{"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":"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":"660-668"},"PeriodicalIF":2.1,"publicationDate":"2024-11-01","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}
{"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":"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":"751-763"},"PeriodicalIF":2.1,"publicationDate":"2024-11-01","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}
{"title":"Outcomes of five cases of retinoblastoma with optic nerve invasion on imaging.","authors":"Tamae Onishi, Sachiko Nishina, Tadashi Yokoi, Tomoyo Yoshida, Shion Hayashi, Hazuki Morikawa-Anzai, Noriyuki Azuma, Chikako Kiyotani, Keita Terashima, Takako Yoshioka, Hideki Ogiwara, Hiroshi Fuji, Masayuki Kitamura, Yoshiyuki Tsutsumi","doi":"10.1007/s10384-024-01112-z","DOIUrl":"10.1007/s10384-024-01112-z","url":null,"abstract":"<p><strong>Purpose: </strong>To investigate the timing of enucleation, treatment course, and outcome for retinoblastoma (RB) with optic nerve (ON) invasion on imaging.</p><p><strong>Study design: </strong>Retrospective clinical study.</p><p><strong>Methods: </strong>Of the 160 patients with RB who presented to the National Center for Child Health and Development in Japan between 2005 and 2022, ON invasion on imaging at the initial presentation was seen in five patients. The clinical, computed tomography (CT), and magnetic resonance imaging (MRI) findings, and treatment courses were reviewed retrospectively.</p><p><strong>Results: </strong>MRI showed ON invasion in all five patients (three with unilateral RB, 2 with bilateral RB); in two patients CT detected no invasion. Enucleation was performed in four patients, three of whom underwent neoadjuvant therapy and one had a positive ON resection margin following the enucleation as initial treatment. One patient did not undergo enucleation due to cerebrospinal fluid dissemination. All enucleated patients underwent adjuvant chemotherapy. Four patients underwent radiotherapy. During follow-up (mean, 89.4 months), four patients survived and one died.</p><p><strong>Conclusion: </strong>MRI is recommended to evaluate ON invasion and determine the timing of enucleation for RB. The appropriate choice of neoadjuvant or adjuvant therapy would be helpful to avoid radiotherapy for RB with ON invasion on imaging.</p>","PeriodicalId":14563,"journal":{"name":"Japanese Journal of Ophthalmology","volume":" ","pages":"741-750"},"PeriodicalIF":2.1,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11607017/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142346824","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ai Fujita Sajiki, Keiko Kataoka, Jun Takeuchi, Hikaru Ota, Yuyako Nakano, Etsuyo Horiguchi, Hiroki Kaneko, Hiroko Terasaki, Yasuki Ito, Koji M Nishiguchi
{"title":"Clinical utility of swept-source optical coherence tomography angiography for the diagnosis of exudative maculopathy.","authors":"Ai Fujita Sajiki, Keiko Kataoka, Jun Takeuchi, Hikaru Ota, Yuyako Nakano, Etsuyo Horiguchi, Hiroki Kaneko, Hiroko Terasaki, Yasuki Ito, Koji M Nishiguchi","doi":"10.1007/s10384-024-01115-w","DOIUrl":"10.1007/s10384-024-01115-w","url":null,"abstract":"<p><strong>Purpose: </strong>To assess the feasibility of swept-source optical coherence tomography angiography (SS-OCTA) to differentiate macular diseases, including nonpolypoidal macular neovascularization (MNV), polypoidal choroidal vasculopathy (PCV), type 3 MNV, and chronic central serous chorioretinopathy (CSC) without indocyanine green angiography (ICGA).</p><p><strong>Study design: </strong>Retrospective observational study.</p><p><strong>Methods: </strong>This study examined 63 eyes of 63 patients with treatment-naive neovascular age-related macular degeneration (AMD), including 23 eyes with nonpolypoidal MNV, 17 eyes with PCV, and 1 eye with type 3 MNV and 22 eyes with chronic CSC. Two independent retina specialists, blinded to the clinical diagnosis, assessed each case of neovascular AMD and chronic CSC using only B-scan and en face images of SS-OCTA without referring to other examination outcomes.</p><p><strong>Results: </strong>By SS-OCTA alone, 19 eyes were diagnosed with nonpolypoidal MNV, 17 eyes with PCV, 2 eyes with type 3 MNV, and 22 eyes with chronic CSC, indicating high sensitivity (82.6%, 94.1%, 100%, and 100%, respectively) and specificity (100%, 97.8%, 98.4%, and 100%, respectively); however, three eyes could not be diagnosed because of obscure images. The agreement of diagnosis with SS-OCTA alone was high between the two specialists (κ = 0.82).</p><p><strong>Conclusion: </strong>SS-OCTA showed high sensitivity and specificity in the differentiation of nonpolypoidal MNV, PCV, type 3 MNV, and chronic CSC. The differential criteria based on SS-OCTA could be a substitute for the ICGA-based diagnoses.</p>","PeriodicalId":14563,"journal":{"name":"Japanese Journal of Ophthalmology","volume":" ","pages":"614-620"},"PeriodicalIF":2.1,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142107525","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}
{"title":"Establishing the cutoff value of near visual acuity for assessment of early presbyopia.","authors":"Akiko Hanyuda, Miyuki Kubota, Shunsuke Kubota, Sachiko Masui, Kenya Yuki, Masahiko Ayaki, Kazuno Negishi","doi":"10.1007/s10384-024-01114-x","DOIUrl":"10.1007/s10384-024-01114-x","url":null,"abstract":"<p><strong>Purpose: </strong>There is limited evidence to evaluate the numerical cutoff point for detecting early presbyopia. Thus, we aimed to establish a clinically relevant optimal cutoff value of near visual acuity for detecting early presbyopia.</p><p><strong>Study design: </strong>Prospective diagnostic accuracy study.</p><p><strong>Methods: </strong>We included consecutive individuals aged ≥ 20 years with a binocular-corrected distance visual acuity of ≥ 20/25 who did not undergo ophthalmic surgery between December 17, 2020 and December 19, 2021, at two healthcare facilities in Japan. Binocular distance-corrected near visual acuity at 40 cm, accommodative amplitude, awareness of presbyopia, and Near Activity Visual Questionnaire scores were examined. The optimal cutoff values of distance-corrected near visual acuity for diagnosing early presbyopia were evaluated using receiver operating characteristic plots.</p><p><strong>Results: </strong>Among 115 participants, 74 (64.3%) had presbyopia. The proportion of participants with no difficulty performing near-vision tasks decreased markedly when near visual acuity decreased to 20/20 (> 0.00 logMAR). A cutoff value of 0.00 logMAR for distance-corrected near visual acuity was optimal, showing high sensitivity of 56.76% and specificity of 92.68%, as opposed to the commonly used cutoff value of 0.40 logMAR (20/50; sensitivity, 9.46% and specificity, 100%) for diagnosing early presbyopia.</p><p><strong>Conclusion: </strong>Near visual acuity of 0.00 logMAR (20/20) could be the optimal cutoff value for diagnosing early presbyopia.</p>","PeriodicalId":14563,"journal":{"name":"Japanese Journal of Ophthalmology","volume":" ","pages":"709-716"},"PeriodicalIF":2.1,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11607044/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142107526","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Pharmacokinetics of ganciclovir eye drops: a comparative study of solutions prepared from ganciclovir for intravenous infusion and ganciclovir gel.","authors":"Naoki Okumura, Toshiyuki Tanaka, Yuya Fukui, Noriko Koizumi","doi":"10.1007/s10384-024-01106-x","DOIUrl":"10.1007/s10384-024-01106-x","url":null,"abstract":"<p><strong>Purpose: </strong>To evaluate the pharmacokinetics of ganciclovir eye drops by comparing solutions prepared from ganciclovir for intravenous infusion and ganciclovir gel and to assess the impact of systemic administration on drug levels in ocular tissues and serum.</p><p><strong>Study design: </strong>Experimental study design.</p><p><strong>Methods: </strong>Ganciclovir solutions (0.5% and 1.0%) prepared by diluting DENOSINE <sup>®</sup> IV Infusion in saline and 0.15% ganciclovir gel (Virgan<sup>®</sup>) were topically administered in rabbit eyes, with and without concomitant systemic administration of ganciclovir. The concentrations of ganciclovir in the corneal epithelium, stroma, and endothelium, aqueous humor; and blood plasma were analyzed by high-performance liquid chromatography (HPLC).</p><p><strong>Results: </strong>The ganciclovir solutions (0.5% and 1.0%) maintained therapeutic ganciclovir levels in the corneal endothelium above the effective dose required for 50% inhibition (ED50) up to 6 h, albeit with a swift decline thereafter. The 0.15% ganciclovir gel maintained higher therapeutic concentrations in the corneal endothelium for up to 12 h, exceeding the ED50. Serum concentrations of ganciclovir were significantly elevated in the groups receiving combined systemic administration.</p><p><strong>Conclusion: </strong>Topical application of 0.15% ganciclovir gel maintained high endothelial concentrations, well above the therapeutic threshold, with or without systemic administration. Furthermore, the observed increase in ganciclovir levels within the plasma and aqueous humor following systemic administration posits it as a viable strategy for severe cases of cytomegalovirus corneal endotheliitis or those inadequately managed by local treatments alone.</p>","PeriodicalId":14563,"journal":{"name":"Japanese Journal of Ophthalmology","volume":" ","pages":"764-770"},"PeriodicalIF":2.1,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142107441","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}
Kazuki Matsuura, Dai Miyazaki, Yoshitsugu Inoue, Yumi Sasaki, Yumiko Shimizu
{"title":"Comparison of iodine compounds and levofloxacin as postoperative instillation; conjunctival bacterial flora and antimicrobial susceptibility following cataract surgery.","authors":"Kazuki Matsuura, Dai Miyazaki, Yoshitsugu Inoue, Yumi Sasaki, Yumiko Shimizu","doi":"10.1007/s10384-024-01117-8","DOIUrl":"10.1007/s10384-024-01117-8","url":null,"abstract":"<p><strong>Purpose: </strong>To compare the cleanliness of the conjunctival sac following the use of iodine compounds (PAI) and levofloxacin as postoperative eye drops.</p><p><strong>Study design: </strong>A prospective open-label study.</p><p><strong>Patients and methods: </strong>Either topical levofloxacin or fourfold-diluted PAI was administered for 1 week postoperatively in 128 eyes of 128 patients who underwent routine cataract surgery. Conjunctival samples were obtained at three time points: pre-surgery, 1 week postoperatively, and 1 month postoperatively.</p><p><strong>Results: </strong>The respective positive bacterial culture rates for postoperative iodine and levofloxacin were 88.1% and 85.2% pre-surgery, 71.6% and 50.8% 1 week postoperatively, and 92.5% and 86.5% 1 month postoperatively. Positive bacterial culture rates in both groups significantly declined at 1 week, and the rates returned to the baseline level 1 month postoperatively. The magnitude of reduction of DNA copy number detected by polymerase chain reaction at 1 week was larger in the levofloxacin group, although no significant differences were seen at pre-surgery or 1 month postoperatively. In the levofloxacin group, only one strain was culture positive at 1 week, however, its minimum inhibitory concentration (MIC) against S. epidermidis was high (128 µg/ml). The MIC value increased from 2.31 ± 2.19 µg/ml pre-surgery to 57.14 ± 22.34 µg/ml 1 month postoperatively, while no significant change was found in the iodine group.</p><p><strong>Conclusion: </strong>Postoperative iodine and levofloxacin eye drops both reduced bacterial contamination in the conjunctival sac, with a superior level of disinfection in the levofloxacin group. However, postoperative levofloxacin eye drops enhanced the emergence of highly resistant bacteria, whereas no such development was seen in the iodine group.</p>","PeriodicalId":14563,"journal":{"name":"Japanese Journal of Ophthalmology","volume":" ","pages":"702-708"},"PeriodicalIF":2.1,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142140107","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}
{"title":"Mutations of CYP1B1 and FOXC1 genes for childhood glaucoma in Japanese individuals.","authors":"Nobuo Fuse, Masae Kimura, Ai Shimizu, Seizo Koshiba, Teruhiko Hamanaka, Makoto Nakamura, Nobuo Ishida, Hiroshi Sakai, Yoko Ikeda, Kazuhiko Mori, Atsushi Endo, Masao Nagasaki, Fumiki Katsuoka, Jun Yasuda, Yoichi Matsubara, Toru Nakazawa, Masayuki Yamamoto","doi":"10.1007/s10384-024-01103-0","DOIUrl":"10.1007/s10384-024-01103-0","url":null,"abstract":"<p><strong>Purpose: </strong>To explore the frequency and positions of genetic mutations in CYP1B1 and FOXC1 in a Japanese population.</p><p><strong>Study design: </strong>Molecular genetic analysis.</p><p><strong>Methods: </strong>Genomic DNA was extracted from 31 Japanese patients with childhood glaucoma (CG) from 29 families. We examined the CYP1B, FOXC1, and MYOC genes using Sanger sequencing and whole-exome sequencing (WES).</p><p><strong>Results: </strong>For CYP1B1, we identified 9 families that harbored novel mutations, p.A202T, p.D274E, p.Q340*, and p.V420G; the remaining mutations had been previously reported. When mapped to the CYP1B1 protein structure, all mutations appeared to influence the enzymatic activity of CYP1B1 by provoking structural deformity. Five patients were homozygotes or compound heterozygotes, supporting the recessive inheritance of the CYP1B1 mutations in CG. In contrast, four patients were heterozygous for the CYP1B1 mutation, suggesting the presence of regulatory region mutations or strong modifiers. For the FOXC1 gene, we identified 3 novel mutations, p.Q23fs, p.Q70R, and p.E163*, all of which were identified in a heterozygous state. No mutation was found in the MYOC gene in these CG patients. All individuals with CYP1B1 and FOXC1 mutations were severely affected by early-onset CG. In the CYP1B1-, FOXC1-, and MYOC-negative families, we also searched for variants in the other candidate genes reported for CG through WES, but could not find any mutations in these genes.</p><p><strong>Conclusions: </strong>Our analyses of 29 CG families revealed 9 families with point mutations in the CYP1B1 gene, and four of those patients appeared to be heterozygotes, suggesting the presence of complex pathogenic mechanisms. FOXC1 appears to be another major causal gene of CG, indicating that panel sequencing of CYP1B1 and FOXC1 will be useful for diagnosis of CG in Japanese individuals.</p>","PeriodicalId":14563,"journal":{"name":"Japanese Journal of Ophthalmology","volume":" ","pages":"688-701"},"PeriodicalIF":2.1,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11607050/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141999971","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Hiroko Nakai, Kosuke Ueda, Koji Kitazawa, Hideki Fukuoka, Tsutomu Inatomi, Norihiko Yokoi, Shigeru Kinoshita, Go Horiguchi, Satoshi Teramukai, Chie Sotozono
{"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":"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":"731-740"},"PeriodicalIF":2.1,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11607001/pdf/","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":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"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}