circumferentially fracture the trabecular meshwork and inner wall of Schlemm’s canal. Tis method can reduce intraocular pressure by increasing the outfow of aqueous humor. Te physiological outfow pathway of aqueous humor is reconstructed, which can avoid the resistance of trabecular meshwork and realizing the direct entry of the aqueous humor directly into the collector channel from the anterior chamber. With a wide range of indications, GAT is mainly used in open-angle glaucoma, including primary open-angle glaucoma and secondary open-angle glaucoma, and is also used in primary closed- angle glaucoma. Additionally, GATT can be the preferred surgical modality for open-angle glaucoma, as it has the following advantages: minimally invasive, independent of fltration bleb, can signifcantly reduce the use of medications, stable medium- and long-term efcacy, high safety, and has fewer sight-threatening complications. In order to provide a reference for clinical application, this article reviews the indications, mechanism of action, surgical procedures, efectiveness, complication and factors afecting therapeutic efect.
因不同的眼部和神经性疾病,导致视觉功能严重受损,为低视力患者日常活动(如阅读及驾驶)及生活质量、心理健康带来严重的影响。人们对外界信息的感知主要来源于视觉,除威胁生命的重大疾病外,对人感官影响最大的损害当属视觉损伤。且随着人口日益老龄化,该问题日趋加重,低视力已成为目前全球范围内一个严重的公共卫生问题。目前,低视力康复发展面临着临床和科研的巨大挑战,要研发出一种能有效改善视觉功能,同时能兼顾多种功能的视障辅助技术,这需要医学、生物学、工程学、微电子学、计算机学等多学科的共同发展和相互合作。低视力康复通过为患者提供适宜的视障辅助技术,最大化利用患者的残余视力及视觉功能,改善与低视力相关的功能限制,有效改善其独立性和整体生活质量,使其独立生活、工作并融入社会成为可能。该文对经典的助视器、人工视觉(视觉假体/视觉感官替代设备)、经颅刺激及视觉生物反馈训练等视障辅助技术在低视力康复中的应用进展进行综述。
Patients with low vision are severely impaired in visual function due to different ocular and neurological disorders,which have a serious impact on their daily activities (such as reading and driving), quality of life and mental health.People's perception of external information mainly comes from vision. Expect for the life-threatening major diseases,visual damage has the greatest impact on people's senses. With the ageing of the population, the problem is getting worse, and low vision has become a serious public health problem in the world. Currently the development of low vision rehabilitation is facing a huge challenge in clinical and scientific research, to develop a visual impairment assistance technology that can effectively improve visual function while balancing multiple functions. It requires the joint development and cooperation of multiple disciplines such as medicine, biology, engineering, microelectronics, and computer science. Low vision rehabilitation provides patients with appropriate visual impairment assistance technology,maximizing the use of residual vision and visual function of patients, improving the functional limitations associated with low vision, effectively improving their independence and overall quality of life, and makes it possible for them to live, work and integrate into the society independently. This article reviews the progress in the application on visual impaired assistive technologies such as classic visual aids, artificial vision (visual prostheses/visual sensory replacement devices), transcranial stimulation and visual biofeedback training in low vision rehabilitation.
目的:比较硬膜外导管辅助双路置硅胶管术与传统双路置硅胶管术在泪小管断裂吻合术中的疗效。方法:随机将连云港市第二人民医院52例(52眼)行泪小管断裂吻合术的患者分成两组,使用硬膜外导管辅助双路置硅胶管术为A组(30例);使用传统手术方式(双路置硅胶管术)为B组(22例)。比较两组患者术中置管时间、平均手术时间、鼻腔出血率、术中疼痛评分、一次性吻合成功率的差异。结果:在术中置管时间方面,A组为(11.20±3.80) min,B组为(21.50±12.60) min;在平均手术时间方面,A组为(42.70±5.50) min,B组为(62.20±15.20) min;在术中疼痛评分方面,A组为(3.10±0.80)分,B组为(4.60±1.25)分;在鼻腔出血率方面,A组为3.33%(1/30),B组为18.2%(4/22),以上差异均有统计学意义(均P<0.05);但在一次性吻合成功率方面,A组有效率为93.3%(28/30),B组有效率为86.4%(19/22),差异无统计学意义(P>0.05)。结论:在泪小管断裂吻合术中,应用硬膜外导管辅助双路置硅胶管术较传统双路置硅胶管术,在术中置管时间、手术平均时间、鼻腔出血率、患者疼痛程度等方面具有优势,2种置管一次性成功率的差异无统计学意义,硬膜外导管辅助双路置硅胶术方法安全、可靠、优势明显,值得临床手术推广。
Objective: To compare the efficacy of bicanalicular silicone intubation assisted with epidural catheters and traditional bicanalicular silicone intubation in the anastomosis of lacrimal canaliculus rupture. Methods: Fifty-two patients (52 eyes) were randomly divided into two groups. Patients in group A (30 cases) were treated by bicanalicular silicone intubation assisted with epidural catheters, while patients in group B (22 cases) were treated with conventional operation (bicanalicular silicone intubation). The intubation time, average operation time, nasal bleeding rate, intraoperative pain score and one-time success rate were compared between the 2 groups. Results: Intubation time in group A was (11.20±3.80) min and that in group B was (21.50±12.60) min(P<0.05). The mean operation time of group A was (42.70±5.50) min and that of group B was (62.20±15.20) min(P<0.05). Intraoperative pain score was 3.10±0.80 in group A and 4.60±1.25 in group B (P<0.05). The rate of nasal hemorrhage was 3.33% (1/30) in group A and 18.2% (4/22) in group B (P<0.05). With respect to one-time anastomosis success rate assessment, the effective rate was 93.3% (28/30) in group A, and 86.4% (19/22) in group B (P>0.05). Conclusion: During lacrimal canalicular anastomosis, bicanalicular silicone intubation assisted with epidural catheters is superior to bicanalicular silicone intubation in intubation time, average operation time, nasal bleeding rate and pain degree. There is no significant difference between the two methods in one-time success rate. Bicanalicular silicone intubation assisted with epidural catheters is safe, reliable, and worthy of promotion.
目的:评估白内障人工智能辅助诊断系统在社区筛查中的应用效果。方法:采用前瞻性观察性研究方法对白内障人工辅助诊断系统的应用效果进行分析,结合远程医疗的模式,由社区卫生人员对居民进行病史采集、视力检查和裂隙灯眼前节检查等,将数据上传至云平台,由白内障人工智能辅助诊断系统和人类医生依次进行白内障评估。结果:受检人群中男性所占比例为35.7%,年龄中位数为66岁,裂隙灯眼前节照片有98.7%的图像质量合格。该白内障人工智能辅助诊断系统在外部验证集中检出重度白内障的曲线下面积为0.915。在人类医生建议转诊的病例中,有80.3%也由人工智能系统给出了相同的建议。结论:该白内障人工智能辅助诊断系统在白内障社区筛查的应用中具有较好的可行性和准确性,为开展社区筛查疾病提供了参考依据。
Objective: To evaluate the effectiveness of an artificial intelligence-assisted diagnostic system for cataract screening in community. Methods: A prospective observational study was carried out based on a telemedicine platform. Patient history, medical records and anterior ocular segment images were collected and transmitted from community healthcare centers to Zhongshan Ophthalmic Center for evaluation by both ophthalmologists and artificial intelligence-assisted cataract diagnostic system. Results: Of all enumerated subjects, 35.7% were male and the median age was 66 years old. Of all enumerated slit-lamp images, 98.7% met the requirement of acceptable quality. This artificial intelligence-assisted diagnostic system achieved an AUC of 0.915 for detection of severe cataracts in the external validation dataset. For subjects who were advised to be referred to tertiary hospitals by doctors, 80.3% of them received the same suggestion from this artificial intelligence-assisted diagnostic system.Conclusion: This artificial intelligence-assisted cataract diagnostic system showed high applicability and accuracy in community-based cataract screening and could be a potential model of care in community-based disease screening.
目的:评价手术视频辅助Wetlab眼睑手术教学的效果。方法:回顾性分析2021年4月至2021年9月在中山大学中山眼科中心住院医师规范化培训学员中使用全眼模型开展Wetlab外眼手术教学的情况。对照组(12人)采用传统教学方法,实验组(15人)在传统教学方法的基础上引入手术视频辅助教学,对学员第3、6、9次练习视频进行评分,分析教学效果。结果:2组学员的基线水平与学习曲线相似,练习第3次到第6次之间评分提高快(对照组P3~6=0.001,实验组P3~6<0.001),第6次到第9次之间提高速度放缓(对照组P6~9=0.007,实验组P6~9=0.012)。对照组学员在练习第3次用时更长[(80.3±16.1) min],随着练习次数增多,用时逐渐缩短并保持稳定(P3~6=0.040,P6~9=0.886,P3~9=0.020),而实验组学员在练习第3次用时更短[(71.7±15.0) min],练习过程中保持稳定(P3~6=0.568,P3~9=0.519)。结论:手术视频辅助教学有助于学员熟悉手术操作,提高练习效率。
Objective: To assess the efficacy of video-assisted Wetlab eyelid surgery teaching. Methods: From April 2021 to September 2021, the porcine orbit model was used to conduct a Wetlab teaching course on eyelid surgeries among trainees of standardized training for residents in Zhongshan Ophthalmic Center, Sun Yat-sen University. The control group (12 trainees) used conventional teaching methods. Video-assisted teaching was offered to the test group (15 trainees) based on conventional teaching methods. The videos records of the 3rd, 6th, and 9th practices were scored to analyze the teaching efficiency. Results: Trainees from the 2 groups showed a simila baseline and learning curve. Rapid improvement was found between the 3rd and 6th practice (P3–6=0.001 in control group, P3–6<0.001 in test group). The increment was slower between the 6th and 9th practice (P6–9=0.007 from control group, P6–9=0.012 from test group). Longer time was required by trainees from the control group at the 3rd practice [(80.3±16.1) min]. As they practiced more, the time required gradually decreased and remained stable (P3–6=0.040, P6–9=0.886, P3–9=0.020 from control group). Trainees from the test group spent less time at the 3rd practice [(71.7±15.0) min]. The time remained stable during all practices (P3–6=0.568, P3–9=0.519 from test group). Conclusion: Video-assisted teaching can help trainees get familiar with surgical operations and improve the efficiency of practices.
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.
目的:探索局部麻醉辅助小剂量丙泊酚联合瑞芬太尼镇静镇痛在成人斜视矫正术中的应用效果。方法:本研究为前瞻性队列研究,选取2020年10月1日至2021年5月31日于北京同仁医院行斜视矫正术的成年患者24例,单纯局部麻醉组、镇静镇痛组各12例。所有患者均应用2%利多卡因10 mL+0.1% 肾上腺素0.1 mL混合液进行眼部局部浸润注射,静脉滴注昂丹司琼8 mg。镇静镇痛组患者静脉滴注咪达唑仑1 mg、舒芬太尼5 μg,继之以丙泊酚0.6~3 mg/(kg·h)、瑞芬太尼0.01~0.05 μg/(kg·min)持续输注,使Ramsay镇静分级维持在II级。记录两组患者术中视觉模拟评分(visual analog scale,VAS)、脑电双频指数(bispectral index,BIS)、术者满意度评分及调节眼位配合度评分,术中恶心呕吐、眼心反射、呼吸抑制、血压心率等情况,以及丙泊酚、瑞芬太尼输注速度。结果:镇静镇痛组患者丙泊酚持续输注速度为0.6~1.8 mg/(kg·h),瑞芬太尼持续输注速度为0.01~0.03 μg/(kg·min)。镇静镇痛组患者 术中VAS、BIS、心率增快发生率均低于单纯局部麻醉组(P<0.05),术者满意度评分、血压下降发生率均高于单纯局部麻醉组(P<0.05);两组患者术中恶心呕吐、眼心反射、呼吸抑制、血压升高发生率及调节眼位配合度评分差异均无统计学意义(P>0.05)。结论:在成人斜视矫正术中,局部麻醉辅 助小剂量丙泊酚联合瑞芬太尼镇静镇痛可有效减轻患者术中疼痛,作用安全可靠。
Objective: To explore the effect of local anesthesia assisted with sedation and analgesia of low-dose propofol combined with remifentanil in adult strabismus surgery. Methods: This study was a prospective cohort study. Twenty-four adult patients who underwent strabismus surgery in Beijing Tongren Hospital from October 1, 2020 to May 31, 2021 were selected and divided into local anesthesia group, and sedation and analgesia group, eachwith 12 patients. All patients received local anesthesia with a mixture of 2% lidocaine 10 mL and 0.1% epinephrine 0.1 mL, and intravenous ondansetron 8 mg. Patients in the sedation and analgesia group received intravenous infusion of midazolam 1mg and sufentanil 5 μg, followed by continuous infusion of propofol 0.6–3 mg/(kg·h) and remifentanil 0.01~0.05 μg/(kg·min) to maintain Ramsay sedation score at grade II. Visual Analogue Scale (VAS), bispectral index (BIS), operator’s satisfaction score, patient’s coordination score, nausea and vomiting, oculocardiac reflex, respiratory depression, blood pressure, heart rate and the infusion rate of propofol and remifentanil during operation were recorded in these two groups. Results: In the sedative and analgesic group, the infusion rates of propofol and remifentanil were 0.6–1.8 mg/(kg·h) and 0.01–0.03 μg/(kg·min), respectively. VAS, BIS and the incidence of increased heart rate in the sedation and analgesia group were lower than those in the local anesthesia group (P<0.05); operator’s satisfaction score and the incidence of decreased blood pressure in the sedation and analgesia group were higher than those in the local anesthesia group (P<0.05); there was no significant difference in the incidence of intraoperative nausea and vomiting, oculocardiac reflex, respiratory depression, elevated blood pressure and patient’s coordination score between the two groups (P>0.05). Conclusion: In adult strabismus surgery, local anesthesia assisted with sedation and analgesia of low-dose propofol combined with remifentanil can effectively relieve intraoperative pain, which is safe and reliable.