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The Discrepancy Between Visual Acuity Decline and Foveal Involvement in Geographic Atrophy. 地理萎缩患者视力下降与眼窝受累之间的差异
IF 4.4 Q1 OPHTHALMOLOGY Pub Date : 2024-08-08 DOI: 10.1016/j.oret.2024.07.025
Maria Vittoria Cicinelli, Eugenio Barlocci, Federico Rissotto, Alessandro Russo, Chiara Giuffrè, Ugo Introini, Francesco Bandello

Purpose: To investigate the discrepancy between visual acuity (VA) decline and foveal involvement in geographic atrophy (GA) secondary to nonexudative age-related macular degeneration (AMD), and to explore how early retinal changes impact the progression of visual impairment.

Design: Retrospective, longitudinal cohort study.

Subjects: This study evaluated 80 eyes from 60 patients (mean age, 74.2 ± 10 years) with progressing non-neovascular AMD.

Methods: Blue-light fundus autofluorescence (FAF) and spectral-domain OCT (SD-OCT) were utilized to monitor GA progression and the onset of foveal involvement. The study analyzed VA changes over an average follow-up of 60 ± 26.4 months, encompassing 785 observations. Mixed-effects models with natural splines assessed the effects of demographic and ocular characteristics on baseline VA and its rate of decline. Survival analyses compared the timing of anatomic changes with the most rapid functional declines, indicated by the highest first derivative of VA trajectories. Discrepancies between visual and anatomic changes were explored using generalized linear mixed-effects models.

Main outcome measures: Monthly VA changes, onset and impact of foveal involvement, and factors influencing baseline VA and rate of decline.

Results: Visual acuity declined consistently by an average of 0.010 logarithm of the minimum angle of resolution (LogMAR) per month (standard error [SE], 0.0003; P < 0.001). The onset of foveal involvement significantly exacerbated this decline, adding an average loss of 0.15 LogMAR (SE, 0.02; P < 0.001). Stabilization of VA typically occurred around 41 months post-foveal involvement. Significant factors associated with worse baseline VA were older age, female gender, unifocal GA morphology, and drusen-associated forms of GA (P < 0.05). The most rapid declines in VA typically occurred about 9 months (interquartile range, 0-27 months) before detectable subfoveal changes. The reticular FAF pattern (27/46 [59%] vs. 2/13 [15%], P = 0.02) and smaller baseline GA lesions (P = 0.01) were associated with faster deterioration preceding visible foveal damage.

Conclusions: This study demonstrates that significant VA loss in GA can precede detectable foveal involvement, suggesting a window for early interventions to slow the progression of visual impairment. Identifying specific GA characteristics and FAF patterns as predictors of rapid VA decline supports the need for personalized treatment strategies to optimize outcomes for patients with nonexudative AMD.

Financial disclosure(s): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

目的:研究继发于非渗出性老年性黄斑变性(AMD)的地理萎缩(GA)中视力(VA)下降与眼窝受累之间的差异,并探讨早期视网膜变化如何影响视力损伤的进展:设计:回顾性纵向队列研究:本研究使用蓝光眼底自发荧光(FAF)和光谱域光学相干断层扫描(SD-OCT)对 60 名进展期非新生血管性黄斑变性患者(平均年龄为 74.2±10 岁)的 80 只眼睛进行了评估。该研究监测了眼窝受累的起始时间,并分析了平均随访 60±26.4 个月的视力变化,共观察了 785 次。采用自然样条的混合效应模型评估了人口统计学和眼部特征对基线视力及其下降率的影响。生存分析比较了解剖变化的时间与功能下降最快的时间,功能下降最快的时间是视力下降轨迹的最高一阶导数。使用广义线性混合效应模型探讨了视觉和解剖变化之间的差异:结果:视力持续下降,平均每月下降 0.010 LogMAR(SE:0.0003,p):这项研究表明,GA 患者视力的显著下降可能发生在可检测到的眼窝受累之前,这为早期干预以减缓视力损伤的进展提供了机会。将特定的GA特征和FAF模式确定为视力快速下降的预测因素,支持了对个性化治疗策略的需求,以优化非渗出性AMD患者的预后。
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引用次数: 0
Efficacy and Safety of Anti-VEGF Injections and Surgery for Age-Related Macular Degeneration-Related Submacular Hemorrhage: A Systematic Review and Meta-Analysis. 抗血管内皮生长因子注射和手术治疗 AMD 相关黄斑下出血的有效性和安全性:系统回顾与元分析》。
IF 4.4 Q1 OPHTHALMOLOGY Pub Date : 2024-08-03 DOI: 10.1016/j.oret.2024.07.024
Abdulla Shaheen, Divy Mehra, Seyyedehfatemeh Ghalibafan, Shivam Patel, Fatima Buali, Sugi Panneerselvam, Nathalie Perez, Sandra Hoyek, Harry W Flynn, Nimesh Patel, Nicolas A Yannuzzi

Topic: This systematic review and meta-analysis investigates the efficacy and safety of anti-VEGF injections compared with surgical intervention in improving visual acuity (VA) and reducing complications for patients with submacular hemorrhage (SMH) due to neovascular age-related macular degeneration (AMD).

Clinical relevance: Determining the optimal intervention for SMH in AMD is crucial for patient care.

Methods: We included studies on anti-VEGF injections or surgical interventions for SMH in AMD from 7 databases, searched up to May 2024. Data extraction and quality assessment were done by 2 independent reviewers. Certainty of evidence was assessed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach. Meta-analysis employed random-effects models. Primary outcomes were pooled mean logarithm of the minimum angle of resolution VA difference (initial examination minus last follow-up VA) and adverse events rates.

Results: A total of 43 observational studies were included: 21 (960 eyes) on anti-VEGF and 22 (455 eyes) on surgery. Comparisons were made across separate studies due to lack of head-to-head studies. Meta-analysis included 11 anti-VEGF studies (444 eyes) and 12 surgical studies (195 eyes) for VA outcomes. The mean difference in VA was -0.16 (95% confidence interval (CI), -0.24 to -0.08) for anti-VEGF and -0.36 (95% CI, -0.68 to -0.04) for surgery, with no significant difference between groups (chi-square = 1.70, df = 1, P = 0.19). Heterogeneity was high in surgical studies (I2 = 96.2%, τ2 = 0.23, P < 0.01) and negligible in anti-VEGF studies (I2 = 7%, τ2 = 0.003, P = 0.38). The GRADE certainty was moderate for anti-VEGF and low for surgery. Anti-VEGF had lower rates of cataract (0% vs. 4.6%), proliferative vitreoretinopathy (0.1% vs. 2.0%), and retinal detachment (0.1% vs. 10.6%), but similar rates of recurrent hemorrhage (5.4% vs. 5.3%). Complications were summarized descriptively due to zero-cell problem.

Conclusion: Both anti-VEGF and surgery treat SMH in AMD with similar VA outcomes but different safety profiles. Anti-VEGF is preferred for less severe hemorrhage, whereas surgery is suited for extensive hemorrhage. Despite uncertain comparative VA outcomes, treatment should be guided by clinical judgment and patient factors.

Financial disclosure(s): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

主题本系统综述和荟萃分析研究了抗血管内皮生长因子(anti-VEGF)注射与手术干预相比,在改善新生血管性老年黄斑变性(AMD)引起的黄斑下出血(SMH)患者视力(VA)和减少并发症方面的有效性和安全性:临床相关性:确定治疗老年性黄斑变性黄斑下出血的最佳干预方法对患者护理至关重要:我们从 7 个数据库中纳入了有关抗血管内皮生长因子注射或手术干预 AMD SMH 的研究,检索时间截至 2024 年 5 月。数据提取和质量评估由两名独立审稿人完成。对证据的确定性采用 GRADE 方法进行评估。元分析采用随机效应模型。主要结果为汇总的平均对数MAR VA差值(初始检查减去最后一次随访VA)和不良事件发生率:共纳入 43 项观察性研究:结果:共纳入 43 项观察性研究:21 项研究(960 只眼)涉及抗 VEGF,22 项研究(455 只眼)涉及手术。由于缺乏 "头对头 "研究,因此对不同研究进行了比较。Meta 分析纳入了 11 项抗血管内皮生长因子研究(444 只眼)和 12 项手术研究(195 只眼)的 VA 结果。抗血管内皮生长因子的 VA 平均差异(MD)为-0.16(95%CI:-0.26,-0.07),手术为-0.36(95%CI:-0.68,-0.04),组间差异不显著(X2=1.70,df=1,p=0.19)。手术研究的异质性较高(I2=96.2%,tau2=0.23,p2=7%,tau2=0.003,p=0.38)。抗血管内皮生长因子的 GRADE 确定性为中度,手术的 GRADE 确定性为低度。抗 VEGF 的白内障(0% vs 4.6%)、增殖性玻璃体视网膜病变(PVR,0.1% vs 2.0%)和视网膜脱离(RD,0.1% vs 10.6%)发生率较低,但复发性出血发生率相似(5.4% vs 5.3%)。结论:抗血管内皮生长因子和手术都能治疗视网膜病变:抗血管内皮生长因子和手术治疗 AMD SMH 的 VA 结果相似,但安全性不同。抗血管内皮生长因子疗法适用于不太严重的出血,而手术则适用于大面积出血。尽管视网膜损伤的比较结果不确定,但治疗应根据临床判断和患者因素而定。
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引用次数: 0
Ultrawidefield OCT Angiography of Incontinentia Pigmenti with Macular Hole 伴有黄斑孔的 Pigmenti 失禁症的超宽视场 OCT 血管造影。
IF 4.4 Q1 OPHTHALMOLOGY Pub Date : 2024-08-01 DOI: 10.1016/j.oret.2024.01.003
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引用次数: 0
Microperimetry and Structural Risk Factors on OCT in Intermediate Age-Related Macular Degeneration 中度年龄相关性黄斑变性的微观视力和光学相干断层扫描结构风险因素。
IF 4.4 Q1 OPHTHALMOLOGY Pub Date : 2024-08-01 DOI: 10.1016/j.oret.2024.02.016

Purpose

To determine the relationship between structural biomarkers on OCT that increase the risk of disease progression and microperimetric retinal sensitivity in patients with intermediate age-related macular degeneration (iAMD).

Design

Prospective cross-sectional, observational study.

Participants

Forty-five eyes of 23 patients with iAMD.

Methods

Patients underwent OCT and microperimetry. OCT scans were evaluated for the risk factors intraretinal hyperreflective foci (HRF), hyporeflectivity within drusenoid lesions (HRDL), subretinal drusenoid deposits, double-layer sign (DLS), and drusen volume. Microperimetric retinal sensitivity was analyzed with a 33-point grid covering the macula. With a novel method of determining what part of the retina corresponded to each microperimetry point, a Voronoi diagram was constructed, dividing the macula in cells consisting of the region nearer to each point than any other. The Voronoi diagram was superimposed on the OCT, making it possible to determine the point-to-point location of the OCT risk factors. Univariable and multivariable linear mixed-effect models were used for analysis.

Main Outcome Measures

Association between microperimetric retinal sensitivity and OCT risk factors at individual measuring points.

Results

One thousand four hundred seventy-nine points of retinal sensitivity and corresponding structural area on OCT were included in this study. Retinal sensitivity was significantly decreased with presence of the OCT risk factors HRF, HRDL, DLS, and drusen volume (all P < 0.001) when analyzed with the univariable linear mixed-effect model. The multivariable model showed a significant decrease of retinal sensitivity with presence of HRF (P < 0.001), DLS (P = 0.025), and greater drusen volume (P < 0.001).

Conclusions

Presence of HRF, DLS, and greater drusen volume, all of which increase the risk of disease progression, is significantly and independently associated with decreased microperimetric retinal sensitivity in patients with iAMD.

Financial Disclosure(s)

Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

目的:确定增加中度年龄相关性黄斑变性(iAMD)患者疾病进展风险的光学相干断层扫描(OCT)结构生物标志物与显微透视视网膜灵敏度之间的关系 设计:前瞻性横断面观察研究 参与者:23 名 iAMD 患者:23 名 iAMD 患者的 45 只眼睛 方法:患者接受 OCT 和微观视力测定。根据视网膜内高反射灶(HRF)、类髓鞘病变内低反射(HRDL)、视网膜下类髓鞘沉积(SDD)、双层征(DLS)和髓鞘体积等风险因素对 OCT 扫描进行评估。用覆盖黄斑的 33 点网格分析了微透视视网膜灵敏度。用一种新方法确定视网膜的哪个部分与每个微透视点相对应,构建了一个沃罗诺伊图,将黄斑划分为由比其他任何点都更接近每个点的区域组成的单元。将 Voronoi 图叠加到 OCT 上,就能确定 OCT 风险因素的点对点位置。采用单变量和多变量线性混合效应模型进行分析:单个测量点的微透视视网膜灵敏度与 OCT 风险因素之间的关联 结果:本研究纳入了 1479 个视网膜灵敏度点和相应的 OCT 结构区。采用单变量线性混合效应模型进行分析时,视网膜灵敏度随 OCT 风险因素 HRF、HRDL、DLS 和色素沉着量的存在而明显下降(所有 P <0.001)。多变量模型显示,存在 HRF(P < 0.001)、DLS(P = 0.025)和更大的色素沉着量(P < 0.001)时,视网膜灵敏度会显著降低。
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引用次数: 0
Removal of the Metallic Intraocular Foreign Body via Posterior Capsule Defect 通过后囊缺损取出金属眼内异物。
IF 4.4 Q1 OPHTHALMOLOGY Pub Date : 2024-08-01 DOI: 10.1016/j.oret.2024.01.005
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引用次数: 0
Clinical Characteristics and Surgical Outcomes of Patients Undergoing Pars Plana Vitrectomy for Proliferative Diabetic Retinopathy 接受玻璃体旁切除术治疗增殖性糖尿病视网膜病变患者的临床特征和手术疗效
IF 4.4 Q1 OPHTHALMOLOGY Pub Date : 2024-08-01 DOI: 10.1016/j.oret.2024.02.015

Objective

To evaluate clinical characteristics impacting surgical outcomes of patients undergoing pars plana vitrectomy (PPV) for complications of proliferative diabetic retinopathy (PDR).

Design

Retrospective consecutive observational case series of patients at a large county hospital in Dallas, Texas, from 2014 to 2019.

Subjects

Seven hundred thirty-two patients (933 eyes) undergoing PPV for PDR complications.

Methods

Collected data included demographics, surgical indication, adjuvant therapies, intraoperative course, complications, and best corrected visual acuity (BCVA). Patients with < 6 months of follow-up were excluded. Best corrected visual acuity was converted to logarithm of the minimum angle of resolution for analysis. Statistics performed included t test, analysis of variance, and multivariate analyses.

Main Outcome Measures

Postoperative BCVA, primary anatomic success rate, and postoperative complications.

Results

Three hundred ninety-three patients were male (509 eyes; 54.5%) with an average age of 52 years. Postoperative BCVA at 6 months was significantly different among surgical indications: 0.79 versus 0.77 versus 1.20 (P < 0.0001) for vitreous hemorrhage (VH), vitreomacular interface abnormalities, and tractional retinal detachment (TRD), respectively. Adjuvant preoperative therapy with panretinal photocoagulation (PRP) versus no PRP (0.95 vs. 1.25; P < 0.001) and insulin versus no insulin (0.99 vs. 1.17; P < 0.01) were associated with improved vision. Iatrogenic breaks were associated with decreased postoperative vision (1.40 vs. 0.88; P < 0.001). The primary anatomic success rate for TRD was 85% (495 eyes). Combined TRD/RRD (tractional and rhegmatogenous retinal detachment) was associated with a lower success rate compared with macula-on/macula-off TRD, with odds ratios of 0.36, 0.46, and 0.53, respectively. Patients experiencing recurrent detachment postsurgery had worse preoperative visual acuity (VA) (1.93 vs. 1.63; P < 0.01) and were younger (47.6 vs. 50.0; P = 0.02). Postoperative complications occurred in 699 eyes (75%), with VH (498 eyes, 53%), cataract (465, 50%), and elevated intraocular pressure (149, 16%) being the most common. Two hundred thirty-six eyes (25%) required a second PPV operation. Endophthalmitis (1 eye; <1%) and choroidal detachment (5 eyes; <1%) were rare.

Conclusions

In this retrospective series analyzing surgical outcomes among patients with complications from PDR, vitrectomy led to improved vision on average, with a meaningful proportion of patients receiving additional surgical intervention. Surgical indication, presentin

目的:评估影响手术效果的临床特征:评估影响因增殖性糖尿病视网膜病变(PDR)并发症而接受玻璃体旁切除术(PPV)患者手术效果的临床特征:2014-2019年德克萨斯州达拉斯市一家大型县级医院患者的回顾性连续观察病例系列:方法:收集的数据包括人口统计学、手术指征、辅助治疗、术中过程、并发症和最佳矫正视力(BCVA)。随访时间不足 6 个月的患者排除在外。BCVA转换为logMAR进行分析。进行的统计包括t检验、方差分析(ANOVA)和多变量分析:主要结果测量指标:术后BCVA、主要解剖成功率和术后并发症:393名患者为男性(509眼,54.5%),平均年龄52岁。不同手术适应症患者术后 6 个月的 BCVA 有显著差异:0.79 vs. 0.77 vs. 1.20(p结论:在这组分析 PDR 并发症患者手术效果的回顾性系列研究中,玻璃体切除术平均改善了患者的视力,有相当一部分患者接受了额外的手术干预。手术指征、当前视力、年龄和辅助疗法似乎都会影响手术效果。
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引用次数: 0
Propensity-Matched Analysis of the Risk of Age-Related Macular Degeneration with Systemic Immune-Mediated Inflammatory Disease 全身免疫介导的炎症性疾病导致老年性黄斑变性风险的倾向匹配分析。
IF 4.4 Q1 OPHTHALMOLOGY Pub Date : 2024-08-01 DOI: 10.1016/j.oret.2024.01.026

Purpose

The pathogenesis of age-related macular degeneration (AMD) involves aberrant complement activation and is a leading cause of vision loss worldwide. Complement aberrations are also implicated in many systemic immune-mediated inflammatory diseases (IMIDs), but the relationship between AMD and these conditions remains undescribed. The aim of this study is to first assess the association between AMD and IMIDs, and then assess the risk of AMD in patients with specific IMIDs associated with AMD.

Design

Cross-sectional study and cohort study.

Subjects and Controls

Patients with AMD were compared with control patients with cataracts and no AMD to ensure evaluation by an ophthalmologist. Patients with IMIDs were compared with patients without IMIDs but with cataracts.

Methods

This study used deidentified data from a national database (2006–2023), using International Classification of Diseases 10 codes to select for IMIDs. Propensity score matching was based on patients on age, sex, race, ethnicity, and smoking. Odds ratios were generated for IMIDs and compared between AMD and control patients. For IMIDs associated with AMD, the risk of AMD in patients with the IMID versus patients without IMIDs was determined utilizing a cohort study design.

Main Outcome Measures

Odds ratio of IMID, risk ratios (RRs), and 95% confidence intervals (CIs) of AMD diagnosis, given an IMID.

Results

After propensity score matching, AMD and control cohorts (n = 217 197 each) had a mean ± standard deviation age of 74.7 ± 10.4 years, were 56% female, and 9% of patients smoked. Age-related macular degeneration showed associations with systemic lupus erythematosus (SLE), Crohn’s disease, ulcerative colitis, rheumatoid arthritis (RA), psoriasis, sarcoidosis, scleroderma, giant cell arteritis, and vasculitis. Cohorts for each positively associated IMID were created and matched to control cohorts with no IMID history. Patients with RA (RR, 1.40; 95% CI, 1.30–1.49), SLE (RR, 1.73; 95% CI, 1.37–2.18), Crohn’s disease (RR, 1.42; 95% CI, 1.20–1.71), ulcerative colitis (RR, 1.45; 95% CI, 1.29–1.63), psoriasis (RR, 1.48; 95% CI, 1.37–1.60), vasculitis (RR, 1.48; 95% CI, 1.33–1.64), scleroderma (RR, 1.65; 95% CI, 1.35–2.02), and sarcoidosis (RR, 1.42; 95% CI, 1.24–1.62) showed a higher risk of developing AMD compared with controls.

Conclusions

The results suggest that there is an increased risk of developing AMD in patients with RA, SLE, Crohn’s disease, ulcerative colitis, psoriasis, vasculitis, scleroderma, and sarcoidosis compared with patients with no IMIDs.

Financial Disclosure(s)

Proprietary or commer

目的:老年性黄斑变性(AMD)的发病机制涉及异常补体激活,是全球视力丧失的主要原因之一。补体畸变也与许多全身性免疫介导的炎症性疾病(IMIDs)有关,但老年性黄斑变性与这些疾病之间的关系尚不清楚。本研究旨在首先评估 AMD 与 IMIDs 之间的关联,然后评估与 AMD 相关的特定 IMIDs 患者患 AMD 的风险:横断面研究和队列研究:将患有AMD的患者与患有白内障且未患有AMD的对照组患者进行比较,以确保由眼科医生进行评估。IMID患者与无IMID但患有白内障的患者进行比较:本研究使用了来自国家数据库(2006-2023 年)的去标识化数据,使用 ICD-10 编码来选择 IMIDs。根据患者的年龄、性别、种族、民族和吸烟情况进行倾向得分匹配。为IMIDs生成比值比,并在AMD患者和对照组患者之间进行比较。对于与 AMD 相关的 IMID,利用队列研究设计确定了 IMID 患者与无 IMID 患者发生 AMD 的风险:主要结果测量指标:IMID的比值比、IMID导致AMD诊断的风险比(RR)和95%置信区间(CI):经过倾向分数匹配后,AMD 和对照组(各为 217,197 人)的平均年龄为 74.7+/- 10.4 岁,56% 为女性,9% 的患者吸烟。AMD 与系统性红斑狼疮 (SLE)、克罗恩病 (Crohn's)、溃疡性结肠炎 (UC)、类风湿性关节炎、银屑病、类肉瘤病、硬皮病、巨细胞动脉炎 (GCA) 和血管炎有关联。为每种正相关的 IMID 建立了队列,并与无 IMID 病史的对照队列相匹配。RA(RR 1.40,95% CI 1.30-1.49)、系统性红斑狼疮(RR 1.73,1.37-2.18)、克罗恩病(RR 1.42,1.20-1.71)、UC(RR 1.45,1.29-1.63)、银屑病(RR 1.48,1.37-1.60)、血管炎(RR 1.48,1.33-1.64)、硬皮病(RR 1.65,1.35-2.02)和类肉瘤病(RR 1.42,1.24-1.62)与对照组相比,患AMD的风险更高:结果表明,与没有IMIDs的患者相比,患有RA、系统性红斑狼疮、克罗恩病、UC、银屑病、血管炎、硬皮病和类肉瘤病的患者罹患AMD的风险更高。
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引用次数: 0
Compartmental Exudative Dynamics in Neovascular Age-Related Macular Degeneration 新生血管性黄斑变性的区室渗出动态:III 期临床试验中的体积结果和波动的影响。
IF 4.4 Q1 OPHTHALMOLOGY Pub Date : 2024-08-01 DOI: 10.1016/j.oret.2024.02.010

Purpose

To examine retinal feature dynamics in eyes with neovascular age-related macular degeneration (nAMD) treated with anti-VEGF therapy and the relationship of these features with visual acuity.

Design

Post hoc analysis of the phase III, randomized, HAWK nAMD clinical trial.

Participants

Participants randomized to the brolucizumab 6 mg or aflibercept 2 mg arms of the trial.

Methods

Spectral-domain OCT scans collected at 4-week intervals were analyzed using an automated machine learning–enhanced segmentation and feature-extraction platform with manual verification. Quantitative volumetric measures of retinal and exudative features were exported at multiple timepoints over 48 weeks. Volatility of exudative features was calculated as the standard deviation of each feature value during the maintenance phase (week 12–48) of treatment. These features were examined for their associations with anatomic and functional outcomes.

Main Outcome Measures

Longitudinal intraretinal fluid (IRF) and subretinal fluid (SRF) volume, subretinal hyperreflective material (SHRM) volume, ellipsoid zone (EZ) integrity (EZ–retinal pigment epithelium [RPE] volume/thickness), and correlation with best-corrected visual acuity (BCVA).

Results

Intraretinal fluid, SRF, and SHRM demonstrated significant volumetric reduction from baseline with anti-VEGF therapy (P < 0.001 at each timepoint). Ellipsoid zone integrity measures demonstrated significant improvement from baseline (P < 0.001 at each timepoint). Both EZ integrity and SHRM measures correlated significantly with BCVA at all timepoints (EZ-RPE volume: 0.38 ≤ r ≤ 0.47; EZ-RPE central subfield thickness: 0.22 ≤ r ≤ 0.41; SHRM volume: −0.33 ≤ r ≤ −0.44). After treatment initiation, correlations of IRF and SRF volume with BCVA were weak or nonsignificant. Eyes with lower volatility of IRF, SRF, and SHRM volumes during the maintenance phase showed greater improvements in EZ integrity (all P < 0.01) and greater gains in BCVA (all P < 0.01) at week 48 compared with eyes with higher volatility in those exudative parameters.

Conclusions

Quantitative measures of SHRM volume and EZ integrity correlated more strongly with BCVA than retinal fluid volumes during treatment. High volatility of exudative parameters, including SRF, during the maintenance phase of treatment was associated with loss of EZ integrity and BCVA.

Financial Disclosure(s)

Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

目的:研究接受抗血管内皮生长因子(anti-VEGF)治疗的新生血管性老年黄斑变性(nAMD)患者的视网膜特征动态,以及这些特征与视力的关系:设计:3期随机HAWK nAMD临床试验的事后分析:方法:光谱域光学相干断层扫描:使用机器学习增强型自动分割和特征提取平台分析每 4 周采集一次的光谱域光学相干断层扫描(OCT)扫描结果,并进行人工验证。在 48 周内的多个时间点输出视网膜和渗出特征的定量体积测量值。渗出特征的波动性按治疗维持阶段(第 12-48 周)每个特征值的标准偏差计算。主要结果测量:纵向视网膜内积液(IRF)和视网膜下积液(SRF)体积、视网膜下超反光材料(SHRM)体积、椭圆形区(EZ)完整性(EZ-视网膜色素上皮[RPE]体积/厚度)以及与最佳矫正视力(BCVA)的相关性:结果:抗血管内皮生长因子治疗(PC)后,IRF、SRF 和 SHRM 的体积较基线明显缩小:在治疗过程中,SHRM体积和EZ完整性的定量测量与BCVA的相关性比视网膜积液体积的相关性更强。在治疗维持阶段,包括SRF在内的渗出参数的高波动性与EZ完整性和BCVA的丧失有关。
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引用次数: 0
Horizontal Smoke Stack Leak in Multifocal Central Serous Chorioretinopathy 多灶性中央浆液性脉络膜视网膜病变中的水平烟囱泄漏
IF 4.4 Q1 OPHTHALMOLOGY Pub Date : 2024-08-01 DOI: 10.1016/j.oret.2024.01.011
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引用次数: 0
Bacillary Layer Detachment in Neovascular Age-Related Macular Degeneration from a Phase III Clinical Trial 从 3 期临床试验看新生血管性老年黄斑变性中的芽胞层脱落
IF 4.4 Q1 OPHTHALMOLOGY Pub Date : 2024-08-01 DOI: 10.1016/j.oret.2024.02.007

Objective

To evaluate the incidence of bacillary layer detachment in patients with neovascular age-related macular degeneration (nAMD) and their response to anti-VEGF therapy.

Design

Post hoc analysis of the brolucizumab 6-mg and aflibercept 2-mg arms from the HAWK clinical trial, a 48-week, prospective, double-masked, phase III trial.

Participants

Participants (n = 652 and 652 eyes) randomized to brolucizumab 6-mg and aflibercept 2-mg arms from HAWK (NCT02307682).

Methods

Spectral-domain OCT scans were obtained at 4-week intervals throughout the HAWK trial and segmented automatically using a proprietary, machine learning–enabled, higher-order feature extraction platform.

Main Outcome Measures

The incidence of bacillary layer detachment and effect of anti-VEGF therapy in these eyes on best-corrected visual acuity (BCVA), central subfield thickness (CST), retinal fluid volumes, subretinal hyper-reflective material (SHRM) volume, and ellipsoid zone (EZ) integrity from baseline to week 48.

Results

Classic bacillary layer detachment was identified in 7.2% (47/652) of eyes, demonstrating worse BCVA and higher CST, EZ total attenuation, subretinal fluid (SRF), and SHRM volume at baseline than eyes without bacillary layer detachment. Anti-VEGF treatment resulted in resolution of bacillary layer detachment in 97.9% of eyes by week 48. In eyes with bacillary layer detachment, anti-VEGF treatment improved BCVA and decreased SRF and SHRM volume; however, eyes with bacillary layer detachment never reached the level of BCVA improvement as eyes without bacillary layer detachment. A greater proportion of eyes with bacillary layer detachment had high-exudative volatility (increased mean standard deviation after loading dose) of CST, SRF, and total fluid than eyes without bacillary layer detachment (P < 0.05 for each comparison).

Conclusions

Bacillary layer detachment, an OCT signature representing photoreceptor schisis, is identifiable in a notable proportion of eyes with nAMD. Anti-VEGF therapy resulted in a very high proportion of bacillary layer detachment resolution with significantly decreased SRF and SHRM volumes. The majority of eyes with bacillary layer detachment have high-exudative volatility, which may be associated with lower BCVA outcomes. The presence of bacillary layer detachment may provide an important imaging biomarker to be considered for clinical trial inclusion/exclusion based on trial design and therapeutic goals because of its unique behavior.

Financial Disclosure(s)

Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

目的评估新生血管性年龄相关性黄斑变性(nAMD)患者的棘层脱落发生率及其对抗血管内皮生长因子(VEGF)疗法的反应 设计:对HAWK临床试验(一项为期48周的前瞻性双盲3期试验)中的brolucizumab 6毫克和aflibercept 2毫克治疗组进行事后分析 参与者: HAWK临床试验(NCT02307682)中随机接受brolucizumab 6毫克和aflibercept 2毫克治疗组的参与者(n=652和652只眼睛):方法:在整个 HAWK 试验过程中,每隔 4 周采集一次 SD-OCT 扫描结果,并使用专有的、支持机器学习的高阶特征提取平台进行自动分割:从基线到第 48 周,这些眼球中的棘层脱离发生率以及抗 VEGF 治疗对最佳矫正视力 (BCVA)、中央子场厚度 (CST)、视网膜积液体积、视网膜下超反光材料 (SHRM) 体积和椭圆形区 (EZ) 完整性的影响 结果:7.2%(47/652)的眼球中发现典型的棘层脱离。2%(47/652)的眼球显示BCVA恶化,基线时的CST、EZ总衰减、视网膜下积液(SRF)和SHRM体积均高于无棘层脱落的眼球。抗 VEGF 治疗使 97.9% 的眼球在第 48 周时解决了棘层脱落问题。抗血管内皮生长因子治疗改善了有乳头状纤维层脱离的眼睛的BCVA,减少了SRF和SHRM体积;但是,有乳头状纤维层脱离的眼睛的BCVA改善程度从未达到无乳头状纤维层脱离眼睛的改善程度。与没有发生毛细血管层脱落的眼睛相比,有毛细血管层脱落的眼睛中有更大比例的 CST、SRF 和总液体具有高渗出波动性(负荷剂量后平均 SD 值增加)(每项比较的 P < .05 结论:在相当大比例的 nAMD 眼睛中,可以识别出代表光感受器分裂的毛细血管层脱落这一 OCT 标志。抗血管内皮生长因子(VEGF)治疗可使很高比例的棘层脱落得到缓解,SRF 和 SHRM 体积显著减少。大多数伴有毛细血管层脱离的眼球都有较高的渗出波动性,这可能与较低的 BCVA 结果有关。由于其独特的行为,存在棘层脱离可能会提供一个重要的成像生物标志物,根据试验设计和治疗目标来考虑临床试验的纳入/排除。
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引用次数: 0
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Ophthalmology. Retina
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