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Capsular Tension Ring Implantation Improves Intraocular Lens Power Prediction Accuracy in Cataract with Retinitis Pigmentosa. 人工晶状体张力环植入术提高色素性白内障人工晶状体度数预测的准确性。
IF 3.2 3区 医学 Q2 OPHTHALMOLOGY Pub Date : 2025-12-22 DOI: 10.1007/s40123-025-01292-y
Siyan Li, Dandan Wang, Qin Chu, Ke Feng, Jiaying Wu, Yinying Zhao, Er Mo, Hongzhe Li, Pingjun Chang, Yun-E Zhao

Introduction: Patients with retinitis pigmentosa (RP) frequently exhibit zonular weakness, which poses challenges for intraocular lens (IOL) stability and refractive prediction. This study aimed to evaluate the impact of capsular tension ring (CTR) implantation on the predictive accuracy of 12 IOL power calculation formulas in patients with RP receiving cataract surgery.

Methods: We conducted a retrospective cohort study where the predictive accuracy of 12 IOL formulas was assessed using refractive prediction error (PE), mean absolute error (MAE), root-mean-square absolute error (RMSAE), and the percentage of eyes achieving target refraction within ± 0.25 D to ± 1.00 D. These metrics were compared between eyes with (n = 23) and without (n = 30) CTR implantation. The influence of lens thickness (LT) on formula accuracy was also evaluated.

Results: In the overall cohort of 53 eyes from 38 patients with RP, the Barrett Universal II (BUII) formula yielded the lowest numerical MAE (0.45 D) and RMSAE (0.56 D), though none of the formulas were statistically superior in RMSAE. In the CTR group, significantly lower MAE was observed for Cooke K6 (P = 0.024), Kane (P = 0.016), Emmetropia Verifying Optical (EVO) 2.0 (P = 0.040), and PEARL-DGS (P = 0.021) compared to the non-CTR group. The CTR group also exhibited a significantly higher percentage of eyes within ± 0.50 D (P = 0.016), ± 0.75 D (P < 0.001), and ± 1.00 D (P < 0.001) of target refraction. Increasing LT correlated with a hyperopic shift for all formulas; however, BUII demonstrated relatively stable MAE across LT quartiles.

Conclusions: Implantation of a CTR was associated with significantly improved predictive accuracy for several modern IOL formulas in patients with RP. The BUII formula showed the highest overall predictive accuracy.

摘要色素性视网膜炎(RP)患者经常表现为视网膜带性无力,这对人工晶状体(IOL)的稳定性和屈光预测提出了挑战。本研究旨在评估晶状体手术后囊膜张力环(CTR)植入术对12种人工晶体度数计算公式预测准确性的影响。方法:我们进行了一项回顾性队列研究,通过屈光预测误差(PE)、平均绝对误差(MAE)、均方根绝对误差(RMSAE)和在±0.25 D至±1.00 D内达到目标屈光的眼睛百分比来评估12种IOL配方的预测准确性。这些指标在植入CTR的眼睛(n = 23)和未植入CTR的眼睛(n = 30)之间进行了比较。同时还评价了透镜厚度对公式精度的影响。结果:在来自38例RP患者的53只眼的整体队列中,Barrett Universal II (BUII)配方产生了最低的数值MAE (0.45 D)和RMSAE (0.56 D),尽管没有任何配方在RMSAE方面具有统计学优势。CTR组Cooke K6 (P = 0.024)、Kane (P = 0.016)、Emmetropia Verifying Optical (EVO) 2.0 (P = 0.040)、PEARL-DGS (P = 0.021)的MAE均显著低于非CTR组。CTR组在±0.50 D (P = 0.016)和±0.75 D (P)范围内的眼睛比例也显著提高。结论:在RP患者中,植入CTR可显著提高几种现代IOL配方的预测准确性。BUII公式显示出最高的总体预测准确性。
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引用次数: 0
Influence of Refractive Status, Residential Climate, and Adverse Environmental Factors in Contact Lens Dropout: Insights from a Survey-Based Study. 屈光状态、居住气候和不利环境因素对隐形眼镜脱落的影响:一项基于调查的研究。
IF 3.2 3区 医学 Q2 OPHTHALMOLOGY Pub Date : 2025-12-15 DOI: 10.1007/s40123-025-01290-0
Joan Gispets, Aurora Torrents, Hanan Haulani, Antonio Ballesteros-Sánchez

Introduction: This study aimed to analyze the influence of refractive status, residential climate, and exposure to adverse environmental factors in contact lens (CL) dropout.

Methods: This cross-sectional study involved a face-to-face survey conducted by trained optometrists among former and current CL wearers (CLWs) at General Óptica centers throughout Spain. The survey included questions related to demographic characteristics, refractive status, residential climate, and adverse environmental factors. The chi-square test and a forward stepwise binary logistic regression analysis were performed.

Results: A total of 1094 surveys were included, comprising 509 former CLWs and 585 current CLWs. Age (B = 0.03; OR 1.03, 95% CI 1.02-1.04) and exposure to chemical (B = 3.51; OR 41.67, 95% CI 12.06-143.95) or dusty environments (B = 1.05; OR 2.93, 95% CI 1.16-7.41) were significantly associated with CL dropout. However, residing in a continental climate was associated with a lower CL dropout compared with a Mediterranean climate (B = - 1.39; OR 0.25, 95% CI 0.15-0.42). Spherical refraction, cylindrical refraction, and near addition power did not show statistically significant associations with CL dropout. Furthermore, the model excluded sex, exposure to high-humidity or dry environments, and the interactions between adverse environmental factors and residential climate as predictive factors.

Conclusions: Older age, residence in the Mediterranean climate, and exposure to chemical or dusty environments increase the risk of contact lens dropout. However, climate-specific conditions do not appear to significantly influence dropout rates, suggesting that other factors may play a more important role.

本研究旨在分析屈光状态、居住气候和暴露于不良环境因素对隐形眼镜(CL)脱落的影响。方法:这项横断面研究包括面对面的调查,由训练有素的验光师在西班牙的Óptica中心对以前和现在的CL佩戴者(clw)进行调查。调查的问题包括人口特征、屈光状态、居住气候和不利环境因素。卡方检验和正向逐步二元logistic回归分析。结果:共进行了1094项调查,包括509名前任劳工劳工及585名现任劳工劳工。年龄(B = 0.03; OR 1.03, 95% CI 1.02-1.04)、暴露于化学物质(B = 3.51; OR 41.67, 95% CI 12.06-143.95)或多尘环境(B = 1.05; OR 2.93, 95% CI 1.16-7.41)与CL辍学显著相关。然而,与地中海气候相比,居住在大陆性气候中与较低的CL辍学相关(B = - 1.39; OR 0.25, 95% CI 0.15-0.42)。球面折射、柱面折射和近加法力与结合力无统计学意义。此外,该模型排除了性别、暴露于高湿或干燥环境以及不利环境因素与居住气候之间的相互作用作为预测因素。结论:年龄较大、居住在地中海气候、接触化学物质或粉尘环境会增加隐形眼镜脱落的风险。然而,特定气候条件似乎对辍学率没有显著影响,这表明其他因素可能起着更重要的作用。
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引用次数: 0
Aflibercept 8 mg in Neovascular AMD-A Fast-Drying Anti-VEGF Drug: A Prospective Morpho-Functional Pilot Study. afliberept 8mg在新生血管amd -一种快干抗vegf药物中的应用:一项前瞻性形态-功能的初步研究。
IF 3.2 3区 医学 Q2 OPHTHALMOLOGY Pub Date : 2025-12-12 DOI: 10.1007/s40123-025-01296-8
Michele Rinaldi, Gilda Cennamo, Marina Concilio, Gaetano Corvino, Alessia Riccardo, Raffaele Nubi, Ciro Costagliola

Introduction: This study investigated early anatomical and functional outcomes in patients with treatment-naïve neovascular age-related macular degeneration (nAMD) treated with 8 mg aflibercept compared to patients treated with the standard dose of 2 mg aflibercept using spectral domain optical coherence tomography (SD-OCT), microperimetry, and macular pigment optical density (MPOD) after loading phase administration.

Methods: This prospective, observational study included 30 eyes of 30 patients (mean age 70 ± 5 years; 15 male, 15 female) recruited between January and June 2025 at the Eye Clinic of the University of Naples "Federico II". Patients were assigned to one of two age- and gender-matched groups receiving intravitreal injections of aflibercept at the dose of 2 mg (group A) or 8 mg (group B). All patients underwent complete ophthalmological examination, SD-OCT, OCT angiography, microperimetry, fixation stability, and measurement of MPOD at baseline, month 2, and month 4.

Results: Group B showed an improvement in all parameters, compared to group A, in particular: a greater reduction in central macular thickness (CMT) (p = 0.008), an improvement in best-corrected visual acuity (BCVA) (p = 0.012), increased retinal sensitivity (p = 0.015), increased MPOD (p = 0.027), and reduced bivariate contour ellipse area (BCEA) (p = 0.039). Group B showed a faster drying rate during the first 2 months (70 vs. 40 μm/month) and overall at month 4.

Conclusions: Intravitreal injections of aflibercept 8 mg resulted in significant short-term anatomical and functional improvement compared to standard dose and thus appear to be an effective option to achieve faster results in nAMD. MPOD can be considered as a potential new biomarker of macular health to study retinal functional response.

Trial registration: The research protocol was registered on ClinicalTrials.gov (NCT07074054).

本研究通过光谱域光学相干断层扫描(SD-OCT)、显微显微镜和加载期给药后黄斑色素光密度(MPOD),研究了接受8mg阿非利西普治疗的treatment-naïve新生血管性年龄相关性黄斑变性(nAMD)患者与接受标准剂量2mg阿非利西普治疗的患者的早期解剖和功能结果。方法:这项前瞻性观察性研究纳入了2025年1月至6月在那不勒斯“费德里科二世”大学眼科诊所招募的30例患者的30只眼睛(平均年龄70±5岁,男15例,女15例)。患者被分配到年龄和性别匹配的两组中的一组,接受2mg (A组)或8mg (B组)的玻璃体内注射afliberept。所有患者均在基线、第2个月和第4个月进行了完整的眼科检查、SD-OCT、OCT血管造影、显微镜检查、固定稳定性和MPOD测量。结果:与A组相比,B组各项指标均有改善,特别是黄斑中心厚度(CMT)下降幅度更大(p = 0.008),最佳矫正视力(BCVA)改善(p = 0.012),视网膜敏感性增加(p = 0.015), MPOD增加(p = 0.027),双变量轮廓椭圆面积(BCEA)减少(p = 0.039)。B组在前2个月的干燥速度更快(70 μm/月vs. 40 μm/月),第4个月的总体干燥速度更快。结论:与标准剂量相比,玻璃体内注射阿非利西贝8mg可在短期内显著改善解剖和功能,因此似乎是快速治疗nAMD的有效选择。MPOD可作为一种潜在的黄斑健康生物标志物,用于研究视网膜功能反应。试验注册:研究方案已在ClinicalTrials.gov (NCT07074054)上注册。
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引用次数: 0
One-Year Outcomes of Faricimab in Treatment-Naïve Neovascular Age-Related Macular Degeneration: A Swiss Retina Research Network Report. Faricimab治疗Treatment-Naïve新生血管性年龄相关性黄斑变性的一年疗效:瑞士视网膜研究网络报告。
IF 3.2 3区 医学 Q2 OPHTHALMOLOGY Pub Date : 2025-12-01 Epub Date: 2025-10-17 DOI: 10.1007/s40123-025-01252-6
Anne Tillmann, Richard Stillenmunkes, Justus G Garweg, Jennifer Cattaneo, Nicolò Bartolomeo, Gabriela Grimaldi, Tahm Spitznagel, Eva C De Oliveira Figueiredo, Aude Ambresin, Moreno Menghini, Gábor M Somfai, Sandrine Zweifel, Jacqueline Fröhlich, Dmitri Artemiev, Andreas Ebneter, Katja Hatz, Andreas Weinberger, Isabel B Pfister, Christin Schild, Chiara Eandi, Marion R Munk

Introduction: This study evaluates the efficacy and safety of faricimab in a real-world cohort of treatment-naïve patients with neovascular age-related macular degeneration (nAMD). Data were retrospectively collected from 130 eyes of 118 patients across 11 centers of the Swiss Retina Research Network, all treated with faricimab using a treat-and-extend regimen and followed for 12 months between May 2022 and October 2024.

Methods: Demographic data, visual and anatomical outcomes, treatment intervals, and adverse events were extracted from the electronic medical records over a 12-month follow-up period. Main outcomes included change in best corrected visual acuity (BCVA), central retinal thickness (CRT), presence of intra- and subretinal fluid, retinal pigment epithelial detachment (PED), injection intervals, and safety. Data are presented as mean ± standard deviation.

Results: Twelve months after the initiation of faricimab therapy, mean BCVA improved from 64.6 ± 14.1 to 69.2 ± 20.3 ETDRS (Early Treatment of Diabetic Retinopathy Study) letters (p < 0.001), while mean CRT decreased from 386.3 ± 172.3 to 246.6 ± 90.4 μm (p < 0.001). An early anatomical response to faricimab was observed in 34.6% of eyes achieving complete retinal fluid resolution after the first injection and in 55.6% after 12 months. The mean treatment interval was extended to 10.5 ± 4.3 weeks, with 26.2% of eyes achieving intervals of 8-11 weeks and 39.2% achieving intervals of ≥ 12 weeks after 12 months. Intraocular inflammation occurred in 0.77% of eyes (n = 1, anterior uveitis); serious adverse events were not reported.

Conclusion: Faricimab demonstrates favorable anatomical and functional outcomes with extended treatment intervals in a majority of patients with treatment-naïve nAMD, offering the potential of reduced treatment burden and the absence of retinal fluid in more than half of the subjects during the first year, while maintaining safety in a real-world setting.

本研究评估了faricimab在treatment-naïve新生血管性年龄相关性黄斑变性(nAMD)患者中的有效性和安全性。从瑞士视网膜研究网络11个中心的118名患者的130只眼睛中回顾性收集数据,所有患者均使用法利昔单抗治疗并延长治疗方案,并在2022年5月至2024年10月期间进行了12个月的随访。方法:在12个月的随访期间,从电子病历中提取人口统计数据、视觉和解剖结果、治疗间隔和不良事件。主要结果包括最佳矫正视力(BCVA)、视网膜中央厚度(CRT)、视网膜内液和视网膜下液的存在、视网膜色素上皮脱离(PED)、注射间隔和安全性的变化。数据以平均值±标准差表示。结果:法利西单抗治疗开始12个月后,平均BCVA从64.6±14.1改善到69.2±20.3 ETDRS(早期治疗糖尿病视网膜病变研究)字母(p)Faricimab在大多数treatment-naïve nAMD患者中显示出良好的解剖和功能结果,延长了治疗间隔,提供了减轻治疗负担的潜力,并且在第一年超过一半的受试者中没有视网膜液,同时在现实环境中保持安全性。
{"title":"One-Year Outcomes of Faricimab in Treatment-Naïve Neovascular Age-Related Macular Degeneration: A Swiss Retina Research Network Report.","authors":"Anne Tillmann, Richard Stillenmunkes, Justus G Garweg, Jennifer Cattaneo, Nicolò Bartolomeo, Gabriela Grimaldi, Tahm Spitznagel, Eva C De Oliveira Figueiredo, Aude Ambresin, Moreno Menghini, Gábor M Somfai, Sandrine Zweifel, Jacqueline Fröhlich, Dmitri Artemiev, Andreas Ebneter, Katja Hatz, Andreas Weinberger, Isabel B Pfister, Christin Schild, Chiara Eandi, Marion R Munk","doi":"10.1007/s40123-025-01252-6","DOIUrl":"10.1007/s40123-025-01252-6","url":null,"abstract":"<p><strong>Introduction: </strong>This study evaluates the efficacy and safety of faricimab in a real-world cohort of treatment-naïve patients with neovascular age-related macular degeneration (nAMD). Data were retrospectively collected from 130 eyes of 118 patients across 11 centers of the Swiss Retina Research Network, all treated with faricimab using a treat-and-extend regimen and followed for 12 months between May 2022 and October 2024.</p><p><strong>Methods: </strong>Demographic data, visual and anatomical outcomes, treatment intervals, and adverse events were extracted from the electronic medical records over a 12-month follow-up period. Main outcomes included change in best corrected visual acuity (BCVA), central retinal thickness (CRT), presence of intra- and subretinal fluid, retinal pigment epithelial detachment (PED), injection intervals, and safety. Data are presented as mean ± standard deviation.</p><p><strong>Results: </strong>Twelve months after the initiation of faricimab therapy, mean BCVA improved from 64.6 ± 14.1 to 69.2 ± 20.3 ETDRS (Early Treatment of Diabetic Retinopathy Study) letters (p < 0.001), while mean CRT decreased from 386.3 ± 172.3 to 246.6 ± 90.4 μm (p < 0.001). An early anatomical response to faricimab was observed in 34.6% of eyes achieving complete retinal fluid resolution after the first injection and in 55.6% after 12 months. The mean treatment interval was extended to 10.5 ± 4.3 weeks, with 26.2% of eyes achieving intervals of 8-11 weeks and 39.2% achieving intervals of ≥ 12 weeks after 12 months. Intraocular inflammation occurred in 0.77% of eyes (n = 1, anterior uveitis); serious adverse events were not reported.</p><p><strong>Conclusion: </strong>Faricimab demonstrates favorable anatomical and functional outcomes with extended treatment intervals in a majority of patients with treatment-naïve nAMD, offering the potential of reduced treatment burden and the absence of retinal fluid in more than half of the subjects during the first year, while maintaining safety in a real-world setting.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":"3079-3091"},"PeriodicalIF":3.2,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12579096/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145308866","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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
International Survey of Current Approaches to the Management of Neuropathic Corneal Pain by Experts. 目前专家对神经性角膜疼痛管理方法的国际调查。
IF 3.2 3区 医学 Q2 OPHTHALMOLOGY Pub Date : 2025-12-01 Epub Date: 2025-10-08 DOI: 10.1007/s40123-025-01242-8
Samy El Omda, Nikolaos Tzoumas, Margarita Calonge, Francisco Figueiredo

Introduction: Neuropathic corneal pain (NCP) is a challenging condition with limited consensus on its diagnosis and management. This study aimed to gather global insights from corneal specialists on the causes, investigative approaches, and management strategies for NCP.

Methods: A 32-question survey covering demographic, causes, investigations, treatments, and multidisciplinary engagement was sent to 152 invited international corneal specialists; 51 (34%) responded. We explored descriptive statistics and examined how responder characteristics influenced their answers.

Results: The most reported causes of NCP were chronic ocular surface disease (n = 41; 41%) and post-surgical factors (n = 34; 34%). The most common investigations, routinely performed by respondents, were the anesthetic challenge test, Schirmer's test, and corneal esthesiometry. In vivo confocal microscopy (IVCM) was routinely used by 37% (n = 19), with 69% (n = 29) of specialists stating that an abnormal result influenced their management. Ocular surface and pain questionnaires were used by 69% (n = 35), with the Ocular Surface Disease Index being the most popular (n = 25; 31%). Common treatments included artificial tears (n = 48; 94%), serum/plasma-derived tears (n = 41; 80%), topical corticosteroids (n = 34; 67%), and topical cyclosporin (n = 30; 59%). Only 38% (n = 19) felt comfortable independently prescribing systemic pharmacotherapy. A multidisciplinary approach was adopted by 47% (n = 24), with the two most common specialties involved being pain management (n = 30; 37%) and neurology (n = 26, 32%).

Conclusions: This survey provides valuable global insights into the causes, investigations, and management of NCP from the perspective of corneal specialists. These findings support further research and the development of guidelines to address this challenging condition.

神经性角膜疼痛(NCP)是一种具有挑战性的疾病,对其诊断和治疗的共识有限。本研究旨在收集全球角膜专家对NCP的病因、调查方法和管理策略的见解。方法:向152名受邀的国际角膜专家发送一份包含人口统计学、病因、调查、治疗和多学科参与的32个问题的调查;51人(34%)回应。我们探索了描述性统计,并检查了应答者的特征如何影响他们的答案。结果:报告最多的NCP病因是慢性眼表疾病(n = 41; 41%)和术后因素(n = 34; 34%)。最常见的检查是麻醉激发试验、Schirmer试验和角膜感觉测量。37% (n = 19)的专家常规使用体内共聚焦显微镜(IVCM), 69% (n = 29)的专家表示异常结果影响了他们的治疗。69% (n = 35)使用眼表和疼痛问卷,其中眼表疾病指数最受欢迎(n = 25; 31%)。常见的治疗方法包括人工泪液(n = 48; 94%)、血清/血浆来源泪液(n = 41; 80%)、外用皮质类固醇(n = 34; 67%)和外用环孢素(n = 30; 59%)。只有38% (n = 19)的患者对独立开全身药物治疗处方感到放心。47% (n = 24)的患者采用多学科方法,其中两个最常见的专科是疼痛管理(n = 30, 37%)和神经病学(n = 26, 32%)。结论:本调查从角膜专家的角度对NCP的病因、调查和管理提供了有价值的全球见解。这些发现支持进一步的研究和指导方针的发展,以解决这一具有挑战性的条件。
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引用次数: 0
Restoring Vision with Noninvasive Brain Stimulation: A Narrative Review. 用无创脑刺激恢复视力:一个叙述性的回顾。
IF 3.2 3区 医学 Q2 OPHTHALMOLOGY Pub Date : 2025-12-01 Epub Date: 2025-10-02 DOI: 10.1007/s40123-025-01249-1
Xinyan Duan, Yulian Zhou, Peng Zhang, Wen Wen, Chen Zhao

Vision impairment resulting from defects in the visual pathway was once considered irreversible. The main barrier is the limited plasticity of the visual system after the critical period. However, as our understanding of noninvasive brain stimulation (NIBS) deepens, its ability to enhance neural plasticity and regulate the neural system indicates a transformation in treatment and rehabilitation strategies. To verify the potential of NIBS in visual restoration, this review elaborates on the mechanisms underlying the immediate effects and aftereffects of NIBS with proofs from molecular, cellular, and systematic levels. The concept of neural oscillation is especially emphasized as it contributes greatly to cognition and can be interfered with by NIBS. Meanwhile, it discusses recent clinical findings on the use of NIBS, with or without visual perceptual learning, focusing on two key questions which have not been specified in previous reviews: (1) the duration of behavioral improvements, and (2) the optimal treatment period required for different visual functions and NIBS modalities. On the basis of the inconsistency in existing studies, this review is also devoted to optimizing the practical application of combining NIBS with VPL and concludes that the location, timing, and form of NIBS are crucial to achieving satisfying complementary effects.

视觉通路缺陷导致的视力损害曾被认为是不可逆转的。主要障碍是关键期后视觉系统的可塑性有限。然而,随着我们对非侵入性脑刺激(NIBS)认识的加深,其增强神经可塑性和调节神经系统的能力预示着治疗和康复策略的转变。为了验证NIBS在视力恢复中的潜力,本文从分子、细胞和系统层面阐述了NIBS的即时效应和后效机制。神经振荡的概念被特别强调,因为它对认知有很大的贡献,并且可以被NIBS干扰。同时,本文讨论了NIBS的最新临床研究结果,包括有无视觉知觉学习,重点讨论了两个在以前的综述中没有明确的关键问题:(1)行为改善的持续时间;(2)不同视觉功能和NIBS模式所需的最佳治疗时间。在现有研究不一致的基础上,本文还对NIBS与VPL结合的实际应用进行了优化,认为NIBS的位置、时间和形式是实现令人满意的互补效果的关键。
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引用次数: 0
Administration of the Travoprost Intracameral Implant in an Office-Based Surgery Setting. 曲伏前列素在办公室手术环境中的应用。
IF 3.2 3区 医学 Q2 OPHTHALMOLOGY Pub Date : 2025-12-01 Epub Date: 2025-10-04 DOI: 10.1007/s40123-025-01254-4
Inder Paul Singh, George R Reiss, Brian E Flowers, L Jay Katz, Dale W Usner, David Applegate, Angela C Kothe, Tomas Navratil

Introduction: The purpose of this analysis was to assess the safety outcomes of a subgroup of patients who received a travoprost intracameral implant in an office-based surgery setting from one of the phase 3 registration trials, GC-012, for the implant.

Methods: Adult patients with open-angle glaucoma or ocular hypertension on 0 to 3 pre-study intraocular pressure (IOP)-lowering medications underwent a washout period (if applicable). Patients who qualified based on having an unmedicated mean diurnal IOP of 21 mmHg or greater and an IOP of 36 mmHg or less at each of the diurnal timepoints received a travoprost intracameral implant and were followed for safety outcomes at eight visits over a 12-month period. Safety evaluations included adverse events, slit-lamp examination, gonioscopy, pachymetry, dilated fundus examination, specular microscopy, perimetry, and best-corrected visual acuity.

Results: A total of 37 patients received a travoprost intracameral implant in an office-based surgery setting. Administration of the implant was successful in 100% of patients. There were no serious ocular adverse events or ocular infections in patients administered the implant.

Conclusions: This subgroup analysis demonstrated that administration of the travoprost intracameral implant in an office-based surgery setting was safe and well tolerated.

Trial registration: ClinicalTrials.gov identifier, NCT03868124.

本分析的目的是评估一组在办公室手术环境中接受曲伏前列素房内植入物的患者的安全性结果,该植入物来自一项3期注册试验GC-012。方法:开角型青光眼或高眼压的成人患者在研究前服用0 - 3种降眼压药物,并进行洗脱期(如果适用)。根据未用药的平均每日IOP为21mmhg或更高,每个每日时间点IOP为36mmhg或更低的患者接受曲伏前列素内膜植入,并在12个月的时间内随访8次安全性结果。安全性评估包括不良事件、裂隙灯检查、角镜检查、厚视检查、眼底扩张检查、镜面显微镜、周边检查和最佳矫正视力。结果:共有37名患者在办公室手术环境中接受了曲伏前列素内耳植入。植入物的使用在100%的患者中成功。在接受植入的患者中没有严重的眼部不良事件或眼部感染。结论:该亚组分析表明,在办公室手术环境中使用曲伏前列素是安全且耐受性良好的。试验注册:ClinicalTrials.gov识别码,NCT03868124。
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引用次数: 0
Machine Learning Identifies Predictors of Amniotic Membrane Graft Failure in Neurotrophic Keratitis. 机器学习识别神经营养性角膜炎羊膜移植失败的预测因素。
IF 3.2 3区 医学 Q2 OPHTHALMOLOGY Pub Date : 2025-12-01 Epub Date: 2025-10-14 DOI: 10.1007/s40123-025-01259-z
Danae Fernandes, Hannah Crowdy, Vincent Daien, Frederic Michon

Introduction: Neurotrophic keratitis (NK) is a rare, vision-threatening corneal disease characterized by impaired epithelial healing and frequent recurrence of defects. Amniotic membrane transplantation (AMT) is an established therapeutic option, but outcomes remain variable and predictors of failure are poorly defined. We aimed to identify clinical and systemic factors associated with recurrence following AMT using both classical statistics and machine learning approaches.

Methods: We conducted a retrospective cohort study of 66 patients with NK who underwent AMT at a tertiary referral center between 2019 and 2025. The primary endpoint was post-AMT epithelial defect recurrence. The prespecified primary analysis was a multivariable logistic regression, complemented by exploratory machine learning approaches. Clinical, demographic, and ophthalmic variables were abstracted from medical records. All patients had complete outcome data; covariate-level missingness was minimal and handled with complete-case analyses. Associations with recurrence were examined using bivariate tests and multivariable regression; data structure was explored with principal component analysis (PCA) and hierarchical clustering; and predictive performance was additionally evaluated using random forest classifiers.

Results: Epithelial defect recurrence occurred in 46 patients (70%). Multivariable analysis identified systemic immunosuppressive therapy (odds ratio [OR] 19.9; p = 0.023) and number of AMTs (OR 2.73 per graft; p = 0.040) as independent predictors, with prior ocular surgery showing a borderline association (p = 0.060). PCA and clustering revealed three phenotypic subgroups, including a high-risk cluster (72% recurrence) characterized by immunosuppression, multiple AMTs, prior surgery, and inflammatory complications. Random forest classification confirmed the predictive role of these variables, achieving an AUC of 0.82 with balanced sensitivity (74%) and specificity (81%).

Conclusion: Systemic immunosuppression, repeated AMTs, and prior ocular surgery are key predictors of AMT failure in NK. Combining regression models, clustering, and machine learning provides a robust framework for risk stratification. These findings support the development of personalized monitoring and treatment strategies to improve surgical outcomes in NK.

神经营养性角膜炎(NK)是一种罕见的、威胁视力的角膜疾病,其特征是上皮愈合受损和缺损频繁复发。羊膜移植(AMT)是一种确定的治疗选择,但结果仍然可变,失败的预测因素定义不清。我们的目的是使用经典统计学和机器学习方法确定与AMT后复发相关的临床和全身因素。方法:我们对2019年至2025年间在三级转诊中心接受AMT治疗的66例NK患者进行了回顾性队列研究。主要终点是amt后上皮缺损复发。预先指定的主要分析是多变量逻辑回归,辅以探索性机器学习方法。从医疗记录中提取临床、人口统计学和眼科变量。所有患者均有完整的结局数据;协变量水平缺失是最小的,并处理完整的案例分析。使用双变量检验和多变量回归检验与复发的关系;利用主成分分析(PCA)和层次聚类对数据结构进行分析;此外,还使用随机森林分类器对预测性能进行了评估。结果:上皮缺损复发46例(70%)。多变量分析发现,全身免疫抑制治疗(优势比[OR] 19.9; p = 0.023)和amt数量(每个移植物的优势比[OR] 2.73; p = 0.040)是独立的预测因素,既往眼部手术显示出边缘相关性(p = 0.060)。PCA和聚类显示了三个表型亚组,包括一个高风险群(72%复发率),其特征是免疫抑制、多发amt、既往手术和炎症并发症。随机森林分类证实了这些变量的预测作用,实现了0.82的AUC,平衡了敏感性(74%)和特异性(81%)。结论:全身免疫抑制、反复AMT治疗和眼部手术史是NK患者AMT治疗失败的关键预测因素。结合回归模型、聚类和机器学习为风险分层提供了一个健壮的框架。这些发现支持个性化监测和治疗策略的发展,以改善NK的手术结果。
{"title":"Machine Learning Identifies Predictors of Amniotic Membrane Graft Failure in Neurotrophic Keratitis.","authors":"Danae Fernandes, Hannah Crowdy, Vincent Daien, Frederic Michon","doi":"10.1007/s40123-025-01259-z","DOIUrl":"10.1007/s40123-025-01259-z","url":null,"abstract":"<p><strong>Introduction: </strong>Neurotrophic keratitis (NK) is a rare, vision-threatening corneal disease characterized by impaired epithelial healing and frequent recurrence of defects. Amniotic membrane transplantation (AMT) is an established therapeutic option, but outcomes remain variable and predictors of failure are poorly defined. We aimed to identify clinical and systemic factors associated with recurrence following AMT using both classical statistics and machine learning approaches.</p><p><strong>Methods: </strong>We conducted a retrospective cohort study of 66 patients with NK who underwent AMT at a tertiary referral center between 2019 and 2025. The primary endpoint was post-AMT epithelial defect recurrence. The prespecified primary analysis was a multivariable logistic regression, complemented by exploratory machine learning approaches. Clinical, demographic, and ophthalmic variables were abstracted from medical records. All patients had complete outcome data; covariate-level missingness was minimal and handled with complete-case analyses. Associations with recurrence were examined using bivariate tests and multivariable regression; data structure was explored with principal component analysis (PCA) and hierarchical clustering; and predictive performance was additionally evaluated using random forest classifiers.</p><p><strong>Results: </strong>Epithelial defect recurrence occurred in 46 patients (70%). Multivariable analysis identified systemic immunosuppressive therapy (odds ratio [OR] 19.9; p = 0.023) and number of AMTs (OR 2.73 per graft; p = 0.040) as independent predictors, with prior ocular surgery showing a borderline association (p = 0.060). PCA and clustering revealed three phenotypic subgroups, including a high-risk cluster (72% recurrence) characterized by immunosuppression, multiple AMTs, prior surgery, and inflammatory complications. Random forest classification confirmed the predictive role of these variables, achieving an AUC of 0.82 with balanced sensitivity (74%) and specificity (81%).</p><p><strong>Conclusion: </strong>Systemic immunosuppression, repeated AMTs, and prior ocular surgery are key predictors of AMT failure in NK. Combining regression models, clustering, and machine learning provides a robust framework for risk stratification. These findings support the development of personalized monitoring and treatment strategies to improve surgical outcomes in NK.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":"3059-3077"},"PeriodicalIF":3.2,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12579097/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145286643","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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
Cenegermin for the Treatment of Moderate or Severe Neurotrophic Keratopathy: Results from a Prospective, Phase IV, Open-Label Study in China. Cenegermin用于治疗中度或重度神经营养性角膜病变:来自中国一项前瞻性、IV期、开放标签研究的结果
IF 3.2 3区 医学 Q2 OPHTHALMOLOGY Pub Date : 2025-12-01 Epub Date: 2025-10-05 DOI: 10.1007/s40123-025-01253-5
Suxia Li, Jianjiang Xu, Jin Yuan, Zhiqiang Pan, Giacomo Siri, Scott G Hauswirth, Flavio Mantelli, Weiyun Shi

Introduction: Neurotrophic keratopathy (NK) is a rare degenerative disease that can lead to epithelial breakdown, corneal ulceration, and potentially perforation and vision loss. Cenegermin is a recombinant human nerve growth factor approved for stage 2/3 NK, though data on its efficacy outside of United States/European populations are limited.

Methods: This prospective, phase IV, open-label, multicenter study investigated the efficacy, safety, and pharmacokinetics (PK) of cenegermin eye drops in Chinese patients with stage 2/3 NK in a routine clinical setting (CTR20220066). Patients received cenegermin eye drops (20 mcg/mL; 6 times/day at 2-hour intervals) for 8 weeks with follow-up to week 56. The primary endpoint was corneal healing at week 8 per investigator assessment. Additional endpoints included lesion worsening, corneal healing through week 56, safety, and PK.

Results: Of the 28 patients receiving cenegermin, 22/26 (84.6%, 95% confidence interval 65.1-95.6%; 2 missing) achieved corneal healing at week 8; 3/22 (13.6%) reported recurrence during 48-week follow-up but 20/22 (90.9%) were healed at week 56; and 2/28 (7.1%) experienced lesion worsening during 8-week treatment. In addition, 25/28 (89.3%) experienced ≥ 1 treatment-emergent adverse event (TEAE); for the majority (23/28, 82.2%) of these patients, TEAEs were mild/moderate. None of the serious TEAEs reported by 10 (35.7%) patients were assessed as related to cenegermin or led to treatment discontinuation. Eye pain was the most common cenegermin-related TEAE (5/28, 17.9%), primarily limited to the treatment period.

Conclusions: These findings demonstrate that cenegermin eye drops are an effective, generally well-tolerated treatment in Chinese patients with stage 2/3 NK, supporting their use in this patient population.

Trial registration: CTR20220066.

神经营养性角膜病变(NK)是一种罕见的退行性疾病,可导致上皮破坏,角膜溃疡,潜在穿孔和视力丧失。Cenegermin是一种重组人神经生长因子,被批准用于2/3期NK,但其在美国/欧洲以外人群的疗效数据有限。方法:这项前瞻性、开放标签、多中心的IV期研究在常规临床环境(CTR20220066)中调查了genegermin滴眼液在中国2/3期NK患者中的疗效、安全性和药代动力学(PK)。患者接受genegermin滴眼液(20 mcg/mL, 6次/天,间隔2小时),持续8周,随访至第56周。主要终点是第8周的角膜愈合。其他终点包括病变恶化、第56周的角膜愈合、安全性和pkk。结果:在接受genegermin治疗的28例患者中,22/26(84.6%,95%置信区间65.1-95.6%,2例缺失)在第8周实现角膜愈合;3/22(13.6%)患者随访48周复发,20/22(90.9%)患者随访56周痊愈;2/28(7.1%)患者在8周治疗期间出现病变恶化。此外,25/28(89.3%)患者出现≥1次治疗不良事件(TEAE);大多数患者(23/28,82.2%)teae为轻/中度。10例(35.7%)患者报告的严重teae均未被评估为与肾上腺素相关或导致停止治疗。眼部疼痛是最常见的与萌芽相关的TEAE(5/ 28,17.9%),主要局限于治疗期间。结论:这些研究结果表明,绿芽明滴眼液在中国2/3期NK患者中是一种有效且耐受性良好的治疗方法,支持在这一患者群体中使用。试验注册号:CTR20220066。
{"title":"Cenegermin for the Treatment of Moderate or Severe Neurotrophic Keratopathy: Results from a Prospective, Phase IV, Open-Label Study in China.","authors":"Suxia Li, Jianjiang Xu, Jin Yuan, Zhiqiang Pan, Giacomo Siri, Scott G Hauswirth, Flavio Mantelli, Weiyun Shi","doi":"10.1007/s40123-025-01253-5","DOIUrl":"10.1007/s40123-025-01253-5","url":null,"abstract":"<p><strong>Introduction: </strong>Neurotrophic keratopathy (NK) is a rare degenerative disease that can lead to epithelial breakdown, corneal ulceration, and potentially perforation and vision loss. Cenegermin is a recombinant human nerve growth factor approved for stage 2/3 NK, though data on its efficacy outside of United States/European populations are limited.</p><p><strong>Methods: </strong>This prospective, phase IV, open-label, multicenter study investigated the efficacy, safety, and pharmacokinetics (PK) of cenegermin eye drops in Chinese patients with stage 2/3 NK in a routine clinical setting (CTR20220066). Patients received cenegermin eye drops (20 mcg/mL; 6 times/day at 2-hour intervals) for 8 weeks with follow-up to week 56. The primary endpoint was corneal healing at week 8 per investigator assessment. Additional endpoints included lesion worsening, corneal healing through week 56, safety, and PK.</p><p><strong>Results: </strong>Of the 28 patients receiving cenegermin, 22/26 (84.6%, 95% confidence interval 65.1-95.6%; 2 missing) achieved corneal healing at week 8; 3/22 (13.6%) reported recurrence during 48-week follow-up but 20/22 (90.9%) were healed at week 56; and 2/28 (7.1%) experienced lesion worsening during 8-week treatment. In addition, 25/28 (89.3%) experienced ≥ 1 treatment-emergent adverse event (TEAE); for the majority (23/28, 82.2%) of these patients, TEAEs were mild/moderate. None of the serious TEAEs reported by 10 (35.7%) patients were assessed as related to cenegermin or led to treatment discontinuation. Eye pain was the most common cenegermin-related TEAE (5/28, 17.9%), primarily limited to the treatment period.</p><p><strong>Conclusions: </strong>These findings demonstrate that cenegermin eye drops are an effective, generally well-tolerated treatment in Chinese patients with stage 2/3 NK, supporting their use in this patient population.</p><p><strong>Trial registration: </strong>CTR20220066.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":"3021-3033"},"PeriodicalIF":3.2,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12579034/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145228393","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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
AI-Based Quantitative Assessment of Retinal Vascular Morphology in Circumscribed Choroidal Hemangioma. 基于人工智能的边界脉络膜血管瘤视网膜血管形态定量评价。
IF 3.2 3区 医学 Q2 OPHTHALMOLOGY Pub Date : 2025-12-01 Epub Date: 2025-10-22 DOI: 10.1007/s40123-025-01256-2
Zhen-Yu Liu, Hai-Long He, Xuan-Yu Chen, Zhi-Han Zhang, Xiao-Yan Peng, Zi-Bing Jin

Introduction: This study aimed to apply a deep learning-based artificial intelligence (AI) system for quantitative analysis of retinal vascular morphology in patients with circumscribed choroidal hemangioma (CCH), and to explore differences based on lesion location.

Methods: This retrospective case-control study included 45 treatment-naive CCH eyes and their contralateral healthy eyes as controls, recruited from 45 patients (mean age: 44.91 ± 11.98 years; 10 female patients). Retinal photographs were analyzed using AI software to extract vascular parameters, including vessel density, caliber, tortuosity, and fractal dimension. Inter-group comparisons and conditional logistic regression were conducted. Subgroup analysis was performed based on the lesion's position relative to the optic disc.

Results: Compared with controls, CCH eyes showed significantly reduced vascular density (p < 0.005) within 3 mm and 5 mm of the fovea. Venular caliber was significantly increased across multiple concentric zones (1.0-2.5 papillary diameter, PD), while arteriole-to-venule ratio (AVR) was decreased (p < 0.001). Tortuosity and fractal dimension of both arterioles and venules were significantly reduced (all p < 0.05). Logistic regression confirmed vessel caliber (p = 0.001), AVR (p = 0.001), tortuosity (p = 0.006), and fractal dimension (p = 0.004) as significant parameters associated with CCH. Lesions within 1.0 PD of the optic disc were linked to lower arteriolar caliber and AVR (p < 0.05).

Conclusion: Retinal vascular morphological alterations are evident in CCH and vary with lesion location. Key parameters, such as vascular density, venular caliber, AVR, and fractal dimension, may serve as potential imaging biomarkers for evaluating and monitoring CCH-related retinal changes.

摘要:本研究旨在应用基于深度学习的人工智能(AI)系统定量分析局限性脉络膜血管瘤(CCH)患者的视网膜血管形态,并探讨基于病变位置的差异。方法:本回顾性病例对照研究从45例患者(平均年龄:44.91±11.98岁,女性10例)中招募45只治疗初期CCH眼及其对侧健康眼作为对照。利用人工智能软件对视网膜照片进行分析,提取血管参数,包括血管密度、口径、弯曲度和分形维数。进行组间比较和条件逻辑回归。根据病变相对视盘的位置进行亚组分析。结果:与对照组相比,CCH组视网膜血管密度明显降低(p)。结论:CCH组视网膜血管形态改变明显,且随病变部位不同而不同。关键参数,如血管密度、静脉口径、AVR和分形维数,可能作为评估和监测cch相关视网膜变化的潜在成像生物标志物。
{"title":"AI-Based Quantitative Assessment of Retinal Vascular Morphology in Circumscribed Choroidal Hemangioma.","authors":"Zhen-Yu Liu, Hai-Long He, Xuan-Yu Chen, Zhi-Han Zhang, Xiao-Yan Peng, Zi-Bing Jin","doi":"10.1007/s40123-025-01256-2","DOIUrl":"10.1007/s40123-025-01256-2","url":null,"abstract":"<p><strong>Introduction: </strong>This study aimed to apply a deep learning-based artificial intelligence (AI) system for quantitative analysis of retinal vascular morphology in patients with circumscribed choroidal hemangioma (CCH), and to explore differences based on lesion location.</p><p><strong>Methods: </strong>This retrospective case-control study included 45 treatment-naive CCH eyes and their contralateral healthy eyes as controls, recruited from 45 patients (mean age: 44.91 ± 11.98 years; 10 female patients). Retinal photographs were analyzed using AI software to extract vascular parameters, including vessel density, caliber, tortuosity, and fractal dimension. Inter-group comparisons and conditional logistic regression were conducted. Subgroup analysis was performed based on the lesion's position relative to the optic disc.</p><p><strong>Results: </strong>Compared with controls, CCH eyes showed significantly reduced vascular density (p < 0.005) within 3 mm and 5 mm of the fovea. Venular caliber was significantly increased across multiple concentric zones (1.0-2.5 papillary diameter, PD), while arteriole-to-venule ratio (AVR) was decreased (p < 0.001). Tortuosity and fractal dimension of both arterioles and venules were significantly reduced (all p < 0.05). Logistic regression confirmed vessel caliber (p = 0.001), AVR (p = 0.001), tortuosity (p = 0.006), and fractal dimension (p = 0.004) as significant parameters associated with CCH. Lesions within 1.0 PD of the optic disc were linked to lower arteriolar caliber and AVR (p < 0.05).</p><p><strong>Conclusion: </strong>Retinal vascular morphological alterations are evident in CCH and vary with lesion location. Key parameters, such as vascular density, venular caliber, AVR, and fractal dimension, may serve as potential imaging biomarkers for evaluating and monitoring CCH-related retinal changes.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":"3093-3108"},"PeriodicalIF":3.2,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12579022/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145346441","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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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Ophthalmology and Therapy
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