DME

DME
  • 文章类型: Journal Article
    背景:这项研究的目的是评估糖尿病性黄斑水肿(DME)和视网膜静脉阻塞(RVO)引起的黄斑水肿患者的近距和远距视力(VA)及其与美国国家眼科研究所视觉功能问卷(NEIVFQ-25)结果的相关性。
    方法:在这项前瞻性研究中,我们纳入了诊断为DME(n=61)和RVO(n=26)的患者的87只眼,他接受了阿柏西普治疗,并一直随访到第8次注射。1号检查了VA附近,2nd,3rd,第四,6th,第8次注射,患者在1日完成了NEIVFQ-25,第四,和第8次阿柏西普注射液。
    结果:所有眼睛基线时VA附近的平均值为0.89±0.12logMAR。每一届政府,有统计学上的显着改善;在第4次(0.70±0.19;p=0.000)和第8次应用(0.60±0.19;p=0.000)。在基线,平均NEIVFQ-25总分为71±14%,在第8次注射时提高到81±13%(p=0.000)。最显著的得分增加记录在近VA分量表中(+20±14%,p=0.000)。DME和RVO组在问卷或近VA结果上没有统计学上的显著差异。
    结论:阿柏西普治疗在第8次应用后通过4行logMAR视模显著改善了近视力。近视力问卷分量表,最初得分最低,在治疗期间表现出最大的增益。这强调了DME和RVO患者近视力和阅读能力的重要性。
    BACKGROUND: The aim of this study is to evaluate near and distance visual acuity (VA) and their correlation with the National Eye Institute Visual Function Questionnaire (NEI VFQ-25) outcomes in patients with diabetic macular edema (DME) and macular edema due to retinal vein occlusion (RVO) treated with aflibercept.
    METHODS: In this prospective study, we included 87 eyes of patients diagnosed with DME (n = 61) and RVO (n = 26), who received aflibercept treatment and were followed until the 8th injection. Near VA was examined on the 1st, 2nd, 3rd, 4th, 6th, and 8th injection, and patients completed the NEI VFQ-25 on the 1st, 4th, and 8th aflibercept injection.
    RESULTS: The mean near VA at baseline in all eyes was 0.89 ± 0.12 logMAR. With every administration, there was a statistically significant improvement; on the 4th (0.70 ± 0.19; p = 0.000) and the 8th application (0.60 ± 0.19; p = 0.000). At baseline, the mean NEI VFQ-25 total score was 71 ± 14%, and improved to 81 ± 13% (p = 0.000) on the 8th injection. The most significant score gain was recorded in the near VA subscale (+ 20 ± 14%, p = 0.000). There was no statistically significant difference between DME and RVO group in the questionnaire or near VA outcomes.
    CONCLUSIONS: Aflibercept treatment resulted in a remarkable improvement of near vision by 4 lines of logMAR optotype after the 8th application. The near vision questionnaire subscale, initially scoring the lowest, exhibited the greatest gain during the treatment period. This underscores the importance of near vision and reading ability for patients with DME and RVO.
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  • 文章类型: Journal Article
    目的:客观评估玻璃体内治疗黄斑水肿的即时反应,并比较不同药物之间的反应。
    方法:本回顾性研究,对比研究纳入了糖尿病性视网膜病变(DME)或静脉阻塞引起的黄斑水肿患者,这些患者接受了玻璃体腔注射类固醇(曲安奈德或地塞米松缓释植入物)或抗血管内皮生长因子抗体(VEGF)治疗.注射后1天测量中央视网膜厚度(CRT)和最佳矫正视力(BCVA),并与立即注射前的值进行比较。
    结果:79只眼(57例),其中51只眼患有DME,18伴有视网膜分支静脉阻塞水肿(BRVO-ME),10只眼视网膜中央静脉阻塞水肿(CRVO-ME)。玻璃体内药物是曲安奈德(TA)(n=15),地塞米松缓释植入物(DEX)(n=22),雷珠单抗(n=19),和贝伐单抗(n=23)。在所有注射组中观察到CRT的统计学显著改善(p<0.05),而平均BCVA的改善仅在TA组中显著(p=0.009)。与抗VEGF相比,类固醇的CRT平均变化最大;即。159.47µinTA,115.45µinDEX,雷珠单抗中的86.10µ,贝伐单抗组78.78µ。海绵状黄斑水肿的变化最小(18.73µ),而平均BCVA的改善仅在囊样组中具有统计学意义(p=0.01)。
    结论:相比之下,类固醇药物对治疗的即时反应优于抗VEGF药物.注射曲安奈德后,中央视网膜厚度最大程度地减少。膀胱样水肿比海绵状视网膜增厚表现出更好的即时反应。
    OBJECTIVE: To objectively assess the immediate response to intravitreal treatment for macular edema and compare it across different agents.
    METHODS: This retrospective, comparative study included patients with macular edema due to diabetic retinopathy (DME) or vein occlusion who were treated with intravitreal injections of either steroids (triamcinolone acetonide or dexamethasone sustained release implant) or anti-vascular endothelial growth factor antibodies (VEGF). The central retinal thickness (CRT) and the best corrected visual acuity (BCVA) were measured 1 day after the injection and compared with immediate pre-injection values.
    RESULTS: There were 79 eyes (57 patients) including 51 eyes with DME, 18 with branch retinal vein occlusion edema (BRVO-ME), and 10 eyes with central retinal vein occlusion edema (CRVO-ME). The intravitreal agents were triamcinolone acetonide (TA)(n = 15), dexamethasone sustained release implant (DEX)(n = 22), ranibizumab (n = 19), and bevacizumab (n = 23). Statistically significant improvement in CRT was seen in all injection groups (p < 0.05) while improvement in mean BCVA was significant only in the TA group (p = 0.009). The mean change in CRT was maximum with steroids than with anti-VEGFs; viz. 159.47 µ in TA, 115.45 µ in DEX, 86.10 µ in ranibizumab, and 78.78 µ in bevacizumab group. Least amount of change was noted in the spongy type of macular edema (18.73 µ) while improvement in mean BCVA was statistically significant only in the cystoid group (p = 0.01).
    CONCLUSIONS: Comparatively, steroid agents showed better immediate response to therapy than anti-VEGFs. Maximum reduction in central retinal thickness was seen following triamcinolone acetonide injection. Cystoid edema showed better immediate response than spongy retinal thickening.
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  • 文章类型: Journal Article
    光学相干断层扫描(OCT)被广泛认为是评估眼视网膜疾病的主要方法。在诊断视网膜病变中发挥关键作用,同时保持非侵入性模式。OCT图像体积的增加强调了自动化图像分析的日益重要。年龄相关性糖尿病性黄斑变性(AMD)和糖尿病性黄斑水肿(DME)是视觉障碍的最常见原因。早期发现和及时干预糖尿病相关疾病对于预防光学并发症和降低失明风险至关重要。本研究介绍了一种基于卷积神经网络(CNN)模型的新型计算机辅助诊断(CAD)系统,旨在将OCT视网膜图像识别和分类为AMD,DME,和普通班。利用CNN的效率,包括特征学习和分类,各种CNN,包括预先训练的VGG16,VGG19,Inception_V3,一个自定义的从头开始模型,BCNN(VGG16)2,BCNN(VGG19)2,和BCNN(Inception_V3)2,是为AMD的分类而开发的,DME,和正常OCT图像。所提出的方法已经在两个数据集上进行了评估,包括DUKE公共数据集和突尼斯私人数据集。Inception_V3模型和从所提出的自定义CNN中提取的特征的组合在DUKE数据集中实现了99.53%的最高精度值。在DUKE公共和突尼斯数据集上获得的结果表明,所提出的方法是有效和自动视网膜OCT图像分类的重要工具。
    Optical Coherence Tomography (OCT) is widely recognized as the leading modality for assessing ocular retinal diseases, playing a crucial role in diagnosing retinopathy while maintaining a non-invasive modality. The increasing volume of OCT images underscores the growing importance of automating image analysis. Age-related diabetic Macular Degeneration (AMD) and Diabetic Macular Edema (DME) are the most common cause of visual impairment. Early detection and timely intervention for diabetes-related conditions are essential for preventing optical complications and reducing the risk of blindness. This study introduces a novel Computer-Aided Diagnosis (CAD) system based on a Convolutional Neural Network (CNN) model, aiming to identify and classify OCT retinal images into AMD, DME, and Normal classes. Leveraging CNN efficiency, including feature learning and classification, various CNN, including pre-trained VGG16, VGG19, Inception_V3, a custom from scratch model, BCNN (VGG16) 2 , BCNN (VGG19) 2 , and BCNN (Inception_V3) 2 , are developed for the classification of AMD, DME, and Normal OCT images. The proposed approach has been evaluated on two datasets, including a DUKE public dataset and a Tunisian private dataset. The combination of the Inception_V3 model and the extracted feature from the proposed custom CNN achieved the highest accuracy value of 99.53% in the DUKE dataset. The obtained results on DUKE public and Tunisian datasets demonstrate the proposed approach as a significant tool for efficient and automatic retinal OCT image classification.
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  • 文章类型: Journal Article
    背景:成像技术的最新进展,特别是结构光学相干断层扫描(OCT),改善了对糖尿病性黄斑水肿(DME)病理生理学的理解,并为疾病进展和视觉结果提供了有价值的生物标志物。这项前瞻性研究旨在研究通过OCT成像识别的特定视网膜生物标志物与先前治疗过的持续性DME与已解决DME且视力良好的患者的阅读性能指标之间的关联。
    方法:纳入35例有DME病史患者的49只眼。使用Radner阅读图表评估阅读性能,其中包括具有几何尺寸的标准化句子。内外视网膜的结构改变,以及视网膜色素上皮(RPE),根据OCT图像进行分级。
    结果:阅读性能,以最大读取速度测量,与特定的视网膜生物标志物相关。旁凹区域椭圆体区(EZ)的破坏和旁凹视网膜内层(DRIL)的混乱与阅读速度降低有关。这些关联与视网膜内或视网膜下液的存在无关。
    结论:了解视网膜生物标志物与阅读能力之间的关系有助于全面评估DME患者的视功能和生活质量,导致更好的管理策略和治疗结果。
    BACKGROUND: Recent advancements in imaging technologies, particularly structural optical coherence tomography (OCT), have improved the understanding of diabetic macular edema (DME) pathophysiology and provided valuable biomarkers for disease progression and visual outcomes. This prospective study aimed to investigate the association between specific retinal biomarkers identified through OCT imaging and reading performance metrics in patients with previously treated persistent versus resolved DME and good visual acuity.
    METHODS: Forty-nine eyes from 35 patients with a history of DME were enrolled. Reading performance was assessed using the Radner reading charts, which include standardized sentences with geometrically progressing print sizes. Structural alterations in the inner and outer retina, as well as the retinal pigment epithelium (RPE), were graded based on OCT images.
    RESULTS: Reading performance, measured as maximum reading speed, was associated with specific retinal biomarkers. The disruption of the ellipsoid zone (EZ) in the parafoveal region and the presence of disorganization of the inner retinal layers (DRIL) in the parafovea were correlated with reduced reading speed. These associations were independent of the presence of intraretinal or subretinal fluid.
    CONCLUSIONS: Understanding the relationship between retinal biomarkers and reading performance could contribute to a comprehensive evaluation of visual function and quality of life in patients with DME, leading to better management strategies and treatment outcomes.
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  • 文章类型: Journal Article
    背景:先前的研究表明,玻璃体内贝伐单抗和脉络膜上腔注射曲安奈德联合治疗DME具有良好的疗效。然而,需要进一步的研究。
    目的:评估玻璃体内注射齐夫-阿柏西普和脉络膜上注射曲安奈德联合使用定制针头治疗初治和新发型糖尿病性黄斑水肿(DME)患者的疗效和安全性,每8周治疗24周。
    方法:通过谱域光学相干断层扫描测量中央黄斑厚度,最佳矫正视力通过Snellen图在基线和注射后4,8,12,16和24周测量。此外,白内障进展,眼内压(IOP),并对眼部安全性进行了分析。
    结果:6例患者的10只眼接受了脉络膜上腔注射曲安奈德联合玻璃体内注射Ziv-aflibercept治疗。视力从基线时的0.69log最小分辨率角度(MAR)提高到治疗后的0.39logMAR。中心黄斑厚度从基线的462.3±166μm显著降低至注射后24周的362.7±77.6μm。
    结论:使用定制的针头和玻璃体内药物Ziv-阿柏西普的脉络膜上注射曲安奈德治疗从头/初始中央型DME具有良好的结果和足够的安全性结果。此外,这项研究表明,调整以前的治疗组合,将抗VEGF治疗的间隔时间从4周延长至8周,这可以防止进一步的开支,特别是在低收入国家。然而,需要随访时间较长的大型多中心随机临床试验来评估这种治疗途径,特别是在低收入和资源丰富的国家。
    BACKGROUND: Previous studies have shown promising effects of combining intravitreal bevacizumab and suprachoroidal injection of triamcinolone acetonide in treating DME. However, further research is needed.
    OBJECTIVE: To assess the efficacy and safety of combining both intravitreal Ziv-aflibercept and suprachoroidal injection of triamcinolone acetonide using a custom-made needle in naïve and de novo central diabetic macular edema (DME) patients every eight weeks for 24 weeks.
    METHODS: Central macular thickness was measured via spectral domain-optical coherence tomography, and best-corrected visual acuity was measured via a Snellen chart at baseline and at 4, 8, 12, 16, and 24 weeks postinjection. Additionally, cataract progression, intraocular pressure (IOP), and ocular safety were analyzed.
    RESULTS: A total of 10 eyes of 6 patients were treated with suprachoroidal injections of triamcinolone acteonid combined with an intravitreal injection of Ziv-aflibercept. Vision improved from 0.69 log minimum angle of resolution (MAR) at baseline to 0.39 log MAR after treatment. Central macular thickness significantly decreased from 462.3 ± 166 μm at baseline to 362.7 ± 77.6 μm at 24 weeks postinjection.
    CONCLUSIONS: Suprachoroidal injection of triamcinolone using a custom-made needle with the intravitreal agent Ziv-aflibercept to treat de novo/naïve central DME has favorable outcomes and adequate safety results. Moreover, this study demonstrated the benefit of adapting the previous treatment combination for extending the interval between anti-VEGF treatments from 4 to 8 weeks, which could prevent further expenses, especially in low-income countries.However, large multicenter randomized clinical trials with longer follow-up periods are needed to assess this treatment route, especially in low-income and resourced countries.
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  • 文章类型: Journal Article
    糖尿病性黄斑水肿(DME)是与糖尿病相关的重要疾病,可导致视力丧失。最近,治疗的愿望有了显著的变化,转向抗血管内皮生长因子(抗VEGF)治疗和玻璃体内类固醇治疗,同时远离传统的激光治疗。这项全面的荟萃分析明确比较了两种治疗DME的疗效:抗VEGF治疗和皮质类固醇治疗。我们使用PubMed和GoogleScholar进行了全面搜索,以确定比较抗VEGF治疗和皮质类固醇植入物对DME影响的出版物。使用ReviewManager5.0(RevMan),我们纳入了九项研究的数据,共涉及877人。该小组分为两个派系:453名患者接受了皮质类固醇治疗,而466例患者接受了抗VEGF治疗。我们的研究表明,皮质类固醇和抗VEGF治疗均可积极改善最佳矫正视力(BCVA)并降低中央黄斑厚度(CMT)。然而,比较最小分辨角(logMAR)标度对数的平均BCVA显示,两种治疗之间无统计学显著变化.这表明相当不一致,加权平均差(WMD)为-0.13(-0.41,0.16),P值为0.39,I2值为99%。此外,与初始测量相比,两种治疗方法均提高了BCVA.然而,与抗VEGF治疗相比,皮质类固醇无统计学意义的获益,WMD为0.03(-0.07,0.13),P值为0.55,I2值为80%。对平均CMT的检查也得出了缺乏统计学意义的发现,显示显著的变异量(WMD-36.37,95%置信区间[-127.52,54.78],P=0.43,I2=98%)。值得注意的是,抗VEGF治疗组没有显著改变,尽管CMT从初始测量值开始升高.从我们的研究中得出的主要结论是,皮质类固醇在BCVA和CMT中表现出令人鼓舞的立即增强。然而,抗VEGF治疗似乎提供了更显著的长期优势.然而,重要的是要认识到皮质类固醇组更容易出现眼内压(IOP)升高和青光眼的可能性.
    Diabetic macular edema (DME) is a significant condition linked to diabetes that can result in visual loss. In recent times, there has been a notable change in the desire for treatment, with a shift toward anti-vascular endothelial growth factor (anti-VEGF) therapy and intravitreal steroids while moving away from conventional laser therapies. This comprehensive meta-analysis explicitly compares the efficacy of two therapies for DME: anti-VEGF therapy and corticosteroid. We conducted a thorough search using PubMed and Google Scholar to identify publications that compare the effects of anti-VEGF therapy and corticosteroid implants on DME. Using Review Manager 5.0 (RevMan), we incorporated data from nine research studies, which involved a total of 877 people. The group was split into two factions: 453 patients were administered corticosteroids, while 466 patients underwent treatment with anti-VEGF therapy. Our investigation demonstrated that both corticosteroid and anti-VEGF therapy positively improved the best-corrected visual acuity (BCVA) and reduced the central macular thickness (CMT). Nevertheless, comparing the mean BCVA on the logarithm of the minimum angle of resolution (logMAR) scale revealed no statistically significant changes between the two treatments. This indicates considerable inconsistency, as evidenced by the weighted mean difference (WMD) of -0.13 (-0.41, 0.16) with a P-value of 0.39 and an I2 value of 99%. In addition, both treatments improved BCVA compared to the initial measurement. However, there was no statistically significant benefit for corticosteroid over anti-VEGF therapy, as indicated by the WMD of 0.03 (-0.07, 0.13) with a P-value of 0.55 and an I2 value of 80%. The examination of the average CMT also yielded findings that lacked statistical significance, displaying a significant amount of variation (WMD -36.37, 95% confidence interval [-127.52, 54.78], P = 0.43, I2 = 98%). Remarkably, there were no significant alterations among the anti-VEGF therapy group despite a rise in CMT from the initial measurement. The main conclusion drawn from our research is that corticosteroid demonstrates encouraging immediate enhancements in BCVA and CMT. However, anti-VEGF therapy seems to provide more significant long-term advantages. Nevertheless, it is crucial to acknowledge that the corticosteroid group had a greater susceptibility to acquiring elevated intraocular pressure (IOP) and the possibility of glaucoma.
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  • 文章类型: Journal Article
    糖尿病性黄斑水肿(DME)是糖尿病性视网膜病变(DR)的常见威胁视力的并发症,也是工作年龄人群中严重视力障碍的主要原因。有几种治疗选择可用于DME的管理,包括玻璃体内皮质类固醇.它们传统上被用作二线治疗,由于眼内压升高和白内障相关不良事件的风险。然而,最近注意力集中在玻璃体内皮质类固醇的主要或早期使用,由于越来越多的证据表明炎症在DME的发病机制中起着至关重要的作用。此外,与抗血管内皮生长因子试剂(抗VEGF)相比,玻璃体内类固醇植入物提供更长的作用持续时间的额外优点。这篇综述旨在总结地塞米松(DEX)玻璃体内植入的有效性和安全性的现有证据。特别关注临床方案,在这些方案中,通过适当选择患者,可以考虑甚至首选作为一线治疗方案,同时考虑优势和可能的不良事件。有抗VEGF禁忌症的患者,DME与高炎性OCT生物标志物,行白内障手术的假性晶状体患者和有晶状体眼患者以及玻璃体切除的眼都可能受益于一线DEX植入。此外,DME对抗VEGF无反应者应考虑转换为DEX植入物,DEX植入物和抗VEGF的联合治疗可能是严重和持续性DME的有效选择。
    Diabetic macular edema (DME) is a common sight-threatening complication of diabetic retinopathy (DR) and the leading cause of severe visual impairment among the working-age population. Several therapeutic options are available for the management of DME, including intravitreal corticosteroids. They have been traditionally used as second-line treatment, due to the risk of intraocular pressure increase and cataract-related adverse events. However, attention has recently been focused on the primary or early use of intravitreal corticosteroids, due to growing evidence of the crucial role of inflammation in the pathogenesis of DME. Furthermore, intravitreal steroid implants offer the additional advantage of a longer duration of action compared to anti-vascular endothelial growth factor agents (anti-VEGF). This review aims to summarize the available evidence on the efficacy and safety profile of dexamethasone (DEX) intravitreal implant, with a specific focus on clinical scenarios in which it might be considered or even preferred as first-line treatment option by adequate selection of patients, considering both advantages and possible adverse events. Patients with contraindications to anti-VEGF, DME with high inflammatory OCT biomarkers, pseudophakic patients and phakic patients\' candidates to cataract surgery as well as vitrectomized eyes may all benefit from first-line DEX implant. Additionally, DME not responders to anti-VEGF should be considered for a switch to DEX implant and a combination therapy of DEX implant and anti-VEGF could be a valid option in severe and persistent DME.
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  • 文章类型: Journal Article
    This work is dedicated to the study of the effect of the synthesis conditions (drying and calcination) of sulfated zirconia on the final catalytic behavior of bifunctional composite catalysts prepared by the physical mixing of the sulfated zirconia (methanol dehydration catalyst) with Cu/ZnO/Al2O3 (CZA; methanol synthesis catalyst). The main objective was to optimize the CZA-ZrO2/SO42- composite catalyst for its use in the direct production of dimethyl ether (DME) from syngas. Sulfated zirconia aerogel (AZS) and xerogel (XZS) were prepared using the sol-gel method using different solvent evacuation conditions and calcination temperatures, while the Cu-ZnO(Al) catalyst was synthesized using the coprecipitation procedure. The effectivity of CZA-ZrO2/SO42- composite catalysts for the direct production of dimethyl ether (DME) from syngas was evaluated in a flow reactor at 250 °C and 30 bar total pressure. The characterization of the sulfated zirconia aerogels and xerogels using different techniques showed that the mesoporous aerogel (AZS0.5300) exhibited the best textural and acidic properties due to the gel drying under supercritical conditions and calcination at 300 °C. As a result, the composite catalyst CZA-AZS0.5300 exhibited seven times higher DME production than its xerogel-containing counterpart (364 vs. 52 μmolDME·min-1·gcat-1). This was attributed to its well-matched metal surface, mesoporous structure, optimal crystallite size and, most importantly, its higher acidity.
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  • 文章类型: Journal Article
    评估糖尿病性黄斑水肿(DME)患者接受康柏西普玻璃体腔注射(IVC)治疗的功能和解剖学影响,这些患者对之前的抗血管内皮生长因子(抗VEGF)注射反应不足。
    我们回顾性纳入了至少3次玻璃体内注射雷珠单抗(IVR)后患有持续性DME的眼睛。分析包括在转换后6个月内评估最佳矫正视力(BCVA)和中央黄斑厚度(CMT)。
    共包括30例患者(30只眼)。在IVC的1、2、3和6个月后,CMT从基线的437.8±40.67μm急剧下降至363.59±45.09,312.52±39.15,278.51±37.92和292.59±38.09,分别(p<0.001)。在1、2、3和6个月后,以对数MAR单位表示的BCVA从基线时的0.73±0.15显著提高到0.50±0.09、0.46±0.72、0.40±0.06和0.48±0.04,分别(p<0.001)。
    转换为Conbercept可有效改善DME患者的视觉和解剖结构,这些患者对先前的抗VEGF注射反应不满意。
    UNASSIGNED: To assess the functional and anatomical effects of transitioning to conbercept intravitreal injection (IVC) treatment in patients with diabetic macular edema (DME) who had inadequate responses to prior anti-vascular endothelial growth factor (anti-VEGF) injections.
    UNASSIGNED: We retrospectively included eyes with persistent DME after at least 3 injections of intravitreal ranibizumab (IVR). The analysis included the assessment of best corrected visual acuity (BCVA) and central macular thickness (CMT) during 6 months after the switch.
    UNASSIGNED: A total of 30 patients (30 eyes) were included. CMT dropped sharply from 437.8±40.67μm at baseline to 363.59±45.09,312.52 ± 39.15, 278.51 ± 37.92, and 292.59 ± 38.09 after 1, 2, 3 and 6 months of IVC, respectively (p <0.001). BCVA in log MAR units was significantly improved from 0.73±0.15 at baseline to 0.50±0.09,0.46±0.72, 0.40±0.06 and 0.48±0.04 after 1, 2, 3 and 6 months, respectively (p <0.001).
    UNASSIGNED: Switching to Conbercept effectively improved visual and anatomical structure in DME patients who had not responded satisfactorily to previous anti-VEGF injections.
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  • 文章类型: Journal Article
    糖尿病与包括糖尿病性黄斑水肿(DME)在内的眼部并发症有关。目前的疗法是侵入性的并且包括重复的玻璃体内注射和激光治疗。光生物调节(PBM)是一种利用选定波长的光来诱导细胞益处(包括减少炎症和水肿)的治疗(Tx)。这个单一中心,开放标签,事后分析探索了多波长PBM在DME受试者中的实用性。
    分析包括对使用已批准和上市的PBM医疗器械进行标准临床护理的患者的数据进行审查,Valeda®轻型运输系统。在临床上评估了具有良好视力的早期DME(最佳矫正视力(BCVA)>20/25,logMAR>0.1)的受试者,并使用一系列多波长PBM进行治疗(在3-4周内每周进行3次Tx治疗;总共9次Tx治疗)。临床,解剖学,除主观生活质量外,还评估了安全性参数.
    总共分析了30只眼(19名受试者)。受试者主要为男性(68.4%),平均年龄为56±14岁。减少中央视网膜厚度(CRT),部分患者接受PBM治疗后,观察到视网膜内液体(IRF)的消退和糖尿病视网膜病变严重程度量表评分的改善.基线BCVA在PBM后3个月的随访观察期内保持稳定。大约64%的患者报告了他们的眼部状况的主观改善和日常生活中的影响减少。详细的OCT评估证实在长达16个月的时间内没有与光毒性相关的安全性问题。
    接受Valeda多波长PBM治疗的早期DME受试者在临床和解剖学参数方面表现出改善。Valeda多波长PBM方法在独立OCT审查后显示出良好的安全性,没有光毒性迹象。PBM治疗可能提供另一种选择,早期DME患者的非侵入性治疗策略具有独特的机制和方式。
    UNASSIGNED: Diabetes is associated with ocular complications including diabetic macular edema (DME). Current therapies are invasive and include repeated intravitreal injections and laser therapy. Photobiomodulation (PBM) is a treatment (Tx) that utilizes selected wavelengths of light to induce cellular benefits including reduction of inflammation and edema. This single-center, open-label, post-hoc analysis explored the utility of multiwavelength PBM in subjects with DME.
    UNASSIGNED: Analysis included review of data from patients undergoing standard clinical care with an approved and marketed PBM medical device, the Valeda® Light Delivery System. Subjects with early-stage DME with good vision (Best-corrected visual acuity (BCVA) > 20/25, logMAR > 0.1) were evaluated in clinic and treated with one series of multiwavelength PBM (Tx delivered 3x/week over 3-4 weeks; total of 9 Tx sessions). Clinical, anatomical, and safety parameters were assessed in addition to subjective quality of life.
    UNASSIGNED: A total of 30 eyes (19 subjects) were analyzed. Subjects were predominately male (68.4%) with a mean age of 56 ± 14 years. Reductions in central retinal thickness (CRT), resolution of intraretinal fluid (IRF) and improvement in diabetic retinopathy severity scale scores were observed following PBM treatment in select patients. Baseline BCVA remained stable over the follow-up observation period of 3 months post-PBM. Approximately 64% of patients reported subjective improvements in their ocular condition and decreased influence in everyday life. Detailed OCT evaluations confirmed no safety issues related to phototoxicity up to 16 months.
    UNASSIGNED: Early-stage DME subjects treated with Valeda multiwavelength PBM showed improvements in clinical and anatomical parameters. The Valeda multiwavelength PBM approach demonstrates a favorable safety profile with no signs of phototoxicity following an independent OCT review. PBM therapy may offer an alternative, non-invasive treatment strategy with a unique mechanism and modality for patients with early-stage DME.
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