Isabel Inmaculada Guedes Guedes, Pedro Saavedra Santana, Ángel Ramos de Miguel, Ángel Ramos Macías, Francisco Cabrera López, Ayoze González Hernández
Introduction: Diabetic retinopathy (DR) persists as a predominant cause of preventable vision loss globally, with its prevalence escalating in conjunction with the diabetes epidemic. Efficient, automated screening is needed to enable earlier detection of DR at scale. Artificial intelligence (AI)-driven platforms, such as EyeArt® (Eyenuk Inc.), offer a scalable solution with potential to alleviate the burden on healthcare systems.
Methods: A systematic review (SR) and meta-analysis were conducted following PRISMA and MOOSE guidelines. This review was prospectively registered in PROSPERO (CRD42024571137). Observational studies published between 2016 and 2024 assessing the diagnostic performance of the EyeArt® system for DR detection were retrieved from PubMed, Scopus, and Embase. Data on sensitivity, specificity, and diagnostic odds ratio (DOR) were extracted, and pooled estimates were calculated using a random-effects model. Study quality was assessed using QUADAS-2 and GRADE frameworks.
Results: Seventeen studies, met the inclusion criteria. The pooled log diagnostic odds ratio (LDOR) was 3.96 (95% CI 3.54-4.39), and the area under the summary receiver operating characteristic (SROC) curve was 0.932 (95% CI 0.885-0.985), indicating high overall diagnostic accuracy. No significant heterogeneity was observed in the pooled diagnostic OR, although sensitivity and specificity varied across studies.
Conclusions: EyeArt® demonstrates high diagnostic accuracy for detecting any-grade and referable DR across diverse clinical and geographical settings. Its integration into DR screening programs could improve early detection, optimize healthcare resource allocation, and expand access to ophthalmic care, particularly in resource-limited environments.
Key messages: • EyeArt®demonstrated high diagnostic accuracy for detecting referable or any-grade DR across diverse settings. • Its consistent performance supports its integration into routine DR screening workflows. • Deployment of EyeArt®for DR may optimize resource allocation, streamline diagnostic pathways, and expand access, particularly in resource-limited environments.
导读:糖尿病视网膜病变(DR)一直是全球可预防性视力丧失的主要原因,其患病率随着糖尿病的流行而不断上升。需要高效、自动化的筛查,以便及早大规模发现DR。人工智能(AI)驱动的平台,如EyeArt®(Eyenuk Inc.),提供了一种可扩展的解决方案,有可能减轻医疗保健系统的负担。方法:按照PRISMA和MOOSE指南进行系统评价(SR)和meta分析。本综述在PROSPERO前瞻性注册(CRD42024571137)。从PubMed、Scopus和Embase检索了2016年至2024年间发表的评估EyeArt®系统诊断DR检测性能的观察性研究。提取敏感性、特异性和诊断优势比(DOR)数据,并使用随机效应模型计算汇总估计值。采用QUADAS-2和GRADE框架评估研究质量。结果:17项研究符合纳入标准。合并对数诊断优势比(LDOR)为3.96 (95% CI 3.54 ~ 4.39),总受试者工作特征(SROC)曲线下面积为0.932 (95% CI 0.885 ~ 0.985),总体诊断准确率较高。虽然不同研究的敏感性和特异性不同,但在汇总诊断OR中没有观察到显著的异质性。结论:EyeArt®在不同临床和地理环境中检测任何级别和可参考的DR具有很高的诊断准确性。将其整合到DR筛查计划中可以改善早期发现,优化医疗保健资源分配,并扩大眼科护理的可及性,特别是在资源有限的环境中。•EyeArt®在检测不同设置的可参考或任何级别的DR方面表现出高诊断准确性。•其一致的性能支持其集成到常规DR筛选工作流程。•部署EyeArt®用于DR可以优化资源分配,简化诊断途径,并扩大访问范围,特别是在资源有限的环境中。
{"title":"Diagnostic Accuracy of the EyeArt Artificial Intelligence System for Diabetic Retinopathy: A Systematic Review and Meta-Analysis.","authors":"Isabel Inmaculada Guedes Guedes, Pedro Saavedra Santana, Ángel Ramos de Miguel, Ángel Ramos Macías, Francisco Cabrera López, Ayoze González Hernández","doi":"10.1159/000550443","DOIUrl":"https://doi.org/10.1159/000550443","url":null,"abstract":"<p><strong>Introduction: </strong>Diabetic retinopathy (DR) persists as a predominant cause of preventable vision loss globally, with its prevalence escalating in conjunction with the diabetes epidemic. Efficient, automated screening is needed to enable earlier detection of DR at scale. Artificial intelligence (AI)-driven platforms, such as EyeArt® (Eyenuk Inc.), offer a scalable solution with potential to alleviate the burden on healthcare systems.</p><p><strong>Methods: </strong>A systematic review (SR) and meta-analysis were conducted following PRISMA and MOOSE guidelines. This review was prospectively registered in PROSPERO (CRD42024571137). Observational studies published between 2016 and 2024 assessing the diagnostic performance of the EyeArt® system for DR detection were retrieved from PubMed, Scopus, and Embase. Data on sensitivity, specificity, and diagnostic odds ratio (DOR) were extracted, and pooled estimates were calculated using a random-effects model. Study quality was assessed using QUADAS-2 and GRADE frameworks.</p><p><strong>Results: </strong>Seventeen studies, met the inclusion criteria. The pooled log diagnostic odds ratio (LDOR) was 3.96 (95% CI 3.54-4.39), and the area under the summary receiver operating characteristic (SROC) curve was 0.932 (95% CI 0.885-0.985), indicating high overall diagnostic accuracy. No significant heterogeneity was observed in the pooled diagnostic OR, although sensitivity and specificity varied across studies.</p><p><strong>Conclusions: </strong>EyeArt® demonstrates high diagnostic accuracy for detecting any-grade and referable DR across diverse clinical and geographical settings. Its integration into DR screening programs could improve early detection, optimize healthcare resource allocation, and expand access to ophthalmic care, particularly in resource-limited environments.</p><p><strong>Key messages: </strong>• EyeArt®demonstrated high diagnostic accuracy for detecting referable or any-grade DR across diverse settings. • Its consistent performance supports its integration into routine DR screening workflows. • Deployment of EyeArt®for DR may optimize resource allocation, streamline diagnostic pathways, and expand access, particularly in resource-limited environments.</p>","PeriodicalId":19595,"journal":{"name":"Ophthalmologica","volume":" ","pages":"1-29"},"PeriodicalIF":1.9,"publicationDate":"2026-01-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145966711","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Alban Comet, Frédéric Matonti, John Conrath, Thierry David, François Devin, Christophe Morel, Pierre Gascon, Prithvi Ramtohul
Rhegmatogenous Retinal Detachment (rRD) can cause irreversible damage to the outer retina, leading to loss of visual acuity despite successful surgery. Postoperative complications, such as retinal folds, particularly macular Outer Retinal Folds (mORFs), can affect vision with distortions and visual field defects when the macula is involved. ORFs are characterized as vertical hyperreflective lesions on SD-OCT, whereas on en face SD-OCT they appear as single or multiple linear or curvilinear hyperreflective bands surrounded by a hyporeflective halo. Our study was conducted to assess the time to resolution of mORFs after rRD repair through pars plana vitrectomy. The study included 26 non-consecutive patients with mORFs observed via SD-OCT after surgery. The mean time for mORFs resolution was 3.7 months, with all mORFs fully absorbed within six months. Factors such as mORFs length influenced resorption speed, but no significant association with other variables (e.g., tamponade agent or retinotomy) was found. The study concludes that mORFs after rRD surgery generally resolve without requiring additional interventions and that precise monitoring using SD-OCT is essential for tracking their resolution.
{"title":"Time to resolution of outer retinal folds (ORFs) following pars plana vitrectomy for rhegmatogenous retinal detachment using en face OCT.","authors":"Alban Comet, Frédéric Matonti, John Conrath, Thierry David, François Devin, Christophe Morel, Pierre Gascon, Prithvi Ramtohul","doi":"10.1159/000550319","DOIUrl":"https://doi.org/10.1159/000550319","url":null,"abstract":"<p><p>Rhegmatogenous Retinal Detachment (rRD) can cause irreversible damage to the outer retina, leading to loss of visual acuity despite successful surgery. Postoperative complications, such as retinal folds, particularly macular Outer Retinal Folds (mORFs), can affect vision with distortions and visual field defects when the macula is involved. ORFs are characterized as vertical hyperreflective lesions on SD-OCT, whereas on en face SD-OCT they appear as single or multiple linear or curvilinear hyperreflective bands surrounded by a hyporeflective halo. Our study was conducted to assess the time to resolution of mORFs after rRD repair through pars plana vitrectomy. The study included 26 non-consecutive patients with mORFs observed via SD-OCT after surgery. The mean time for mORFs resolution was 3.7 months, with all mORFs fully absorbed within six months. Factors such as mORFs length influenced resorption speed, but no significant association with other variables (e.g., tamponade agent or retinotomy) was found. The study concludes that mORFs after rRD surgery generally resolve without requiring additional interventions and that precise monitoring using SD-OCT is essential for tracking their resolution.</p>","PeriodicalId":19595,"journal":{"name":"Ophthalmologica","volume":" ","pages":"1-18"},"PeriodicalIF":1.9,"publicationDate":"2026-01-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145934526","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Rachid Bouchikh-El Jarroudi, Pablo Enrique Díaz-Aljaro, Jordi Castellví-Manent, Nevena Romanic Bubalo, Rubén Dario Fernandez-Torrón, Antonio Sabala Llopart, Judit Ruiz-Mata, Susana Castillo-Acedo, María Larrousse Morellón, Cristina Tural Llacher, Susana Ruiz-Bilbao
Purpose: To evaluate the prognostic significance of different optical coherence tomography (OCT)-imaging biomarkers in predicting visual outcomes in patients with retinal vein occlusion (RVO).
Methods: This was a retrospective study conducted on consecutive patients diagnosed with RVO, who were referred to or treated at a Third-level university hospital. The primary endpoints were the mean change in best-corrected visual acuity (BCVA) from baseline to the month-6, month-12, and month-18 follow-up visits, and the influence of OCT-imaging biomarkers, including ellipsoid zone (EZ) alterations, disorganization of the retinal-inner-layers (DRIL), hyperreflective foci (HRF), neurosensorial-detachment (NSD), and fibrosis on functional outcomes, defined as a BCVA improvement of ≥5 ETDRS letters.
Results: One-hundred-and sixty-three eyes were included. In the overall-study sample, mean (Standard-error) BCVA increased significantly from 49.6(1.8) letters at diagnosis to 54.6(1.8) letters at month-6 (p=0.0069), 54.3(1.9) letters at month-12 (p=0.0071), and 53.6(1.9) letters at month18 (p=0.0313). In multivariate analysis, the presence of EZ alterations at diagnosis (OR: 0.19; p = 0.0008) and their persistence to month-12 (OR: 0.34; p=0.0043) were associated with a reduced probability of achieving a BCVA improvement of ≥5 ETDRS letters at month-12. By month 18, significant predictors of visual outcomes included EZ alterations at diagnosis (OR: 0.19; p=0.0008), sustained EZ alterations through 18 months (OR: 0.34; p=0.0043), and DRIL at month-18 (OR: 0.38; p = 0.0321).
Conclusions: The presence of EZ alterations at diagnosis and their persistence at 12 and 18 months, along with DRIL at 18 months, were adverse prognostic markers for BCVA outcomes in patients with RVO.
{"title":"Predictive value of optical coherence tomography biomarkers on visual outcomes in patients with retinal vein occlusion.","authors":"Rachid Bouchikh-El Jarroudi, Pablo Enrique Díaz-Aljaro, Jordi Castellví-Manent, Nevena Romanic Bubalo, Rubén Dario Fernandez-Torrón, Antonio Sabala Llopart, Judit Ruiz-Mata, Susana Castillo-Acedo, María Larrousse Morellón, Cristina Tural Llacher, Susana Ruiz-Bilbao","doi":"10.1159/000550350","DOIUrl":"https://doi.org/10.1159/000550350","url":null,"abstract":"<p><strong>Purpose: </strong>To evaluate the prognostic significance of different optical coherence tomography (OCT)-imaging biomarkers in predicting visual outcomes in patients with retinal vein occlusion (RVO).</p><p><strong>Methods: </strong>This was a retrospective study conducted on consecutive patients diagnosed with RVO, who were referred to or treated at a Third-level university hospital. The primary endpoints were the mean change in best-corrected visual acuity (BCVA) from baseline to the month-6, month-12, and month-18 follow-up visits, and the influence of OCT-imaging biomarkers, including ellipsoid zone (EZ) alterations, disorganization of the retinal-inner-layers (DRIL), hyperreflective foci (HRF), neurosensorial-detachment (NSD), and fibrosis on functional outcomes, defined as a BCVA improvement of ≥5 ETDRS letters.</p><p><strong>Results: </strong>One-hundred-and sixty-three eyes were included. In the overall-study sample, mean (Standard-error) BCVA increased significantly from 49.6(1.8) letters at diagnosis to 54.6(1.8) letters at month-6 (p=0.0069), 54.3(1.9) letters at month-12 (p=0.0071), and 53.6(1.9) letters at month18 (p=0.0313). In multivariate analysis, the presence of EZ alterations at diagnosis (OR: 0.19; p = 0.0008) and their persistence to month-12 (OR: 0.34; p=0.0043) were associated with a reduced probability of achieving a BCVA improvement of ≥5 ETDRS letters at month-12. By month 18, significant predictors of visual outcomes included EZ alterations at diagnosis (OR: 0.19; p=0.0008), sustained EZ alterations through 18 months (OR: 0.34; p=0.0043), and DRIL at month-18 (OR: 0.38; p = 0.0321).</p><p><strong>Conclusions: </strong>The presence of EZ alterations at diagnosis and their persistence at 12 and 18 months, along with DRIL at 18 months, were adverse prognostic markers for BCVA outcomes in patients with RVO.</p>","PeriodicalId":19595,"journal":{"name":"Ophthalmologica","volume":" ","pages":"1-20"},"PeriodicalIF":1.9,"publicationDate":"2026-01-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145912666","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Introduction: The aim of this study is to report 2-year follow-up data on patients with diabetic macular edema (DME) treated with simultaneous intravitreal dexamethasone (DEX) and aflibercept.
Methods: Multicenter, retrospective analysis of eyes with DME treated with simultaneous DEX implant and aflibercept injection. Main outcome measures were changes in best-corrected visual acuity (BCVA) and central retinal thickness (CRT) from baseline to 24 months. The secondary endpoint was the interval of retreatment.
Results: Two-year data were available for 52 of the 76 initially included eyes. Compared to baseline, significant improvements in mean BCVA and CRT were observed at 6, 12, 18, and 24 months. An average of 3.26±1.70 intravitreal treatments was required, with a mean retreatment interval of 10.21±6.35 months throughout the study period.
Conclusions: Simultaneous intravitreal DEX and aflibercept treatment resulted in sustained improvements in both visual and anatomical outcomes over a 24-month period. This combination therapy represents a valid treatment strategy and demonstrates synergistic efficacy in the management of DME.
{"title":"Two-year treatment outcomes of simultaneous intravitreal dexamethasone and aflibercept on diabetic macular edema.","authors":"Tai-Chi Lin, Hsin-Wei Huang, Yu-Chien Chung, Tsui-Kang Hsu, Yi-Ming Huang, Sheng-Chu Chi, Chen-Yu Chao, Po-Chen Tseng","doi":"10.1159/000550320","DOIUrl":"https://doi.org/10.1159/000550320","url":null,"abstract":"<p><strong>Introduction: </strong>The aim of this study is to report 2-year follow-up data on patients with diabetic macular edema (DME) treated with simultaneous intravitreal dexamethasone (DEX) and aflibercept.</p><p><strong>Methods: </strong>Multicenter, retrospective analysis of eyes with DME treated with simultaneous DEX implant and aflibercept injection. Main outcome measures were changes in best-corrected visual acuity (BCVA) and central retinal thickness (CRT) from baseline to 24 months. The secondary endpoint was the interval of retreatment.</p><p><strong>Results: </strong>Two-year data were available for 52 of the 76 initially included eyes. Compared to baseline, significant improvements in mean BCVA and CRT were observed at 6, 12, 18, and 24 months. An average of 3.26±1.70 intravitreal treatments was required, with a mean retreatment interval of 10.21±6.35 months throughout the study period.</p><p><strong>Conclusions: </strong>Simultaneous intravitreal DEX and aflibercept treatment resulted in sustained improvements in both visual and anatomical outcomes over a 24-month period. This combination therapy represents a valid treatment strategy and demonstrates synergistic efficacy in the management of DME.</p>","PeriodicalId":19595,"journal":{"name":"Ophthalmologica","volume":" ","pages":"1-21"},"PeriodicalIF":1.9,"publicationDate":"2026-01-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145906383","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Maria Ludovica Ruggeri, Alberto Quarta, Tommaso Verdina, Daniela Bacherini, Ruggero Tartaro, Corina De Santis Ciacci, Lisa Toto, Rodolfo Mastropasqua
Introduction: Silicone oil removal-related vision loss (SORVL) is a rare, sight-threatening condition occurring in patients who previously underwent silicone oil removal (ROSO) surgery. Today, few cases have been reported in the literature, predominantly described as unrecoverable, and the disease spectrum and its pathophysiology are mostly unknown.
Methods: We retrospectively report 6 different cases of SORVL, analyzing the different clinical outcomes. Patients clinical characteristics at presentation and throughout follow-ups are reported, including cases of significant improvement and a rare case of complete recovery.
Results: Among enrolled patients, 83% were males who underwent ROSO for a previous Rhegmatogenous Retinal detachment (RD) surgery with pars plana vitrectomy (PPV). Two cases (33.3%) presented significant improvement over time, with one of them (16.6%) experiencing complete recovery. Clinical presentation, diagnosis and course of the disease outline both similarities and differences that may help in the hypothesis-generating process on possible underlying mechanisms.
Conclusion: Although sharing connections in the onset of symptoms and clinical spectrum, this case series evidences differences in outcome in SORVL cases and highlights the heterogeneity of SORVL. Future studies should be aimed at investigating the pathophysiology of SORVL and factors influencing the course of this condition.
{"title":"Silicone Oil removal related vision loss: questioning different outcomes.","authors":"Maria Ludovica Ruggeri, Alberto Quarta, Tommaso Verdina, Daniela Bacherini, Ruggero Tartaro, Corina De Santis Ciacci, Lisa Toto, Rodolfo Mastropasqua","doi":"10.1159/000550106","DOIUrl":"https://doi.org/10.1159/000550106","url":null,"abstract":"<p><strong>Introduction: </strong>Silicone oil removal-related vision loss (SORVL) is a rare, sight-threatening condition occurring in patients who previously underwent silicone oil removal (ROSO) surgery. Today, few cases have been reported in the literature, predominantly described as unrecoverable, and the disease spectrum and its pathophysiology are mostly unknown.</p><p><strong>Methods: </strong>We retrospectively report 6 different cases of SORVL, analyzing the different clinical outcomes. Patients clinical characteristics at presentation and throughout follow-ups are reported, including cases of significant improvement and a rare case of complete recovery.</p><p><strong>Results: </strong>Among enrolled patients, 83% were males who underwent ROSO for a previous Rhegmatogenous Retinal detachment (RD) surgery with pars plana vitrectomy (PPV). Two cases (33.3%) presented significant improvement over time, with one of them (16.6%) experiencing complete recovery. Clinical presentation, diagnosis and course of the disease outline both similarities and differences that may help in the hypothesis-generating process on possible underlying mechanisms.</p><p><strong>Conclusion: </strong>Although sharing connections in the onset of symptoms and clinical spectrum, this case series evidences differences in outcome in SORVL cases and highlights the heterogeneity of SORVL. Future studies should be aimed at investigating the pathophysiology of SORVL and factors influencing the course of this condition.</p>","PeriodicalId":19595,"journal":{"name":"Ophthalmologica","volume":" ","pages":"1-16"},"PeriodicalIF":1.9,"publicationDate":"2025-12-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145794423","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Efraim Berco, Yuval Kozlov, Michael Ostrovsky, Raman Tuli, Thomas Kin Man Lee, Ksenia Samocha, Eilon Shcolnik, Shalhevet Goldfeather Ben Zaken, Nir Shoham-Hazon
Introduction: This study directly compared the real-world effectiveness of bevacizumab, aflibercept 2 mg, and ranibizumab as first-line treatments for neovascular age-related macular degeneration (nvAMD).
Methods: Multicenter retrospective cohort of treatment-naïve nvAMD eyes managed with a treat-and-extend regimen in Israel and Canada. Primary outcomes were changes in visual acuity (VA) and central retinal thickness (CRT). Secondary outcomes included treatment burden (total injections and final maintained interval), non-response (persistent/worsening exudation or functional decline despite adequate treatment), non-extension (final interval of 4 weeks), and absence of active exudation.
Results: A total of 322 eyes received bevacizumab (n=174), aflibercept (n=110), or ranibizumab (n=38) over a mean follow-up of 16.75 ± 12.66 months. Mean VA improved from 0.77 ± 0.47 to 0.60 ± 0.45 logMAR following an average of 10.5 ± 6.3 injections. Aflibercept produced greater CRT reduction (-51.94 μm; p<0.001), fewer injections (-2.35; p=0.001), longer final intervals (+2.14 weeks; p<0.001), and lower odds of non-response (aOR 0.016; p<0.001) and non-extension (aOR 0.128, p<0.001) versus bevacizumab. It showed the largest mean VA gain, just short of significance on multivariable analysis (p=0.059). Ranibizumab showed greater CRT reduction (-44.53 μm; p=0.012) and lower non-extension odds (aOR 0.079; p=0.001) than bevacizumab, but did not significantly reduce treatment burden or improve VA.
Conclusion: In this first real-world, head-to-head comparison, aflibercept and ranibizumab outperformed bevacizumab in key anatomic and treatment-efficiency outcomes, with aflibercept showing the most consistent advantages. These findings highlight clinically relevant differences among anti-VEGF agents and underscore the importance of real-world data to guide nvAMD management.
{"title":"Comparative Real-World Efficacy of Anti-VEGF Agents in Neovascular AMD: A Multicenter Retrospective Study.","authors":"Efraim Berco, Yuval Kozlov, Michael Ostrovsky, Raman Tuli, Thomas Kin Man Lee, Ksenia Samocha, Eilon Shcolnik, Shalhevet Goldfeather Ben Zaken, Nir Shoham-Hazon","doi":"10.1159/000550160","DOIUrl":"https://doi.org/10.1159/000550160","url":null,"abstract":"<p><strong>Introduction: </strong>This study directly compared the real-world effectiveness of bevacizumab, aflibercept 2 mg, and ranibizumab as first-line treatments for neovascular age-related macular degeneration (nvAMD).</p><p><strong>Methods: </strong>Multicenter retrospective cohort of treatment-naïve nvAMD eyes managed with a treat-and-extend regimen in Israel and Canada. Primary outcomes were changes in visual acuity (VA) and central retinal thickness (CRT). Secondary outcomes included treatment burden (total injections and final maintained interval), non-response (persistent/worsening exudation or functional decline despite adequate treatment), non-extension (final interval of 4 weeks), and absence of active exudation.</p><p><strong>Results: </strong>A total of 322 eyes received bevacizumab (n=174), aflibercept (n=110), or ranibizumab (n=38) over a mean follow-up of 16.75 ± 12.66 months. Mean VA improved from 0.77 ± 0.47 to 0.60 ± 0.45 logMAR following an average of 10.5 ± 6.3 injections. Aflibercept produced greater CRT reduction (-51.94 μm; p<0.001), fewer injections (-2.35; p=0.001), longer final intervals (+2.14 weeks; p<0.001), and lower odds of non-response (aOR 0.016; p<0.001) and non-extension (aOR 0.128, p<0.001) versus bevacizumab. It showed the largest mean VA gain, just short of significance on multivariable analysis (p=0.059). Ranibizumab showed greater CRT reduction (-44.53 μm; p=0.012) and lower non-extension odds (aOR 0.079; p=0.001) than bevacizumab, but did not significantly reduce treatment burden or improve VA.</p><p><strong>Conclusion: </strong>In this first real-world, head-to-head comparison, aflibercept and ranibizumab outperformed bevacizumab in key anatomic and treatment-efficiency outcomes, with aflibercept showing the most consistent advantages. These findings highlight clinically relevant differences among anti-VEGF agents and underscore the importance of real-world data to guide nvAMD management.</p>","PeriodicalId":19595,"journal":{"name":"Ophthalmologica","volume":" ","pages":"1-18"},"PeriodicalIF":1.9,"publicationDate":"2025-12-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145794446","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Sandrine H Sassen, Marlene Sassmannshausen, Josua Sassen, Markus N Preising, Johanna P Scholz, Frank G Holz, Birgit Lorenz, Philipp Herrmann
Introduction: The detection of chorioretinal atrophy (CRA) following voretigene neparvovec (VN) therapy for RPE65-IRD highlights the need for long-term monitoring to better understand the safety and efficacy of this gene augmentation treatment. This study aimed to longitudinally assess the development of VN-associated CRA, its presentation in multimodal retinal imaging, and potential implications on visual function in patients with RPE65-IRD.
Methods: This single-center, prospective cohort study was conducted at the University of Bonn. A total of 21 patients with confirmed RPE65-IRD underwent subretinal VN therapy. Multimodal imaging, including blue-light fundus autofluorescence (BAF), near-infrared imaging (IR), near-infrared fundus autofluorescence (IRAF), and color fundus photography (CFP), assessed atrophy development. The primary outcome measure was the incidence and size of CRA, while secondary outcomes included the relationship between CRA and changes in visual function.
Results: The study reported a 50% (16/32 eyes) incidence of CRA, with lesions primarily located in the macula (86.7%), bleb area (86.67%), injection site (80%), and periphery (80%). Lesion detection and size varied between BAF, IR, IRAF, and CFP, with the largest CRA detected in BAF imaging. Initially, the median enlargement rate of CRA was 60.50 mm2/year (131.20). Notably, eyes with CRA development had significantly better baseline low luminance visual acuity.
Discussion: This study highlights the crucial role of multimodal imaging in monitoring VN-associated CRA. Differences in lesion detection and size assessment across imaging modalities were observed, with the largest CRA extent detected in BAF imaging. Median visual function remained stable. These findings emphasize the complexity of VN therapy outcomes and the need for close surveillance using combined multimodal imaging to better understand the long-term clinical implications.
{"title":"Chorioretinal Atrophy after Voretigene Neparvovec Therapy in <italic>RPE65</italic> Mutation-Associated Inherited Retinal Disease: Longitudinal Characterization in Multimodal Imaging.","authors":"Sandrine H Sassen, Marlene Sassmannshausen, Josua Sassen, Markus N Preising, Johanna P Scholz, Frank G Holz, Birgit Lorenz, Philipp Herrmann","doi":"10.1159/000549548","DOIUrl":"10.1159/000549548","url":null,"abstract":"<p><strong>Introduction: </strong>The detection of chorioretinal atrophy (CRA) following voretigene neparvovec (VN) therapy for RPE65-IRD highlights the need for long-term monitoring to better understand the safety and efficacy of this gene augmentation treatment. This study aimed to longitudinally assess the development of VN-associated CRA, its presentation in multimodal retinal imaging, and potential implications on visual function in patients with RPE65-IRD.</p><p><strong>Methods: </strong>This single-center, prospective cohort study was conducted at the University of Bonn. A total of 21 patients with confirmed RPE65-IRD underwent subretinal VN therapy. Multimodal imaging, including blue-light fundus autofluorescence (BAF), near-infrared imaging (IR), near-infrared fundus autofluorescence (IRAF), and color fundus photography (CFP), assessed atrophy development. The primary outcome measure was the incidence and size of CRA, while secondary outcomes included the relationship between CRA and changes in visual function.</p><p><strong>Results: </strong>The study reported a 50% (16/32 eyes) incidence of CRA, with lesions primarily located in the macula (86.7%), bleb area (86.67%), injection site (80%), and periphery (80%). Lesion detection and size varied between BAF, IR, IRAF, and CFP, with the largest CRA detected in BAF imaging. Initially, the median enlargement rate of CRA was 60.50 mm2/year (131.20). Notably, eyes with CRA development had significantly better baseline low luminance visual acuity.</p><p><strong>Discussion: </strong>This study highlights the crucial role of multimodal imaging in monitoring VN-associated CRA. Differences in lesion detection and size assessment across imaging modalities were observed, with the largest CRA extent detected in BAF imaging. Median visual function remained stable. These findings emphasize the complexity of VN therapy outcomes and the need for close surveillance using combined multimodal imaging to better understand the long-term clinical implications.</p>","PeriodicalId":19595,"journal":{"name":"Ophthalmologica","volume":" ","pages":"1-11"},"PeriodicalIF":1.9,"publicationDate":"2025-12-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12788828/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145743579","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}
{"title":"Acknowledgement to Reviewers.","authors":"","doi":"10.1159/000549003","DOIUrl":"https://doi.org/10.1159/000549003","url":null,"abstract":"","PeriodicalId":19595,"journal":{"name":"Ophthalmologica","volume":" ","pages":"1"},"PeriodicalIF":1.9,"publicationDate":"2025-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145661849","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Andrea Montesel, Riccardo Sacconi, Luke Nicholson, Jay Chhablani, Suzanne Yzer, Danial Mohabati, Camiel J F Boon, Giuseppe Querques
Introduction: The bullous variant of central serous chorioretinopathy (bvCSC) represents a rare and severe manifestation of CSC. This study aims to evaluate the clinical features, underlying systemic factors, and outcomes of bvCSC through a multicentric study.
Methods: A retrospective analysis was conducted on patients diagnosed with bvCSC across five tertiary eye centers. Demographic data, visual acuity (VA), treatment modalities, and follow-up outcomes were analyzed. A literature review was performed to contextualize the findings.
Results: The study included 35 eyes from 25 patients (80% male), with a mean age of 47.7 ± 12.2 years. Systemic comorbidities were identified in 60% of patients. Baseline VA was 1.18 ± 0.89 logMAR. Serous retinal detachment resolved in 63% of eyes, but persistent subretinal fibrosis contributed to limited visual recovery. Treatment varied, with observation (37%) being the most common approach, followed by systemic eplerenone (17%) and focal laser (13%). Available data did not show a clear advantage of any treatment modality.
Conclusion: The bvCSC is frequently associated with systemic conditions and has a guarded visual prognosis despite anatomical resolution in most cases. The study underscores the importance of early diagnosis and a tailored treatment to optimize outcomes in this severe CSC variant.
{"title":"Clinical Features and Outcomes of Bullous Central Serous Chorioretinopathy: A Multicentric Cohort Study.","authors":"Andrea Montesel, Riccardo Sacconi, Luke Nicholson, Jay Chhablani, Suzanne Yzer, Danial Mohabati, Camiel J F Boon, Giuseppe Querques","doi":"10.1159/000549637","DOIUrl":"10.1159/000549637","url":null,"abstract":"<p><strong>Introduction: </strong>The bullous variant of central serous chorioretinopathy (bvCSC) represents a rare and severe manifestation of CSC. This study aims to evaluate the clinical features, underlying systemic factors, and outcomes of bvCSC through a multicentric study.</p><p><strong>Methods: </strong>A retrospective analysis was conducted on patients diagnosed with bvCSC across five tertiary eye centers. Demographic data, visual acuity (VA), treatment modalities, and follow-up outcomes were analyzed. A literature review was performed to contextualize the findings.</p><p><strong>Results: </strong>The study included 35 eyes from 25 patients (80% male), with a mean age of 47.7 ± 12.2 years. Systemic comorbidities were identified in 60% of patients. Baseline VA was 1.18 ± 0.89 logMAR. Serous retinal detachment resolved in 63% of eyes, but persistent subretinal fibrosis contributed to limited visual recovery. Treatment varied, with observation (37%) being the most common approach, followed by systemic eplerenone (17%) and focal laser (13%). Available data did not show a clear advantage of any treatment modality.</p><p><strong>Conclusion: </strong>The bvCSC is frequently associated with systemic conditions and has a guarded visual prognosis despite anatomical resolution in most cases. The study underscores the importance of early diagnosis and a tailored treatment to optimize outcomes in this severe CSC variant.</p>","PeriodicalId":19595,"journal":{"name":"Ophthalmologica","volume":" ","pages":"1-9"},"PeriodicalIF":1.9,"publicationDate":"2025-11-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145573885","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jean-François Korobelnik, Varun Chaudhary, Paul Mitchell, Se Woong Kang, Helmut Allmeier, JinKyung Lee, Xin Zhang, Tobias Machewitz, Clare Bailey
Introduction: Long-term, global data evaluating intravitreal aflibercept (IVT-AFL) 2 mg for treatment of neovascular age-related macular degeneration (nAMD) in real-world practice are needed. This study investigated the long-term, real-world effectiveness and safety of IVT-AFL 2 mg in patients with nAMD.
Methods: XTEND was a multicenter, observational, prospective study. Enrollment was conducted between May 2019 and May 2020; the patient follow-up period was 36 months. Treatment-naïve patients were treated with IVT-AFL 2 mg (fixed dosing or treat-and-extend [T&E]) according to the local label; for the T&E regimen, treatment intervals could be extended according to the national label (either European Medicines Agency [EMA]-aligned or non-EMA-aligned).
Results: Overall, 1,483 patients across 17 countries were treated with IVT-AFL 2 mg; mean ± standard deviation (SD) age was 78.8 ± 8.5 years; 60.4% were female. Overall, 62.6% of patients completed the 36-month follow-up visit. The mean (95% confidence interval [CI]) changes in best-corrected visual acuity from baseline were +4.6 (3.7, 5.4), +2.3 (1.3, 3.3), and +0.9 (-0.2, 1.9) at months 12, 24, and 36, respectively. The mean (95% CI) changes in central subfield thickness from baseline were -106 (-114, -99) μm, -109 (-117, -102) μm, and -110 (-118, -103) μm at months 12, 24, and 36, respectively. The mean ± SD numbers of injections from baseline to months 12, 24, and 36 were 7.7 ± 2.7, 11.3 ± 5.3, and 13.7 ± 7.5, respectively. No new safety concerns were identified.
Conclusion: This study demonstrates that improvements with IVT-AFL 2 mg were maintained through month 36, suggesting that long-term durability of vision is achievable in patients with treatment-naïve nAMD in real-world practice.
{"title":"Aflibercept 2 mg for Neovascular Age-Related Macular Degeneration: XTEND at 3 Years.","authors":"Jean-François Korobelnik, Varun Chaudhary, Paul Mitchell, Se Woong Kang, Helmut Allmeier, JinKyung Lee, Xin Zhang, Tobias Machewitz, Clare Bailey","doi":"10.1159/000549663","DOIUrl":"10.1159/000549663","url":null,"abstract":"<p><strong>Introduction: </strong>Long-term, global data evaluating intravitreal aflibercept (IVT-AFL) 2 mg for treatment of neovascular age-related macular degeneration (nAMD) in real-world practice are needed. This study investigated the long-term, real-world effectiveness and safety of IVT-AFL 2 mg in patients with nAMD.</p><p><strong>Methods: </strong>XTEND was a multicenter, observational, prospective study. Enrollment was conducted between May 2019 and May 2020; the patient follow-up period was 36 months. Treatment-naïve patients were treated with IVT-AFL 2 mg (fixed dosing or treat-and-extend [T&E]) according to the local label; for the T&E regimen, treatment intervals could be extended according to the national label (either European Medicines Agency [EMA]-aligned or non-EMA-aligned).</p><p><strong>Results: </strong>Overall, 1,483 patients across 17 countries were treated with IVT-AFL 2 mg; mean ± standard deviation (SD) age was 78.8 ± 8.5 years; 60.4% were female. Overall, 62.6% of patients completed the 36-month follow-up visit. The mean (95% confidence interval [CI]) changes in best-corrected visual acuity from baseline were +4.6 (3.7, 5.4), +2.3 (1.3, 3.3), and +0.9 (-0.2, 1.9) at months 12, 24, and 36, respectively. The mean (95% CI) changes in central subfield thickness from baseline were -106 (-114, -99) μm, -109 (-117, -102) μm, and -110 (-118, -103) μm at months 12, 24, and 36, respectively. The mean ± SD numbers of injections from baseline to months 12, 24, and 36 were 7.7 ± 2.7, 11.3 ± 5.3, and 13.7 ± 7.5, respectively. No new safety concerns were identified.</p><p><strong>Conclusion: </strong>This study demonstrates that improvements with IVT-AFL 2 mg were maintained through month 36, suggesting that long-term durability of vision is achievable in patients with treatment-naïve nAMD in real-world practice.</p>","PeriodicalId":19595,"journal":{"name":"Ophthalmologica","volume":" ","pages":"1-13"},"PeriodicalIF":1.9,"publicationDate":"2025-11-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12782608/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145573877","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}