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Donor tissue impact on Descemet Membrane Endothelial Keratoplasty (DMEK) graft preparation and clinical outcome. 供体组织对视网膜膜内皮角膜移植术(DMEK)移植物制备及临床效果的影响。
IF 1.9 4区 医学 Q2 OPHTHALMOLOGY Pub Date : 2026-03-17 DOI: 10.1159/000551253
Silvia Schrittenlocher, Jithmi Weliwitage, Mara Serban, Aline Woitas, Mario Matthaei, Björn Bachmann, Claus Cursiefen

Introduction: To determine which donor characteristics, like previous diseases and surgeries, influence the graft preparation difficulty of the Descemet membrane (DM)/endothelial lamella in DMEK-surgery and to analyze the impact on the one-year clinical outcome.

Methods: 1051 eyes with DMEK-surgery between 01/2018 and 01/2021 performed at the University Hospital Cologne, Germany were included in this single-center and retrospective study. Information regarding the donors' previous diseases and surgeries were provided by a large database of a cornea bank (Multi Tissue Bank Mecklenburg-Vorpommern) and merged with the Cologne DMEK database, that contains information regarding preparation characteristics of the surgeon-prepared graft directly preoperatively and postoperative clinical follow-up. Three preparation groups (easy, difficult and very difficult) were correlated to the donors' previous disease and surgeries. Also, outcome parameters, like visual acuity, endothelial cell density and graft survival were correlated to the graft preparation group.

Results: Donor diabetes was found as significant predictor for central adhesions (p<0.001). Diabetes patients are 2-times more likely to have central adhesions complicating preparation than non-diabetes patients (OR =2.2). Previous cataract surgery was significantly associated with difficult stripping and preparation (p <0.001), with an estimated 1.07 fold increase in stripping difficulty (95% CI 0.80-1.34) and overall 1.99 fold increase in preparation difficulty (95% CI 1.71-2.29). Chronic kidney disease (p=0.012) and previous cataract-surgery (p=0.005) show significant associations to tissue loss. Donor diagnosis such as Diabetes Mellitus type 2, chronic ischemic heart disease and respiratory insufficiency have a significant association with the preparation group (p=0.001; p=.004 and p=0.032, respectively). No interactions were found between preparation difficulties and visual acuity (p=0.122), rebubbling rate (p=0.780) or endothelial cell density (p=0.886) nor graft survival (p value=0.157) one year postoperatively.

Conclusions: Donor diabetes mellitus, heart failure, hypertension, respiratory insufficiency, kidney disease and previous cataract surgery are associated with difficult DMEK graft preparation, the latter two also with tissue loss. No impact of donor factors on clinical outcome was found.

前言:确定哪些供体特征(如既往疾病和手术)影响dmek手术中DM /内皮板移植准备难度,并分析其对1年临床结果的影响。方法:2018年1月1日至2021年1月1日在德国科隆大学医院行dmek手术的1051只眼纳入本单中心回顾性研究。有关供体既往疾病和手术的信息由角膜库(Multi Tissue bank Mecklenburg-Vorpommern)的大型数据库提供,并与科隆DMEK数据库合并,该数据库直接包含术前和术后临床随访中手术制备的移植物的制备特征信息。三个准备组(简单、困难和非常困难)与供体既往疾病和手术相关。此外,结果参数,如视力,内皮细胞密度和移植物存活率与移植物准备组相关。结论:供体糖尿病、心力衰竭、高血压、呼吸功能不全、肾脏疾病和既往白内障手术与DMEK移植准备困难有关,后两者也与组织丢失有关。未发现供体因素对临床结果有影响。
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引用次数: 0
Mechanisms and Safety of Therapeutic Strategies in Meibomian Gland Dysfunction: A Narrative Review. 睑板腺功能障碍治疗策略的机制和安全性:综述。
IF 1.9 4区 医学 Q2 OPHTHALMOLOGY Pub Date : 2026-03-13 DOI: 10.1159/000551503
Conrad Helau, Shuowen Zhou, Liangyu Zhou, Ying Chen, Kendrick Co Shih, Hua Wang, Yau Kei Chan

Background Meibomian gland dysfunction (MGD) is a chronic and widespread abnormality of the meibomian glands that often results in symptoms such as eye irritation and blurred vision, significantly affecting patients' daily activities. While conventional treatments like warm compresses and meibomian gland expression remain widely used, their limitations have driven the development of novel therapeutic technologies. Summary This review synthesizes evidence from 71 clinical and experimental studies in Medline databases on both established and emerging therapeutic strategies for MGD, including physical interventions (warm compresses, eyelid cleansing, probing and expression, thermal pulsation systems such as LipiFlow®, and intense pulsed light (IPL)) and pharmacological approaches. Across these modalities, most interventions improve symptoms, tear film stability, and meibum quality primarily by enhancing glandular outflow and modulating ocular surface inflammation. Device-based physical therapies typically offer greater and more long-lasting improvements than conventional methods but are limited by cost, access, and a lack of long-term safety data. Key Messages Though the current range of MGD treatments cannot regenerate affected glands, their secreting functions can be greatly improved. Clinicians should therefore individualize treatment options according to disease stage, meibography findings, comorbid ocular surface conditions, and patient-specific factors such as tolerance, adherence, and cost.

睑板腺功能障碍(MGD)是睑板腺的一种慢性和广泛的异常,常导致眼睛刺激和视力模糊等症状,严重影响患者的日常活动。虽然热敷和睑板腺表达等传统治疗方法仍被广泛使用,但它们的局限性推动了新型治疗技术的发展。本综述综合了Medline数据库中71项临床和实验研究的证据,这些研究涉及已建立的和新兴的MGD治疗策略,包括物理干预(热敷、眼睑清洁、探查和表达、热脉动系统(如LipiFlow®)和强脉冲光(IPL))和药理学方法。在这些模式中,大多数干预措施主要通过增强腺体流出和调节眼表炎症来改善症状、泪膜稳定性和细胞质量。基于设备的物理疗法通常比传统方法提供更大、更持久的改善,但受到成本、可及性和缺乏长期安全性数据的限制。虽然目前的MGD治疗范围不能再生受影响的腺体,但它们的分泌功能可以大大改善。因此,临床医生应根据疾病分期、代谢检查结果、合并症眼表状况和患者特异性因素(如耐受性、依从性和费用)制定个性化治疗方案。
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引用次数: 0
Accuracy of intraocular lens power calculation formulas in cataract eyes after vitrectomy with silicone oil tamponade:a network meta-analysis. 硅油填塞玻璃体切除术后白内障眼人工晶状体度数计算公式的准确性:网络荟萃分析。
IF 1.9 4区 医学 Q2 OPHTHALMOLOGY Pub Date : 2026-03-05 DOI: 10.1159/000551331
Peng Zhao, Meng Li, Zhao-Xing Guo, Zhi-Yong Tian, Jing-Shang Zhang, Ying-Yan Mao, Zheng Xin, Zhong-Yan Li, Xiu-Hua Wan

Objective: To systematically compare the accuracy of artificial intelligence and traditional intraocular lens (IOL) calculation formulas in cataract eyes after vitrectomy with silicone oil tamponade.

Methods: PubMed, Cochrane, Embase, and Web of Science databases were searched to select relevant studies published up to October 29, 2025. 12 formulas (SRK/T, Hoffer Q, Hoffer QST, Haigis, Barrett Universal II, Holladay I, Holladay II, RBF, LSF, EVO, Kane, and Pearl-DGS) were included for final comparison. The primary outcomes were the percentage of eyes with prediction errors (PE) within ±0.50D and ±1.00D.

Results: This meta-analysis included 7 studies comprising 1060 eyes. Overall, compared to traditional formulas, newer formulas demonstrated relatively higher accuracy. The results indicated that among all the formulas being compared, the optimal formula was Kane. For the percentage of eyes with PE within ±0.50 D, Kane had the highest precision. For the IOL power percentage within ±1.00 D, EVO performed the best, with Kane also ranking highly, Furthermore, RBF also performed very well.

Conclusion: Kane and EVO appear to be better choices for silicone oil-filled eyes after vitrectomy.

目的:系统比较人工智能与传统人工晶状体(IOL)计算公式在硅油填塞白内障眼玻璃体切除术后的准确性。方法:检索PubMed、Cochrane、Embase和Web of Science数据库,选取截至2025年10月29日发表的相关研究。12个公式(SRK/T、Hoffer Q、Hoffer QST、Haigis、Barrett Universal II、Holladay I、Holladay II、RBF、LSF、EVO、Kane和Pearl-DGS)用于最终比较。主要结局为预测误差(PE)在±0.50D和±1.00D范围内的眼睛百分比。结果:本荟萃分析包括7项研究,共1060只眼睛。总的来说,与传统公式相比,新公式显示出相对较高的准确性。结果表明,在所有的比较公式中,凯恩公式是最优的。对于PE在±0.50 D范围内的眼睛百分比,Kane具有最高的精度。对于±1.00 D以内的IOL度数百分比,EVO表现最好,Kane排名也较高,RBF表现也很好。结论:Kane和EVO是玻璃体切除术后硅油填充眼的较好选择。
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引用次数: 0
Correlations between Spectral Domain Optical Coherence Tomography Measurements and Visual Acuity in Patients with Retinitis Pigmentosa at Baseline and One-Year Follow-Up. 色素性视网膜炎患者SD-OCT测量与基线和1年随访时视力的相关性
IF 1.9 4区 医学 Q2 OPHTHALMOLOGY Pub Date : 2026-01-01 Epub Date: 2026-02-03 DOI: 10.1159/000550474
Emma Carpenter, Khushi Saigal, Elizabeth Slaney, Jessica Yang Walia, Kyle Fallgatter, Jinghua Chen

Introduction: This study aimed to investigate the relationship between spectral domain optical coherence tomography (SD-OCT) structural findings and visual acuity in patients with retinitis pigmentosa (RP), with and without cystoid macular edema (CME), at baseline and 1-year follow-up.

Methods: This retrospective chart review included 30 patients with RP treated at the University of Florida Health Eye Center from 2014 to 2020. Patient records were analyzed for SD-OCT structural features and visual acuity outcomes. Statistical analyses included descriptive statistics, χ2 tests, independent t tests, and Pearson's correlation tests. Main outcome measures were best corrected visual acuity (BCVA), presence of the ellipsoid zone (EZ) in the fovea and macula, central retinal thickness (CRT), total macular volume (TMV), and presence of an epiretinal membrane (ERM).

Results: The study included 30 patients (21 female, 9 male) with an average age of 46.83 ± 18.86 years (range, 10-80 years). The average follow-up period between visits was 11.9 ± 1.6 months (range, 9-15 months). Among the 60 eyes analyzed, 50% had CME. Eyes with CME had a greater CRT at the follow-up visit (p = 0.029). No significant differences were found in BCVA or TMV between RP patients with and without CME. Correlation analyses revealed a significant relationship between CRT and BCVA at both visits (p = 0.001, p = 0.004) in RP patients without CME, but not in RP patients with CME. EZ foveal sparing consistently predicted BCVA outcomes (p < 0.001) and CRT (p ≤ 0.001) at both visits in RP patients with and without CME. Greater TMV at both visits (p = 0.009, p = 0.012) and the presence of an ERM at the follow-up visit (p = 0.046) were significantly associated with a decline in BCVA between visits in RP patients without CME.

Conclusions: EZ foveal sparing is a significant predictor of visual acuity in RP patients regardless of the presence of CME. While CRT correlates with visual acuity in patients without CME, it does not predict outcomes in those with CME. TMV may serve as a marker for preclinical CME, and both increased TMV and ERM presence may predict visual decline in RP patients with undetectable CME on SD-OCT.

本研究旨在探讨色素性视网膜炎(RP)伴或不伴囊样黄斑水肿(CME)患者在基线和1年随访时的光谱域光学相干断层扫描(SD-OCT)结构表现与视力的关系。方法:本回顾性研究纳入2014年至2020年在佛罗里达大学(UF)健康眼科中心治疗的30例RP患者。分析患者的SD-OCT结构特征和视力结果。统计分析包括描述性统计、χ 2检验、独立t检验和Pearson相关检验。主要观察指标为最佳矫正视力(BCVA)、中央凹和黄斑是否存在椭球区(EZ)、视网膜中央厚度(CRT)、黄斑总体积(TMV)和视网膜前膜(ERM)的存在。结果:共纳入30例患者,其中女性21例,男性9例,平均年龄46.83±18.86岁(范围10 ~ 80岁)。平均随访时间为11.9±1.6个月(范围9 ~ 15个月)。在分析的60只眼睛中,50%有CME。CME患者随访时的CRT值更高(p=0.029)。合并和不合并CME的RP患者的BCVA或TMV无显著差异。相关分析显示,在没有CME的RP患者中,两次就诊时CRT与BCVA之间存在显著相关性(p=0.001, p=0.004),而在有CME的RP患者中则无显著相关性。结论:EZ中央凹保留是RP患者视力的重要预测指标,与CME的存在无关。虽然CRT与无CME患者的视力相关,但它不能预测CME患者的预后。TMV可能作为临床前CME的标志物,TMV和ERM的增加可能预测SD-OCT未检测到CME的RP患者视力下降。
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引用次数: 0
Impact of Diabetic Peripheral Neuropathy on Corneal Sensitivity and Ocular Surface. 糖尿病周围神经病变对角膜敏感性和眼表的影响。
IF 1.9 4区 医学 Q2 OPHTHALMOLOGY Pub Date : 2026-01-01 Epub Date: 2026-01-20 DOI: 10.1159/000550306
Pau Cid-Bertomeu, Magí Vilaltella, Laura Capilla, Valentín Huerva

Introduction: Diabetes mellitus (DM) is frequently associated with microvascular complications, including diabetic peripheral neuropathy (DPN). The cornea, one of the most densely innervated tissues in the body, has been proposed as a surrogate marker for small fiber neuropathy. Patients with DM often present with ocular surface disease (OSD) and corneal sensitivity impairment, but the relationship between DPN, ocular surface alterations, and inflammatory biomarkers remains unclear. This study aimed to evaluate ocular surface parameters between patients with type 2 DM with and without DPN and to explore the associations among corneal sensitivity, ocular surface inflammation (matrix metalloproteinase-9 [MMP-9]), and dry eye-related parameters.

Methods: In this cross-sectional observational study, 158 eyes of 79 patients with type 2 DM were categorized based on the presence or absence of DPN, diagnosed via electromyography. Corneal sensitivity was evaluated using the Brill esthesiometer, and tear MMP-9 levels were assessed with the InflammaDry test. Additional assessments included the Ocular Surface Disease Index (OSDI), tear osmolarity, Schirmer test, noninvasive tear break-up time, and meibography. Corneal impairment was defined as esthesiometry levels 4-6 or pressure thresholds ≥8 mbar in either eye.

Results: Patients with DPN exhibited significantly reduced corneal sensitivity (6.98 ± 2.25 mbar vs. 5.62 ± 2.53 mbar; p = 0.014) and higher OSDI scores (median 26 vs. 10; p < 0.001). MMP-9 positivity was more common in patients with corneal sensory impairment (81.8% vs. 54.3%; p = 0.0215). A significant negative correlation was observed between tear osmolarity and corneal sensitivity (r = -0.182, p = 0.022). Multivariable regression showed that both DPN (β = 1.20) and MMP-9 positivity (β = 1.24) were independently associated with reduced sensitivity.

Conclusions: Reduced corneal sensitivity was significantly associated with the presence of DPN and with MMP-9 positivity and showed a negative correlation with tear osmolarity. Corneal sensitivity testing combined with tear MMP-9 assessment may provide complementary information on ocular surface changes in diabetic patients, although current variability and limited reproducibility prevent their use as standalone screening tools for neuropathy.

糖尿病(DM)常伴有微血管并发症,包括糖尿病周围神经病变(DPN)。角膜是人体内神经支配最密集的组织之一,被认为是小纤维神经病变的替代标志物。糖尿病患者通常表现为眼表疾病(OSD)和角膜敏感性损害,但DPN、眼表改变和炎症生物标志物之间的关系尚不清楚。本研究旨在评估2型DM患者的眼表参数,并探讨DPN、角膜敏感性、眼表炎症(基质金属蛋白酶-9,MMP-9)和干眼病(DED)指标之间的关系。方法:在这项横断面观察研究中,79例2型糖尿病患者158只眼根据是否存在DPN进行分类,通过肌电图诊断。使用Brill触觉计评估角膜敏感性,使用InflammaDry测试评估泪液MMP-9水平。其他评估包括眼表疾病指数(OSDI)、泪液渗透压、Schirmer试验、无创泪液破裂时间(NIBUT)和meibography。角膜损伤定义为双眼感觉水平4-6或压力阈值≥8mbar。结果:DPN患者角膜敏感度显著降低(6.98±2.25 mbar vs. 5.62±2.53 mbar;𝑝= 0.014),OSDI评分较高(中位数26 vs. 10;𝑝< 0.001)。MMP-9阳性在累及角膜的患者中更为常见(81.8%比54.3%;𝑝= 0.0215)。泪液渗透压与角膜敏感性呈显著负相关(r = -0.182,𝑝= 0.022)。多变量回归显示DPN (β = 1.20)和MMP-9阳性(β = 1.24)与敏感性降低独立相关。结论:角膜敏感性降低与DPN、泪液渗透压升高和MMP-9表达显著相关。眼表评估可作为糖尿病神经病变早期检测的非侵入性工具。
{"title":"Impact of Diabetic Peripheral Neuropathy on Corneal Sensitivity and Ocular Surface.","authors":"Pau Cid-Bertomeu, Magí Vilaltella, Laura Capilla, Valentín Huerva","doi":"10.1159/000550306","DOIUrl":"10.1159/000550306","url":null,"abstract":"<p><strong>Introduction: </strong>Diabetes mellitus (DM) is frequently associated with microvascular complications, including diabetic peripheral neuropathy (DPN). The cornea, one of the most densely innervated tissues in the body, has been proposed as a surrogate marker for small fiber neuropathy. Patients with DM often present with ocular surface disease (OSD) and corneal sensitivity impairment, but the relationship between DPN, ocular surface alterations, and inflammatory biomarkers remains unclear. This study aimed to evaluate ocular surface parameters between patients with type 2 DM with and without DPN and to explore the associations among corneal sensitivity, ocular surface inflammation (matrix metalloproteinase-9 [MMP-9]), and dry eye-related parameters.</p><p><strong>Methods: </strong>In this cross-sectional observational study, 158 eyes of 79 patients with type 2 DM were categorized based on the presence or absence of DPN, diagnosed via electromyography. Corneal sensitivity was evaluated using the Brill esthesiometer, and tear MMP-9 levels were assessed with the InflammaDry test. Additional assessments included the Ocular Surface Disease Index (OSDI), tear osmolarity, Schirmer test, noninvasive tear break-up time, and meibography. Corneal impairment was defined as esthesiometry levels 4-6 or pressure thresholds ≥8 mbar in either eye.</p><p><strong>Results: </strong>Patients with DPN exhibited significantly reduced corneal sensitivity (6.98 ± 2.25 mbar vs. 5.62 ± 2.53 mbar; p = 0.014) and higher OSDI scores (median 26 vs. 10; p < 0.001). MMP-9 positivity was more common in patients with corneal sensory impairment (81.8% vs. 54.3%; p = 0.0215). A significant negative correlation was observed between tear osmolarity and corneal sensitivity (r = -0.182, p = 0.022). Multivariable regression showed that both DPN (β = 1.20) and MMP-9 positivity (β = 1.24) were independently associated with reduced sensitivity.</p><p><strong>Conclusions: </strong>Reduced corneal sensitivity was significantly associated with the presence of DPN and with MMP-9 positivity and showed a negative correlation with tear osmolarity. Corneal sensitivity testing combined with tear MMP-9 assessment may provide complementary information on ocular surface changes in diabetic patients, although current variability and limited reproducibility prevent their use as standalone screening tools for neuropathy.</p>","PeriodicalId":19662,"journal":{"name":"Ophthalmic Research","volume":" ","pages":"56-63"},"PeriodicalIF":1.9,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12923250/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146011585","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Long-Term Follow-Up of Faricimab Intravitreal Injections in Naïve Neovascular Age-Related Macular Degeneration. 法昔单抗玻璃体内注射治疗naïve新生血管性年龄相关性黄斑变性的长期随访。
IF 1.9 4区 医学 Q2 OPHTHALMOLOGY Pub Date : 2026-01-01 Epub Date: 2026-02-03 DOI: 10.1159/000550307
Luca Belloni Baroni, Lisa Toto, Federico Formenti, Marzia Passamonti, Alberto Quarta, Maria Ludovica Ruggeri, Raffaella Aloia, Marta Di Nicola, Rodolfo Mastropasqua

Introduction: The aim of the study was to evaluate functional and anatomical changes at the 44-week follow-up in patients with naïve neovascular age-related macular degeneration (nAMD) treated with faricimab intravitreal injections (IVIs).

Methods: Fifty-four eyes of 54 patients with naïve active macular neovascularization and nAMD were enrolled at the Ophthalmology Clinic of University "G. d'Annunzio," Chieti-Pescara, Italy. All patients were scheduled for faricimab IVI. Each patient underwent complete ophthalmic examination including best-corrected visual acuity (BCVA) using the Early Treatment Diabetic Retinopathy Study (ETDRS) charts and optical coherence tomography. All measurements were evaluated at baseline, at week 20 and then according to fixed retreatment interval up to week 44. Fluorescein angiography and indocyanine green angiography were also performed at baseline. Main outcome measures were changes in BCVA, central macular thickness (CMT), subfoveal choroidal thickness (SFCT), intraretinal fluid presence, subfoveal subretinal fluid presence and thickness, the presence of pigment epithelial detachments (PEDs), and its maximum height (PED-MH).

Results: BCVA improved and CMT reduced significantly from baseline to week 44 (p = 0.002 and p = 0.020, respectively) in the overall sample with a higher significant improvement from baseline to week 20 (p < 0.001 for both parameters) and no additional significant improvement from week 20 to week 44 in the overall sample (p = 0.348 and p = 0.146, respectively). At week 20, 72.3% of patients were in the Q12/Q16 interval. Patients in the Q8 interval showed significant improvement in BCVA (p < 0.001) and significant reduction of CMT (p = 0.008) from baseline to week 44, respectively. PED-MH as well showed a significant reduction from baseline to week 44 (p < 0.001). Patients in the Q12 interval showed significant improvement in BCVA (p = 0.030) and significant reduction of CMT, SFCT, and PED-MH from baseline to week 36 (p < 0.001). Patients in the Q16 interval showed significant reduction of BCVA during follow-up (p = 0.026). CMT, SFCT, and PED-MH were significantly reduced from baseline to week 44 (p < 0.001).

Conclusion: Faricimab showed efficacy in the treatment of naïve nAMD patients with an improvement of many anatomical and functional parameters at 44 weeks, allowing the maintenance of a treatment regimen for most patients equal to or greater than 12 weeks.

简介:该研究的目的是评估法利西单抗玻璃体内注射(IVIs)治疗naïve新生血管性年龄相关性黄斑变性(nAMD)患者随访44周后的功能和解剖学变化。方法:选取意大利基蒂- pescara“G. d'Annunzio”大学眼科诊所的54例naïve活动性黄斑新生血管和nAMD患者54只眼。所有患者均计划使用法昔单抗IVI。每位患者都接受了完整的眼科检查,包括使用早期治疗糖尿病视网膜病变研究(ETDRS)图表和光学相干断层扫描(OCT)进行最佳矫正视力(BCVA)检查。在基线、第20周以及直至第44周的固定再治疗间隔评估所有测量结果。荧光素血管造影(FA)和吲哚菁绿血管造影(ICGA)也在基线进行。主要观察指标为最佳矫正视力(BCVA)、黄斑中央厚度(CMT)、中央凹下脉络膜厚度(SFCT)、视网膜内液(IRF)存在、中央凹下视网膜下液(SSRF)存在和厚度、色素上皮脱落(PEDs)存在和最大高度(PED-MH)的变化。结果:从基线到第44周,BCVA得到改善,CMT显著降低(分别为p=0.002和p=0.020),总体样本从基线到第20周有更高的显着改善(pp结论:Faricimab在治疗naïve nAMD患者中显示出有效性,在44周时许多解剖和功能参数得到改善,允许大多数患者维持治疗方案等于或大于12周。
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引用次数: 0
Corneal Fluorescein Staining in FDA-Reviewed Dry Eye Registrational Clinical Trials: Evidence of Limited Endpoint Responsiveness. fda审查的干眼注册临床试验中角膜荧光素染色:有限终点反应性的证据。
IF 1.9 4区 医学 Q2 OPHTHALMOLOGY Pub Date : 2026-01-01 Epub Date: 2026-01-06 DOI: 10.1159/000550166
Zeenal Dabre, Christine Mun, Tanya Sheth, Christian Kim, Monazzah Sarwar, Natalie Ungaretti, Kiera Byrne, Simon Kaja, Sandeep Jain

Introduction: Corneal fluorescein (FL) staining is the most widely used efficacy endpoint in dry eye disease (DED) registrational trials, yet dye diffusion and variable readout timing can blur punctate staining, reducing the precision and consistency of grading. We assessed the performance of FL staining as an efficacy endpoint by analyzing endpoint success across FDA-reviewed DED trials and evaluated whether a standardized, diffusion-resistant dye could provide an alternative quantitative measure of corneal staining.

Methods: We conducted a synthesis of FDA-reviewed DED registrational clinical trials through April 2025 to determine the proportion of trials that met the corneal FL staining efficacy endpoint. Clinical relevance was assessed using a minimal clinically important difference (MCID) of ≥3 units on the 0-15 National Eye Institute (NEI) scale. In a clinical cohort of 50 DED patients (97 eyes), total corneal staining was compared after sequential instillation of 5 µL of 2% FL (readout ∼2.5 min) and 1% lissamine green (LG) (readout ≤30 s).

Results: Among 20 FDA-reviewed registrational trials that prespecified corneal FL staining as an efficacy endpoint, 10 (50%) failed to meet this endpoint. Of the seven trials in which FL staining served as a primary or co-primary endpoint, only one achieved MCID for corneal staining. Across all trials meeting the endpoint, treatment-vehicle differences were small (mean additional reduction 0.4-1.2 units; Cohen's d < 0.5), indicating that FL staining yielded uniformly small effect sizes. In the clinical cohort, 1% LG produced corneal staining that was strongly associated with 2% FL for mild (ρ = 0.99), moderate (ρ = 0.93), and severe (ρ = 0.69) disease (p < 0.001). Bland-Altman analysis showed that while the mean bias was negligible, the width of the 95% limits of agreement (-1.26 to 0.85) suggests the two corneal staining dyes are not fully interchangeable at the individual-measurement level.

Conclusions: Corneal FL staining demonstrates limited responsiveness as an efficacy endpoint in DED registrational trials. Because 1% LG provides corneal staining strongly associated with 2% FL while preserving discrete punctate detail and allowing standardized, early readouts, it may represent a suitable alternative vital dye for future DED efficacy and safety assessments.

角膜荧光素(FL)染色是干眼病(DED)注册试验中最广泛使用的疗效终点,但染料扩散和可变读数时间会模糊点状染色,降低分级的准确性和一致性。我们通过分析fda审查的DED试验的终点成功情况来评估FL染色作为疗效终点的性能,并评估一种标准化的、抗扩散的染料是否可以作为角膜染色的一种替代定量测量方法。方法:我们综合了截至2025年4月fda审查的DED注册临床试验,以确定符合角膜FL染色疗效终点的试验比例。在美国国家眼科研究所(NEI) 0-15评分标准中,使用≥3个单位的最小临床重要差异(MCID)评估临床相关性。在50例DED患者(97眼)的临床队列中,在连续滴入5µL 2% FL(读数~2.5 min)和1% lis胺绿(读数≤30秒)后,比较角膜总染色。结果:在fda审查的20项注册试验中,预先指定角膜FL染色作为疗效终点,10项(50%)未能达到该终点。在将FL染色作为主要或共同主要终点的七项试验中,只有一项达到了角膜染色的MCID。在所有达到终点的试验中,治疗载体差异很小(平均额外减少0.4-1.2个单位;Cohen’s d < 0.5),表明FL染色产生的效应大小一致较小。在临床队列中,在轻度(ρ = 0.99)、中度(ρ = 0.93)和重度(ρ = 0.69)疾病中,1% LG产生的角膜染色与2% FL密切相关(p < 0.001)。Bland-Altman分析显示,虽然平均偏倚可以忽略不计,但95%的一致性限宽(-1.26至0.85)表明,这两种角膜染色染料在个体测量水平上并不是完全可互换的。结论:在DED注册试验中,角膜FL染色显示有限的反应性作为疗效终点。由于1% LG提供了与2% FL密切相关的角膜染色,同时保留了离散的点状细节,并允许标准化的早期读数,因此它可能是未来DED疗效和安全性评估的合适替代重要染料。
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引用次数: 0
Efficacy of Faricimab in Neovascular Age-Related Macular Degeneration: A Single-Arm Systematic Review and Meta-Analysis. 法利西单抗治疗新生血管性年龄相关性黄斑变性的疗效:单组系统评价和荟萃分析
IF 1.9 4区 医学 Q2 OPHTHALMOLOGY Pub Date : 2026-01-01 Epub Date: 2026-01-07 DOI: 10.1159/000550348
Mohammad Karam, Moath Baeshen, Rashed Alfuzaie, Mohammad Mohammad, Asmaa Alshatti, Adam Samet, Manuel Paez-Escamilla, Vincent Sun

Introduction: Neovascular age-related macular degeneration (nAMD) is a leading cause of vision loss and requires long-term anti-vascular endothelial growth factor therapy. This study aimed to evaluate the efficacy and safety of faricimab in patients with nAMD.

Methods: This systematic review and meta-analysis were performed according to the PRISMA guidelines to identify studies assessing faricimab in nAMD. Primary outcomes included visual acuity, central macular thickness (CMT), and dry macula rate. Secondary outcomes included macular status, central choroidal thickness (CCT), and complications. A random-effects model was used to calculate pooled mean with 95% confidence intervals.

Results: Out of the 365 studies identified, 21 studies were included, comprising a total sample size of 1,864 eyes of 1,791 patients. Post-operatively, there was a statistically significant improvement in corrected distance visual acuity (standardized mean difference [SMD]: -0.122, 95% p = 0.039) and CMT (SMD: -3.672, p = 0.010). Similarly, there was a significant improvement in the rate of dry macula at the final follow-up visit (event rate: 0.529; p < 0.05). For the secondary outcomes, there was a statistically significant improvement in CCT (SMD: -0.199, p = 0.026) and in the rate of macular exudates (0.452, p < 0.05), specifically intraretinal fluid (0.140, p < 0.05) and subretinal fluid (0.271, p < 0.05). Complications secondary to faricimab injections included hemorrhagic pigment epithelial detachment with a rate of 0.120 (p < 0.05) and retinal pigment epithelium tear with a rate of 0.025 (p < 0.05).

Conclusions: The use of faricimab injection in patients with nAMD is safe and effective, resulting in significant improvements in a myriad of visual measures and OCT parameters.

目的:评价法利西单抗治疗新生血管性年龄相关性黄斑变性(nAMD)的疗效。方法:根据PRISMA指南进行系统回顾和荟萃分析,以确定评估法利昔单抗在nAMD中的研究。主要结果包括视力、中央黄斑厚度(CMT)和干性黄斑率。次要结局包括黄斑状况、中央脉络膜厚度(CCT)和并发症。采用随机效应模型计算合并均值,置信区间为95%。结果:在确定的365项研究中,包括21项研究,包括1791名患者的1864只眼睛的总样本量。术后矫正距离视力(CDVA) (SMD: -0.122, 95% P = 0.039)和CMT (SMD: -3.672, P = 0.010)改善有统计学意义。同样,在最后一次随访时,干黄斑的发生率也有显著改善(事件率:0.529;P < 0.05)。在次要指标方面,CCT (SMD: -0.199, P = 0.026)和黄斑渗出液率(0.452,P < 0.05),特别是视网膜内液(0.140,P < 0.05)和视网膜下液(0.271,P < 0.05)均有统计学意义的改善。法利西单抗继发并发症为出血性色素上皮脱离(PED),发生率为0.120 (P < 0.05),视网膜色素上皮撕裂(RPE)发生率为0.025 (P < 0.05)。结论:法利西单抗注射液在nAMD患者中使用是安全有效的,可显著改善大量视觉测量和OCT参数。
{"title":"Efficacy of Faricimab in Neovascular Age-Related Macular Degeneration: A Single-Arm Systematic Review and Meta-Analysis.","authors":"Mohammad Karam, Moath Baeshen, Rashed Alfuzaie, Mohammad Mohammad, Asmaa Alshatti, Adam Samet, Manuel Paez-Escamilla, Vincent Sun","doi":"10.1159/000550348","DOIUrl":"10.1159/000550348","url":null,"abstract":"<p><strong>Introduction: </strong>Neovascular age-related macular degeneration (nAMD) is a leading cause of vision loss and requires long-term anti-vascular endothelial growth factor therapy. This study aimed to evaluate the efficacy and safety of faricimab in patients with nAMD.</p><p><strong>Methods: </strong>This systematic review and meta-analysis were performed according to the PRISMA guidelines to identify studies assessing faricimab in nAMD. Primary outcomes included visual acuity, central macular thickness (CMT), and dry macula rate. Secondary outcomes included macular status, central choroidal thickness (CCT), and complications. A random-effects model was used to calculate pooled mean with 95% confidence intervals.</p><p><strong>Results: </strong>Out of the 365 studies identified, 21 studies were included, comprising a total sample size of 1,864 eyes of 1,791 patients. Post-operatively, there was a statistically significant improvement in corrected distance visual acuity (standardized mean difference [SMD]: -0.122, 95% p = 0.039) and CMT (SMD: -3.672, p = 0.010). Similarly, there was a significant improvement in the rate of dry macula at the final follow-up visit (event rate: 0.529; p < 0.05). For the secondary outcomes, there was a statistically significant improvement in CCT (SMD: -0.199, p = 0.026) and in the rate of macular exudates (0.452, p < 0.05), specifically intraretinal fluid (0.140, p < 0.05) and subretinal fluid (0.271, p < 0.05). Complications secondary to faricimab injections included hemorrhagic pigment epithelial detachment with a rate of 0.120 (p < 0.05) and retinal pigment epithelium tear with a rate of 0.025 (p < 0.05).</p><p><strong>Conclusions: </strong>The use of faricimab injection in patients with nAMD is safe and effective, resulting in significant improvements in a myriad of visual measures and OCT parameters.</p>","PeriodicalId":19662,"journal":{"name":"Ophthalmic Research","volume":" ","pages":"43-55"},"PeriodicalIF":1.9,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12893746/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145918144","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Changes of Schlemm's Canal and Trabecular Meshwork Dimensions from Digital Ocular Massage in High Myopia: A Pilot Study. 数字眼按摩对高度近视患者施勒姆氏管和小梁网尺寸的影响:一项初步研究。
IF 1.9 4区 医学 Q2 OPHTHALMOLOGY Pub Date : 2026-01-01 Epub Date: 2025-12-17 DOI: 10.1159/000550144
Andrew K C Lam, Ruby W L Wong, Tiffany H Y Wu, Henry K C Lau, Carmelo H T Lai, Antonia K W Wong

Introduction: This study evaluated changes of Schlemm's canal (SC) and trabecular meshwork (TM) dimensions from digital ocular massage in high myopia.

Methods: Healthy participants with either high myopes (≤-6.00 D) or with refractive errors ≥ -3.00D were recruited. Right eyes underwent digital ocular massage. Intraocular pressure (IOP) was monitored using rebound tonometry. Anterior chamber angle was imaged using swept-source optical coherence tomography. IOP, SC, and TM were compared before and immediately after digital ocular massage.

Results: Sixteen eyes from 16 high myopes (-6.00 D to -8.125 D) and 18 eyes from 18 control participants (+0.50 D to -2.875 D) were included. There was no difference in age and gender distribution between the two groups. The two groups shared similar IOP, SC area, SC length, TM length, and TM thickness at baseline. Both groups had significant IOP drop from a baseline of around 15 mm Hg to 9 mm Hg after ocular massage. High myopia demonstrated a mild enlargement of the SC area (from 10,655.60 ± 4,362.02 µm2 to 12,632.40 ± 4,393.19 µm2, p = 0.098), not reaching statistical significance. The TM thickness was reduced from 160.21 ± 26.29 µm to 151.77 ± 26.91 µm, p = 0.018). Control eyes showed significant enlargement of SC area (from 8,540.71 ± 3,905.98 µm2 to 11,686.53 ± 4,586.37 µm2, p = 0.001) and SC length (from 240.47 ± 69.96 µm to 280.40 ± 59.37 µm, p = 0.041).

Conclusion: Control eyes showed significant enlargement of SC in responding to IOP drop while high myopia did not.

目的:观察高度近视患者数字眼按摩后施莱姆管(SC)和小梁网(TM)尺寸的变化。方法:招募高度近视(≤-6.00 D)或屈光不正(≥-3.00 D)的健康受试者。右眼进行数字眼按摩。用回弹眼压仪监测眼压。前房角成像采用扫源光学相干断层扫描(SS-OCT)。比较眼指按摩前后眼压、SC、TM的差异。结果:包括16只高近视(-6.00 D ~ -8.125 D)的16只眼和18只对照(+0.50 D ~ -2.875 D)的18只眼。两组在年龄和性别分布上没有差异。两组在基线时的IOP、SC面积、SC长度、TM长度和TM厚度相似。眼部按摩后,两组的IOP均从基线约15mmHg下降到9mmHg。高度近视的SC面积轻度扩大(从10655.60 +/- 4362.02µm²增加到12632.40 +/- 4393.19µm²,p = 0.098),但无统计学意义。TM厚度从160.21 +/- 26.29µm降至151.77 +/- 26.91µm, p = 0.018)。对照眼的SC面积(从8540.71 +/- 3905.98µm²增加到11686.53 +/- 4586.37µm²,p = 0.001)和SC长度(从240.47 +/- 69.96µm增加到280.40 +/- 59.37µm, p = 0.041)显著增加。结论:对照眼对眼压下降有明显的SC增大反应,而高度近视眼对眼压下降无明显反应。
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引用次数: 0
Long-Term Trends in the Global Burden of Age-Related Macular Degeneration: Sex Differences, Aging Effects, and Future Projections in Middle-Aged and Older Adults. 全球年龄相关性黄斑变性负担的长期趋势:性别差异、衰老影响和中老年人群的未来预测。
IF 1.9 4区 医学 Q2 OPHTHALMOLOGY Pub Date : 2026-01-01 Epub Date: 2025-12-23 DOI: 10.1159/000550175
Yuanyuan Li, Bo Mou, Xiusheng Song

Introduction: Age-related macular degeneration (AMD) is a major cause of irreversible vision loss in middle-aged and older populations worldwide. Understanding its long-term epidemiological trends is essential for anticipating future healthcare needs and guiding preventive strategies. This study characterizes the global, regional, and national burden of AMD in adults aged ≥45 years, with a focus on sex disparities, aging effects, and projected trends.

Methods: Using data from the Global Burden of Disease Study 2021, we analyzed the prevalence and disability-adjusted life years (DALYs) of AMD across age, sex, region, country, and Socio-Demographic Index (SDI) groups. We applied an age-period-cohort model to disentangle the effects of aging, temporal changes, and birth cohort on AMD risk. Frontier analysis was conducted to identify best-practice benchmarks in disease burden reduction. The association between SDI and AMD burden was assessed to evaluate health inequities. An autoregressive integrated moving average (ARIMA) model was used to project age-standardized DALY rate (ASDR) and prevalence rate from 2022 to 2036.

Results: Between 1990 and 2021, the absolute number of AMD cases and DALYs nearly doubled. In 2021, both prevalence and DALY rates increased exponentially with age, with females exhibiting consistently higher rates across all age groups. The age-period-cohort model indicated a declining trend in AMD risk over successive birth cohorts, suggesting potential improvements in early-life or cumulative risk factors. Notably, the highest age-standardized rates were observed in low-SDI regions, highlighting significant global inequities in disease burden. ARIMA projections suggest a modest but concerning increase in the global ASDR, rising to 6.80 (95% CI: 5.82-7.78) by 2036, with female ASDR reaching 7.46 (95% CI: 6.29-8.63).

Conclusion: The burden of AMD remains substantial and is projected to grow, particularly among aging populations and in low-resource settings. The persistent sex disparity, especially the elevated burden in elderly women, calls for targeted screening and intervention programs. These findings emphasize the need for equitable, age- and sex-sensitive public health strategies to mitigate the rising impact of AMD in the coming decades.

背景:年龄相关性黄斑变性(AMD)是全球中老年人群不可逆视力丧失的主要原因。了解其长期流行病学趋势对于预测未来的保健需求和指导预防战略至关重要。本研究描述了全球、地区和国家年龄≥45岁成人AMD负担的特征,重点关注性别差异、老龄化影响和预测趋势。方法:使用来自2021年全球疾病负担研究的数据,我们分析了不同年龄、性别、地区、国家和社会人口指数(SDI)组的AMD患病率和残疾调整生命年(DALYs)。我们采用年龄-时期-队列(APC)模型来分析年龄、时间变化和出生队列对AMD风险的影响。进行了前沿分析,以确定减少疾病负担的最佳实践基准。评估了SDI和AMD负担之间的关系,以评估健康不公平。采用自回归综合移动平均(ARIMA)模型预测2022年至2036年年龄标准化DALY率(ASDR)和患病率(ASPR)。结果:1990年至2021年间,AMD病例和DALYs的绝对数量几乎翻了一番。2021年,患病率和伤残补偿年率均随年龄呈指数增长,所有年龄组的女性发病率均持续较高。APC模型显示,在连续的出生队列中,AMD风险呈下降趋势,表明早期生活或累积风险因素可能有所改善。值得注意的是,在低sdi地区观察到最高的年龄标准化率,突出了疾病负担方面的重大全球不平等。ARIMA预测显示,全球ASDR将出现温和但令人担忧的增长,到2036年将升至6.80 (95% CI: 5.82-7.78),其中女性ASDR将达到7.46 (95% CI: 6.29-8.63)。结论:AMD的负担仍然很大,并且预计会增加,特别是在老龄化人口和低资源环境中。持续存在的性别差异,特别是老年妇女负担的增加,需要有针对性的筛查和干预计划。这些发现强调了在未来几十年需要制定公平的、对年龄和性别敏感的公共卫生策略来减轻AMD日益增加的影响。
{"title":"Long-Term Trends in the Global Burden of Age-Related Macular Degeneration: Sex Differences, Aging Effects, and Future Projections in Middle-Aged and Older Adults.","authors":"Yuanyuan Li, Bo Mou, Xiusheng Song","doi":"10.1159/000550175","DOIUrl":"10.1159/000550175","url":null,"abstract":"<p><strong>Introduction: </strong>Age-related macular degeneration (AMD) is a major cause of irreversible vision loss in middle-aged and older populations worldwide. Understanding its long-term epidemiological trends is essential for anticipating future healthcare needs and guiding preventive strategies. This study characterizes the global, regional, and national burden of AMD in adults aged ≥45 years, with a focus on sex disparities, aging effects, and projected trends.</p><p><strong>Methods: </strong>Using data from the Global Burden of Disease Study 2021, we analyzed the prevalence and disability-adjusted life years (DALYs) of AMD across age, sex, region, country, and Socio-Demographic Index (SDI) groups. We applied an age-period-cohort model to disentangle the effects of aging, temporal changes, and birth cohort on AMD risk. Frontier analysis was conducted to identify best-practice benchmarks in disease burden reduction. The association between SDI and AMD burden was assessed to evaluate health inequities. An autoregressive integrated moving average (ARIMA) model was used to project age-standardized DALY rate (ASDR) and prevalence rate from 2022 to 2036.</p><p><strong>Results: </strong>Between 1990 and 2021, the absolute number of AMD cases and DALYs nearly doubled. In 2021, both prevalence and DALY rates increased exponentially with age, with females exhibiting consistently higher rates across all age groups. The age-period-cohort model indicated a declining trend in AMD risk over successive birth cohorts, suggesting potential improvements in early-life or cumulative risk factors. Notably, the highest age-standardized rates were observed in low-SDI regions, highlighting significant global inequities in disease burden. ARIMA projections suggest a modest but concerning increase in the global ASDR, rising to 6.80 (95% CI: 5.82-7.78) by 2036, with female ASDR reaching 7.46 (95% CI: 6.29-8.63).</p><p><strong>Conclusion: </strong>The burden of AMD remains substantial and is projected to grow, particularly among aging populations and in low-resource settings. The persistent sex disparity, especially the elevated burden in elderly women, calls for targeted screening and intervention programs. These findings emphasize the need for equitable, age- and sex-sensitive public health strategies to mitigate the rising impact of AMD in the coming decades.</p>","PeriodicalId":19662,"journal":{"name":"Ophthalmic Research","volume":" ","pages":"8-23"},"PeriodicalIF":1.9,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12863732/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145820572","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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Ophthalmic Research
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