Background: Laser photocoagulation restricted to ablation of the avascular retina has been the conventional but not a completely effective treatment strategy in the management of threshold retinopathy of prematurity (ROP). The purpose of this study was to compare the structural outcomes of additional posterior to ridge diode laser compared to conventional diode laser to avascular retina alone in threshold stage III ROP.
Methods: This was a prospective, randomized study involving infants diagnosed with threshold stage III ROP in one or both the eyes. The infants were randomized into control and study groups. Infants under the control group underwent conventional laser to avascular retina alone while infants under the study group received additional two rows of laser posterior to the ridge in the vascular retina. The infants were followed up at 2 weeks, 1 month and up to 6 months after the laser procedure.
Results: During the study period of 1 year, 42 eyes of 24 infants were recruited into this study with 21 eyes in each group. The mean birth weight was 1,310.48±400.92 g in the test group and 1,341.9±396.2 g in the control group. The mean post conceptional age at the time of intervention was 36.43±2.79 weeks in test group and 36.29±2.55 weeks in the control group. At 1-month post laser, 19 eyes in the study group showed regression of neovascularization laser compared to 18 eyes in the control group. However at the end of 3 and 6 months post laser, both groups had showed similar rates regression of neovascularization (19 of 21 eyes in both groups). Five eyes in the study group and six in the control group required additional laser treatment. Two eyes in the study group and one eye in the control group developed post laser vitreous hemorrhage.
Conclusions: Posterior to ridge laser treatment for severe stage 3 ROP did not show any additional benefit compared to conventional laser.
Background: Laser photocoagulation restricted to ablation of the avascular retina has been the conventional but not a completely effective treatment strategy in the management of threshold retinopathy of prematurity (ROP). The purpose of this study was to compare the structural outcomes of additional posterior to ridge diode laser compared to conventional diode laser to avascular retina alone in threshold stage III ROP.
Methods: This was a prospective, randomized study involving infants diagnosed with threshold stage III ROP in one or both the eyes. The infants were randomized into control and study groups. Infants under the control group underwent conventional laser to avascular retina alone while infants under the study group received additional two rows of laser posterior to the ridge in the vascular retina. The infants were followed up at 2 weeks, 1 month and up to 6 months after the laser procedure.
Results: During the study period of 1 year, 42 eyes of 24 infants were recruited into this study with 21 eyes in each group. The mean birth weight was 1,310.48±400.92 g in the test group and 1,341.9±396.2 g in the control group. The mean post conceptional age at the time of intervention was 36.43±2.79 weeks in test group and 36.29±2.55 weeks in the control group. At 1-month post laser, 19 eyes in the study group showed regression of neovascularization laser compared to 18 eyes in the control group. However at the end of 3 and 6 months post laser, both groups had showed similar rates regression of neovascularization (19 of 21 eyes in both groups). Five eyes in the study group and six in the control group required additional laser treatment. Two eyes in the study group and one eye in the control group developed post laser vitreous hemorrhage.
Conclusions: Posterior to ridge laser treatment for severe stage 3 ROP did not show any additional benefit compared to conventional laser.
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.
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.
目的：观察玻璃体腔内注射不同剂量康柏西普治疗早产儿视网膜病变(retinopathy of prematurity，ROP)的疗效以及术后的眼压变化。方法：前瞻性随机对照研究。将2018年1月1日至2021年6月30日在厦门市妇幼保健院确诊为Ι型阈值前期ROP、阈值期ROP、急进性ROP(aggressive ROP，A-ROP)的患儿纳入研究。随机分为减量组和常量组，分别玻璃体腔注射10 mg/mL康柏西普注射液0.015 mL(含康柏西普0.15 mg)和0.025 mL(含康柏西普0.25 mg)。测量并记录注射前5min、注射后5min、30min、1h、12h及24 h的眼压情况。术后1周开始随访眼底情况。疗效评价分为一次治愈、复发和加重。结果：共49例98眼纳入研究，常量组27例54眼，一次治愈成功率79.6%(43/54)，复发率16.7%(9/54)，加重率3.7%(2/54)；减量组2 2例44眼，一次治愈成功率68.2%(30/44)，复发率27.3%(12/44)，加重率4.5%(2/44)；两组间差异无统计学意义(χ 2=1.672，P=0.196)。治疗前5min两组眼压差异无统计学意义(P=0.494)；注药后5 min、1 h、12h两组眼压差异有统计学意义(均P<0.05)；注药后24 h两组间的眼压差异无统计学意义(P=0.101)。常量组注药前5 min和注药后24 h眼压差异有统计学意义(P=0.03)，减量组注药前5 min和注药后24h眼压差异无统计学意义(P=0.84)。结论：减量剂量康柏西普(0.15mg)治疗ROP有效，疗效与常规剂量(0.25 mg)相近，且术后眼压升高幅度较低，更快恢复至术前水平，更安全。
Objective: To evaluate the effectiveness of intravitreal injection of various doses of conbercept in the treatment of retinopathy of prematurity (ROP) and change of intraocular pressure (IOP) after operation. Methods: It was a prospective randomized controlled study. Children who were diagnosed with pre-threshold ROP, threshold phrase ROP, and aggressive ROP (A-ROP) in Xiamen Maternity and Child Healthcare Hospital from January 1, 2018 to June 30, 2021 were included in the study. The children were randomly divided into a reduction group and a constant group, and received intravitreal injection of10 mg/mL conbercept at 0.015 mL (containing 0.15 mg of conbercept) and 0.025 mL (containing 0.25 mg of conbercept) respectively. IOP was measured and recorded 5 min before injection, 5 min, 30 min, 1 h, 12 h and 24 h after injection. The fundus condition was followed up 1 week after the operation. The efficacy evaluation is divided into one cure, recurrence and exacerbation. Results: A total of 98 eyes of 49 cases were included in thestudy. For 27 cases of 54 eyes in the constant group, the one-time cure success rate was 79.6% (43/54), the recurrence rate was 16.7% (9/54), and the exacerbation rate was 3.7% (2/54). In the reduction group, there were 22 cases (44 eyes). The one-time cure success rate was 68.2% (30/44), the recurrence rate was 27.3% (12/44), and the exacerbation rate was 4.5% (2/44). There was no significant difference between the two groups (χ2=1.672,P=0.196). There was no significant difference in IOP between the 2 groups 5 min before treatment (P=0.494). There were statistically significantdifferences in IOP between the 2 groups at 5 min after injection, 1 h after injection, and 12 h after injection (all P<0.05). There was no difference in IOP between the two groups 24 h after injection (P=0.101). There was a statistically significant difference in IOP between 5 min before and 24 h after injection in the constant group (P=0.03), and there was no significant difference in IOP between 5 min before and 24 h after injection in the reduction group (P=0.84). Conclusion: Reduced dose of conbercept (0.15 mg) is effective in the treatment of ROP, and the efficacy is similar to that of conventional dose (0.25 mg). The reduction can help lower the increase of postoperative IOP, returning to the preoperative level more rapidly and safely.
目的：研究早产儿视网膜病变患儿经不同治疗措施后屈光状态的改变。方法：将72例(127眼)早产儿视网膜病变患儿按治疗方式分为3组：激光光凝组、注药(抗血管内皮生长因子药物)组和自然消退组。并于治疗前，治疗后1、4、7、12个月对其进行睫状肌麻痹检影验光，对比分析3组的球镜和等效球镜的差异。结果：在治疗后1、4、7及12个月，三组患儿的球镜度和等效球镜度的差异有统计学意义(P<0.05)：注药组的球镜和等效球镜小于自然退化组及激光组(均P0.05)。治疗后12个月时激光光凝组、注药组和自然消退组近视发生率分别是2.4%、7.8%和2.0%，差异无统计学意义(P=0.356)。结论：经不同治疗措施的ROP患儿近视发生率无明显差异，但经玻璃体腔注射抗VEGF药物的ROP患儿正视化进程更快。
Objective: To observe the changes of refractive statues in infants with retinopathy of prematurity retinopathyof prematurity (ROP) after different treatments. Methods: According to different treatment methods, 72 cases(127 eyes) of infants with ROP were divided into 3 groups: laser photocoagulation group, intravitreal injectionof anti-vascular endothelial growth factor (VEGF) drugs group and natural regression group. Their sphere andspherical equivalent were measured by retinoscopy optometrist after the ciliary muscles paralyzed. The data beforetreatments and 1, 4, 7 and 12 months after treatments were recorded and analyzed. Results: The differences ofsphere and spherical equivalent among three groups were statistically significant: intravitreal injection of VEGFdrugs group was lower than natural regression group and the laser photocoagulation group, but there was no significant difference between natural regression group and laser photocoagulation group. Incidence of myopiaof laser photocoagulation, intravitreal injection of VEGF drugs, natural regression group were 2.4%, 7.8%, 2.0%,which was not statistically significant. Conclusion: There was no significant difference about the incidence rate ofmyopia among the three groups, but the emmetropization in infants with ROP after intravitreal injection of anti-VEGF drugs might be faster in the future.
糖尿病视网膜病变(diabetic retinopathy，DR)在糖尿病肾病(diabetic nephropathy，DN)人群，特别是终末期糖尿病肾病(end stage diabetic nephropathy，ESRD)患者中的发病率和严重程度明显高于糖尿病人群。其中ESRD的一项重要治疗手段——血液透析(Hemodialysis，HD)可能会增加机体氧化应激反应、出血风险以及视神经的缺血缺氧，加重DR的发生发展；但另一方面也可通过清除尿毒症毒素、控制血压以及清除多余体液等途径改善糖尿病和DN对眼部的损伤。
The incidence and severity of diabetic retinopathy (DR) in patients with diabetic nephropathy (DN), especially those with end-stage renal disease (ESRD), were higher than those with diabetes. Hemodialysis (HD), an important treatment of ESRD, may aggravate DR by increasing the oxidative stress, fundus hemorrhage and hypoxia of the optic nerve. On the other hand, HD can improve the ocular damage caused by diabetes mellitus and DN by removing uremia toxin, controlling blood pressure and removing excess body fluid.
