double-layer sign

  • 文章类型: Journal Article
    背景:晚期年龄相关性黄斑变性(AMD)是视力丧失的主要原因。因此,人们对可以预测或预防晚期AMD发病的前兆病变感兴趣.一个这样的病变是视网膜色素上皮(RPE)和布鲁赫膜(BM)的浅分离,用各种术语来描述,包括双层标志(DLS)。
    方法:在本文中,我们的目的是检查和澄清不同的术语,这些术语指的是RPE和BM的浅分离。我们还回顾了与DLS相关的结果的当前证据:首先,DLS是否可以预测渗出性新生血管性AMD;其次,DLS是否具有针对地理萎缩的潜在保护特性。
    结果:用于描述RPE和BM的浅分离的术语范围反映了DLS可以呈现不同的特征。虽然血管化DLS似乎可以防止萎缩,但可以进展为渗出,非血管化DLS与萎缩风险增加相关.光学相干断层扫描(OCT)血管造影(OCTA)是识别和区分各种形式的DLS的主要方法。如果OCTA不可用或实际上不可能,DLS的简化分类为厚或薄,使用OCT,使血管化的可能性接近。正在研究通过将深度学习算法应用于OCT扫描来自动化DLS检测。
    结论:术语DLS仍然适用于描述RPE和BM的浅分离。该特征的检测和分类提供关于进展为晚期AMD的风险的有价值的信息。然而,DLS的出现及其在预测AMD进展中的价值在不同患者之间可能存在差异.随着进一步的研究,可以确认个性化的风险,以告知适当的治疗。
    年龄相关性黄斑变性(AMD)是一种可能在老年人中发展的眼病,通常是60岁以上的人。在疾病早期,人们通常没有任何症状,但是随着疾病的发展,可能会出现视力丧失。AMD的高级形式被称为新生血管性AMD(也称为“湿性”AMD)和高级干性AMD(称为地理萎缩;GA)。重要的是在眼部扫描中识别特征和体征,以帮助预测AMD患者是否会发展为晚期疾病,因为这将帮助医生计划最合适的治疗方法。眼睛扫描上的一个这样的特征是双层符号(DLS)。在这篇文章中,我们总结了用于DLS的不同名称,并评估DLS是否会增加早期AMD患者发生湿性AMD或GA的可能性。我们得出的结论是,DLS看起来因人而异,这导致DLS被称为各种名称。患有早期AMD和含有DLS的血管的人可能更有可能发展为湿性AMD;而患有早期AMD和没有血管的DLS的人可能更有可能发展为GA。使用光学相干断层扫描血管造影成像对眼睛拍照是识别DLS和确认其是否包含血管的主要方法。
    BACKGROUND: Advanced age-related macular degeneration (AMD) is a major cause of vision loss. Therefore, there is interest in precursor lesions that may predict or prevent the onset of advanced AMD. One such lesion is a shallow separation of the retinal pigment epithelium (RPE) and Bruch\'s membrane (BM), which is described by various terms, including double-layer sign (DLS).
    METHODS: In this article, we aim to examine and clarify the different terms referring to shallow separation of the RPE and BM. We also review current evidence on the outcomes associated with DLS: firstly, whether DLS is predictive of exudative neovascular AMD; and secondly, whether DLS has potential protective properties against geographic atrophy.
    RESULTS: The range of terms used to describe a shallow separation of the RPE and BM reflects that DLS can present with different characteristics. While vascularised DLS appears to protect against atrophy but can progress to exudation, non-vascularised DLS is associated with an increased risk of atrophy. Optical coherence tomography (OCT) angiography (OCTA) is the principal method for identifying and differentiating various forms of DLS. If OCTA is unavailable or not practically possible, simplified classification of DLS as thick or thin, using OCT, enables the likelihood of vascularisation to be approximated. Research is ongoing to automate DLS detection by applying deep-learning algorithms to OCT scans.
    CONCLUSIONS: The term DLS remains applicable for describing shallow separation of the RPE and BM. Detection and classification of this feature provides valuable information regarding the risk of progression to advanced AMD. However, the appearance of DLS and its value in predicting AMD progression can vary between patients. With further research, individualised risks can be confirmed to inform appropriate treatment.
    Age-related macular degeneration (AMD) is an eye disease that may develop in older people, usually those aged over 60 years. Early in the disease, people often do not show any symptoms, but as the disease progresses, vision loss may occur. The advanced forms of AMD are called neovascular AMD (also called “wet” AMD) and advanced dry AMD (called geographic atrophy; GA). It is important to identify features and signs on eye scans that can help to predict if someone with AMD will develop an advanced form of the disease because this will help doctors plan the most appropriate treatment. One such feature on eye scans is the double-layer sign (DLS). In this article, we summarise the different names used for DLS, and assess if having a DLS increases the likelihood of someone with early AMD developing wet AMD or GA. We conclude that how DLS looks varies between people, which leads to DLS being called by various names. Someone with early AMD and a DLS containing blood vessels may be more likely to develop wet AMD; whereas someone with early AMD and a DLS without blood vessels may be more likely to develop GA. Taking photos of the eye using optical coherence tomography angiography imaging is the main method of identifying DLS and confirming whether it contains blood vessels.
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  • 文章类型: Case Reports
    本报告介绍了一名77岁的糖尿病男性患者,患有双侧中心性浆液性脉络膜视网膜病变(CSCR)的独特病例。他接受了多次双侧玻璃体内注射,以推测诊断为湿性年龄相关性黄斑变性(AMD)。眼底检查未显示任何AMD或糖尿病性视网膜病变(DR)的迹象。谱域光学相干断层扫描(OCT)显示双侧视网膜下液。在OCT血管造影上未发现新生血管膜。荧光素眼底血管造影(FFA)证实没有脉络膜新生血管形成(CNV)。值得注意的是,这代表了一例CSCR模仿隐匿性CNV的老年患者的独特病例.
    This report presents a unique case of a 77-year-old diabetic male patient with bilateral central serous chorioretinopathy (CSCR), who was receiving multiple bilateral intravitreal injections for a presumed diagnosis of wet age-related macular degeneration (AMD). The fundus examination did not show any signs of AMD or diabetic retinopathy (DR). The spectral domain optical coherence tomography (OCT) revealed bilateral subretinal fluid. The neovascular membrane was not visible on OCT angiography. Fundus fluorescein angiography (FFA) confirmed the absence of choroidal neovascularization (CNV). Notably, this represents a unique case of an elderly patient with CSCR mimicking occult CNV.
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  • 文章类型: Journal Article
    目的:本研究旨在探讨光学相干断层扫描(OCT)生物标志物作为慢性中心性浆液性脉络膜视网膜病变(CSCR)治疗反应的潜在预测因子。
    方法:这是一项回顾性队列研究,包括42例慢性CSCR患者。完成眼部和血液学检查后,所有患者均接受50mg/d口服依普利酮治疗3个月,随访至少6个月.所有参与者分为两组:第1组参与者对治疗反应积极(6个月时视网膜下液(SRF)完全缓解)和第2组反应不佳(SRF从基线降低中度或低于50%)。主要结果指标是SRF的分辨率,和各种OCT生物标志物,如中央黄斑厚度(CMT),色素上皮脱离(PED),双层标志,感光体外段的伸长,外部限制膜的完整性,椭球区的完整性,外段的超反射焦点,评估SRF中的视网膜下沉积。
    结果:平均年龄为41.33±10.75岁,34名参与者为男性。37名(88.1%)的参与者对依普利酮有良好的反应,在六个月时,SRF的平均高度从最大269.74µm显着降低到最小21.86µm(p<0.001)。平均CMT从第一次就诊时间点到第三次就诊时间降低(p<0.001)。Logistic回归分析评估了PED的缺失和与良好反应相关的双层体征。
    结论:依普利酮治疗慢性CSCR似乎有效,和OCT可以是一个宝贵的援助治疗医生。
    OBJECTIVE: This study aimed to investigate optical coherence tomography (OCT) biomarkers as potential predictors of treatment response in chronic central serous chorioretinopathy (CSCR).
    METHODS: It was a retrospective cohort study that included 42 patients with chronic CSCR. After complete ocular and hematological examinations, all patients received 50 mg/day of oral eplerenone for three months and were followed for at least six months. All participants were divided into two groups: Group 1 participants with a positive response to treatment (complete resolution of subretinal fluid (SRF) at six months) and Group 2 poor responders (moderate or less than 50% reduction in SRF from baseline). The primary outcome measure was the resolution of SRF, and various OCT biomarkers like central macular thickness (CMT), pigment epithelial detachments (PED), double-layer sign, elongation of the photoreceptor\'s outer segment, the integrity of the external limiting membrane, the integrity of the ellipsoid zone, hyperreflective foci in the outer segment, and subretinal deposits in the SRF were assessed.
    RESULTS: The mean age was 41.33 ± 10.75 years, and 34 participants were male. Thirty-seven (88.1%) of the participants had good responses to eplerenone, with the mean height of SRF decreasing significantly from a maximum of 269.74 µm to a minimum of 21.86 µm at six months (p<0.001). The mean CMT decreased from the first visit time point to the third visit time (p<0.001). Logistic regression analysis assessed the absence of PED and double-layer signs associated with a good response.
    CONCLUSIONS: The eplerenone therapy seems to be efficient for chronic CSCR, and OCT can be an invaluable aid to the treating physician.
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  • 文章类型: Journal Article
    背景与目的:早期诊断老年性黄斑变性(AMD)的渗出性,这直接关系到长期保持功能视力。本文的目的是检查双层符号(DLS)与非渗出性黄斑新生血管(MNV)的存在之间的相关性。材料和方法:我们的研究包括60例AMD患者,一只眼睛有渗出性,另一只眼睛没有渗出性。我们使用光学相干断层扫描(OCT)和光学相干断层扫描血管造影(OCT-A)仅分析了非渗出性形式。患者分为三组,根据疾病的持续时间(<2年,2到5年,>5年)。该疾病的发作被认为是在一只眼睛中建立渗出性AMD诊断的时刻。我们使用OCT定义了DLS的存在或不存在,使用OCT-A定义了非渗出性MNV的存在,在3×3毫米和6×6毫米的部分。DLS用作非渗出性MNV的预测生物标志物,目的是建立快速诊断并实现疾病的早期治疗。结果:我们发现,在3×3mm(p<0.001)和6×6mm(p<0.001)成像中,使用OCT诊断的DLS和使用OCT-A诊断的非渗出性MNV之间存在统计学上的显着相关性。在3×3和6×6mm成像中,I组和III组的DLS和MNV的频率之间存在统计学上的显着差异。在6×6mm成像上,DLS和MNV的频率也有统计学上的显着差异。但不是在3×3毫米成像上,第一组和第二组之间。在II组和III组之间的DLS和MNV的频率之间没有发现差异。结论:OCT上的DLS可用作预测生物标志物以评估非渗出性MNV的存在。
    Background and Objectives: Early diagnosis of the exudative form of age-related macular degeneration (AMD) is very important for a timely first treatment, which is directly related to the preservation of functional visual acuity over a long period. The goal of this paper was to examine the correlation between the double-layer sign (DLS) and the presence of non-exudative macular neovascularization (MNV). Materials and Methods: Our research included 60 patients with AMD, exudative in one eye and non-exudative in the other eye. We analyzed only the non-exudative form using optical coherence tomography (OCT) and optical coherence tomography angiography (OCT-A). The patients were classified into three groups, depending on the duration of the disease (<2 years, 2 to 5 years, >5 years). The onset of the disease was deemed the moment of establishing a diagnosis of exudative AMD in one eye. We defined the presence or absence of a DLS using OCT and the presence of non-exudative MNV using OCT-A, both on 3 × 3 mm and 6 × 6 mm sections. DLS was used as a projection biomarker for non-exudative MNV, with the aim of establishing a rapid diagnosis and achieving early treatment of the disease. Results: We found that there was a statistically significant correlation between the DLS diagnosed using OCT and non-exudative MNV diagnosed by OCT-A for both 3 × 3 mm (p < 0.001) and 6 × 6 mm (p < 0.001) imaging. There was a statistically significant difference between the frequencies of both DLS and MNV in Groups I and III on both 3 × 3 and 6 × 6 mm imaging. A statistically significant difference was also noted in the frequencies of DLS and MNV on 6 × 6 mm imaging, but not on 3 × 3 mm imaging, between Groups I and II. No differences were found between the frequencies of DLS and MNV between Groups II and III. Conclusions: The DLS on OCT can be used as a projection biomarker to assess the presence of a non-exudative MNV.
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  • 文章类型: Journal Article
    背景:隐性失血(HBL)越来越受到脊柱外科医生的关注。这项回顾性研究旨在评估在胸椎后纵韧带骨化症(T-OPLL)进行单节段后环状减压手术的患者围手术期HBL及其危险因素。
    方法:我们回顾性研究了2015年8月至2020年6月后环形减压手术后诊断为T-OPLL的112例患者。患者人口统计学,失血相关参数,提取手术相关数据和影像学参数.记录术后并发症。使用Pearson或Spearman相关性分析来研究患者人口统计学与HBL之间的相关性。采用多元线性回归分析确定与HBL相关的独立危险因素。
    结果:45名男性和67名女性参与了这项研究,平均年龄56.4±10.2岁。平均HBL为459.6±275.4ml,占总失血量的56.5%。多元线性回归分析表明,双层符号(P=0.000),骨化占有率(OOR)>60%(P=0.030),年龄(P=0.010),血细胞比容(Hct)损失(P=0.034),术后Hct(P=0.016)是HBL的独立危险因素。然而,OPLL形态(P=0.319),手术时间(P=0.587),血红蛋白(Hb)丢失(P=0.644),术后Hb(P=0.952)与HBL无显著差异。
    结论:围手术期T-OPLL后路环形减压术后发现高比例的HBL,这一点不容忽视。双层标志,OOR>60%,年龄,Hct丢失和术后Hct是HBL的独立危险因素。
    BACKGROUND: Hidden blood loss (HBL) is of increasing interest to spine surgeons. This retrospective study aimed to evaluate perioperative HBL and its risk factors in patients undergoing one-segment posterior circumferential decompression surgery on thoracic ossification of the posterior longitudinal ligament (T-OPLL).
    METHODS: We retrospectively studied 112 patients diagnosed with T-OPLL following posterior circumferential decompression surgery from August 2015 to June 2020. Patient demographics, blood loss-related parameters, surgery-related data and imaging parameters were extracted. Postoperative complications were also recorded. Pearson or Spearman correlation analysis was used to investigate the correlation between patient demographics and HBL. Multivariate linear regression analysis was performed to determine the independent risk factors associated with HBL.
    RESULTS: Forty-five men and 67 women were involved in this research, with an average age of 56.4 ± 10.2 years. The mean HBL was 459.6 ± 275.4 ml, accounting for 56.5% of the total blood loss. Multiple linear regression analysis showed that double-layer sign (P = 0.000), ossification occupancy ratio (OOR) > 60% (P = 0.030), age (P = 0.010), hematocrit (Hct) loss (P = 0.034), and postoperative Hct (P = 0.016) were independent risk factors for HBL. However, OPLL morphology (P = 0.319), operation time (P = 0.587), hemoglobin (Hb) loss (P = 0.644), and postoperative Hb (P = 0.952) were not significantly different from HBL.
    CONCLUSIONS: A high proportion of HBL was found after posterior circumferential decompression surgery on T-OPLL during the perioperative period, which should not be overlooked. Double-layer sign, OOR > 60%, age, Hct loss and postoperative Hct are independent risk factors for HBL.
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  • 文章类型: Journal Article
    目的:确定中间年龄相关性黄斑变性(iAMD)的多个光学相干断层扫描(OCT)生物标志物的频率及其与2年后完全视网膜色素上皮和外视网膜萎缩(cRORA)发展的关系。
    方法:回顾性队列研究。
    方法:这项回顾性分析包括330例连续iAMD患者的330只眼,其中至少一只眼具有24个月的随访数据。
    方法:光谱OCT体积扫描(超过6x6mm的49次B扫描,ART=6,中央凹中心)在基线时评估先前描述的iAMD生物标志物,包括高中央玻璃疣体积(DV;≥0.03mm3),视网膜内超反射焦点(IHRF),视网膜下椎间盘样沉积(SDD),低反射玻璃疣核(hDC),和薄或厚(多层)双层标志(DLS)。同样评估了眼睛的AMD状态,并将其分类为正常或早期AMD。iAMD,渗出性黄斑新生血管(MNV),或crora。
    方法:cRORA的发病率,人口统计学和OCT特征的赔率比(OR)。
    结果:在第24个月,16.36%(54/330)的iAMD眼出现cRORA。几个基线特征,包括高中央DV,IHRF,SDD,hDC,薄DLS,和同侧眼的cRORA与2年时发生cRORA的风险显著增加相关.赔率比,95%置信区间,p值,这些生物标志物的基线频率为:DV(6.510,2.467-17.176,p<0.001,49.1%),IHRF(12.763,4.763-34.202,p<0.001,38.8%),SDD(2.307,1.003-5.304,p=0.049,34.2%),hDC(3.012,1.152-7.873,p=0.024,13.0%),薄DLS(4.517,1.555-13.126,p=0.006,11.8%),和cRORA在同伴眼中(7.184,1.938-26.623,p=0.003,8.2%)。
    结论:除了先前报道的四个因素外,iAMD的显着比例(DV,IHRF,hDC,SDD),薄的DLS,和同侧眼cRORA与2年后进展为cRORA的风险增加相关.这些生物标志物可能有助于预测,风险分层,并选择患者进行临床试验。
    To determine the frequency of multiple OCT biomarkers of intermediate age-related macular degeneration (iAMD) and their relationship with the development of complete retinal pigment epithelium and outer retinal atrophy (cRORA) after 2 years.
    Retrospective cohort study.
    This retrospective analysis included 330 eyes of 330 consecutive patients with iAMD in ≥ 1 eye who had 24 months of follow-up data.
    Spectralis OCT volume scans (49 B-scans over 6 × 6 mm, automatic real time = 6, fovea-centered) at baseline were evaluated for the previously described iAMD biomarkers, including a high-central drusen volume (DV; ≥ 0.03 mm3), intraretinal hyper-reflective foci (IHRF), subretinal drusenoid deposits (SDDs), hypo-reflective drusen cores (hDCs), and a thin or thick (multilayered) double-layer sign (DLS). The age-related macular degeneration (AMD) status in the fellow eye was also assessed and classified as normal or early AMD, iAMD, exudative macular neovascularization, or cRORA.
    Incidence of cRORA, odds ratio for demographics, and OCT features.
    At month 24, 16.36% (54/330) of the iAMD eyes developed cRORA. Several baseline features, including high-central DV, IHRF, SDD, hDC, thin DLS, and cRORA in the fellow eye, were associated with a significantly greater risk for development of cRORA at 2 years. The odds ratio, 95% confidence interval, P value, and baseline frequencies of these biomarkers were DV (6.510, 2.467-17.176, P < 0.001, 49.1%), IHRF (12.763, 4.763-34.202, P < 0.001, 38.8%), SDD (2.307, 1.003-5.304, P = 0.049, 34.2%), hDC (3.012, 1.152-7.873, P = 0.024, 13.0%), thin DLS (4.517, 1.555-13.126, P = 0.006, 11.8%), and cRORA in the fellow eye (7.184, 1.938-26.623, P = 0.003, 8.2%).
    In addition to the 4 previously reported factors that are present in a significant proportion of iAMD (DV, IHRF, hDC, and SDD), a thin DLS and cRORA in the fellow eye were associated with an increased risk of progression to cRORA over 2 years. These biomarkers may aid in prognostication, risk stratification, and selection of patients for clinical trials.
    Proprietary or commercial disclosure may be found after the references.
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  • 文章类型: Journal Article
    背景:颈动脉斑块易损性是评估后续缺血性卒中风险的重要特征之一。尽管磁共振成像(MRI)是评估斑块易损性的金标准,一些患者由于身体或经济问题无法接受MRI检查。计算机断层扫描(CT)更容易获得。这项研究的目的是在CT上建立一个新的钙化类别,并评估其对检测易损斑块的有用性。
    方法:我们回顾性评估了在我们研究所进行颈动脉血运重建前使用CT和MRI进行斑块成像的连续患者。根据新的钙分类将钙化分为4种类型。将患者分为2组,双层符号(DLS)-阳性组和DLS-阴性组。在MRI上测量颈动脉斑块的信号强度比(SIR)以评估斑块的易损性,并比较钙化类型和SIR。
    结果:在评估的132名患者中,DLS阳性组50例(62.5%),DLS阴性组16例(30.8%)出现钙化伴易损斑块(SIR>1.47)(P<0.01)。观察到观察者对钙化类型的实质认同(卡帕,0.79;P<0.01)。多因素分析显示,DLS(比值比3.03;95%置信区间1.35~6.8;P<0.01)和男性(比值比3.15;95%置信区间1.02~9.68;P=0.04)是易损斑块的独立预测因子。
    结论:DLS在CT钙化的新分类中可靠地检测到易损斑块,因此可用于无法接受MRI的患者。
    Carotid plaque vulnerability is one of the important features for evaluating the risk of subsequent ischemic stroke. Although magnetic resonance imaging (MRI) is the gold standard modality for evaluating plaque vulnerability, some patients cannot undergo MRI because of physical or economic issues. Computed tomography (CT) is more readily available. The purpose of this study was to establish a new category of calcification on CT and to assess its usefulness for detecting vulnerable plaque.
    We retrospectively evaluated consecutive patients who underwent plaque imaging using CT and MRI before carotid revascularization at our institute. Calcifications were classified into 4 types according to the new calcium classification. The patients were divided into 2 groups, the double layer sign (DLS)-positive group and the DLS-negative group. Signal intensity ratio (SIR) of carotid plaque was measured on MRI for evaluating plaque vulnerability and compared between type of calcification and SIR.
    Among the 132 patients evaluated, 50 patients (62.5%) in DLS positive group and 16 patients (30.8%) in DLS negative group had calcification with vulnerable plaque (SIR > 1.47) (P < 0.01). Substantial interobserver agreement of type of calcification was observed (kappa, 0.79; P < 0.01). Multivariate analysis showed that DLS (odds ratio 3.03; 95% confidence interval 1.35-6.8; P < 0.01) and male sex (odds ratio 3.15; 95% confidence interval 1.02-9.68; P = 0.04) were independent predictors of vulnerable plaque.
    DLS in our new classification of calcification on CT reliably detects vulnerable plaque and could thus be used in patients who cannot undergo MRI.
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  • 文章类型: Journal Article
    目的:探讨半剂量维维芬光动力治疗(vPDT)后,未治疗的中央性浆液性脉络膜视网膜病变(CSC)患者的谱域光学相干断层扫描(SD-OCT)与视网膜下液(SRF)吸收不完全相关的预后因素。
    方法:这项回顾性研究包括接受半剂量vPDT且随访时间超过3个月的CSC患者。采用Logistic回归分析治疗后3个月与SRF持续相关的危险因素。
    结果:本研究共纳入143例150眼患者(男性102例,女性41例)。所有病例3个月时SRF完全消退率为82.7%。症状持续时间>6个月(比值比[OR]=3.135,95%置信区间[95%CI](1.147-8.573),p=0.026),基础直径>3mm的SRF面积较大(比值比(OR)=4.051,95%CI:1.336-12.284,p=0.013),和较大的平坦不规则色素上皮脱离(FI-PED)面积,基底直径>1mm(OR=3.311,95%CI:1.249-8.780,p=0.016)在OCTB扫描中是半剂量vPDT后SRF吸收不完全的危险因素,而外核层(ONL)厚度与解剖结果无显著相关(OR=1.015,95%CI:0.995-1.036,p=0.145)。
    结论:症状的持续时间,基线SRF,SD-OCT上的FI-PED基径和FI-PED基径是半剂量vPDT后3个月解剖学结局的重要预测因子。需要进一步的研究来为对半剂量vPDT反应较差的患者建立更好的治疗策略。
    OBJECTIVE: To investigate the prognostic factors on spectral domain optical coherence tomography (SD-OCT) associated with incomplete subretinal fluid (SRF) absorption in treated-naïve eyes with central serous chorioretinopathy (CSC) after the half-dose verteporfin photodynamic therapy (vPDT).
    METHODS: Patients with CSC who underwent half-dose vPDT with a follow-up period of more than 3 months were included in this retrospective study. Logistic regression was performed to determine the risk factors associated with the SRF persistence at 3 months after the treatment.
    RESULTS: A total of 143 patients with 150 eyes were enrolled in this study (102 male and 41 female patients). The rate of complete SRF resolution was 82.7% at 3 months for all cases. The duration of symptoms > 6 months (odds ratio [OR] = 3.135, 95% confidence interval [95% CI] (1.147-8.573), p = 0.026), larger SRF area with base diameter > 3 mm (odds ratio (OR) = 4.051, 95% CI: 1.336-12.284, p = 0.013), and larger flat irregular pigment epithelium detachment (FI-PED) area with base diameter > 1 mm (OR = 3.311, 95% CI: 1.249-8.780, p = 0.016) on OCT B-scans were risk factors for incomplete SRF absorption after half-dose vPDT, while outer nuclear layer (ONL) thickness was not significantly associated with the anatomical outcome (OR = 1.015, 95% CI: 0.995-1.036, p = 0.145).
    CONCLUSIONS: The duration of symptoms, baseline SRF, and FI-PED base diameter on SD-OCT were important predictors for the anatomical outcome at 3 months after half-dose vPDT. Further studies are needed to establish a better therapeutic strategy for patients with poor response to half-dose vPDT.
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  • 文章类型: Editorial
    暂无摘要。
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  • 文章类型: Clinical Trial, Phase II
    To evaluate clinical characteristics of eyes in which investigator-determined new-onset exudative age-related macular degeneration (eAMD) developed during the FILLY trial.
    Post hoc analysis of the phase 2 study of intravitreal pegcetacoplan in geographic atrophy (GA).
    Patients with GA secondary to age-related macular degeneration (AMD), n = 246.
    Either 15 mg intravitreal pegcetacoplan or sham given monthly or every other month for 12 months followed by a 6-month off-treatment period.
    Time of new eAMD onset in the study eye, history of eAMD in the fellow eye, presence of double-layer sign (DLS) on structural OCT in the study eye, changes in retinal anatomic features by structural OCT and fluorescein angiography (FA), and changes in visual acuity.
    Exudation was reported in 26 study eyes across treatment groups over 18 months. Mean time to eAMD diagnosis was 256 days (range, 31-555 days). Overall, a higher proportion of patients with a baseline history of eAMD in the fellow eye (P = 0.016) and a DLS in the study eye (P = 0.0001) demonstrated eAMD. Among study eyes in which eAMD developed, 18 of 26 (69%) had history of fellow-eye eAMD and 19 of 26 (73.1%) had DLS at baseline, compared with 76 of 217 study eyes (35%; P = 0.0007) and 70 of 215 study eyes (32.5%; P < 0.0001), respectively, in which eAMD did not develop. All 21 patients with structural OCT imaging at the time of eAMD diagnosis demonstrated subretinal fluid, intraretinal cysts, or both consistent with exudation. Among 17 patients who underwent FA at eAMD diagnosis, 10 showed detectable macular neovascularization (MNV), all occult lesions. Development of eAMD did not have an appreciable impact on visual acuity, and all patients responded to anti-vascular endothelial growth factor (VEGF) therapy.
    Intravitreal pegcetacoplan slowed the rate of GA growth and was associated with an unexpected dose-dependent increased incidence of eAMD with no temporal clustering of onset. Exudative AMD seemed to be associated with baseline eAMD in the contralateral eye and a DLS, suggestive of nonexudative MNV, in the study eye. The safety profile of pegcetacoplan was acceptable to proceed to phase 3 studies without adjustments to enrollment criteria.
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