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：探讨医用自交联透明质酸钠凝胶对鼻内窥镜下泪囊鼻腔吻合术(endonasal endoscopic dacryocystorhinostomy，En-DCR)后的影响。方法：将219例单侧慢性泪囊炎(chronic dacryocystitis CD)患者随机分为医用自交联透明质酸钠凝胶组(A组)和对照组(B组)。所有患者行En-DCR。A组将医用自交联透明质酸钠凝胶填充吻合口，B组不做任何处理。随访12个月。比较创面黏膜上皮化、肉芽形成情况、渗血情况及吻合口通畅成功率。结果：A组98例，B组102例。随访2周，A组86例患者鼻腔吻合口黏膜上皮完整，B组77例患者鼻腔吻合口黏膜上皮完整。随访12个月，A组有7例患者存在瘢痕(7.1%)，8例患者出现肉芽肿(8.2%)，而B组有17例患者存在瘢痕(16.7%)，18例患者出现肉芽肿(17.6%)。两组瘢痕形成及出现肉芽肿差异均有统计学意义(P<0.05)。A组的吻合口通畅成功率达到90.8%(89/98)，而B组的成功率为78.4%(80/102)(P<0.05)。B组患者术后渗血情况A组相当(P>0.05)。结论：医用自交联透明质酸钠凝胶填充吻合口可通过促进En-DCR术后吻合口黏膜上皮愈合和降低伤口瘢痕及肉芽肿生成率，提高En-DCR治疗CD的成功率。
Objective: To investigate the effect of medical self-crosslinking sodium hyaluronate gel on endonasal endoscopic dacryocystorhinostomy (En-DCR). Methods: A total of 219 patients with unilateral chronic dacryocystitis (CD) were selected and randomly divided into two groups: medical self-crosslinking sodium hyaluronate gel group (group A) and control group (group B). All patients underwent En-DCR. Group A received medical self-crosslinking sodium hyaluronate gel filling the ostium at the end of En-DCR, whereas group B received no treatment. Patients were followed-up for 12 months. The mucosal epithelialization of the wound, the granulation formation, bleeding, and the success rate of ostial patency were compared in the two groups. Results: Our study included 98 patients in group A and 102 patients in group B. After 2 weeks, the number of absorbable hemostatic patients who had intact mucosal epithelium lining the ostia was 86 in group A and 77 in group B. At 12 months follow up, there were 7 patients with scar (7.1%) and 8 patients with granuloma (8.2%) in group A, compared with 17 patients with scar (16.7%) and 18 patients with granuloma (17.6%) in group B. There were significant differences in scar formation and granuloma between the two groups (P<0.05). The success rate of anastomotic patency reached 90.8% (89/98) in group A whereas the success rate was 78.4% (80/102) in group B (P<0.05). The situation of postoperative bleeding in group B was similar to that in group A (P>0.05). Conclusion: The medical self-crosslinking sodium hyaluronate gel can improve the success rate of En-DCR treatment of CD through promoting the healing of anastomotic mucosa and reducing the rate of wound scar and granuloma formation.
眶尖部肿瘤为眼科罕见疾病，但因其所处位置特殊，对机体，特别是视神经功能危害极大，错误的诊断、不规范合理的治疗不仅不能解决问题，甚至会对机体造成严重的不可挽回的损害。目前针对眶尖部肿瘤的诊断、治疗多建立在医生的主观认知与经验的基础上，尚未达成共识。本文通过分析眶尖部肿瘤的临床特点，结合以往漏诊、误诊、误治的临床案例，阐述眶尖肿瘤正确诊断的关键要点；同时，结合不同临床案例，客观分析治疗方案，尤其是手术方式、路径，为眶尖部肿瘤的合理化治疗提供依据，以期规范眶尖部肿瘤的诊断和治疗，提高治疗成功率。
Although orbital apical tumor is a rare ophthalmic disease, its special location can cause great harm to the body, especially to the function of the optic nerve. Misdiagnosis and improper treatment are not only unable to solve the problem, but also irretrievably harmful to the body. At present, there is no consensus on the diagnosis and treatment of orbital apical tumors, which are mostly based on subjective cognition and experience of doctors. In this paper, the clinical characters of orbital apical tumors were analyzed through the past clinical cases of misdiagnosis and mistreatment, and the key points of proper diagnosis of orbital apical tumors were expounded. Meanwhile, by combining with different clinical cases, the treatment plans, especially the surgical approaches, were analysed to provide a basis for the appropriate treatment of orbital apical tumors, in order to standardize the diagnosis and treatment of orbital apex tumor, and improve the success rate of treatment.
鼻内镜外科技术延伸到鼻眼相关疾病的诊断和治疗已经有二十余年的历史。随着鼻眼相关解剖研究、影像诊断技术和手术器械的进步和手术临床经验的积累，大量临床和基础研究不断涌现，逐渐形成了相对成熟的内镜鼻眼相关外科理论与实践体系。本文概述了内镜鼻眼相关外科的发展现状，对几种主要手术提供经验总结并提出展望。
Nasal endoscopic surgery technology has gradually developed and involved into the diagnosis and treatment of nose-eye related disease for more than 20 years. With the improvement of anatomical studies on nose-eye, imaging diagnostic technology and surgical instruments, the accumulation of surgical clinical experience, as well as the increasing emergence of a large number of clinical and basic studies on endoscopic rhino-orbital related surgery, a well-established theoretical and practical system of endoscopic nose-eye surgery has gradually been formed. This article summarized the development of endoscopic rhino-orbital surgery, and the advantages and limitations of several major surgical methods. Also, the further research was prospected.
目的：探究短期周边遮盖对成年视皮层双眼优势平衡的作用。方法：对12名正常成年人的各眼 (24只眼)分别进行单眼短期周边遮盖。遮盖方式为单眼佩戴90 min的环形、半透明的塑料遮盖板，遮盖板仅能透光，中央留有1 0°~15°视野范围的圆孔，从而实现周边遮盖。受试者在周边遮盖前、遮盖后的0~3、3~6、6~9、9~12、12~15、30、60和90 min均完成双眼竞争任务 (binocular rivalry task)。记录并分析各时间段中各眼的占优时间、双眼竞争在眼别间切换周期数和各眼占优概率随时间改变的特点等。每位受试者左右眼测试间隔1周进行。结果：在遮盖前，12名正常成年受试者被遮盖眼的占优时间与非遮盖眼的差异无统计学意义(92.78±6.33 s vs 87.22±6.23 s，P>0.05)，提示眼优势平衡。遮盖去除后的0~3 min，被遮盖眼占优比例显著增加至 0.721±0.11(P<0.001)，该效应在遮盖去除后的3~30 min均存在(P<0.05)，直至60 min(P=0.445)双眼基本恢复优势平衡。双眼优势转换周期在周边遮盖前后差异无统计学意义(P=0.064)。主导眼在去除周边遮盖后的0~3 min遮盖眼占优时间比例相对基线的改变幅度与遮盖非主导眼的差异无统 计学意义(P=0.835)。结论：短期的周边遮盖可改变成年双眼优势平衡，有望应用于视觉关键期后的弱视治疗中。视觉关键期后双眼视功能仍保留有一定的可塑性。
Objective: To study the effect of short-term peripheral patching on binocular dominance in adult visual cortex. Methods: Monocular short-term peripheral patching was performed on each eye (24 eyes) of 12 normal adults. The patching was achieved by monocularly wearing a ring-shaped, translucent and plastic patch for 90 minutes. The patch could only transmit light, but not pattern, and there was a circular hole with a visual field of 10°–15°, so as to achieve peripheral patching. Participants completed the binocular rivalry task at baseline and 0–3, 3–6, 6–9, 9–12, 12–15, 30, 60 and 90 min after peripheral patching. The dominance duration of each eye and the number of dominance switches between eyes were recorded. The probability of perceiving stimulus of each eye was calculated in each time period. Each participant’s both left and right eyes performed peripheral patching one week apart. Results: Before patching, the dominance duration of the patched eye was not significantly different from the non-patched eye (92.78±6.33 s vs 87.22±6.23 s, P>0.05), which suggests that the eye dominance was balanced. At 0–3 min after the removal of the patch, the dominance duration of the patched eye was increased significantly (P<0.001), and this effect existed until 30 min after the removal of the patch (P<0.05). The dominance duration of the patched eye at post-60 min was not significantly different from the baseline (P=0.445). There was no significant difference in the dominance switches among baseline and each period after patching (P=0.064). After the removal of patch on the dominant eye, the amplitude of change in the dominance duration of the patched eye at 0–3 min was not significantly different from that after the removal of patch on the non-dominant eyes (P=0.835). Conclusion: Short-term peripheral patching can also change the binocular dominance in adults, and it has the potential to be applied in treatment of adult amblyopia. After the critical period for visual development, binocular vision function still retains plasticity.
息肉状脉络膜血管病变(polypoidal choroidal vasculopathy，PCV)是亚洲人中常见的眼底致盲性疾病，当PCV合并视网膜下出血或玻璃体积血(vitreous hemorrhage，VH)时，患者视力骤然下降，视力预后差异大。但目前聚焦于PCV合并VH的相关文献较少，因此研究和阐明PCV继发VH的治疗方法及预后具有重要的临床意义。目前临床上常选择手术干预，玻璃体切除术(pars plana vitrectomy，PPV)是临床上最常选择的一种术式。其他治疗方式包括玻璃体内注射抗血管内皮生长因子(vascular endothelial growth factor，VEGF)、眼内气体或硅油填充、眼内注射组织纤溶酶原激活剂(tissue plasminogen activator，tPA)和光动力疗法(photodynamic therapy，PDT)。PCV合并VH患者的视力预后决定因素是黄斑视功能的保留程度，也与年龄、术前视力、PCV病变部位、视网膜下出血量、视网膜脱离范围、基线黄斑中心厚度(central macular thickness，CMT)、是否出现术后并发症以及是否形成视网膜瘢痕等因素相关，目前也有研究发现视力预后与单核苷酸多态性(single nucleotide polymorphisms，SNP)相关。本文就PCV继发VH的临床特点、治疗及预后进行综述。
Polypoid choroidal vasculopathy (PCV) is a common fundus blinding disease in Asians. When PCV is associated with subretinal hemorrhage or vitreous hemorrhage (VH), patient's visual acuity decreases suddenly and the visual prognosis varies greatly. There are few relevant literatures focusing on VH secondary to PCV, so it is of great clinical significance to study and clarify the treatment methods and prognosis of VH secondary to PCV. At present, surgical intervention is often selected in clinical practice. Vitrectomy is the most commonly selected surgical procedure in clinical practice. The other treatment modalities include intravitreal injection of antivascular endothelial growth factor (VEGF), intraocular gas or silicone oil filling, intraocular injection of tissue plasminogen activator (tPA) and photodynamic therapy. The prognostic determinant of visual acuity in PCVpatients with VH is the degree of preservation of macular visual function. The prognostic is also related to age, preoperative visual acuity, PCV lesion location, amount of subretinal hemorrhage, extent of retinal detachment, baseline central macular thickness (CMT), postoperative complications and retinal scars. Recent studies also find that the prognosis of visual acuity is related to single nucleotide polymorphisms. This article reviews the clinical characteristics, treatment and visual prognosis of PCV associated with VH.
目的：分析高度近视有晶状体眼后房型人工晶状体植入术后孔源性视网膜脱离的临床特征及预后。方法：回顾分析2012年4月至2021年6月中山眼科中心收治的9例(9只眼)行后房型人工晶状体植入术后孔源性视网膜脱离患者的临床特征、手术方式及疗效，随访(4.96±4.78)个月。结果：患者年龄(30.44±20.11)岁，屈光手术至发病时间(32.10±17.80)个月。4例(44.4%)马蹄形裂孔，1例(11.1%)萎缩性裂孔，4例(44.4%)巨大裂孔；9眼裂孔均位于赤道部前，除2眼(22.2%)为单个巨大裂孔，1眼(11.1%)单个马蹄孔，余6眼(66.7%)均有视网膜周边变性区存在；视网膜脱离范围(3.0±1.12)个象限，8例累及黄斑；增殖性玻璃体视网膜病变C级以上4眼。视网膜初始复位率为77.8%，最终视网膜复位率100%。末次随访最佳矫正视力优于术前(P<0.05)。随访期间，2例硅油填充眼发生并发性白内障，4眼发生术后早期高眼压。结论：有晶状体眼后房型人工晶状体植入术前存在的视网膜变性或术后玻璃体牵引的存在可能是孔源性视网膜脱离发生的危险因素。
Objective: To analyze the clinical presentation, surgical management, and outcomes of rhegmatogenous retinal detachment (RRD) in patients with high-myopia corrected by posterior chamber phakic (PCP) intraocular lens (IOL) implantation. Methods: Nine eyes of 9 patients in whom RRD developed after PCPIOL implantation from April 2012 to June 2021 in Zhongshan Ophthalmic Center were retrospectively studied. Mean follow-up after retinal detachment surgery was (4.96±4.78)months. Results: Mean patient age was (30.44±20.11) years old. RRD occurred (32.10±17.80) months after PCPIOL implantation. Four (44.4%) breaks were horseshoe tear, 1 (11.1%) was atrophic hole and 4 participants (44.4%) had a giant retinal tear. Nine cases had causative breaks located anterior to the equator while peripheral retina lattice degeneration was found in 6 eyes. RRD extended from 1 to 4 quadrants (3.0±1.12 quadrants) and 8 cases were macula-off retinal detachments. Four eyes’ proliferative vitreoretinopathy were more severe than level C. Initial reattachment rate was 77.80%. Final retinal reattachment was 100%. Final follow-up BCVA was significantly better than baseline (P<0.05). Furthermore, concurrent cataract occurred in 2 eyes in which silicone oil was used as tamponade. Ocular hypertension was detected in 4 eyes after surgery. Conclusion: The existed lattice degeneration and postoperative vitreous traction may be risk factors for RRD after PCPIOL implantation.
脂质代谢异常是糖尿病性视网膜病变可能的危险因素。糖尿病性视网膜病变被认为是致盲的主要原因。近年来研究认为总胆固醇、三酰甘油等血脂与糖尿病性视网膜病变及糖尿病黄斑水肿的进展有关，降脂药物的应用能够延缓糖尿病性视网膜病变进展。随着色谱分离和质谱分析等脂质组学分析方法的发展，除了常规的血清脂质标志物以外的各种脂质成分也被发现可能与糖尿病性视网膜病变进展有关。现总结脂质及其衍生物在糖尿病性视网膜病变发病机制中的作用，阐述糖尿病性视网膜病变脂质代谢治疗的潜在靶点和前景。
Abstract Abnormal lipid metabolism is a possible risk factor for diabetic retinopathy. Diabetic retinopathy is considered to be the main cause of blindness. In recent years, studies have shown that serum lipids, such as total cholesterol, triglycerides, are related to the progress of diabetic retinopathy and diabetic macular edema, and lipid-lowering drugs can delay the progress of diabetic retinopathy. With the development of lipidomics analysis methods such as chromatographic separation and mass spectrometry, lipid components other than conventional serum lipid markers have also been found to be related to the progression of diabetic retinopathy. The review summarizes the role of lipids and their derivatives in the pathogenesis of diabetic retinopathy, and highlights the potential targets and prospects of lipid metabolism treatment for diabetic retinopathy.
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：评估屈光不正患者有晶体眼后房型人工晶体(implantable collamer lens，ICL)植入术后视疲劳症状及调节集合功能、眼表、像差的变化，并探讨其对视疲劳症状的影响。方法：前瞻性病例观察分析。连续收集在沧州市中心医院行ICL手术并完成3个月随访的患者，测定术前、术后1周、1个月、3个月时的视疲劳评分、调节幅度(amplitude of accommodation，AA)、正相对调节和负相对调节(positive/negative relative accommodation，PRA/NRA)、调节灵敏度(accommodative facility，AF)、调节性集合(accommodative convergence，AC)与调节(accommodation，A)比率(AC/A)，Schirmer实验、非侵入性泪膜破裂时间(noninvasive breakup time，NBUT)及高阶像差(higher order aberration，HOA)，进行统计学分析。结果：ICL术后第1周视疲劳症状较术前明显加重，随时间推移逐渐减轻，术后1个月仍高于术前，术后3个月时恢复。AA术后1周时较术前降低，术后1个月、3个月时明显高于术前；AF术后1周时较术前下降，术后1个月比术前水平稍好，3个月时明显高于术前；PRA、NRA无明显变化；AC/A术后1周时较术前下降，术后1个月回复到术前水平，术后3个月较术前提高。术后1周、1个月及3个月的NBUT值均较术前明显下降，术后1周时最低；Schiermer值术后1周时轻度下降，术后1个月、3个月时基本恢复。术后的总HOA均较术前有所增加，但各个时间点之间无明显变化。相关性分析显示ICL术后AF越差、NBUT越低，视疲劳症状越重。结论：ICL术后视疲劳症状一过性加重，AF和NBUT是影响视疲劳变化的重要因素。
Objective: To evaluate the changes of visual fatigue symptoms, accommodative functions, ocular surface conditions, and high-order aberrations (HOA) after implantation of implantable collamer lens (ICL), and to explore their effects on asthenopia. Methods: It was a prospective observational case series. Patients with ametropia who underwent ICL surgeries and completed 3-month follow-up in our hospital were enrolled.Asthenopia scores, amplitude of accommodation (AA), positive/negative relative accommodation (PRA/NRA),accommodative facility (AF), the ratio of accommodative convergence and accommodation (AC/A), Schirmer test, non-invasive breakup time (NBUT), and HOA were examined before surgeries and at 1 week, 1 month and 3 months after surgeries, then statistically analyzed. Results: Symptoms of asthenopia were significantly worse at 1 week after ICL surgeries than those before surgeries, but increased gradually as time went by, eventually recovered at 3 months postoperatively. Among regulatory indicators, AA decreased 1 week postoperatively, but was significantly higher at 1 and 3 months after surgeries; AF was lower 1 week after surgery than baseline, slightly better at 1 month postoperatively, and significantly higher at 3 months postoperatively; PRA and NRA had no significant change; AC/A decreased 1 week after surgeries, returned to the baseline at 1 month postoperatively, and increased 3 months postoperatively. Tears and meibomian gland function index: NBUT values at 1 week, 1 month and 3 months after surgeries were significantly decreased compared with those before surgeries, and NBUT at 1 week postoperatively was the lowest; Schiermer values had a slight decrease at 1 week after surgeries, and basically recovered at 1 and 3 months after surgeries. HOA after surgeries were increased compared with those before surgeries, but there was no significant change between each time point. Correlation analysis showed that the lower AF and NBUT after ICL surgeries, the more severe the asthenopia symptoms. Conclusion: The symptoms of asthenopia aggravated transiently after ICL implantation surgeries, but improved gradually with time. AF and NBUT were important factors affecting the changes of asthenopia.
