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).
{"title":"Aflibercept 8 mg in Neovascular AMD-A Fast-Drying Anti-VEGF Drug: A Prospective Morpho-Functional Pilot Study.","authors":"Michele Rinaldi, Gilda Cennamo, Marina Concilio, Gaetano Corvino, Alessia Riccardo, Raffaele Nubi, Ciro Costagliola","doi":"10.1007/s40123-025-01296-8","DOIUrl":"https://doi.org/10.1007/s40123-025-01296-8","url":null,"abstract":"<p><strong>Introduction: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p><p><strong>Trial registration: </strong>The research protocol was registered on ClinicalTrials.gov (NCT07074054).</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-12-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145743661","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Introduction: Despite refractive correction and patching, some patients have residual amblyopia. In the current study, we compared the effectiveness of daily 6-hours (6-h) intensive patching and a newly developed individualized and adaptive vision training (iAVT) protocol for residual amblyopia in children.
Methods: In a randomized clinical trial, 60 children aged 4 to under 11 years with residual amblyopia and visual acuity ranging from 0.2 to 0.8 logarithm of the minimum angle of resolution (logMAR) were assigned to receive either 50 sessions of iAVT training or 6 h of daily patching for 10 weeks.
Results: Visual acuity in the amblyopic eye improved more in the iAVT group than in the extended patching group (0.13 versus 0.07 logMAR; 95% confidence interval (CI) 0.010-0.100; p = 0.017) over 10 weeks. At 2 weeks, the iAVT group also showed a faster improvement compared with the patching group (0.09 versus 0.06 logMAR; 95% CI -0.004 to 0.067; p = 0.076). Meanwhile, no significant between-group difference was found in the area under the log contrast sensitivity function (AULCSF) change. However, the AULCSF of the iAVT group showed a marginally significant within-group improvement from base to week 10 (0.78 versus 0.89; 95% CI -0.225 to 0.001; p = 0.056), while no significant change was observed in the patching group. The iAVT group also reported higher quality-of-life scores after treatment, as monitored by the Pediatric Eye Questionnaire.
Conclusions: The iAVT provided a faster and more effective treatment for residual amblyopia compared with 6-h patching within the 10-week treatment period. These results suggest that iAVT may be an important new approach to treating residual amblyopia.
Trail registration: Chinese Clinical Trial Registry, ChiCTR2300075594. Registered on 8 September 2023-retrospectively registered.
尽管有屈光矫正和配片,一些患者仍有残余弱视。在目前的研究中,我们比较了每天6小时(6小时)强化补片和新开发的个性化和适应性视觉训练(iAVT)方案对儿童残余弱视的有效性。方法:在一项随机临床试验中,60名年龄在4至11岁以下的残弱视儿童,视力范围为最小分辨角(logMAR)的0.2至0.8对数,被分配接受50次iAVT训练或每天6小时的贴片,为期10周。结果:iAVT组弱视眼的视力改善程度高于扩展贴片组(0.13 vs 0.07 logMAR; 95%可信区间(CI) 0.010-0.100;P = 0.017)。在2周时,iAVT组也比贴片组表现出更快的改善(0.09对0.06 logMAR; 95% CI -0.004至0.067;p = 0.076)。同时,对数对比敏感度函数(AULCSF)变化下的面积组间无显著差异。然而,从基础到第10周,iAVT组的AULCSF在组内略有显著改善(0.78 vs 0.89; 95% CI -0.225 to 0.001; p = 0.056),而在贴片组中未观察到显著变化。iAVT组也报告了治疗后更高的生活质量评分,这是由儿科眼科问卷监测的。结论:在10周的治疗期内,iAVT比6小时补片治疗残余弱视更快、更有效。这些结果提示iAVT可能是治疗残余弱视的重要新方法。试验注册:中国临床试验注册中心,ChiCTR2300075594。于2023年9月8日注册,已追溯注册。
{"title":"Effect of Individualized and Adaptive Vision Training versus 6 hours of Patching in Children with Residual Amblyopia: A Randomized Clinical Trial.","authors":"Junli Yuan, Yuanyuan Chen, Lu Wang, Meiping Xu, Na Liao, Zhiyue Dai, Hui Chen, Binjun Zhang, Jinling Xu, Minghui Wan, Suzhong Xu, Yuwen Wang, Xiaolin Huang, Fuhao Zheng, Pingping Huang, Jie Chen, Chang-Bing Huang, Fang-Fang Yan, Xinping Yu, Huanyun Yu","doi":"10.1007/s40123-025-01287-9","DOIUrl":"https://doi.org/10.1007/s40123-025-01287-9","url":null,"abstract":"<p><strong>Introduction: </strong>Despite refractive correction and patching, some patients have residual amblyopia. In the current study, we compared the effectiveness of daily 6-hours (6-h) intensive patching and a newly developed individualized and adaptive vision training (iAVT) protocol for residual amblyopia in children.</p><p><strong>Methods: </strong>In a randomized clinical trial, 60 children aged 4 to under 11 years with residual amblyopia and visual acuity ranging from 0.2 to 0.8 logarithm of the minimum angle of resolution (logMAR) were assigned to receive either 50 sessions of iAVT training or 6 h of daily patching for 10 weeks.</p><p><strong>Results: </strong>Visual acuity in the amblyopic eye improved more in the iAVT group than in the extended patching group (0.13 versus 0.07 logMAR; 95% confidence interval (CI) 0.010-0.100; p = 0.017) over 10 weeks. At 2 weeks, the iAVT group also showed a faster improvement compared with the patching group (0.09 versus 0.06 logMAR; 95% CI -0.004 to 0.067; p = 0.076). Meanwhile, no significant between-group difference was found in the area under the log contrast sensitivity function (AULCSF) change. However, the AULCSF of the iAVT group showed a marginally significant within-group improvement from base to week 10 (0.78 versus 0.89; 95% CI -0.225 to 0.001; p = 0.056), while no significant change was observed in the patching group. The iAVT group also reported higher quality-of-life scores after treatment, as monitored by the Pediatric Eye Questionnaire.</p><p><strong>Conclusions: </strong>The iAVT provided a faster and more effective treatment for residual amblyopia compared with 6-h patching within the 10-week treatment period. These results suggest that iAVT may be an important new approach to treating residual amblyopia.</p><p><strong>Trail registration: </strong>Chinese Clinical Trial Registry, ChiCTR2300075594. Registered on 8 September 2023-retrospectively registered.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-12-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145708828","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-09DOI: 10.1007/s40123-025-01288-8
Xiaoli Li, Hongbin Lin, Guangzhong Fan, Zonghui Yan, Wentian Zhou, Feng Zhu, Xiaoqin Su, Yi Liu, Ling Ling, Yongjin Li, Chao Liao, Zhen Qiu, Mingkui Tan, Quan Liu
Introduction: The aim of this work is to predict the implantable Collamer lens (ICL) vault using machine learning (ML) algorithms and a data wrangling approach based on multicenter big data.
Methods: This retrospective cross-sectional study developed ML models using preoperative biometric data and ICL vault from 6715 eyes across five hospitals. Mutual information regression was employed to identify important parameters. A digital vault information system (DVIS) was constructed for data wrangling. ML models integrated with DVIS were used to develop ICL vault prediction and classification models, which were validated in both internal (6552 eyes) and external (163 eyes) validation.
Results: The XGBoost model combined with DVIS exhibited statistically superior performance in ICL vault prediction, with lower mean absolute error (MAE) of 39.15 μm (internal validation) and 149.72 μm (external validation) compared to other ML algorithms. The R2 value was 0.86 in the internal validation. For ICL vault classification, the XGBoost algorithm achieved accuracies of 81.4% (internal validation) and 57.27% (external validation), representing accuracy gains of 27.1% and 10.2% respectively, compared to traditional ML algorithms.
Conclusions: The development of DVIS is valuable for ICL vault prediction models, as it provides a data wrangling strategy that improves ML efficiency. Experimental results confirm the applicability of this synergistic method in enhancing existing ML approaches for ICL vault prediction, thereby facilitating more informed clinical decision-making in ICL implantation surgery.
{"title":"EVO-ICL Vault Prediction: A Data Wrangling Framework Integrating Multicenter Big Data and Machine Learning.","authors":"Xiaoli Li, Hongbin Lin, Guangzhong Fan, Zonghui Yan, Wentian Zhou, Feng Zhu, Xiaoqin Su, Yi Liu, Ling Ling, Yongjin Li, Chao Liao, Zhen Qiu, Mingkui Tan, Quan Liu","doi":"10.1007/s40123-025-01288-8","DOIUrl":"https://doi.org/10.1007/s40123-025-01288-8","url":null,"abstract":"<p><strong>Introduction: </strong>The aim of this work is to predict the implantable Collamer lens (ICL) vault using machine learning (ML) algorithms and a data wrangling approach based on multicenter big data.</p><p><strong>Methods: </strong>This retrospective cross-sectional study developed ML models using preoperative biometric data and ICL vault from 6715 eyes across five hospitals. Mutual information regression was employed to identify important parameters. A digital vault information system (DVIS) was constructed for data wrangling. ML models integrated with DVIS were used to develop ICL vault prediction and classification models, which were validated in both internal (6552 eyes) and external (163 eyes) validation.</p><p><strong>Results: </strong>The XGBoost model combined with DVIS exhibited statistically superior performance in ICL vault prediction, with lower mean absolute error (MAE) of 39.15 μm (internal validation) and 149.72 μm (external validation) compared to other ML algorithms. The R<sup>2</sup> value was 0.86 in the internal validation. For ICL vault classification, the XGBoost algorithm achieved accuracies of 81.4% (internal validation) and 57.27% (external validation), representing accuracy gains of 27.1% and 10.2% respectively, compared to traditional ML algorithms.</p><p><strong>Conclusions: </strong>The development of DVIS is valuable for ICL vault prediction models, as it provides a data wrangling strategy that improves ML efficiency. Experimental results confirm the applicability of this synergistic method in enhancing existing ML approaches for ICL vault prediction, thereby facilitating more informed clinical decision-making in ICL implantation surgery.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-12-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145715357","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-08DOI: 10.1007/s40123-025-01291-z
Andreas F Borkenstein, Eva-Maria Borkenstein, Anton Kolesnik, Boris Malyugin
Background: Accurate, patient‑specific estimation of vitreous cavity volume can support planning and safety during vitreoretinal surgery and tamponade procedures. We evaluated the performance of the vitreous volume exact (VIVEX) formula-which predicts vitreous volume from axial length (AL)-in a first clinical case series.
Methods: This retrospective observational case series included 27 eyes undergoing vitreoretinal procedures. Intraoperative volume measurements (aspirated fluid in group 1 (G1), injected silicone oil in group 2 (G2), and removed silicone oil in group 3 (G3)) were compared with VIVEX‑predicted volumes computed from AL. Accuracy metrics included mean absolute error (MAE) and mean absolute percentage error (MAPE). Agreement was assessed using Pearson correlation, ordinary least-squares regression (slope, intercept, 95% confidence intervals (CIs)), and Bland-Altman analysis.
Results: Across all eyes (N = 27), VIVEX predictions correlated strongly with intraoperative measurements (r = 0.961, p < 0.0001). Overall, MAE and MAPE were 0.48 mL and 7.43%, respectively. Regression yielded a slope of 0.74 (95% CI 0.65-0.83) and an intercept of 1.17 mL (95% CI 0.60-1.74). Bland-Altman analysis showed a bias of +0.42 mL with 95% limits of agreement from -0.88 to +1.73 mL. Subgroup results were: G1 (n = 17), MAE 0.33 mL and MAPE 6.09%; G2 (n = 5), MAE 0.39 mL and MAPE 6.9%; G3 (n = 5), MAE 1.07 mL and MAPE 12.51%, with a positive bias indicating slightly higher VIVEX values than intraoperative measurements.
Conclusions: The VIVEX formula demonstrates high correlation and clinically useful accuracy for individualized vitreous volume estimation across common surgical contexts. It seems that the largest error and a positive bias occur during silicone oil removal, warranting caution in oil-filled eyes. In such cases, measurement artifacts due to altered optical pathways in silicone-oil-filled eyes and the possible presence of residual oil remnants after removal may contribute to minor discrepancies between calculated and true intraoperative volumes, indicating a need for further evaluation. Overall, VIVEX may assist preoperative planning and realistic volume targeting in routine practice. As this is the first clinical case series evaluating the VIVEX formula in real surgical settings, larger prospective multicenter studies are needed to confirm and expand the findings.
{"title":"Real-World Validation of the VIVEX Formula for Vitreous Volume Estimation in Vitreoretinal Surgery: A First Clinical Case Series.","authors":"Andreas F Borkenstein, Eva-Maria Borkenstein, Anton Kolesnik, Boris Malyugin","doi":"10.1007/s40123-025-01291-z","DOIUrl":"https://doi.org/10.1007/s40123-025-01291-z","url":null,"abstract":"<p><strong>Background: </strong>Accurate, patient‑specific estimation of vitreous cavity volume can support planning and safety during vitreoretinal surgery and tamponade procedures. We evaluated the performance of the vitreous volume exact (VIVEX) formula-which predicts vitreous volume from axial length (AL)-in a first clinical case series.</p><p><strong>Methods: </strong>This retrospective observational case series included 27 eyes undergoing vitreoretinal procedures. Intraoperative volume measurements (aspirated fluid in group 1 (G1), injected silicone oil in group 2 (G2), and removed silicone oil in group 3 (G3)) were compared with VIVEX‑predicted volumes computed from AL. Accuracy metrics included mean absolute error (MAE) and mean absolute percentage error (MAPE). Agreement was assessed using Pearson correlation, ordinary least-squares regression (slope, intercept, 95% confidence intervals (CIs)), and Bland-Altman analysis.</p><p><strong>Results: </strong>Across all eyes (N = 27), VIVEX predictions correlated strongly with intraoperative measurements (r = 0.961, p < 0.0001). Overall, MAE and MAPE were 0.48 mL and 7.43%, respectively. Regression yielded a slope of 0.74 (95% CI 0.65-0.83) and an intercept of 1.17 mL (95% CI 0.60-1.74). Bland-Altman analysis showed a bias of +0.42 mL with 95% limits of agreement from -0.88 to +1.73 mL. Subgroup results were: G1 (n = 17), MAE 0.33 mL and MAPE 6.09%; G2 (n = 5), MAE 0.39 mL and MAPE 6.9%; G3 (n = 5), MAE 1.07 mL and MAPE 12.51%, with a positive bias indicating slightly higher VIVEX values than intraoperative measurements.</p><p><strong>Conclusions: </strong>The VIVEX formula demonstrates high correlation and clinically useful accuracy for individualized vitreous volume estimation across common surgical contexts. It seems that the largest error and a positive bias occur during silicone oil removal, warranting caution in oil-filled eyes. In such cases, measurement artifacts due to altered optical pathways in silicone-oil-filled eyes and the possible presence of residual oil remnants after removal may contribute to minor discrepancies between calculated and true intraoperative volumes, indicating a need for further evaluation. Overall, VIVEX may assist preoperative planning and realistic volume targeting in routine practice. As this is the first clinical case series evaluating the VIVEX formula in real surgical settings, larger prospective multicenter studies are needed to confirm and expand the findings.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-12-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145708848","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-07DOI: 10.1007/s40123-025-01281-1
Julie Poteet, Cecelia Koetting, Priya S Vakharia
No current treatments are curative for age-related macular degeneration (AMD), and preventing disease progression is challenging. Dietary factors play a role in the course of macular degeneration, and management of AMD commonly includes nutraceuticals (e.g., supplementation with a combination of antioxidant vitamins and minerals). This commentary summarizes the existing literature, emerging evidence, and upcoming research on the role of B vitamins in both preventing the development of AMD and slowing its progression.
{"title":"Role of B Vitamins in Preventing the Development and Progression of Age-Related Macular Degeneration.","authors":"Julie Poteet, Cecelia Koetting, Priya S Vakharia","doi":"10.1007/s40123-025-01281-1","DOIUrl":"https://doi.org/10.1007/s40123-025-01281-1","url":null,"abstract":"<p><p>No current treatments are curative for age-related macular degeneration (AMD), and preventing disease progression is challenging. Dietary factors play a role in the course of macular degeneration, and management of AMD commonly includes nutraceuticals (e.g., supplementation with a combination of antioxidant vitamins and minerals). This commentary summarizes the existing literature, emerging evidence, and upcoming research on the role of B vitamins in both preventing the development of AMD and slowing its progression.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-12-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145701442","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-05DOI: 10.1007/s40123-025-01289-7
Marco R Pastore, Elena Verdimonti, Kamal El Majdoubi El Idrissi, Marianna Presotto, Massimo Borelli, Alexandra Miere, Daniele Tognetto, Eric H Souied
Introduction: This work compares the tolerability of 0.6% povidone-iodine (PI) and 0.5% liposomal ozonated oil (LOZ) as antiseptic prophylaxis in patients undergoing intravitreal injections (IVI), aiming to optimize preventive strategies against injection-related endophthalmitis.
Methods: This multicenter cohort study was conducted at the University Paris Est, Créteil, and the University of Trieste between November 2024 and June 2025. A total of 691 patients with maculopathies (329 in the PI group, 362 in the LOZ group) were enrolled. Patients received either 0.6% PI or 0.5% OZ topical prophylaxis three times daily for 3 days before and after IVI. Clinical tolerability was assessed by slit-lamp examination, grading conjunctival hyperemia, discharge, tarsal papillae, corneal changes, burning, and foreign body sensation (0-4 scale). Patient-reported discomfort was evaluated using a Visual Analogue Scale (VAS), classified into four categories: 0-10 mm (score 0), 11-40 mm (score 1), 41-70 mm (score 2), and 71-100 mm (score 3). Statistical analyses included generalized linear models adjusted for dry eye and prostaglandin therapy.
Results: LOZ treatment was associated with significantly lower mean scores for hyperemia (0.52 vs. 1.51), discharge (0.15 vs. 0.91), tarsal papillae (0.02 vs. 0.57), corneal changes (0.04 vs. 0.58), burning (0.25 vs. 1.69), and foreign body sensation (0.21 vs. 1.58) compared to 0.6% PI (all p < 0.001). VAS scores confirmed superior tolerability in the LOZ group (mean 0.23 vs. 1.58). No cases of endophthalmitis occurred in either group.
Conclusions: LOZ (0.5%) represents an ophthalmic antiseptic that addresses the limitations of traditional povidone-iodine preparations, suggesting it may represent a more patient-friendly prophylactic alternative for IVI.
{"title":"Tolerability of 0.5% Liposomal Ozonated Oil Versus 0.6% Povidone-Iodine in Antiseptic Prophylaxis for Intravitreal Injections.","authors":"Marco R Pastore, Elena Verdimonti, Kamal El Majdoubi El Idrissi, Marianna Presotto, Massimo Borelli, Alexandra Miere, Daniele Tognetto, Eric H Souied","doi":"10.1007/s40123-025-01289-7","DOIUrl":"https://doi.org/10.1007/s40123-025-01289-7","url":null,"abstract":"<p><strong>Introduction: </strong>This work compares the tolerability of 0.6% povidone-iodine (PI) and 0.5% liposomal ozonated oil (LOZ) as antiseptic prophylaxis in patients undergoing intravitreal injections (IVI), aiming to optimize preventive strategies against injection-related endophthalmitis.</p><p><strong>Methods: </strong>This multicenter cohort study was conducted at the University Paris Est, Créteil, and the University of Trieste between November 2024 and June 2025. A total of 691 patients with maculopathies (329 in the PI group, 362 in the LOZ group) were enrolled. Patients received either 0.6% PI or 0.5% OZ topical prophylaxis three times daily for 3 days before and after IVI. Clinical tolerability was assessed by slit-lamp examination, grading conjunctival hyperemia, discharge, tarsal papillae, corneal changes, burning, and foreign body sensation (0-4 scale). Patient-reported discomfort was evaluated using a Visual Analogue Scale (VAS), classified into four categories: 0-10 mm (score 0), 11-40 mm (score 1), 41-70 mm (score 2), and 71-100 mm (score 3). Statistical analyses included generalized linear models adjusted for dry eye and prostaglandin therapy.</p><p><strong>Results: </strong>LOZ treatment was associated with significantly lower mean scores for hyperemia (0.52 vs. 1.51), discharge (0.15 vs. 0.91), tarsal papillae (0.02 vs. 0.57), corneal changes (0.04 vs. 0.58), burning (0.25 vs. 1.69), and foreign body sensation (0.21 vs. 1.58) compared to 0.6% PI (all p < 0.001). VAS scores confirmed superior tolerability in the LOZ group (mean 0.23 vs. 1.58). No cases of endophthalmitis occurred in either group.</p><p><strong>Conclusions: </strong>LOZ (0.5%) represents an ophthalmic antiseptic that addresses the limitations of traditional povidone-iodine preparations, suggesting it may represent a more patient-friendly prophylactic alternative for IVI.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-12-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145678170","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-05DOI: 10.1007/s40123-025-01285-x
Andrew Hopkinson, Mohamed Elalfy, Mayank A Nanavaty
Subepithelial corneal haze remains a clinical risk after excimer laser-based surface ablation (ELSA), especially with deep ablations, high myopia or retreatments, with downstream effects on vision and quality of life. Mitomycin C (MMC) is widely used intraoperatively for haze prophylaxis and has multi-study support; however, its antiproliferative, anti-fibrotic action does not directly address early inflammation, epithelial barrier restoration or neuroregeneration, and use remains off-label with heterogeneous protocols. This narrative review synthesises preclinical, early clinical (non-randomised/small trials) and established clinical evidence (randomised trials/systematic reviews or guidelines) on amniotic membrane transplantation (AMT) as a complementary adjunct in ELSA. We emphasise modern, sutureless, dehydrated AMT (dAM), including vision-preserving formats suited to peri-operative workflows. Across adjacent ocular-surface indications, AMT demonstrates multi-modal properties: anti-inflammatory/immunomodulatory, antioxidant, anti-proteinase (including matrix metalloproteinase-9 suppression) and support of epithelial and nerve recovery. In ELSA-specific work, preclinical photorefractive keratectomy (PRK) models show reduced haze and faster epithelialisation with patch-AMT; one prospective laser-assisted sub-epithelial keratectomy (LASEK) human study reports faster healing and lower opacity versus standard care. By contrast, small fellow-eye studies using ring-mounted cryopreserved-AMT devices showed no superiority for routine myopic PRK, underscoring the importance of format and protocol. This review outlines a complementary paradigm: MMC targets downstream fibrosis, whilst patch-AMT acts earlier on inflammation, epithelial repair, protease imbalance (including MMP-9) and neurotrophic support. With major international guidelines now recognising sutureless patch-AMT for regeneration and inflammation/oxidative stress control in dry eye, prospective refractive-cohort trials with standardised product/placement protocols, long-term follow-up, patient-reported outcomes and embedded health-economic evaluation are warranted to define AMT's role alongside MMC in routine ELSA.
{"title":"Amniotic Membrane in Excimer Laser Surface Ablation (ELSA): Mechanisms for Haze Prevention and Broader Ocular Surface Optimisation.","authors":"Andrew Hopkinson, Mohamed Elalfy, Mayank A Nanavaty","doi":"10.1007/s40123-025-01285-x","DOIUrl":"https://doi.org/10.1007/s40123-025-01285-x","url":null,"abstract":"<p><p>Subepithelial corneal haze remains a clinical risk after excimer laser-based surface ablation (ELSA), especially with deep ablations, high myopia or retreatments, with downstream effects on vision and quality of life. Mitomycin C (MMC) is widely used intraoperatively for haze prophylaxis and has multi-study support; however, its antiproliferative, anti-fibrotic action does not directly address early inflammation, epithelial barrier restoration or neuroregeneration, and use remains off-label with heterogeneous protocols. This narrative review synthesises preclinical, early clinical (non-randomised/small trials) and established clinical evidence (randomised trials/systematic reviews or guidelines) on amniotic membrane transplantation (AMT) as a complementary adjunct in ELSA. We emphasise modern, sutureless, dehydrated AMT (dAM), including vision-preserving formats suited to peri-operative workflows. Across adjacent ocular-surface indications, AMT demonstrates multi-modal properties: anti-inflammatory/immunomodulatory, antioxidant, anti-proteinase (including matrix metalloproteinase-9 suppression) and support of epithelial and nerve recovery. In ELSA-specific work, preclinical photorefractive keratectomy (PRK) models show reduced haze and faster epithelialisation with patch-AMT; one prospective laser-assisted sub-epithelial keratectomy (LASEK) human study reports faster healing and lower opacity versus standard care. By contrast, small fellow-eye studies using ring-mounted cryopreserved-AMT devices showed no superiority for routine myopic PRK, underscoring the importance of format and protocol. This review outlines a complementary paradigm: MMC targets downstream fibrosis, whilst patch-AMT acts earlier on inflammation, epithelial repair, protease imbalance (including MMP-9) and neurotrophic support. With major international guidelines now recognising sutureless patch-AMT for regeneration and inflammation/oxidative stress control in dry eye, prospective refractive-cohort trials with standardised product/placement protocols, long-term follow-up, patient-reported outcomes and embedded health-economic evaluation are warranted to define AMT's role alongside MMC in routine ELSA.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-12-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145678243","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-04DOI: 10.1007/s40123-025-01284-y
Neslihan D Koseoglu, Luiz L Lamazales, Stephanie M Cox, Ana Balbuena-Pareja, Onur Olcucu, Pedram Hamrah
Introduction: Intact corneal sensation plays a vital role in maintaining ocular surface health. Various ocular surface pathologies can present with differing levels of decreased corneal sensation, while in some cases patients may instead experience heightened sensation. This study compared corneal sensitivity with the new quantitative non-contact esthesiometer (NCE, Brill, USA) and the conventional qualitative cotton wisp (CW) test in patients with ocular surface diseases (OSD).
Methods: A retrospective, cross-sectional study was conducted, including patients with OSDs, who had both CW and NCE test results available. Descriptive analysis of one eye per patient was performed to compare the distribution of patients according to NCE and CW responses.
Results: Of 139 eyes (n = 139 patients), 129 (92.8%) were CW+ and 10 eyes were CW- (7.2%). Among these, 111 eyes responded to levels 1-3 when assessed with NCE, with 38 (34.2%) responding to level 1, 45 (40.5%) to level 2, and 28 (25.2%) to level 3. However, of CW+ eyes, 10 (7.8%) responded to level 4 and 6 (4.7%) responded to level 5 of NCE, while 2 (1.6%) had no response to any NCE stimulation (i.e., level 6), indicating varying degrees of hyposensitivity not detected by CW. Of the 10 eyes (7.2%) that did not respond to CW (CW-), 3 responded to level 4, and one to level 5 of NCE, while 4 eyes (40.0%) failed to respond to NCE (level 6). Notably, two CW- patients responded to level 1 NCE, suggesting potential hypersensitivity. Results showed high sensitivity (98.2%, 95% CI 93.8-99.8%) but low specificity (30.8%, 95% CI 14.3-51.8%) of the CW test in patients with OSD when level 4 of NCE (i.e., levels 4, 5, and 6) was used as the cutoff for defining corneal hyposensitivity.
Conclusion: Our results demonstrate that the low specificity of the qualitative CW test, combined with a broad confidence interval, indicates a high likelihood of false-positive results. This suggests that a positive CW test may not reliably rule out hyposensitivity, underscoring the need for further evaluation in the setting of a positive CW test result.
完整的角膜感觉在维持眼表健康中起着至关重要的作用。不同的眼表病变可表现为不同程度的角膜感觉下降,而在某些情况下,患者可能会体验到增强的感觉。本研究比较了新型定量非接触感测仪(NCE, Brill, USA)和常规定性棉线(CW)试验对眼表疾病(OSD)患者角膜敏感度的影响。方法:回顾性、横断面研究,纳入有CW和NCE检测结果的osd患者。对每位患者进行一只眼的描述性分析,根据NCE和CW反应比较患者的分布。结果139只眼(n = 139例)中,CW+ 129只(92.8%),CW- 10只(7.2%)。其中111只眼睛在NCE评估时对1-3级有反应,38只(34.2%)对1级有反应,45只(40.5%)对2级有反应,28只(25.2%)对3级有反应。然而,在CW+眼中,10只(7.8%)对NCE 4级有反应,6只(4.7%)对NCE 5级有反应,而2只(1.6%)对任何NCE刺激都没有反应(即6级),表明CW未检测到不同程度的低敏感性。10只眼(7.2%)对CW (CW-)无反应,3只眼对NCE 4级有反应,1只眼对NCE 5级有反应,4只眼(40.0%)对NCE 6级无反应。值得注意的是,两名CW-患者对1级NCE有反应,提示潜在的过敏。结果显示,当使用4级NCE(即4、5、6级)作为定义角膜低敏感性的临界值时,OSD患者的CW检测灵敏度高(98.2%,95% CI 93.8-99.8%),但特异性低(30.8%,95% CI 14.3-51.8%)。结论:我们的结果表明,定性CW测试的低特异性,加上广泛的置信区间,表明假阳性结果的可能性很高。这表明,阳性连续波试验可能不能可靠地排除低敏感性,强调需要在阳性连续波试验结果的背景下进一步评估。
{"title":"Corneal Sensitivity with the Non-contact Esthesiometer as Compared to the Cotton Wisp Test in Patients with Ocular Surface Diseases.","authors":"Neslihan D Koseoglu, Luiz L Lamazales, Stephanie M Cox, Ana Balbuena-Pareja, Onur Olcucu, Pedram Hamrah","doi":"10.1007/s40123-025-01284-y","DOIUrl":"https://doi.org/10.1007/s40123-025-01284-y","url":null,"abstract":"<p><strong>Introduction: </strong>Intact corneal sensation plays a vital role in maintaining ocular surface health. Various ocular surface pathologies can present with differing levels of decreased corneal sensation, while in some cases patients may instead experience heightened sensation. This study compared corneal sensitivity with the new quantitative non-contact esthesiometer (NCE, Brill, USA) and the conventional qualitative cotton wisp (CW) test in patients with ocular surface diseases (OSD).</p><p><strong>Methods: </strong>A retrospective, cross-sectional study was conducted, including patients with OSDs, who had both CW and NCE test results available. Descriptive analysis of one eye per patient was performed to compare the distribution of patients according to NCE and CW responses.</p><p><strong>Results: </strong>Of 139 eyes (n = 139 patients), 129 (92.8%) were CW+ and 10 eyes were CW- (7.2%). Among these, 111 eyes responded to levels 1-3 when assessed with NCE, with 38 (34.2%) responding to level 1, 45 (40.5%) to level 2, and 28 (25.2%) to level 3. However, of CW+ eyes, 10 (7.8%) responded to level 4 and 6 (4.7%) responded to level 5 of NCE, while 2 (1.6%) had no response to any NCE stimulation (i.e., level 6), indicating varying degrees of hyposensitivity not detected by CW. Of the 10 eyes (7.2%) that did not respond to CW (CW-), 3 responded to level 4, and one to level 5 of NCE, while 4 eyes (40.0%) failed to respond to NCE (level 6). Notably, two CW- patients responded to level 1 NCE, suggesting potential hypersensitivity. Results showed high sensitivity (98.2%, 95% CI 93.8-99.8%) but low specificity (30.8%, 95% CI 14.3-51.8%) of the CW test in patients with OSD when level 4 of NCE (i.e., levels 4, 5, and 6) was used as the cutoff for defining corneal hyposensitivity.</p><p><strong>Conclusion: </strong>Our results demonstrate that the low specificity of the qualitative CW test, combined with a broad confidence interval, indicates a high likelihood of false-positive results. This suggests that a positive CW test may not reliably rule out hyposensitivity, underscoring the need for further evaluation in the setting of a positive CW test result.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-12-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145669205","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-04DOI: 10.1007/s40123-025-01293-x
Josep Torras-Sanvicens, Marc Figueras-Roca, Carlos Rocha-de-Losada, Inés Bourleau, Ariadna Garreta, Elena Millá-Griñó, Ricardo P Casaroli-Marano
{"title":"Correction: Tomographic Differences in Thin Corneas Following DMEK in Fuchs Dystrophy: A Case-Control Study.","authors":"Josep Torras-Sanvicens, Marc Figueras-Roca, Carlos Rocha-de-Losada, Inés Bourleau, Ariadna Garreta, Elena Millá-Griñó, Ricardo P Casaroli-Marano","doi":"10.1007/s40123-025-01293-x","DOIUrl":"10.1007/s40123-025-01293-x","url":null,"abstract":"","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-12-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145669251","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-04DOI: 10.1007/s40123-025-01286-w
Giuseppe Giannaccare, Filippo Lixi, Carina Slidsborg, Gamze Ozkan, Alina Gabriela Gheorghe, Ana-Maria Arghirescu, Assem Namazbayeva, Mana Monfared, Rohan Bir Singh, Vishal Jhanji, Carlo Nucci, Giulia Coco
Corneal disorders are among the leading causes of visual impairment worldwide, with corneal transplantation historically serving as the cornerstone of surgical treatment. However, the global shortage of donor tissue, risk of immune rejection, and variable long-term graft survival underscore the urgent need for alternative approaches, particularly in the setting of ocular surface diseases such as inflammation or dry eye that can compromise graft survival. Regenerative medicine has emerged as a transformative paradigm, offering strategies to restore corneal architecture and function through cell-based therapies, tissue engineering, and gene modulation. These strategies are promising, addressing structural repair and modulating wound-healing responses. In the corneal epithelium, cultivated limbal epithelial transplantation, simple limbal epithelial transplantation, and cultivated oral mucosal epithelial transplantation have expanded therapeutic options for limbal stem cell deficiency, with clinical trials demonstrating long-term ocular surface stability. Regulatory approval of commercial products, such as Holoclar and Nepic, confirms the potential of standardized regenerative products. Stromal regeneration with stromal and mesenchymal stem cells has shown promise in preclinical and early phase clinical trials, with intrastromal stem cell injection improving corneal transparency and biomechanics and potentially stabilizing progressive disorders such as keratoconus. For endothelial dysfunction, intracameral injection of cultured corneal endothelial cells supplemented with Rho-associated protein kinase (ROCK) inhibitors has yielded sustained corneal clarity and visual restoration at 5-10 years, marking a paradigm shift from transplantation to minimally invasive, donor-independent therapies. Tissue engineering innovations, including matrices, hydrogels, and three-dimensional bioprinting, are advancing toward translation, while gene therapy approaches using viral vectors and Clustered Regularly Interspaced Short Palindromic Repeats -Cas9 are being explored to modulate angiogenesis, fibrosis, and inherited dystrophies. Overall, regenerative medicine is reshaping corneal therapeutics, offering effective alternatives to conventional transplantation with reduced donor dependence and improved safety. Future work must focus on long-term safety, cost-effectiveness, and equitable global access to realize its full clinical potential.
{"title":"Current Landscape and Future Prospects of Corneal Regenerative Medicine.","authors":"Giuseppe Giannaccare, Filippo Lixi, Carina Slidsborg, Gamze Ozkan, Alina Gabriela Gheorghe, Ana-Maria Arghirescu, Assem Namazbayeva, Mana Monfared, Rohan Bir Singh, Vishal Jhanji, Carlo Nucci, Giulia Coco","doi":"10.1007/s40123-025-01286-w","DOIUrl":"https://doi.org/10.1007/s40123-025-01286-w","url":null,"abstract":"<p><p>Corneal disorders are among the leading causes of visual impairment worldwide, with corneal transplantation historically serving as the cornerstone of surgical treatment. However, the global shortage of donor tissue, risk of immune rejection, and variable long-term graft survival underscore the urgent need for alternative approaches, particularly in the setting of ocular surface diseases such as inflammation or dry eye that can compromise graft survival. Regenerative medicine has emerged as a transformative paradigm, offering strategies to restore corneal architecture and function through cell-based therapies, tissue engineering, and gene modulation. These strategies are promising, addressing structural repair and modulating wound-healing responses. In the corneal epithelium, cultivated limbal epithelial transplantation, simple limbal epithelial transplantation, and cultivated oral mucosal epithelial transplantation have expanded therapeutic options for limbal stem cell deficiency, with clinical trials demonstrating long-term ocular surface stability. Regulatory approval of commercial products, such as Holoclar and Nepic, confirms the potential of standardized regenerative products. Stromal regeneration with stromal and mesenchymal stem cells has shown promise in preclinical and early phase clinical trials, with intrastromal stem cell injection improving corneal transparency and biomechanics and potentially stabilizing progressive disorders such as keratoconus. For endothelial dysfunction, intracameral injection of cultured corneal endothelial cells supplemented with Rho-associated protein kinase (ROCK) inhibitors has yielded sustained corneal clarity and visual restoration at 5-10 years, marking a paradigm shift from transplantation to minimally invasive, donor-independent therapies. Tissue engineering innovations, including matrices, hydrogels, and three-dimensional bioprinting, are advancing toward translation, while gene therapy approaches using viral vectors and Clustered Regularly Interspaced Short Palindromic Repeats -Cas9 are being explored to modulate angiogenesis, fibrosis, and inherited dystrophies. Overall, regenerative medicine is reshaping corneal therapeutics, offering effective alternatives to conventional transplantation with reduced donor dependence and improved safety. Future work must focus on long-term safety, cost-effectiveness, and equitable global access to realize its full clinical potential.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-12-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145669220","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}