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  • 文章类型: Case Reports
    我们描述了一名患者在定制交联(CXL)进行性圆锥角膜后出现自发消退的角膜水肿。
    一名24岁的男性左眼进行性圆锥角膜接受了定制的CXL手术,总能量为10J/cm2,持续16.4分钟。术前校正的远距视力(CDVA)为20/30,最大角膜曲率(K)值为58.6屈光度(D),最薄点测量为414μm。术前内皮细胞密度(ECD)为2414细胞/mm2。治疗期间,上皮清创术后角膜厚度为325μm,应用含0.1%核黄素的HPMC后角膜厚度为375μm。治疗后,抗生素和类固醇滴剂开了5天和3周,分别。在CXL访视后1个月,患者没有投诉,视力和临床检查未显示不规则。在CXL访视后4个月,患者抱怨视力模糊。CDVA为20/100,裂隙灯检查显示微囊性角膜水肿。测量的最薄点的角膜厚度为440μm。一个月后,水肿自发消退,CDVA恢复到20/25。测得最薄点的角膜厚度415μm,ECD为1514个细胞/mm2,共聚焦显微镜显示CXL后前基质的正常结构变化,分界线位于414μm的深度,就在角膜内皮上方。
    我们报告了一例定制CXL后角膜水肿,内皮细胞丧失自发消退。我们建议在施用UV-A照射之前坚持400μm的最小基质厚度,使用隐形眼镜或调整照射,以防止这种复杂性。
    UNASSIGNED: We describe a patient after customized crosslinking (CXL) for progressive keratoconus who developed corneal edema with spontaneous resolution.
    UNASSIGNED: A 24-year-old male with progressive keratoconus of the left eye underwent a customized CXL procedure with a total energy of 10 J/cm2 for 16.4 minutes. Preoperative corrected distance visual acuity (CDVA) was 20/30 with a maximum keratometry (K)-value of 58.6 diopter (D) and the thinnest point measured 414 μm. The preoperative endothelial cell density (ECD) was 2414 cells/mm2. During treatment, corneal thickness was 325 μm after epithelial debridement and 375 μm after the application of 0.1 % riboflavin containing HPMC. After the treatment, antibiotic and steroid drops were prescribed for 5 days and 3 weeks, respectively. At the 1-month post-CXL visit the patient had no complaints, visual acuity and clinical examination showed no irregularities. At the 4-months post-CXL visit the patient complained of blurry vision. The CDVA was 20/100 and slit-lamp examination showed microcystic corneal edema. The corneal thickness at the thinnest point measured 440 μm. One month later the edema had resolved spontaneously and CDVA had restored to 20/25. Corneal thickness at the thinnest point measured 415 μm, the ECD was 1514 cells/mm2 and confocal microscopy showed normal structural changes in the anterior stroma after CXL, with the demarcation line located at a depth of 414 μm, just above the corneal endothelium.
    UNASSIGNED: We report a case of corneal edema following customized CXL with endothelial cell loss that resolved spontaneously. We recommend either adhering to a minimal stromal thickness of 400 μm before administering UV-A irradiation, using a contact lens or adjusting the irradiation to prevent this complication.
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  • 文章类型: Journal Article
    目的:在全膝关节置换术(TKA)中,在保持可接受的下肢对齐的同时实现软组织平衡有时是困难的,并且可能导致患者不满意。理论上,针对患者的植入物可以带来巨大的好处,而缺乏精确的手术工具可能会阻碍结局的改善。这项研究的目的是说明手术技术和评估运动学和早期临床结果的机器人辅助TKA使用患者特定的植入物。
    方法:基于术前CT扫描,股骨和胫骨组件进行3D打印。胫骨内侧和外侧衬垫分开,厚度不同,后坡和整合。TiRobotRecon机器人用于手术,并配备了量化差距的智能工具,力和股骨胫骨轨道。我们收集了人口统计数据,术中间隙平衡和股骨-胫骨运动。在后续行动中,我们评估了运动范围,视觉模拟量表(VAS),遗忘联合得分(FJS),膝关节损伤和骨关节炎结果评分,关节置换(KOOS,JR)得分。还收集了放射学数据。
    结果:纳入15例患者(17膝),平均年龄为64.6±6.4(53-76)岁。在5个膝盖,我们用了对称的胫骨衬垫,其余的是不对称的。手术后,平均比对为1.6±2.0(-3-5)度内翻。平均随访6.7±4.2(1~14)个月。平均视觉模拟评分为0.8±0.7(0-2),FJS为62.4±25.3(0-87),KOOS为86.5±9.4(57-97)。11名患者“非常满意”,3对结果“满意”,1例患者在5个月随访时由于延期受限和康复不令人满意而保持中立.
    结论:使用特定于患者的植入物和机器人技术,TKA可以通过数学方法进行,被称为“差分”TKA。术中运动学在间隙力平衡和股骨胫骨相对运动方面非常出色。初步临床结果总体令人满意。
    OBJECTIVE: In total knee arthroplasty (TKA), achieving soft-tissue balance while retaining acceptable lower limb alignment is sometimes difficult and may lead to patient dissatisfaction. Theoretically, patient-specific implants can bring great benefits, while the lack of precise surgical tools may hinder the improvement of outcomes. The objective of this study was to illustrate surgical techniques and evaluate kinematics and early clinical outcomes of robotic-assisted TKA using patient-specific implants.
    METHODS: Based on preoperative CT scan, femoral and tibial components were 3D printed. Medial and lateral tibial liners were separate with different thicknesses, posterior slopes and conformity. TiRobot Recon Robot was used for surgery, and was armed with smart tools that quantify gap, force and femoral-tibial track. We collected data on demographics, intraoperative gap balance and femoral-tibial motion. In the follow-up, we evaluated the range of motion, Visual Analogue Scale (VAS), forgotten joint score (FJS), Knee injury and Osteoarthritis Outcome Score, Joint Replacement (KOOS, JR) score. Radiological data were also harvested.
    RESULTS: Fifteen patients (17 knees) were enrolled with a mean age of 64.6 ± 6.4 (53-76) years. In 5 knees, we used symmetric tibial liners, the rest were asymmetric. After surgery, the average alignment was 1.6 ± 2.0 (-3-5) degrees varus. The average follow-up lasted 6.7 ± 4.2 (1-14) months. The mean visual analogue scale was 0.8 ± 0.7 (0-2), FJS was 62.4 ± 25.3 (0-87), KOOS was 86.5 ± 9.4 (57-97). 11 patients were \"very satisfied\", 3 were \"satisfied\" with the result, and one patient was neutral due to restricted extension and unsatisfactory rehabilitation at five months\' follow-up.
    CONCLUSIONS: With patient-specific implants and robotics, TKA could be performed by a mathematical way, which was dubbed a \"differential\" TKA. Intraoperative kinematics was excellent in terms of gap-force balancing and femoral-tibial relative motion. Preliminary clinical outcomes were overall satisfactory.
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  • 文章类型: Journal Article
    手术是每个医生日常生活中常见的手术。现有的常规静脉查找器是昂贵的并且不容易获得。本文重点介绍了临时静脉探测器的使用。
    Venesection is common procedure performed in day to day life of every doctor. Conventional vein finders available are costly and not easily available. The present paper highlights the use of makeshift vein finder.
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  • 文章类型: Journal Article
    背景:大于胎龄胎儿的妊娠发生不良母婴结局的风险增加。在这种怀孕中如何管理分娩存在不确定性。目前的指导方针建议与女性讨论各种选择的利弊,包括期待管理,引产和剖腹产。为了让女性能够做出关于出生的明智决定,产前检测胎龄大是必不可少的。
    目的:探讨产前超声扫描预测出生时胎龄大的能力。
    方法:在这项回顾性队列研究中,我们分析了来自西米德兰兹郡的常规数据库的数据,联合王国。我们纳入了在妊娠35+0和38+0周之间进行了产前超声检查的孕妇,以及一个亚组,扫描的原因是胎儿被怀疑是大的。胎龄大被定义为>90个定制的增长百分位数,估计胎儿体重以及新生儿体重。我们还测试了非定制标准的性能,Hadlock胎儿体重>90分位数,新生儿体重>4kg。我们计算了整个人群以及具有不同母体体重指数的组的诊断特征。
    结果:研究队列包括26,527例孕妇,平均在妊娠256天进行扫描,20天后分娩,中位时间为276天(四分位距15)。总共2241(8.4%)的新生儿按定制百分位数计算胎龄较大,其中1459人(65.1%)的扫描估计胎儿体重>90百分位,假阳性率为8.6%,阳性预测值为41.0%。在912例(3.4%)怀孕的亚组中,对可疑的大胎儿进行了扫描,293(32.1%)婴儿出生时胎龄较大,给出50.3%的阳性预测值,敏感性为77.1%,假阳性率为36.0%。当比较从低(<18.5kg/m2)到高体重指数(>30kg/m2)的亚组时,灵敏度从55.6%增加到67.8%,假阳性率从5.2%到11.5%,阳性预测值从32.1%到42.3%。共有2585名(9.7%)婴儿为大体(出生体重>4kg),根据Hadlock的生长标准,这1058例(40.9%)产前胎龄大(>90分),假阳性率为4.9%,阳性预测值为41.0%。在低体重指数(<18.5;诊断比值比23.0vs6.4)和高体重指数(>30;诊断比值比16.2vs8.8)方面,亚组内的分析显示,与未定制的标准相比,定制的性能更好。
    结论:妊娠晚期超声评估胎儿体重的任何适应症都具有很好的识别和预测出生时胎龄大的能力。并使用定制标准进行改进。对疑似大胎儿进行超声检查时,检出率较好,然而,在更高的假阳性诊断的风险。我们的结果为妇女和临床医生提供了信息,以帮助有关怀疑胎龄较大的胎儿出生的产前决策。
    BACKGROUND: Pregnancies with large-for-gestational-age fetuses are at increased risk of adverse maternal and neonatal outcomes. There is uncertainty about how to manage birth in such pregnancies. Current guidelines recommend a discussion with women of the pros and cons of options, including expectant management, induction of labor, and cesarean delivery. For women to make an informed decision about birth, antenatal detection of large for gestational age is essential.
    OBJECTIVE: To investigate the ability of antenatal ultrasound scans to predict large for gestational age at birth.
    METHODS: In this retrospective cohort study, we analyzed data from a routinely collected database from the West Midlands, United Kingdom. We included pregnancies that had an antenatal ultrasound-estimated fetal weight between 35+0 and 38+0 weeks gestation for any indication and a subgroup where the reason for the scan was that the fetus was suspected to be big. Large for gestational age was defined as >90th customized GROW percentile for estimated fetal weight as well as neonatal weight. In addition, we tested the performance of an uncustomized standard, with Hadlock fetal weight >90th percentile and neonatal weight >4 kg. We calculated diagnostic characteristics for the whole population and groups with different maternal body mass indexes.
    RESULTS: The study cohort consisted of 26,527 pregnancies, which, on average, had a scan at 36+4 weeks gestation and delivered 20 days later at a median of 39+3 weeks (interquartile range 15). In total, 2241 (8.4%) of neonates were large for gestational age by customized percentiles, of which 1459 (65.1%) had a scan estimated fetal weight >90th percentile, with a false positive rate of 8.6% and a positive predictive value of 41.0%. In the subgroup of 912 (3.4%) pregnancies scanned for a suspected large fetus, 293 (32.1%) babies were large for gestational age at birth, giving a positive predictive value of 50.3%, with a sensitivity of 77.1% and false positive rate of 36.0%. When comparing subgroups from low (<18.5 kg/m2) to high body mass index (>30 kg/m2), sensitivity increased from 55.6% to 67.8%, false positive rate from 5.2% to 11.5%, and positive predictive value from 32.1% to 42.3%. A total of 2585 (9.7%) babies were macrosomic (birthweight >4 kg), and of these, 1058 (40.9%) were large for gestational age (>90th percentile) antenatally by Hadlock\'s growth standard, with a false positive rate of 4.9% and a positive predictive value 41.0%. Analysis within subgroups showed better performance by customized than uncustomized standards for low body mass index (<18.5; diagnostic odds ratio, 23.0 vs 6.4) and high body mass index (>30; diagnostic odds ratio, 16.2 vs 8.8).
    CONCLUSIONS: Late third-trimester ultrasound estimation of fetal weight for any indication has a good ability to identify and predict large for gestational age at birth and improves with the use of a customized standard. The detection rate is better when an ultrasound is performed for a suspected large fetus but at the risk of a higher false positive diagnosis. Our results provide information for women and clinicians to aid antenatal decision-making about the birth of a fetus suspected of being large for gestational age.
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  • 文章类型: Journal Article
    吸入皮质类固醇(ICS)是控制哮喘和预防持续性哮喘患者恶化的主要治疗方法。使用了许多类型的ICS药物,单独或与其他控制药物组合。尽管ICSs的广泛使用,在许多哮喘患者中,哮喘控制仍不理想.次优控制导致反复发作,导致频繁的急诊室就诊和住院,是由于多种因素。一个这样的因素是对于患者不适当的ICS选择。虽然存在许多针对其他因素的干预措施,不太关注不适当的ICS选择。哮喘是一种异质性疾病,具有可变的潜在炎症和生物标志物。由于ICS代谢酶的遗传变异,多达50%的哮喘患者对某些ICS表现出一定程度的抵抗或不敏感。导致对ICS的不同反应。然而,ICS选择,尤其是在初级保健环境中,通常不适合患者的特征。相反,ICS的选择在很大程度上取决于试错,通常由保险报销决定,组织规定政策,或成本,导致许多患者无法实现最佳控制的一刀切的方法。迫切需要一种决策支持工具,该工具可以在护理点预测有效的ICS,并指导提供者选择最有可能和快速缓解患者症状并改善哮喘控制的ICS。迄今为止,没有这样的工具存在。预测哪个患者对哪个ICS反应良好是开发这种工具的第一步。然而,没有研究预测ICS反应,形成一个缺口。虽然哮喘的生物学异质性很大,几个,如果有的话,生物标志物和基因型可用于系统分析所有哮喘患者并预测ICS反应。因为对所有患者进行基因分型或基因分型是不可行的,在临床护理期间收集的现成的电子健康记录数据提供了低成本,可靠,以及更全面的方式来描述所有患者。在本文中,我们指出需要开发决策支持工具来指导ICS的选择,以及在满足需求方面的差距。然后,我们概述了一种通过创建机器学习模型并应用因果推断来根据患者的特征预测患者明年的ICS反应来缩小这一差距的方法。该模型使用电子健康记录数据来表征所有患者,并提取可能反映内生型或基因型的模式。本文为未来的研究提供了路线图,最终目标是将哮喘护理从一刀切转变为个性化护理,改善结果,节省医疗资源。
    Inhaled corticosteroid (ICS) is a mainstay treatment for controlling asthma and preventing exacerbations in patients with persistent asthma. Many types of ICS drugs are used, either alone or in combination with other controller medications. Despite the widespread use of ICSs, asthma control remains suboptimal in many people with asthma. Suboptimal control leads to recurrent exacerbations, causes frequent ER visits and inpatient stays, and is due to multiple factors. One such factor is the inappropriate ICS choice for the patient. While many interventions targeting other factors exist, less attention is given to inappropriate ICS choice. Asthma is a heterogeneous disease with variable underlying inflammations and biomarkers. Up to 50% of people with asthma exhibit some degree of resistance or insensitivity to certain ICSs due to genetic variations in ICS metabolizing enzymes, leading to variable responses to ICSs. Yet, ICS choice, especially in the primary care setting, is often not tailored to the patient\'s characteristics. Instead, ICS choice is largely by trial and error and often dictated by insurance reimbursement, organizational prescribing policies, or cost, leading to a one-size-fits-all approach with many patients not achieving optimal control. There is a pressing need for a decision support tool that can predict an effective ICS at the point of care and guide providers to select the ICS that will most likely and quickly ease patient symptoms and improve asthma control. To date, no such tool exists. Predicting which patient will respond well to which ICS is the first step toward developing such a tool. However, no study has predicted ICS response, forming a gap. While the biologic heterogeneity of asthma is vast, few, if any, biomarkers and genotypes can be used to systematically profile all patients with asthma and predict ICS response. As endotyping or genotyping all patients is infeasible, readily available electronic health record data collected during clinical care offer a low-cost, reliable, and more holistic way to profile all patients. In this paper, we point out the need for developing a decision support tool to guide ICS selection and the gap in fulfilling the need. Then we outline an approach to close this gap via creating a machine learning model and applying causal inference to predict a patient\'s ICS response in the next year based on the patient\'s characteristics. The model uses electronic health record data to characterize all patients and extract patterns that could mirror endotype or genotype. This paper supplies a roadmap for future research, with the eventual goal of shifting asthma care from one-size-fits-all to personalized care, improve outcomes, and save health care resources.
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  • 文章类型: Journal Article
    越来越多的临床医生和研究人员正在探索大型语言模型聊天机器人的用途,比如ChatGPT,为了研究,传播,和教育目的。因此,考虑这个工具的全部潜力变得越来越重要,包括当前通过应用程序编程接口可用的特殊功能。这些特征之一是称为温度的变量,这改变了模型生成输出中涉及随机性的程度。临床医生和研究人员对此特别感兴趣。通过降低这个变量,一个人可以产生更一致的输出;通过增加它,一个人可以收到更多的创造性回应。对于正在为各种任务探索这些工具的临床医生和研究人员来说,将产出调整为缺乏创造性的能力可能对需要一致性的工作有益。此外,获得更具创造性的文本生成可能使科学作者能够用更通用的语言描述他们的研究,并有可能通过社交媒体与更广泛的公众联系。在这个观点中,我们呈现温度特征,讨论潜在用途,并提供一些例子。
    More clinicians and researchers are exploring uses for large language model chatbots, such as ChatGPT, for research, dissemination, and educational purposes. Therefore, it becomes increasingly relevant to consider the full potential of this tool, including the special features that are currently available through the application programming interface. One of these features is a variable called temperature, which changes the degree to which randomness is involved in the model\'s generated output. This is of particular interest to clinicians and researchers. By lowering this variable, one can generate more consistent outputs; by increasing it, one can receive more creative responses. For clinicians and researchers who are exploring these tools for a variety of tasks, the ability to tailor outputs to be less creative may be beneficial for work that demands consistency. Additionally, access to more creative text generation may enable scientific authors to describe their research in more general language and potentially connect with a broader public through social media. In this viewpoint, we present the temperature feature, discuss potential uses, and provide some examples.
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  • 文章类型: Journal Article
    六氟化硫(SF6)气体被广泛用作电气设备的断路器和隔离开关中的绝缘和灭弧介质。它有效地将电路与大气隔离,并迅速熄灭电弧。因此,SF6气体泄漏问题对相关应用领域构成重大威胁,SF6气体泄漏的检测变得极其重要。红外成像检测具有非接触式、高精度,和可视化。然而,大多数现有的红外检测系统只配备一个过滤器来检测SF6气体。捕获的图像包含背景噪声和系统噪声,使这些系统容易受到这些噪音的干扰。为了解决这些问题,我们提出了一种基于定制双目成像(CBI)系统的SF6气体泄漏监测方法。CBI系统有两个过滤器,大大降低了系统噪声和背景噪声的干扰。第一滤波器具有SF6气体的吸收共振峰。第二个滤波器用于记录背景噪声和系统噪声。需要注意的一个方面是,为了避免其他气体的干扰,该第二滤光器的中心波长应远离那些气体的吸收共振峰。因此,我们定制的滤光片的中心波长被确定为10,630nm和8370nm,分别。然后,两个相同类型的相机分别组装了一个定制的过滤器,完成了CBI原型。最后,我们使用CBI系统捕获的两幅红外图像使用差分方法,监测SF6气体泄漏。结果表明,我们开发的系统在检测SF6气体方面达到了99.8%以上的高精度。此外,CBI系统支持即插即用定制,以检测不同场景的各种气体。
    Sulfur hexafluoride (SF6) gas is extensively utilized as an insulating and arc-quenching medium in the circuit breakers and isolating switches of electrical equipment. It effectively isolates the circuits from the atmosphere and promptly extinguishes arcs. Therefore, the issue of SF6 gas leakage poses a significant threat to the related application fields, and the detection of SF6 gas leakage becomes extremely important. Infrared imaging detection offers advantages including non-contact, high precision, and visualization. However, most existing infrared detection systems are equipped with only one filter to detect SF6 gas. The images captured contain background noise and system noise, making these systems vulnerable to interference from such noises. To address these issues, we propose a method for monitoring SF6 gas leakage based on a customized binocular imaging (CBI) system. The CBI system has two filters, greatly reducing the interference of system noise and background noise. The first filter features the absorption resonant peak of SF6 gas. The second filter is used to record background noise and system noise. One aspect to note is that, in order to avoid the interference of other gases, the central wavelength of this second filter should keep away from the absorption resonant peaks of those gases. Accordingly, the central wavelengths of our customized filters were determined as 10,630 nm and 8370 nm, respectively. Then, two cameras of the same type were separately assembled with a customized filter, and the CBI prototype was accomplished. Finally, we utilized the difference method using two infrared images captured by the CBI system, to monitor the SF6 gas leakage. The results demonstrate that our developed system achieves a high accuracy of over 99.8% in detecting SF6 gas. Furthermore, the CBI system supports a plug-and-play customization to detect various gases for different scenarios.
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  • 文章类型: Case Reports
    一名30岁男性因左侧股骨远端开放性骨折伴9厘米节段性骨缺损和左侧胫骨近端闭合性骨折入院。他使用混合(钛笼和骨移植)Masquelet诱导膜技术(MIMT)成功治疗。他的股骨骨折术后3个月愈合。最初用两个锁定钢板治疗左胫骨。感染后,采用外固定和常规MIMT治疗3厘米的胫骨骨间隙。胫骨骨折术后12个月合并。
    在这种具有挑战性的情况下,混合MIMT成功治愈。
    UNASSIGNED: A 30-year-old male was admitted in our hospital having an open left distal femoral fracture with 9-cm segmental bone defect and a closed proximal left tibial fracture. He was treated successfully using a Hybrid (Titanium Cage and Bone Graft) Masquelet Induction Membrane Technique (MIMT). His femoral fracture united 3-months post - operatively. The left tibia was treated initially with two locking plates. Following infection, a 3-cm tibial bone gap was treated with external fixation and conventional MIMT. The tibial fracture united 12-months post- operatively.
    UNASSIGNED: The Hybrid MIMT achieved a successful healing outcome in this challenging case.
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  • 文章类型: Journal Article
    背景:最近的研究已经能够显示定制的某些好处,单独制造(CIM)与现成(OTS)全膝关节置换术(TKAs)相比,但仍缺乏有关这些植入系统的益处的证据.本研究旨在通过比较CIM和OTS植入物来发现评分和功能结局的差异,在单外科医生设置中使用患者报告的结果测量(PROM)和日常生活活动的功能测试。
    方法:共48例患者(16CIMvs.连续纳入32个OTS)并进行盲目检查。功能测试使用四个定时功能测试(TUG,WALK,TUDS,和BBS)和疼痛的VAS。然后基于三个功能测试的平均时间的相加计算聚集运动功能(ALF)评分。
    结果:TheCIM组在所有功能测试中显示出显着更快的时间和显着更好的ALF评分。两组在最大疼痛感觉的评估上有显著差异,在CIM组中具有优势。PROM分析显示,CIM组中项目目标和功能(KSS)的优秀和良好评分比例更高。
    结论:研究表明,使用aCIM假体可以明显更快地完成有时间限制的日常生活活动(ADL),并且该组中有更高的百分比报告在某些负荷期间没有疼痛。PROM分数的部分方面在该组中也更好;然而,对于本研究中收集的大多数PROM评分,这种优势无法显示.
    BACKGROUND: Recent studies have been able to show certain benefits of Customized, Individually Made (CIM) compared to Off-the-Shelf (OTS) total knee arthroplasties (TKAs), but evidence is still lacking regarding the benefits of these implant systems. This study aimed to find differences in scores and functional outcome by comparing CIM and OTS implants, using Patient-Reported Outcome Measures (PROMs) and functional tests for activities of daily living in a single-surgeon setup.
    METHODS: A total of 48 patients (16 CIM vs. 32 OTS) were consecutively enrolled and blindly examined. Functional testing was performed using four timed functional tests (TUG, WALK, TUDS, and BBS) and the VAS for pain. The Aggregated Locomotor Function (ALF) score was then calculated based on the addition of the average times of the three functional tests.
    RESULTS: The CIM group showed significantly faster times in all functional tests and significantly better ALF scores. There were remarkable differences in the assessment of maximum pain sensation between the two groups, with superiority in the CIM group. The PROMs analysis revealed a higher proportion of excellent and good ratings for the items objective and function (KSS) in the CIM group.
    CONCLUSIONS: The study showed that time-limited activities of daily living (ADLs) can be completed significantly faster with a CIM prosthesis and that a significantly higher percentage in this group reports freedom from pain during certain loads. Partial aspects of the PROM scores are also better in this group; however, this superiority could not be shown with regard to most PROM scores collected in this study.
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  • 文章类型: Clinical Trial Protocol
    背景:圆锥角膜是一种角膜的退行性疾病,导致角膜突出和变薄,视力丧失。阻止进展的唯一治疗方法是角膜交联(CXL),它使用核黄素和UV-A光来硬化角膜。最近的超微结构检查表明,该疾病是区域性的,不会影响整个角膜。仅用CXL处理受影响的区域可能与标准CXL一样好,治疗整个角膜。
    方法:我们建立了一项比较标准CXL(sCXL)和定制CXL(cCXL)的多中心非劣效性随机对照临床试验。包括16至45岁的进行性圆锥角膜患者。进展基于12个月内以下一种或多种变化:1屈光度(D)角膜曲率测量增加(Kmax,K1,K2);或角膜厚度减少10%;或近视或屈光散光增加1D,需要角膜交联。
    结论:本研究的目的是评估cCXL在角膜扁平化和圆锥角膜进展停止方面的有效性是否不劣于sCXL。仅处理受影响的区域可能有利于最小化损伤周围组织的风险和更快的伤口愈合。最近的非随机研究表明,基于患者角膜断层扫描的定制交联方案可能会阻止圆锥角膜的进展,并导致角膜变平。
    背景:这项研究于8月31日在ClinicalTrials.gov进行了前瞻性注册,2020年,该研究的标识符为NCT04532788。
    BACKGROUND: Keratoconus is a degenerative disorder of the cornea leading to a protrusion and thinning with loss of visual acuity. The only treatment to halt the progression is corneal crosslinking (CXL), which uses riboflavin and UV-A light to stiffen the cornea. Recent ultra-structural examinations show that the disease is regional and does not affect the entire cornea. Treating only the affected zone with CXL could be as good as the standard CXL, that treats the entire cornea.
    METHODS: We set up a multicentre non-inferiority randomized controlled clinical trial comparing standard CXL (sCXL) and customized CXL (cCXL). Patients between 16 and 45 years old with progressive keratoconus were included. Progression is based on one or more of the following changes within 12 months: 1 dioptre (D) increase in keratometry (Kmax, K1, K2); or 10% decrease of corneal thickness; or 1 D increase in myopia or refractive astigmatism, requiring corneal crosslinking.
    CONCLUSIONS: The goal of this study is to evaluate whether the effectiveness of cCXL is non-inferior to sCXL in terms of flattening of the cornea and halting keratoconus progression. Treating only the affected zone could be beneficial for minimalizing the risk of damaging surrounding tissues and faster wound healing. Recent non-randomized studies suggest that a customized crosslinking protocol based on the tomography of the patient\'s cornea may stop the progression of keratoconus and result in flattening of the cornea.
    BACKGROUND: This study was prospectively registered at ClinicalTrials.gov on August 31st, 2020, the identifier of the study is NCT04532788.
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