Purpose: To investigate the usage status of biologics for the chronic treatment of optic neuritis including neuromyelitis optica spectrum disorders in Japan.
Design: Multicenter retrospective case series.
Methods: Patients diagnosed with anti-aquaporin 4 antibody (AQP4-Ab) positive optic neuritis and had been initiated on biologics (satralizumab, eculizumab, and inebilizumab) between January 2020 and August 2022 were identified at 30 facilities in Japan. These patients were investigated regarding changes in oral steroid doses, optic neuritis relapse, and adverse events after initiation of biologics.
Results: Eighty-eight patients with AQP4-Ab positive optic neuritis initiated on biologics were included. Satralizumab was the most common biologic used (79 patients), followed by eculizumab (6 patients) and inebilizumab (3 patients). In the satralizumab group, during the observation period (10.0±7.0 months) until February 2023, the oral steroid dose was reduced significantly from 13.8 ± 8.6 mg/day at the time of initiation to 5.3 ± 4.8 mg/day (p < 0.001). No relapse of optic neuritis was observed in 76 of 79 patients (96.2%) after initiation of satralizumab. Furthermore, in 15 patients who succeeded in discontinuing steroids during 8.5 ± 5.8 months after initiation of satralizumab, no relapse of optic neuritis was observed throughout the observation period. Adverse events occurred in 7 patients with satralizumab and 2 patients with eculizumab, but no serious infections were observed.
Conclusions: Satralizumab was the most commonly used biologic for AQP4-Ab positive optic neuritis in Japan. This study demonstrates the efficacy and safety of satralizumab in preventing the relapse of optic neuritis.
{"title":"Usage status of biologics for the chronic treatment of optic neuritis in neuromyelitis optica spectrum disorders in Japan.","authors":"Yohei Takahashi, Takeshi Kezuka, Keigo Shikishima, Akiko Yamagami, Hideki Chuman, Makoto Nakamura, Satoshi Ueki, Akiko Kimura, Masato Hashimoto, Sonoko Tatsui, Kimiyo Mashimo, Hitoshi Ishikawa","doi":"10.1007/s10384-024-01129-4","DOIUrl":"https://doi.org/10.1007/s10384-024-01129-4","url":null,"abstract":"<p><strong>Purpose: </strong>To investigate the usage status of biologics for the chronic treatment of optic neuritis including neuromyelitis optica spectrum disorders in Japan.</p><p><strong>Design: </strong>Multicenter retrospective case series.</p><p><strong>Methods: </strong>Patients diagnosed with anti-aquaporin 4 antibody (AQP4-Ab) positive optic neuritis and had been initiated on biologics (satralizumab, eculizumab, and inebilizumab) between January 2020 and August 2022 were identified at 30 facilities in Japan. These patients were investigated regarding changes in oral steroid doses, optic neuritis relapse, and adverse events after initiation of biologics.</p><p><strong>Results: </strong>Eighty-eight patients with AQP4-Ab positive optic neuritis initiated on biologics were included. Satralizumab was the most common biologic used (79 patients), followed by eculizumab (6 patients) and inebilizumab (3 patients). In the satralizumab group, during the observation period (10.0±7.0 months) until February 2023, the oral steroid dose was reduced significantly from 13.8 ± 8.6 mg/day at the time of initiation to 5.3 ± 4.8 mg/day (p < 0.001). No relapse of optic neuritis was observed in 76 of 79 patients (96.2%) after initiation of satralizumab. Furthermore, in 15 patients who succeeded in discontinuing steroids during 8.5 ± 5.8 months after initiation of satralizumab, no relapse of optic neuritis was observed throughout the observation period. Adverse events occurred in 7 patients with satralizumab and 2 patients with eculizumab, but no serious infections were observed.</p><p><strong>Conclusions: </strong>Satralizumab was the most commonly used biologic for AQP4-Ab positive optic neuritis in Japan. This study demonstrates the efficacy and safety of satralizumab in preventing the relapse of optic neuritis.</p>","PeriodicalId":14563,"journal":{"name":"Japanese Journal of Ophthalmology","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2024-10-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142545467","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 : 2024-10-28DOI: 10.1007/s10384-024-01127-6
Ryo Matoba, Yuki Morizane
Epiretinal membrane (ERM) is a frequently diagnosed macular disease associated with aging, characterized by a fibrous membrane forming on the internal limiting membrane (ILM) and leading to visual dysfunctions such as metamorphopsia. Various hypotheses regarding the pathology of metamorphopsia have been proposed; however, the complete pathophysiologic mechanism underlying ERM remains unclear. Optical coherence tomography (OCT) provides detailed images enabling precise diagnosis and characterization of ERM, with several recent studies using the latest OCT imaging techniques. Surgical removal of ERM is the only treatment option; however, criteria for surgical intervention are not established, complicating the decision-making processes. Furthermore, the debate on whether simultaneous peeling of the ILM during ERM surgery enhances outcomes or poses unnecessary risks is ongoing, with no definite conclusion having yet been reached. This review also focuses on epiretinal proliferation, which is different from ERM and is characteristic of lamellar macular hole (LMH). Recently, diagnostic criteria for LMH and related diseases were proposed. Reports on effective surgical procedures for LMH exist, although more research is needed to confirm the long-term outcomes. Thus, this review article aims to provide an overview and updated knowledge of ERM, LMH, and related diseases.
视网膜外膜(ERM)是一种常被诊断为与衰老相关的黄斑疾病,其特征是在内缘膜(ILM)上形成一层纤维膜,并导致视功能障碍,如变形性视力。人们对变色龙的病理提出了各种假说,但 ERM 的完整病理生理机制仍不清楚。光学相干断层扫描(OCT)提供了详细的图像,可对 ERM 进行精确诊断和定性,最近有几项研究采用了最新的 OCT 成像技术。手术切除 ERM 是唯一的治疗方案,但手术干预的标准尚未确定,这使得决策过程变得复杂。此外,关于 ERM 手术中同时剥离 ILM 是会提高疗效还是会带来不必要的风险的争论仍在继续,尚未得出明确的结论。本综述还关注视网膜外增殖,它不同于 ERM,是板层黄斑孔(LMH)的特征。最近,人们提出了 LMH 及相关疾病的诊断标准。目前已有关于 LMH 有效手术方法的报道,但还需要更多的研究来证实其长期疗效。因此,这篇综述文章旨在提供有关 ERM、LMH 及相关疾病的概述和最新知识。
{"title":"Epiretinal membrane: an overview and update.","authors":"Ryo Matoba, Yuki Morizane","doi":"10.1007/s10384-024-01127-6","DOIUrl":"https://doi.org/10.1007/s10384-024-01127-6","url":null,"abstract":"<p><p>Epiretinal membrane (ERM) is a frequently diagnosed macular disease associated with aging, characterized by a fibrous membrane forming on the internal limiting membrane (ILM) and leading to visual dysfunctions such as metamorphopsia. Various hypotheses regarding the pathology of metamorphopsia have been proposed; however, the complete pathophysiologic mechanism underlying ERM remains unclear. Optical coherence tomography (OCT) provides detailed images enabling precise diagnosis and characterization of ERM, with several recent studies using the latest OCT imaging techniques. Surgical removal of ERM is the only treatment option; however, criteria for surgical intervention are not established, complicating the decision-making processes. Furthermore, the debate on whether simultaneous peeling of the ILM during ERM surgery enhances outcomes or poses unnecessary risks is ongoing, with no definite conclusion having yet been reached. This review also focuses on epiretinal proliferation, which is different from ERM and is characteristic of lamellar macular hole (LMH). Recently, diagnostic criteria for LMH and related diseases were proposed. Reports on effective surgical procedures for LMH exist, although more research is needed to confirm the long-term outcomes. Thus, this review article aims to provide an overview and updated knowledge of ERM, LMH, and related diseases.</p>","PeriodicalId":14563,"journal":{"name":"Japanese Journal of Ophthalmology","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2024-10-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142521953","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 : 2024-10-21DOI: 10.1007/s10384-024-01130-x
Ken Hayashi, Motoaki Yoshida, Shin-Ichi Manabe, Akira Hirata
Purpose: To compare the improvements in all-distance visual acuity (VA) and contrast sensitivity early after cataract surgery among eyes implanted with multifocal and monofocal intraocular lenses (IOLs).
Study design: Nonrandomized comparative study.
Methods: Forty-two eyes with a trifocal IOL (Alcon, PanOptix®), 42 eyes with a combined bifocal and extended-depth-of-focus (EDF) IOL (Johnson & Johnson, Synergy®), and 84 eyes with a monofocal IOL were recruited. Uncorrected or corrected VA at various distances, and photopia and mesopic contrast VA were examined at 1 day and 3 months postoperatively. Improvements in these VAs were compared between time points and among groups.
Results: Mean uncorrected as well as corrected VA improved significantly between 1 day and 3 months postoperatively at almost all distances in the trifocal and combined bifocal + EDF groups (P ≤ 0.018), and at the intermediate distance of 1.0 m and far distances in the monofocal group (P ≤ 0.031). Mean improvements in near uncorrected VA at 0.3 m, intermediate VA at 0.5 m, and far VA at 2.0, 3.0, and 5.0 m were significantly greater in the multifocal groups than in the monofocal group (P ≤ 0.032). Improvements in photopic and mesopic contrast VA at most contrasts were significantly better in the multifocal groups (P ≤ 0.021).
Conclusion: Mean uncorrected or corrected VA at almost all distances and contrast sensitivity at most contrasts improved significantly early after surgery in eyes implanted with multifocal IOLs, and the improvements in VA at most distances and in contrast sensitivity were better with multifocal IOLs than with monofocal IOLs.
{"title":"Improvements in visual function early after cataract surgery in eyes implanted with multifocal intraocular lenses.","authors":"Ken Hayashi, Motoaki Yoshida, Shin-Ichi Manabe, Akira Hirata","doi":"10.1007/s10384-024-01130-x","DOIUrl":"https://doi.org/10.1007/s10384-024-01130-x","url":null,"abstract":"<p><strong>Purpose: </strong>To compare the improvements in all-distance visual acuity (VA) and contrast sensitivity early after cataract surgery among eyes implanted with multifocal and monofocal intraocular lenses (IOLs).</p><p><strong>Study design: </strong>Nonrandomized comparative study.</p><p><strong>Methods: </strong>Forty-two eyes with a trifocal IOL (Alcon, PanOptix<sup>®</sup>), 42 eyes with a combined bifocal and extended-depth-of-focus (EDF) IOL (Johnson & Johnson, Synergy<sup>®</sup>), and 84 eyes with a monofocal IOL were recruited. Uncorrected or corrected VA at various distances, and photopia and mesopic contrast VA were examined at 1 day and 3 months postoperatively. Improvements in these VAs were compared between time points and among groups.</p><p><strong>Results: </strong>Mean uncorrected as well as corrected VA improved significantly between 1 day and 3 months postoperatively at almost all distances in the trifocal and combined bifocal + EDF groups (P ≤ 0.018), and at the intermediate distance of 1.0 m and far distances in the monofocal group (P ≤ 0.031). Mean improvements in near uncorrected VA at 0.3 m, intermediate VA at 0.5 m, and far VA at 2.0, 3.0, and 5.0 m were significantly greater in the multifocal groups than in the monofocal group (P ≤ 0.032). Improvements in photopic and mesopic contrast VA at most contrasts were significantly better in the multifocal groups (P ≤ 0.021).</p><p><strong>Conclusion: </strong>Mean uncorrected or corrected VA at almost all distances and contrast sensitivity at most contrasts improved significantly early after surgery in eyes implanted with multifocal IOLs, and the improvements in VA at most distances and in contrast sensitivity were better with multifocal IOLs than with monofocal IOLs.</p>","PeriodicalId":14563,"journal":{"name":"Japanese Journal of Ophthalmology","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2024-10-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142465583","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 : 2024-10-14DOI: 10.1007/s10384-024-01131-w
Yuto Iwaki, Sotaro Mori, Mina Okuda-Arai, Fumio Takano, Kaori Ueda, Mari Sakamoto, Yuko Yamada-Nakanishi, Makoto Nakamura
Purpose: This study investigated the association between one-year surgical outcomes following trabeculectomy and age, accounting for confounding factors.
Study design: Retrospective observational study.
Method: Analyzing data from 305 patients undergoing initial trabeculectomy from 2019 onward, we employed three approaches to adjust variables: stratified analysis, regression analysis, and propensity score matching. Surgical success at 1-year post-surgery was defined by two criteria: achieving intraocular pressure of between 5 and 15 mmHg with a ≥ 20% reduction compared to pre-surgery levels and no additional glaucoma surgery (Criterion A); achieving intraocular pressure of between 5 and 12 mmHg with a ≥ 30% reduction compared to pre-surgery levels and no additional glaucoma surgery (Criterion B).
Results: Stratified analysis by age unveiled a significant increase in exfoliation glaucoma (XFG) and a trend towards shorter axial lengths with advancing age (both p < 0.0001). Older age groups were more likely to experience surgical failure in both Criterion A and B (p = 0.21, < 0.01). Univariate analysis showed age as a significant factor in surgical failure for Criterion A (p < 0.05) and a nearly significant factor for Criterion B (p = 0.12). However, this trend was not evident in multivariate analysis (p = 0.23/0.88), where XFG became a significant factor for surgical failure (both p < 0.001) in Criteria A and B. Propensity score matching revealed no significant differences in surgical success rates for Criteria A and B between younger and older patients (p = 1.00 and 0.88).
Conclusion: Age is not a primary determinant of failure in trabeculectomy; however, the increasing incidence of XFG with aging suggests a potential for poorer outcomes.
目的:本研究调查了小梁切除术后一年手术结果与年龄之间的关系,并考虑了混杂因素:回顾性观察研究:我们采用了三种方法来调整变量:分层分析、回归分析和倾向得分匹配。术后1年的手术成功率由两个标准定义:眼压达到5至15 mmHg,与术前水平相比降低≥20%,且未再进行青光眼手术(标准A);眼压达到5至12 mmHg,与术前水平相比降低≥30%,且未再进行青光眼手术(标准B):结果:按年龄进行的分层分析显示,随着年龄的增长,剥脱性青光眼(XFG)显著增加,轴长呈缩短趋势(均为 p 结论:年龄不是决定青光眼发病率的主要因素:年龄并不是小梁切除术失败的主要决定因素;但是,随着年龄的增长,XFG的发生率也在增加,这表明可能会出现较差的结果。
{"title":"One-year results of trabeculectomy with emphasis on the effect of patients' age.","authors":"Yuto Iwaki, Sotaro Mori, Mina Okuda-Arai, Fumio Takano, Kaori Ueda, Mari Sakamoto, Yuko Yamada-Nakanishi, Makoto Nakamura","doi":"10.1007/s10384-024-01131-w","DOIUrl":"https://doi.org/10.1007/s10384-024-01131-w","url":null,"abstract":"<p><strong>Purpose: </strong>This study investigated the association between one-year surgical outcomes following trabeculectomy and age, accounting for confounding factors.</p><p><strong>Study design: </strong>Retrospective observational study.</p><p><strong>Method: </strong>Analyzing data from 305 patients undergoing initial trabeculectomy from 2019 onward, we employed three approaches to adjust variables: stratified analysis, regression analysis, and propensity score matching. Surgical success at 1-year post-surgery was defined by two criteria: achieving intraocular pressure of between 5 and 15 mmHg with a ≥ 20% reduction compared to pre-surgery levels and no additional glaucoma surgery (Criterion A); achieving intraocular pressure of between 5 and 12 mmHg with a ≥ 30% reduction compared to pre-surgery levels and no additional glaucoma surgery (Criterion B).</p><p><strong>Results: </strong>Stratified analysis by age unveiled a significant increase in exfoliation glaucoma (XFG) and a trend towards shorter axial lengths with advancing age (both p < 0.0001). Older age groups were more likely to experience surgical failure in both Criterion A and B (p = 0.21, < 0.01). Univariate analysis showed age as a significant factor in surgical failure for Criterion A (p < 0.05) and a nearly significant factor for Criterion B (p = 0.12). However, this trend was not evident in multivariate analysis (p = 0.23/0.88), where XFG became a significant factor for surgical failure (both p < 0.001) in Criteria A and B. Propensity score matching revealed no significant differences in surgical success rates for Criteria A and B between younger and older patients (p = 1.00 and 0.88).</p><p><strong>Conclusion: </strong>Age is not a primary determinant of failure in trabeculectomy; however, the increasing incidence of XFG with aging suggests a potential for poorer outcomes.</p>","PeriodicalId":14563,"journal":{"name":"Japanese Journal of Ophthalmology","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2024-10-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142465584","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 : 2024-10-02DOI: 10.1007/s10384-024-01125-8
Byung Joo Lee, Jimin Park, Hyosook Ahn, Hyun Taek Lim
Purpose: To comparatively analyze the clinical characteristics of patients with ocular myasthenia gravis (OMG) referred to an ophthalmology clinic, according to anti-acetylcholine receptor antibody (AchR Ab)-seropositivity.
Study design: Retrospective Cohort Study.
Methods: Medical records of patients with OMG who presented to a tertiary eye care center between 2003 and 2020 were retrospectively reviewed. Demographics, ophthalmologic characteristics, response to medical treatment, presence of autoimmune thyroid disease and thyroid autoantibody were compared between the AchR Ab seropositive and seronegative groups.
Results: A total of 130 patients with OMG were identified; among them, 46 patients (35.4%) had autoantibody against acetylcholine receptors. The mean age at symptom onset was 42.4 ± 18.9 years. There were no differences in mean age at symptom onset, gender ratio, and mean follow-up period between patients with seropositive and seronegative OMG. Graves ophthalmopathy was significantly more frequent in seronegative patients (p = 0.04), while thymic disease (p < 0.01) was more frequent in seropositive patients (p < 0.01). Among patients with seropositive OMG, 52.3% showed a good response to medical treatment, while only 31.4% of the seronegative patients were classified as good responders (p = 0.01). Thyroid dysfunction was found in 27.4% patients with OMG and the proportion of thyroid dysfunction was not different according to anti-acetylcholine receptor antibody-seropositivity.
Conclusion: Seropositivity to acetylcholine receptor antibody is associated with a better response to medical treatment and lower risk of concomitant autoimmune thyroid disease in patients with OMG.
{"title":"Analysis of clinical features and outcomes in patients with ocular myasthenia gravis according to anti-acetylcholine receptor antibody-seropositivity.","authors":"Byung Joo Lee, Jimin Park, Hyosook Ahn, Hyun Taek Lim","doi":"10.1007/s10384-024-01125-8","DOIUrl":"https://doi.org/10.1007/s10384-024-01125-8","url":null,"abstract":"<p><strong>Purpose: </strong>To comparatively analyze the clinical characteristics of patients with ocular myasthenia gravis (OMG) referred to an ophthalmology clinic, according to anti-acetylcholine receptor antibody (AchR Ab)-seropositivity.</p><p><strong>Study design: </strong>Retrospective Cohort Study.</p><p><strong>Methods: </strong>Medical records of patients with OMG who presented to a tertiary eye care center between 2003 and 2020 were retrospectively reviewed. Demographics, ophthalmologic characteristics, response to medical treatment, presence of autoimmune thyroid disease and thyroid autoantibody were compared between the AchR Ab seropositive and seronegative groups.</p><p><strong>Results: </strong>A total of 130 patients with OMG were identified; among them, 46 patients (35.4%) had autoantibody against acetylcholine receptors. The mean age at symptom onset was 42.4 ± 18.9 years. There were no differences in mean age at symptom onset, gender ratio, and mean follow-up period between patients with seropositive and seronegative OMG. Graves ophthalmopathy was significantly more frequent in seronegative patients (p = 0.04), while thymic disease (p < 0.01) was more frequent in seropositive patients (p < 0.01). Among patients with seropositive OMG, 52.3% showed a good response to medical treatment, while only 31.4% of the seronegative patients were classified as good responders (p = 0.01). Thyroid dysfunction was found in 27.4% patients with OMG and the proportion of thyroid dysfunction was not different according to anti-acetylcholine receptor antibody-seropositivity.</p><p><strong>Conclusion: </strong>Seropositivity to acetylcholine receptor antibody is associated with a better response to medical treatment and lower risk of concomitant autoimmune thyroid disease in patients with OMG.</p>","PeriodicalId":14563,"journal":{"name":"Japanese Journal of Ophthalmology","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2024-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142361503","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}
To evaluate the efficacy and safety of a cultured human corneal endothelial cell (cHCEC) product in eyes with bullous keratopathy (BK). Combined analysis of multicenter phase II and III clinical trials. This analysis involved 15 BK eyes in the phase II trial and 12 BK eyes in the phase III trial that underwent cHCEC transplant therapy. Safety was assessed in all the cases. Efficacy was assessed in 17 cases with exclusion of the low- and medium-dose groups in the phase II trial. The primary endpoint was a corneal endothelial cell density of 1000 cells/mm2 or more at 24 weeks post-transplant, which was attained in 94.1% of the eyes (16 of 17), with a 95% CI of 71.3-99.9%. Additionally, 82.4% of the eyes (14 of 17) met the secondary endpoint of reduction in corneal thickness to less than 630 µm without corneal epithelial edema within the same time frame, with a 95% CI of 56.6-96.2%. The mean decrease in corneal thickness from baseline to 24 weeks post-transplant was -187.4 µm (95% CI, -240.2 µm to -134.5 µm). Furthermore, all the eyes exhibited improvement in best-corrected visual acuity from baseline to 24 weeks post-transplant (95% CI, 80.5-100.0%). By 24 weeks post-transplant, 88.9% of the patients (24 of 27) had experienced adverse events, which were mostly local, mild, and transient. The cHCEC product of this study reconstitutes the corneal endothelial layer with high cellular density and restores corneal thickness and improves visual acuity.
评估培养人角膜内皮细胞(cHCEC)产品对牛皮状角膜病(BK)患者的疗效和安全性。对多中心 II 期和 III 期临床试验进行综合分析。该分析涉及 15 只接受过 cHCEC 移植治疗的 II 期试验 BK 眼和 12 只接受过 cHCEC 移植治疗的 III 期试验 BK 眼。对所有病例进行了安全性评估。对 17 例病例进行了疗效评估,并排除了 II 期试验中的低剂量组和中等剂量组。主要终点是移植后24周时角膜内皮细胞密度达到或超过1000个/平方毫米,94.1%的眼睛(17例中的16例)达到了这一目标,95% CI为71.3-99.9%。此外,82.4%的眼睛(17 只眼睛中的 14 只)达到了次要终点,即在同一时间内角膜厚度减少到小于 630 微米且无角膜上皮水肿,95% CI 为 56.6%-96.2%。从基线到移植后24周,角膜厚度的平均降幅为-187.4微米(95% CI,-240.2微米至-134.5微米)。此外,从基线到移植后24周,所有眼睛的最佳矫正视力都有所提高(95% CI,80.5%-100.0%)。到移植后 24 周,88.9% 的患者(27 例中的 24 例)出现了不良反应,这些不良反应大多是局部的、轻微的和短暂的。本研究的 cHCEC 产品能以高细胞密度重建角膜内皮层,恢复角膜厚度并提高视力。
{"title":"Comprehensive combined analysis of physician-initiated phase II and III clinical trials on a cultured human corneal endothelial cell product for treating bullous keratopathy.","authors":"Morio Ueno, Kojiro Imai, Yasufumi Tomioka, Go Horiguchi, Takanori Kameda, Satoshi Teramukai, Akitaka Tsujikawa, Tsutomu Inatomi, Chie Sotozono, Shigeru Kinoshita","doi":"10.1007/s10384-024-01123-w","DOIUrl":"https://doi.org/10.1007/s10384-024-01123-w","url":null,"abstract":"<p><p>To evaluate the efficacy and safety of a cultured human corneal endothelial cell (cHCEC) product in eyes with bullous keratopathy (BK). Combined analysis of multicenter phase II and III clinical trials. This analysis involved 15 BK eyes in the phase II trial and 12 BK eyes in the phase III trial that underwent cHCEC transplant therapy. Safety was assessed in all the cases. Efficacy was assessed in 17 cases with exclusion of the low- and medium-dose groups in the phase II trial. The primary endpoint was a corneal endothelial cell density of 1000 cells/mm<sup>2</sup> or more at 24 weeks post-transplant, which was attained in 94.1% of the eyes (16 of 17), with a 95% CI of 71.3-99.9%. Additionally, 82.4% of the eyes (14 of 17) met the secondary endpoint of reduction in corneal thickness to less than 630 µm without corneal epithelial edema within the same time frame, with a 95% CI of 56.6-96.2%. The mean decrease in corneal thickness from baseline to 24 weeks post-transplant was -187.4 µm (95% CI, -240.2 µm to -134.5 µm). Furthermore, all the eyes exhibited improvement in best-corrected visual acuity from baseline to 24 weeks post-transplant (95% CI, 80.5-100.0%). By 24 weeks post-transplant, 88.9% of the patients (24 of 27) had experienced adverse events, which were mostly local, mild, and transient. The cHCEC product of this study reconstitutes the corneal endothelial layer with high cellular density and restores corneal thickness and improves visual acuity.</p>","PeriodicalId":14563,"journal":{"name":"Japanese Journal of Ophthalmology","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2024-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142361510","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}
Purpose: To investigate the associations of tomographic parameters in anterior segment optical coherence tomography (AS-OCT) with sex and age in a cohort study.
Study design: A cohort design.
Materials and methods: AS-OCT data from 391 Japanese participants aged ≥ 35 years were obtained using swept-source OCT. In the cornea, the keratometric power at the flat (Kf) and steep (Ks) meridians, maximum keratometric power (Kmax), keratometric cylinder, spherical power, regular astigmatism, asymmetry, higher-order irregularity (HOI) from the anterior and posterior surfaces, and the central and thinnest corneal thicknesses were evaluated. Also, anterior chamber depth (ACD), lens thickness, crystalline lens rise (CLR), and nasal and temporal angle opening distances at 500 μm from the scleral spur (AOD500) were assessed. Sex differences and age-related changes were analyzed.
Results: Women exhibited higher anterior Kf, Ks, and Kmax and lower posterior Kf, Ks, and Kmax than men. The ACD and nasal/temporal AOD500 were shorter in women than in men. The CLR was higher in women, whereas the lens thickness did not differ between the sexes, indicating a more anteriorly positioned lens in women. Age-related changes included increased anterior/posterior HOI, increased lens thickness and CLR resulting in decreased ACD and AOD500.
Conclusion: This study reveals sex-related differences in corneal shape, anterior chamber conformation, and lens position, as well as age-related changes in tomographic parameters. ACD, CLR, nasal and temporal AOD500 showed significant sex differences in the 50-70 s, whereas lens thickness showed no difference.
{"title":"Associations of ocular anterior segment structures with sex and age: the Yamagata study (Funagata).","authors":"Hiroyuki Namba, Naoyuki Maeda, Makoto Tsukamoto, Hiroshi Utsunomiya, Yutaka Kaneko, Koichi Nishitsuka, Hidetoshi Yamashita, Yasuyuki Ohta, Tomohiko Usui, Masahiko Sugimoto","doi":"10.1007/s10384-024-01126-7","DOIUrl":"https://doi.org/10.1007/s10384-024-01126-7","url":null,"abstract":"<p><strong>Purpose: </strong>To investigate the associations of tomographic parameters in anterior segment optical coherence tomography (AS-OCT) with sex and age in a cohort study.</p><p><strong>Study design: </strong>A cohort design.</p><p><strong>Materials and methods: </strong>AS-OCT data from 391 Japanese participants aged ≥ 35 years were obtained using swept-source OCT. In the cornea, the keratometric power at the flat (Kf) and steep (Ks) meridians, maximum keratometric power (Kmax), keratometric cylinder, spherical power, regular astigmatism, asymmetry, higher-order irregularity (HOI) from the anterior and posterior surfaces, and the central and thinnest corneal thicknesses were evaluated. Also, anterior chamber depth (ACD), lens thickness, crystalline lens rise (CLR), and nasal and temporal angle opening distances at 500 μm from the scleral spur (AOD500) were assessed. Sex differences and age-related changes were analyzed.</p><p><strong>Results: </strong>Women exhibited higher anterior Kf, Ks, and Kmax and lower posterior Kf, Ks, and Kmax than men. The ACD and nasal/temporal AOD500 were shorter in women than in men. The CLR was higher in women, whereas the lens thickness did not differ between the sexes, indicating a more anteriorly positioned lens in women. Age-related changes included increased anterior/posterior HOI, increased lens thickness and CLR resulting in decreased ACD and AOD500.</p><p><strong>Conclusion: </strong>This study reveals sex-related differences in corneal shape, anterior chamber conformation, and lens position, as well as age-related changes in tomographic parameters. ACD, CLR, nasal and temporal AOD500 showed significant sex differences in the 50-70 s, whereas lens thickness showed no difference.</p>","PeriodicalId":14563,"journal":{"name":"Japanese Journal of Ophthalmology","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2024-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142361504","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 : 2024-10-02DOI: 10.1007/s10384-024-01111-0
Hiroko Nakai, Kosuke Ueda, Koji Kitazawa, Hideki Fukuoka, Tsutomu Inatomi, Norihiko Yokoi, Shigeru Kinoshita, Go Horiguchi, Satoshi Teramukai, Chie Sotozono
Purpose: To investigate the visual prognosis of ocular surface squamous neoplasia (OSSN) after tumor resection and ocular surface reconstruction, and clarify factors that influence recurrence.
Study design: Retrospective cohort study.
Methods: Medical records of all patients who underwent surgical treatment for OSSN at our hospital between January 1996 and December 2019 were reviewed. Tumor size/location, histological classification, surgical procedure, intraoperative mitomycin-C use, and postoperative topical 5-fluorouracil (5-FU) administration were examined, and pre and postoperative visual acuity (VA) were compared to elucidate factors that influence disease recurrence.
Results: Tumor excision was performed in 70 eyes of 70 cases (43 men, 27 women; average age: 71.6 ± 12.6 years) with dysplasia (8 eyes), carcinoma in situ (26 eyes), and invasive squamous cell carcinoma (36 eyes). Tumors were found in the limbus (N = 59 eyes), palpebral conjunctiva (N = 8 eyes), and from the bulbar to palpebral conjunctiva (N = 3 eyes). Surgical procedures performed were limbal transplantation/keratoepithelioplasty (N = 29 eyes), cultivated oral mucosal epithelial transplantation (N = 3 eyes), and auto-conjunctival epithelium transplantation (N = 2 eyes). Ocular surface was reconstructed using amniotic membrane, donor cornea, or cultivated epithelial sheet. The mean follow-up was 38.6 ± 38.6 months (range, 2 months to 13.8 years). VA postoperatively improved in 25 (61.0%) cases. Recurrence occurred in 19 (27.1%) cases at from 2 to 50 months (median: 12.5 months) postoperative. Uni- and multivariate analyses revealed that presurgical tumor size and postoperative administration of 5-FU were significantly related to recurrence.
Conclusion: Combined surgical excision and postoperative topical 5-FU administration effectively prevented OSSN recurrence, and ocular surface reconstruction contributed to improvement of VA.
{"title":"Excision combined with ocular surface reconstruction followed by topical chemotherapy for ocular surface squamous neoplasia.","authors":"Hiroko Nakai, Kosuke Ueda, Koji Kitazawa, Hideki Fukuoka, Tsutomu Inatomi, Norihiko Yokoi, Shigeru Kinoshita, Go Horiguchi, Satoshi Teramukai, Chie Sotozono","doi":"10.1007/s10384-024-01111-0","DOIUrl":"https://doi.org/10.1007/s10384-024-01111-0","url":null,"abstract":"<p><strong>Purpose: </strong>To investigate the visual prognosis of ocular surface squamous neoplasia (OSSN) after tumor resection and ocular surface reconstruction, and clarify factors that influence recurrence.</p><p><strong>Study design: </strong>Retrospective cohort study.</p><p><strong>Methods: </strong>Medical records of all patients who underwent surgical treatment for OSSN at our hospital between January 1996 and December 2019 were reviewed. Tumor size/location, histological classification, surgical procedure, intraoperative mitomycin-C use, and postoperative topical 5-fluorouracil (5-FU) administration were examined, and pre and postoperative visual acuity (VA) were compared to elucidate factors that influence disease recurrence.</p><p><strong>Results: </strong>Tumor excision was performed in 70 eyes of 70 cases (43 men, 27 women; average age: 71.6 ± 12.6 years) with dysplasia (8 eyes), carcinoma in situ (26 eyes), and invasive squamous cell carcinoma (36 eyes). Tumors were found in the limbus (N = 59 eyes), palpebral conjunctiva (N = 8 eyes), and from the bulbar to palpebral conjunctiva (N = 3 eyes). Surgical procedures performed were limbal transplantation/keratoepithelioplasty (N = 29 eyes), cultivated oral mucosal epithelial transplantation (N = 3 eyes), and auto-conjunctival epithelium transplantation (N = 2 eyes). Ocular surface was reconstructed using amniotic membrane, donor cornea, or cultivated epithelial sheet. The mean follow-up was 38.6 ± 38.6 months (range, 2 months to 13.8 years). VA postoperatively improved in 25 (61.0%) cases. Recurrence occurred in 19 (27.1%) cases at from 2 to 50 months (median: 12.5 months) postoperative. Uni- and multivariate analyses revealed that presurgical tumor size and postoperative administration of 5-FU were significantly related to recurrence.</p><p><strong>Conclusion: </strong>Combined surgical excision and postoperative topical 5-FU administration effectively prevented OSSN recurrence, and ocular surface reconstruction contributed to improvement of VA.</p>","PeriodicalId":14563,"journal":{"name":"Japanese Journal of Ophthalmology","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2024-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142361511","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}
Purpose: To clarify the clinical features including multimodal imaging of primary choroidal lymphoma.
Study design: Retrospective, observational case series METHODS: Six consecutive patients with primary choroidal lymphoma diagnosed at Tokyo Medical University Hospital were studied. Demographic profile, clinical features and multimodal imaging were reviewed retrospectively.
Results: The patients comprised 3 men and 3 women with average age of 68.2 ± 12.4 years. Clinical diagnosis before referring to our hospital included Vogt-Koyanagi-Harada disease, posterior scleritis, and choroidal hemangioma, and no patients had been diagnosed with choroidal lymphoma. Average duration from onset of ocular symptoms to establishing a diagnosis was 14.2 months. Ocular fundus examination revealed yellowish orange nummular infiltration in all six cases, and granular pigment deposits at the posterior pole in four cases. Optical coherence tomography showed increased choroidal thickness and waving of the retinal pigment epithelium in all cases. Ultrasonography depicted choroidal thickening and extraocular nodular lesions adjacent to the posterior sclera in all cases. None of the cases showed elevated interleukin-10 in the aqueous humor. Ocular fundus manifestations and visual acuity improved after external beam radiation therapy, except one case with bullous retinal detachment from the initial visit.
Conclusions: Characteristic ocular fundus manifestation together with multimodal imaging findings are useful for the clinical diagnosis of primary choroidal lymphoma.
{"title":"Clinical features and multimodal imaging of primary choroidal lymphoma.","authors":"Hiroshi Goto, Kazuhiko Umazume, Yoshihiko Usui, Noriko Nishikawa","doi":"10.1007/s10384-024-01102-1","DOIUrl":"https://doi.org/10.1007/s10384-024-01102-1","url":null,"abstract":"<p><strong>Purpose: </strong>To clarify the clinical features including multimodal imaging of primary choroidal lymphoma.</p><p><strong>Study design: </strong>Retrospective, observational case series METHODS: Six consecutive patients with primary choroidal lymphoma diagnosed at Tokyo Medical University Hospital were studied. Demographic profile, clinical features and multimodal imaging were reviewed retrospectively.</p><p><strong>Results: </strong>The patients comprised 3 men and 3 women with average age of 68.2 ± 12.4 years. Clinical diagnosis before referring to our hospital included Vogt-Koyanagi-Harada disease, posterior scleritis, and choroidal hemangioma, and no patients had been diagnosed with choroidal lymphoma. Average duration from onset of ocular symptoms to establishing a diagnosis was 14.2 months. Ocular fundus examination revealed yellowish orange nummular infiltration in all six cases, and granular pigment deposits at the posterior pole in four cases. Optical coherence tomography showed increased choroidal thickness and waving of the retinal pigment epithelium in all cases. Ultrasonography depicted choroidal thickening and extraocular nodular lesions adjacent to the posterior sclera in all cases. None of the cases showed elevated interleukin-10 in the aqueous humor. Ocular fundus manifestations and visual acuity improved after external beam radiation therapy, except one case with bullous retinal detachment from the initial visit.</p><p><strong>Conclusions: </strong>Characteristic ocular fundus manifestation together with multimodal imaging findings are useful for the clinical diagnosis of primary choroidal lymphoma.</p>","PeriodicalId":14563,"journal":{"name":"Japanese Journal of Ophthalmology","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2024-09-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142346822","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}
Purpose: Few studies have addressed the clinical impact of fluctuation in pulse rate before cataract surgery. This study aimed to determine the effectiveness of prior pulse monitoring and intervention to prevent blood pressure changes in patients undergoing cataract surgery under local anesthesia.
Study design: Retrospective study METHODS: Patients who underwent cataract surgery under local anesthesia were included. In the pulse rate (PR) group, intervention was performed on the basis of early monitoring of blood pressure and PR changes. In the conventional group, blood pressure was managed on the basis of blood pressure alone. Systolic blood pressure, diastolic blood pressure, intraoperative nicardipine use, and physician consultation time were retrospectively compared between the groups.
Results: The study included 684 eyes from 684 patients aged 73.5 ± 9.5 years (PR group: 297 eyes, conventional group: 387 eyes). No intergroup differences were found in systolic blood pressure or pulse and heart rates; however, diastolic blood pressure was significantly lower in the PR group than in the conventional group at both the beginning and the end of surgery (P <.001 and P = .0028, respectively). Intravenous nicardipine administration in the operating room was significantly less frequent in the PR group (P = .041), and physician consultation time after entering the operating room and at the beginning of surgery was significantly shorter in the PR group (both P <.001).
Conclusion: Early monitoring of PR with blood pressure and intervention were effective for preventing preoperative hypertension.
{"title":"Management of preoperative hypertension and anxiety based on early monitoring of pulse rate before cataract surgery.","authors":"Takashi Ono, Takuya Iwasaki, Rie Tomari, Toshihiro Sakisaka, Yosai Mori, Ryohei Nejima, Kazunori Miyata","doi":"10.1007/s10384-024-01124-9","DOIUrl":"https://doi.org/10.1007/s10384-024-01124-9","url":null,"abstract":"<p><strong>Purpose: </strong>Few studies have addressed the clinical impact of fluctuation in pulse rate before cataract surgery. This study aimed to determine the effectiveness of prior pulse monitoring and intervention to prevent blood pressure changes in patients undergoing cataract surgery under local anesthesia.</p><p><strong>Study design: </strong>Retrospective study METHODS: Patients who underwent cataract surgery under local anesthesia were included. In the pulse rate (PR) group, intervention was performed on the basis of early monitoring of blood pressure and PR changes. In the conventional group, blood pressure was managed on the basis of blood pressure alone. Systolic blood pressure, diastolic blood pressure, intraoperative nicardipine use, and physician consultation time were retrospectively compared between the groups.</p><p><strong>Results: </strong>The study included 684 eyes from 684 patients aged 73.5 ± 9.5 years (PR group: 297 eyes, conventional group: 387 eyes). No intergroup differences were found in systolic blood pressure or pulse and heart rates; however, diastolic blood pressure was significantly lower in the PR group than in the conventional group at both the beginning and the end of surgery (P <.001 and P = .0028, respectively). Intravenous nicardipine administration in the operating room was significantly less frequent in the PR group (P = .041), and physician consultation time after entering the operating room and at the beginning of surgery was significantly shorter in the PR group (both P <.001).</p><p><strong>Conclusion: </strong>Early monitoring of PR with blood pressure and intervention were effective for preventing preoperative hypertension.</p>","PeriodicalId":14563,"journal":{"name":"Japanese Journal of Ophthalmology","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2024-09-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142346823","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}