Luke Michaels, Mariantonia Ferrara, Joseph van Batenburg-Sherwood, Mario R Romano, Jean-Yves Guillemaut, Tom H Williamson
{"title":"Gas Concentration Errors in Vitreoretinal Surgery: Insights from a Model of Gas Mass Transfer Dynamics.","authors":"Luke Michaels, Mariantonia Ferrara, Joseph van Batenburg-Sherwood, Mario R Romano, Jean-Yves Guillemaut, Tom H Williamson","doi":"10.1159/000551468","DOIUrl":"https://doi.org/10.1159/000551468","url":null,"abstract":"<p><strong>Introduction: </strong>Concentration mix errors of fluorinated gases commonly used in vitreoretinal surgery can lead to catastrophic elevations in intraocular pressure. The timing and optimal management of this complication is poorly understood. This study aims to evaluate the impact of controlled venting on intraocular pressure (IOP) elevation following simulated gas mix errors.</p><p><strong>Methods: </strong>A validated mass transfer model of intraocular gas dynamics was used to simulate the properties of \"isovolumetric\" gas concentrations of 20% SF6, 16% C2F6 and 12% C3F8, along with the most common concentration mix errors: double concentration, 10/3 (3.33x) concentration and 100% gas. Simulations were performed on eyes with vitreous cavity volumes of 4.0 ml, 7.2 ml, and 10.0 ml (representing hyperopic to highly myopic eyes). The model calculated gas volume and IOP over time, both before and after controlled venting events to normalise IOP.</p><p><strong>Results: </strong>All gas concentration errors produced complete gas fill and rapid IOP elevations. Only double-concentration errors generated IOPs potentially manageable with medical therapy (peak 60 mmHg for 40% SF₆, 75 mmHg for 32% C₂F₆, 61 mmHg for 24% C₃F₈). Simulated 10/3 (3.33x) and 100% concentrations resulted in extreme IOP elevations incompatible with ocular perfusion. Controlled gas venting at day 1, normalised IOP for SF₆ but repeated venting procedures were required for C₂F₆ and C₃F₈ due to continued gas re-expansion. Eyes with larger vitreous cavities experienced prolonged IOP elevation and delayed equilibration after venting.</p><p><strong>Conclusion: </strong>Gas concentration mix errors produce rapid and often unsalvageable IOP rises. While limited SF₆ over-concentrations may be temporarily stabilised with medical therapy and controlled venting, most scenarios, especially involving C₂F₆ or C₃F₈, require urgent surgical complete gas exchange.</p>","PeriodicalId":19595,"journal":{"name":"Ophthalmologica","volume":" ","pages":"1-17"},"PeriodicalIF":1.9,"publicationDate":"2026-03-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147459345","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}
Pablo Carnota-Méndez, Lidia Remolí-Sargues, Sergio Copete, Álvaro Fernández-Vega-Gonzálezd, Javier Montero-Hernández, Javier Zarranz-Ventura, Maria Socorro Alforja-Castiella, Arturo Renú-Jornet, Antonio Doncel-Moriano, Francisco Gómez-Ulla, Susana Ruiz-Bilbao, José Viéitez-Vázquez, Carlos Méndez-Vázquez, Cristina Blanco-Marchite, Almudena Moreno-Martínez, Nicolás Sánchez-Maluf, Nuria Olivier-Pascual
{"title":"Clinical Guidelines for the Diagnosis and Management of Retinal Artery Occlusions by the Spanish Society of Retina and Vitreous.","authors":"Pablo Carnota-Méndez, Lidia Remolí-Sargues, Sergio Copete, Álvaro Fernández-Vega-Gonzálezd, Javier Montero-Hernández, Javier Zarranz-Ventura, Maria Socorro Alforja-Castiella, Arturo Renú-Jornet, Antonio Doncel-Moriano, Francisco Gómez-Ulla, Susana Ruiz-Bilbao, José Viéitez-Vázquez, Carlos Méndez-Vázquez, Cristina Blanco-Marchite, Almudena Moreno-Martínez, Nicolás Sánchez-Maluf, Nuria Olivier-Pascual","doi":"10.1159/000551309","DOIUrl":"10.1159/000551309","url":null,"abstract":"<p><p>Retinal artery occlusions (RAOs) constitute a rare but serious ophthalmological emergency with a poor prognosis for visual recovery, for which there is currently no adequate therapeutic strategy. However, there is substantial evidence highlighting the importance of systemic (non-ophthalmological) management of patients with RAO. Since RAOs are the ocular analogous of a cerebral stroke, they require a similar urgent, multidisciplinary approach involving laboratory tests and imaging studies that go beyond the typical scope of ophthalmologists. This calls for cooperation and understanding from all stakeholders, including neurologists, radiologists, interventional neuroradiologists, emergency and primary care physicians, as well as patients and the wider community. Therefore, while there are presently no proven therapies to restore vision following RAOs, the ophthalmologist's primary responsibility lies in prompt systemic referral. It is imperative to exclude underlying vascular pathology to rule out concurrent cerebrovascular disease and to minimize the risk of subsequent cerebrovascular and cardiovascular events. These guidelines have been developed by a panel of retina specialists in Spain, representing the Spanish Retina and Vitreous Society (SERV). The recommendations provided are derived from an evidence-based expert consensus methodology and not from a formal systematic review. The aim was to inform ophthalmologists and other healthcare professionals who care for these patients about the significance and seriousness of the condition, support decision-making regarding appropriate ophthalmological and systemic management, and provide a foundation for creating protocols.</p>","PeriodicalId":19595,"journal":{"name":"Ophthalmologica","volume":" ","pages":"1-24"},"PeriodicalIF":1.9,"publicationDate":"2026-03-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147444502","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}
Emilia Maggio, Filippo Avogaro, Lorenzo Casillo, Maurizio Mete, Enzo Maria Vingolo, Giorgia Maraone, Lorenza Sanfilippo, Massimo Guerriero, Grazia Pertile
{"title":"Long-Term Evolution and Growth Rate Assessment of Non-Exudative Macular Neovascularization: A Multicenter Analysis.","authors":"Emilia Maggio, Filippo Avogaro, Lorenzo Casillo, Maurizio Mete, Enzo Maria Vingolo, Giorgia Maraone, Lorenza Sanfilippo, Massimo Guerriero, Grazia Pertile","doi":"10.1159/000551308","DOIUrl":"10.1159/000551308","url":null,"abstract":"<p><strong>Introduction: </strong>Non-exudative macular neovascularization (neMNV) in age-related macular degeneration (AMD) may remain stable or progress to exudation with vision loss, but its natural history is not well established. This study aimed to assess the prevalence of neMNV, the conversion rate to exudation, and to discern differences between neMNVs that exhibited exudation versus those that remained non-exudative.</p><p><strong>Methods: </strong>In this retrospective, multicentric, longitudinal study, consecutive patients treated with anti-VEGF between august 2008 and June 2023, presenting exudative AMD in one eye and intermediate AMD in the fellow eye, were analyzed. The presence of neMNVs in the fellow eyes and their conversion rate to exudation were assessed. Clinical and anatomical features were compared between eyes that developed exudation versus those that did not. The correlation between lesion major diameters and areas was examined to evaluate their equivalence as parameters for assessing neMNV growth rate.</p><p><strong>Results: </strong>A total of 61 eyes out of 840 (7.3%) exhibited neMNV. Of these, 21 neMNV (34.42%) converted to exudation in a mean time of 24.14 months (min. 7 - max. 113). The remaining 40 eyes did not develop exudation during a mean follow-up of 32.5 months (min. 12 - max. 101). No significant differences were found regarding visual acuity, OCT angiography features, or baseline lesion diameters. NeMNV that developed exudation exhibited a higher lesion growth rate (p value <0.001). The growth rate evaluated using lesion major diameters was consistent with that obtained through lesion area measurements.</p><p><strong>Conclusion: </strong>The results highlight lesion growth rate as a marker of conversion risk. Lesion diameter was identified as a reliable parameter for monitoring neMNV progression. Even considering a long-term follow-up, many lesions did not develop exudation. These results support the idea that neMNV may represent a spectrum of neovascularizations with different characteristics and clinical courses.</p>","PeriodicalId":19595,"journal":{"name":"Ophthalmologica","volume":" ","pages":"1-11"},"PeriodicalIF":1.9,"publicationDate":"2026-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147356075","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}
{"title":"Quality of life in Patients with Retinal Vein Occlusion: A Review of the Literature.","authors":"Dimitrios Kazantzis, Genovefa Machairoudia, Panagiotis Theodossiadis, Irini Chatziralli","doi":"10.1159/000551378","DOIUrl":"https://doi.org/10.1159/000551378","url":null,"abstract":"<p><strong>Background: </strong>Retinal vein occlusion (RVO) is the second most common retinal vascular disorder after diabetic retinopathy and represents a significant cause of visual loss worldwide. Beyond visual impairment, RVO can profoundly affect patients' wellbeing and overall vision-related quality of life (QoL). Increasing evidence indicates that vision-related disability contributes to increased levels of anxiety and social limitations in affected individuals. This narrative review synthesizes current evidence on QoL outcomes in patients with RVO, highlight factors influencing psychological outcomes and explore the role of treatment interventions in modifying patient-reported wellbeing.</p><p><strong>Summary: </strong>Across the included studies, patients with retinal vein occlusion (RVO) reported significantly reduced vision-related quality of life (QoL) compared with healthy controls, as assessed by the NEI VFQ-25. Anti-VEGF therapies, including ranibizumab, aflibercept, and bevacizumab, consistently improved QoL scores, with gains evident as early as one month and sustained up to 12 months. Improvements were most pronounced in visual function and daily activity subscales, although near vision, mental health, and social functioning frequently remained below normal levels. Predictors of better QoL outcomes included stereopsis, fellow-eye vision, and central macular thickness reduction, while systemic comorbidities such as hypertension and diabetes were associated with poorer outcomes.</p><p><strong>Key messages: </strong>While anti-VEGF therapy improves QoL in patients with RVO, long-term management should extend beyond vision restoration. A multidisciplinary approach-integrating ophthalmology, primary care, and psychological support-is essential to address systemic risk factors, reduce treatment burden, and improve overall wellbeing. Future studies should explore long-term QoL outcomes and evaluate strategies that support holistic, patient-centered care.</p>","PeriodicalId":19595,"journal":{"name":"Ophthalmologica","volume":" ","pages":"1-12"},"PeriodicalIF":1.9,"publicationDate":"2026-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147356044","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}
Cesare Mariotti, Silvia Iorio, Giulia Gregori, Enrico Nacciarriti, Lorenzo Mangoni, Clara Rizzo, Marco Lupidi
{"title":"Comparative Evaluation of High- versus Low-Viscosity Silicone Oil in Macula-Off Retinal Detachment: Emulsification, Inflammation, and AI-Assisted Biomarker Detection.","authors":"Cesare Mariotti, Silvia Iorio, Giulia Gregori, Enrico Nacciarriti, Lorenzo Mangoni, Clara Rizzo, Marco Lupidi","doi":"10.1159/000551074","DOIUrl":"10.1159/000551074","url":null,"abstract":"<p><strong>Introduction: </strong>The aim of this study was to compare the emulsification rates, intraocular pressure (IOP) changes, and retinal hyperreflective foci (HRF) between low-viscosity (1,000 cS) and high-viscosity (5,000 cS) silicone oils (SOs) used as tamponade agents following 25-gauge pars plana vitrectomy (PPV) in cases of naïve macula-off rhegmatogenous retinal detachment using an artificial intelligence (AI)-based quantification approach.</p><p><strong>Methods: </strong>This retrospective study was conducted in eyes treated with PPV and SO tamponade. The clinical parameters that were assessed included best-corrected visual acuity (BCVA), IOP, the presence of emulsification in the iridocorneal angle - in the anterior or posterior chambers, and structural retinal biomarkers such as intraretinal fluid, subretinal fluid, and HRF detected and quantified through an AI-based analysis of spectral-domain optical coherence tomography (OCT) images.</p><p><strong>Results: </strong>Twenty-five eyes were enrolled (12 with 1,000-cS SO and 13 with 5,000-cS SO endotamponades) for this study. No statistically significant differences in BCVA or anatomical outcomes between the two groups were found. However, SO emulsification occurred more often in the 1,000-cS group (66%) compared to the 5,000-cS group (7%) (p = 0.0036). Elevated IOP was more frequent in the 1,000-cS group (8 vs. 4 cases; p = 0.03), and HRF count was significantly higher in eyes with 1,000-cS oil (p = 0.04).</p><p><strong>Conclusion: </strong>High-viscosity SO demonstrated a lower emulsification rate and reduced inflammatory response compared to low-viscosity SO, with no compromise in visual outcomes. AI-assisted OCT analysis enabled an accurate, automated detection of HRF, supporting its utility in monitoring SO-related complications.</p>","PeriodicalId":19595,"journal":{"name":"Ophthalmologica","volume":" ","pages":"1-8"},"PeriodicalIF":1.9,"publicationDate":"2026-02-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147308677","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}
Mario R Romano, Mariantonia Ferrara, Martin Zinkernagel, David H Steel, Salvador Pastor-Idoate, Antonio Boccardi, Aude Couturier, Jana D'Amato Tothova, Vivek Pravin Dave, Belma Dikme, Martina Dunkel, Nicole Eter, Jens Folke Kiilgaard, Francesc March de Ribot, Helge Menz, Siegfried Priglinger, Peter Szurman, Tom H Williamson, Anat Loewenstein, Alistair Laidlaw
{"title":"Consensus Recommendations on the Use of Per- and Polyfluoroalkyl Substances-Containing Ocular Endotamponades.","authors":"Mario R Romano, Mariantonia Ferrara, Martin Zinkernagel, David H Steel, Salvador Pastor-Idoate, Antonio Boccardi, Aude Couturier, Jana D'Amato Tothova, Vivek Pravin Dave, Belma Dikme, Martina Dunkel, Nicole Eter, Jens Folke Kiilgaard, Francesc March de Ribot, Helge Menz, Siegfried Priglinger, Peter Szurman, Tom H Williamson, Anat Loewenstein, Alistair Laidlaw","doi":"10.1159/000550950","DOIUrl":"10.1159/000550950","url":null,"abstract":"<p><p>We conducted an expert-led consensus to develop recommendations on the use of per- and polyfluoroalkyl substances (PFAS)-containing ocular endotamponades (OEs) in vitreoretinal surgery, aiming to promote a more sustainable surgical practice. We used a modified Delphi methodology with panel consisting of fourteen vitreoretinal surgeons and five representatives of companies involved in OEs production and marketing. Based on a literature review and the latest updates on European Union's PFAS restriction proposal, the facilitator prepared a list of statements on PFAS-containing OEs currently used. Each statement was graded individually using a nine-point scale (from 1 \"absolutely disagree\" to 9 \"absolutely agree\") and the consensus was defined as a score between 7 and 9 from ≥80% of members. After two rounds, and related discussion, the recommendations highlighted the crucial role of PFAS-containing OEs in surgical practice and the potential negative impact of their ban on patients' outcomes. There was a strong agreement on the need of perfluorocarbon liquids as intraoperative tool, although it was also pointed out that their use should be avoided if possible. Fluorinated gases were deemed essential with no agreement on the possibility to replace SF6 and/or C2F6 with C3F8 at different concentrations. Conversely, semifluorinated alkanes as rinsing solution as well as F6H8 were considered extraneous. No consensus was reached about the current role of heavy silicone oils. Finally, the use of air as alternative and environment-friendly OE was judged not supported by sufficient evidence but worth of further investigation.</p>","PeriodicalId":19595,"journal":{"name":"Ophthalmologica","volume":" ","pages":"1-13"},"PeriodicalIF":1.9,"publicationDate":"2026-02-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146258907","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}
Pietro Maria Talli, Ginevra Giovanna Adamo, Sami Al-Nawaiseh, Antonio Cartabellotta, Laura Sarti, Abdulrahman Badawi, Marco Pellegrini, Marco Mura
{"title":"Burn and Bury: A Novel Technique to Avoid Conjunctival Peritomy.","authors":"Pietro Maria Talli, Ginevra Giovanna Adamo, Sami Al-Nawaiseh, Antonio Cartabellotta, Laura Sarti, Abdulrahman Badawi, Marco Pellegrini, Marco Mura","doi":"10.1159/000550624","DOIUrl":"10.1159/000550624","url":null,"abstract":"<p><strong>Introduction: </strong>The aim of the study was to evaluate the safety and feasibility of a novel surgical technique for subconjunctival burial of 10-0 Prolene sutures without conjunctival peritomy.</p><p><strong>Methods: </strong>A retrospective case series of 12 patients who underwent trans-scleral suture fixation or silicone oil retention suture placement using 10-0 Prolene sutures was conducted between January 2024 and February 2025 at Sant'Anna University Hospital, University of Ferrara, Italy. Inclusion criteria included adults requiring scleral fixation with 10-0 Prolene. Exclusion criteria included prior conjunctival surgery at the site, active ocular surface disease, or inability to complete follow-up. Instead of conjunctival peritomy, a linear high-temperature cautery was applied along the intended suture path to create a fibrotic track. Sutures were passed trans-scleral and left exposed on the cauterized zone, allowing spontaneous re-epithelialization. Follow-up included slit-lamp examination, anterior segment photography, and optical coherence tomography at 1 day, 1 week, and 1, 3, and 6 months.</p><p><strong>Results: </strong>A total of 12 patients (12 eyes) were included. Successful suture burial was achieved in all 12 eyes (100%) without exposure, extrusion, or conjunctival dehiscence during the 6-month follow-up. Re-epithelialization was complete by day 7 in all cases (12/12, 100%). No patient reported foreign body sensation after day 7. There were no infections, granulomas, or surgery revisions.</p><p><strong>Conclusions: </strong>The \"Burn and Bury\" technique is a safe and minimally invasive alternative to conjunctival peritomy for burying trans-scleral Prolene sutures. It preserves conjunctival integrity, reduces surgical trauma, promotes rapid epithelial healing, and enhances patient comfort. This technique may be broadly applicable in anterior segment procedures requiring scleral suture fixation and warrants prospective validation.</p>","PeriodicalId":19595,"journal":{"name":"Ophthalmologica","volume":" ","pages":"1-6"},"PeriodicalIF":1.9,"publicationDate":"2026-02-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146227606","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}
Marco R Pastore, Alberto Grotto, Marco Celega, Cosmin Sava, Alessandra Martina, Olimpia Colombo, Eric H Souied, Daniele Tognetto
{"title":"Intravitreal Tamponade Agents in Vitreoretinal Surgery: Current Advances and Future Directions.","authors":"Marco R Pastore, Alberto Grotto, Marco Celega, Cosmin Sava, Alessandra Martina, Olimpia Colombo, Eric H Souied, Daniele Tognetto","doi":"10.1159/000550824","DOIUrl":"10.1159/000550824","url":null,"abstract":"<p><strong>Background: </strong>Intravitreal tamponades are essential tools in vitreoretinal surgery, widely used for the treatment of posterior segment pathologies. Conventional tamponade agents - such as intraocular gases and silicone oils - have significantly improved surgical outcomes but are associated with limitations including the need for specific postoperative positioning, intraocular pressure fluctuations, and in some cases, secondary removal procedures.</p><p><strong>Summary: </strong>This review provides a comprehensive overview of currently available intravitreal tamponade agents, highlighting their indications, physical properties, clinical applications, and complications. Special attention is given to heavy tamponades, perfluorocarbon liquids, and recent developments in tamponade strategies. The article also explores future directions, including drug-eluting tamponades and the development of synthetic vitreous substitutes that aim to mimic the native vitreous body and reduce the need for postoperative interventions.</p><p><strong>Key message: </strong>While current tamponade agents remain indispensable in vitreoretinal surgery, ongoing research into smarter, safer, and more physiologically compatible materials holds great promise. Future tamponades may not only offer mechanical support but also actively contribute to retinal healing and pharmacologic delivery, potentially transforming the standard of care in retinal surgery.</p>","PeriodicalId":19595,"journal":{"name":"Ophthalmologica","volume":" ","pages":"1-16"},"PeriodicalIF":1.9,"publicationDate":"2026-02-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146181753","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}
Avery W Zhou, Ryan A Sahraravand, Liisa M Baumann, Gail Megan Teagle, Jeremiah Brown, Dante Pieramici, Sarah E Holy, Michael J Borne, Robert W Wong, Matthew A Cunningham, William A Pearce, Effie Z Rahman, Margaret Chang, Abdhish R Bhavsar, David M Brown, Daniel Virgil Alfaro, Kenneth C Fan, Lasse Jørgensen Cehofski, Michael Ip, Srinivas R Sadda, Luis A Lesmes, Justis P Ehlers, Varun Chaudhary, Hasenin Al-Khersan, Charles C Wykoff
{"title":"MAGIC: Study Design and Rationale for the Phase 2 Clinical Trial of Faricimab for Non-Proliferative Diabetic Retinopathy.","authors":"Avery W Zhou, Ryan A Sahraravand, Liisa M Baumann, Gail Megan Teagle, Jeremiah Brown, Dante Pieramici, Sarah E Holy, Michael J Borne, Robert W Wong, Matthew A Cunningham, William A Pearce, Effie Z Rahman, Margaret Chang, Abdhish R Bhavsar, David M Brown, Daniel Virgil Alfaro, Kenneth C Fan, Lasse Jørgensen Cehofski, Michael Ip, Srinivas R Sadda, Luis A Lesmes, Justis P Ehlers, Varun Chaudhary, Hasenin Al-Khersan, Charles C Wykoff","doi":"10.1159/000550491","DOIUrl":"10.1159/000550491","url":null,"abstract":"<p><strong>Purpose: </strong>Describe the design and rationale of the MAGIC (<ext-link ext-link-type=\"uri\" xlink:href=\"http://ClinicalTrials.gov\" xmlns:xlink=\"http://www.w3.org/1999/xlink\">ClinicalTrials.gov</ext-link> identifier, NCT05681884) trial assessing change in retinal nonperfusion (RNP) among eyes with non-proliferative diabetic retinopathy (NPDR) in sham and treated patients.</p><p><strong>Design: </strong>Phase 2 prospective, randomized, multicenter, open-label, clinical trial.</p><p><strong>Participants: </strong>Adults with NPDR and substantial RNP (>5 disc areas) on ultra-widefield fluorescein angiography images.</p><p><strong>Methods: </strong>Patients will be randomized (1:1) into 1 of 2 arms: group 1 receiving intravitreal faricimab 6 mg every 4 weeks (Q4W) and group 2 being observed Q16W. At 48 weeks, group 1 will receive faricimab Q16W and group 2 will initiate faricimab Q4W through the final trial endpoint at year 2. The primary endpoint is change in RNP area through week 48. Secondary endpoints include change in RNP area through week 96; percentage of neovascularization, vitreous hemorrhage, DME, and/or PDR development; change in best-corrected visual acuity; change in central subfield thickness; contrast sensitivity (CS) measured using the quantitative contrast sensitivity function (qCSF); detection of apoptosing retinal cells (DARC) analysis; and proportion of subjects with ≥ 2-step improvement in Diabetic Retinopathy Severity Score (DRSS). Safety outcomes include incidence and severity of adverse events.</p><p><strong>Main outcome measures: </strong>Study design rationale.</p><p><strong>Results: </strong>Recruitment commenced in May 2023 and was completed in May 2024. Group 1 will be dosed Q4W to maximize detection of an impact on RNP progression compared to the untreated group 2. During year 2, group 1 will be dosed Q16W to assess for maintenance of any changes in RNP trajectory achieved during year 1. Group 2 will assess the natural history of RNP progression through year 1, then transition to maximal dosing to evaluate for a potential change in trajectory of RNP progression. Additional assessments, including CS and DARC, will address the unmet need for a better understanding of visual dysfunction among patients with NPDR and investigate the potential role of apoptosis in RNP, respectively.</p><p><strong>Conclusion: </strong>MAGIC is a randomized clinical trial that assesses RNP progression among eyes with NPDR, including its natural history and the impact of faricimab. Its innovative study design also explores the utility of novel assessments of retinal physiology and function.</p>","PeriodicalId":19595,"journal":{"name":"Ophthalmologica","volume":" ","pages":"1-10"},"PeriodicalIF":1.9,"publicationDate":"2026-01-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13008387/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146053156","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}
OphthalmologicaPub Date : 2026-01-01Epub Date: 2025-11-01DOI: 10.1159/000549175
Denise Yang-Seeger, Annkathrin Schellstede, Laurenz J B Pauleikhoff, Martin S Spitzer, Johannes Birtel
{"title":"Patients' Perspectives on Climate Change, Health, and Sustainability in Ophthalmology.","authors":"Denise Yang-Seeger, Annkathrin Schellstede, Laurenz J B Pauleikhoff, Martin S Spitzer, Johannes Birtel","doi":"10.1159/000549175","DOIUrl":"10.1159/000549175","url":null,"abstract":"<p><p><p>Introduction: Sustainability is becoming increasingly important in ophthalmology due to growing environmental, economic, and social responsibilities. Integrating sustainability into clinical practice requires not only advocacy by clinicians but also patients' collaboration and awareness. This study aimed to understand patients' perspectives on sustainability and the role attributed to ophthalmologists.</p><p><strong>Methods: </strong>In this multi-item survey, ophthalmologic patients were assessed regarding their views on sustainability in general and in ophthalmology in particular. Levels of agreement were measured using a Likert scale.</p><p><strong>Results: </strong>In total, 105 patients were included. There was high agreement on statements that anthropogenic climate change is an urgent issue, requires action, and is impacting population health (all, ≥85%). Patients supported advocacy of ophthalmologists for more sustainability, and there was broad agreement (74%) that ophthalmology practices should become more environmentally sustainable. No clear trend was observed whether the healthcare sector is taking sufficient measures to become more sustainable and whether the carbon footprint of ophthalmology is smaller compared to other specialties (44% and 33% disagreed; 41% and 63% [strongly] agreed, respectively). Patients aged ≥70 years agreed significantly more than younger patients that healthcare plays an important role in fighting climate change. A similar trend was observed for female compared to male patients. Female and older patients also tended to express greater expectations for ophthalmologists to advocate for sustainability, along with a call for increased advocacy from legislators and ophthalmology societies.</p><p><strong>Conclusion: </strong>Patients showed strong awareness of anthropogenic climate change and the need for ophthalmology to become more sustainable. Especially female and older patients tended to expect more advocacy from ophthalmologists, ophthalmological societies, and the legislators. </p>.</p>","PeriodicalId":19595,"journal":{"name":"Ophthalmologica","volume":" ","pages":"1-7"},"PeriodicalIF":1.9,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12707902/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145426952","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}