Japanese Journal of Ophthalmology最新文献

{"title":"Effectiveness and safety of biosimilar infliximab CT-P13 in the treatment of refractory uveitis associated with Behçet's disease.","authors":"Chiuping Lee, Masaki Takeuchi, Tatsukata Kawagoe, Jutaro Nakamura, Etsuko Shibuya, Mami Ishihara, Norihiro Yamada, Yuki Mizuki, Akira Meguro, Yohei Kirino, Yutaro Soejima, Lisa Hirahara, Yuki Iizuka, Nobuhisa Mizuki","doi":"10.1007/s10384-025-01206-2","DOIUrl":"https://doi.org/10.1007/s10384-025-01206-2","url":null,"abstract":"<p><strong>Purpose: </strong>This study evaluated the effectiveness and safety of the biosimilar infliximab CT-P13 in treating refractory uveitis associated with Behçet's disease.</p><p><strong>Study design: </strong>Retrospective study.</p><p><strong>Methods: </strong>A retrospective analysis of medical records from seven patients was conducted, categorizing them into two groups: those initially treated with CT-P13 (Group 1) and those switched from other tumor necrosis factor inhibitors (Group 2). Data on demographics, treatment duration, ocular inflammatory attacks, visual acuity changes, relapse rates, and adverse events were collected.</p><p><strong>Results: </strong>Seven patients (mean age: 32.0 ± 17.7 years) with refractory uveitis associated with Behçet's disease were included. Four patients in Group 1 received CT-P13 as their first-line biologic therapy, of whom two (50%) achieved remission. All patients exhibited a significant reduction in relapses in the 6 months before and after CT-P13 treatment (Wilcoxon test, p = 0.031). Three patients in Group 2, switched from original infliximab, maintained remission for an average of 11.0 ± 2.0 months. Overall, 71.4% of patients achieved remission. No significant changes in visual acuity were observed in either group. One adverse event occurred, but no adverse drug reactions were reported.</p><p><strong>Conclusion: </strong>The biosimilar infliximab CT-P13 appears to be an effective and cost-efficient option for managing refractory uveitis in Behçet's disease. This finding highlights its potential in managing this challenging condition and warrants further investigation in larger patient cohorts.</p>","PeriodicalId":14563,"journal":{"name":"Japanese Journal of Ophthalmology","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2025-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144008699","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":"Comparison of Heidelberg Multi-Color Anomaloskop with NEITZ anomaloscope OT-II to diagnose color-vision deficiency.","authors":"Kumiko Mokuno, Hiroki Kaneko, Hirotaka Ito, Hiroshi Takahashi, Tetsushi Yasuma","doi":"10.1007/s10384-025-01198-z","DOIUrl":"https://doi.org/10.1007/s10384-025-01198-z","url":null,"abstract":"<p><strong>Purpose: </strong>To determine the degree of agreement between the results of the Heidelberg Multi-Color Anomaloskop (HMC) and NEITZ anomaloscope OT-II (OT-II).</p><p><strong>Study design: </strong>Retrospective.</p><p><strong>Methods: </strong>The study included 53 patients who underwent color-vision testing at Kariya Toyota General Hospital between March 2019 and April 2022. The participants included 2 patients with normal color vision, 10 with protanopia, 3 with protanomaly, 22 with deuteranopia, and 16 with deuteranomaly. Color-vision testing was performed using the Ishihara Test for Colour Deficiency, Standard Pseudoisochromatic Plates Part 1, Farnsworth Dichotomous Test for Color Blindness Panel-15, HMC, and OT-II. An agreement was determined using intraclass correlation coefficients (ICC) and Bland-Altman analysis. The minimum, median, and maximum red-green mixture and yellow monochromatic values of the equal values obtained from HMC and OT-II were examined.</p><p><strong>Results: </strong>The ICCs between the results of HMC and OT-II were 0.979, 0.979, and 0.985, for the minimum, median, and maximum red-green mixture and 0.943, 0.755, and 0.919 for the yellow monochromatic values, respectively (p < 0.0001 in all). In the Bland-Altman analysis, the differences were mostly within the limits of agreement. Fixed errors were observed for the maximum red-green mixture and minimum yellow monochromatic values. Proportional errors were observed for the maximum red-green mixture and yellow monochromatic values.</p><p><strong>Conclusions: </strong>HMC and OT-II showed high agreement for all values in the ICC and Bland-Altman analyses. In the Bland-Altman analysis, systemic errors were observed in the maximum red-green mixture value and the minimum and maximum yellow monochromatic values.</p>","PeriodicalId":14563,"journal":{"name":"Japanese Journal of Ophthalmology","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2025-04-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144020313","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":"Clarity of surgical field displayed on 3D monitor with local dimming technology during heads-up surgery.","authors":"Kosuke Nakajima, Jun Takeuchi, Tadashi Yokoi, Masaharu Mizuno, Takashi Koto, Tomoka Ishida, Hitomi Ozawa, Makoto Inoue","doi":"10.1007/s10384-025-01202-6","DOIUrl":"https://doi.org/10.1007/s10384-025-01202-6","url":null,"abstract":"<p><strong>Purpose: </strong>To compare the clarity of images displayed on a 3D local dimming technology (LDT) monitor (LMD-XH550MT) to that on a conventional 3D monitor (LMD-X550MT) integrated into the Artevo 800^® system.</p><p><strong>Study design: </strong>Laboratory investigation METHODS: Six vitreoretinal surgeons evaluated the clarity of the surgical field on photographs displayed simultaneously on 2 monitors during cataract and vitreous surgery by the Artevo 800^® system. The visibility scores were made on a 5-point scale for images recorded during anterior capsulotomy, phacoemulsification, cortex aspiration, core vitrectomy, and peeling an epiretinal membrane or an internal limiting membrane (ILM). The skewness and kurtosis of the images during anterior and posterior segment surgery were evaluated.</p><p><strong>Results: </strong>The mean visibility scores were significantly higher with the LDT monitor at 4.7±0.1 than with the conventional monitor at 2.9±0.1 (P<0.001). The visibility scores for anterior capsulotomy (P=0.034), phacoemulsification (P=0.036), cortex aspiration (P=0.036), core vitrectomy (P=0.035), peeling of epiretinal membrane (P=0.036), and ILM (P=0.036) were significantly higher with the LDT monitor than with the conventional monitor. The absolute value of skewness during anterior segment surgery was significantly lower with the LDT monitor (0.20±0.05) than with the conventional monitor (-0.44±0.06, P=0.03).</p><p><strong>Conclusion: </strong>Higher contrast with the LDT monitor was attained by adjusting the backlight brightness according to the brightness of the images, which provided better image clarity for 3D heads-up cataract and vitreous surgery.</p>","PeriodicalId":14563,"journal":{"name":"Japanese Journal of Ophthalmology","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2025-04-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143983182","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":"Choroidal circulation time by wide-field indocyanine green angiography in central serous chorioretinopathy.","authors":"Akiyuki Kawamura, Ryusaburo Mori, Koji Tanaka, Yu Wakatsuki, Kyoko Fujita, Hiroyuki Nakashizuka","doi":"10.1007/s10384-025-01188-1","DOIUrl":"https://doi.org/10.1007/s10384-025-01188-1","url":null,"abstract":"<p><strong>Purpose: </strong>Asymmetric dilated vortex veins (ADVV) extending continuously to the vortex ampullae seen on Indocyanine green angiography (ICGA) findings, are thought to indicate choroidal venous congestion in central serous chorioretinopathy (CSC). In addition, the sclera is thickened compared to normal eyes, suggesting that obstruction of the scleral passage is the pathophysiological mechanism of CSC. The purpose of this study was to examine the choroidal circulation in and around the vortex vein ampulla.</p><p><strong>Study design: </strong>Single-center retrospective study.</p><p><strong>Methods: </strong>The subjects were 23 CSC eyes with macular central serous detachment (SRD) undergoing wide-field ICGA with Spectralis^®. Choroidal circulation time was defined as the time from the onset of filling in the choroidal artery to the first appearance of dye in the vortex vein ampulla. The choroidal circulation time in the superior and inferior vortex veins were measured separately. The relationship between the ADVV and the choroidal circulation time was investigated.</p><p><strong>Results: </strong>The mean choroidal circulation time was 4.44 seconds for the superior temporal side and 4.33 seconds for the inferior temporal side, with no significant difference (p=0.494). The mean choroidal circulation time was 3.89 seconds on the ADVV side and 4.88 seconds on the non-ADVV side, with a shorter mean circulation time on the ADVV side (p=0.00005). In 21 of 23 eyes, there was a time difference in the filling of the choroidal veins entering the vortex vein ampulla.</p><p><strong>Conclusion: </strong>On the side of the ADVV, no obstruction to the passage of the sclera is thought to have occurred.</p>","PeriodicalId":14563,"journal":{"name":"Japanese Journal of Ophthalmology","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2025-04-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144005538","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":"Clinical features in four patients with syphilitic outer retinopathy.","authors":"Tomoyuki Oga, Kazuki Kuniyoshi, Akihiko Sugino, Tomoko Sato, Fukutaro Mano, Masuo Sakamoto, Chiharu Iwahashi, Koji Sugioka, Shunji Kusaka","doi":"10.1007/s10384-025-01191-6","DOIUrl":"https://doi.org/10.1007/s10384-025-01191-6","url":null,"abstract":"<p><strong>Purpose: </strong>To present the clinical findings of patients diagnosed with syphilitic outer retinopathy.</p><p><strong>Study design: </strong>A retrospective clinical study.</p><p><strong>Patients and methods: </strong>The study involved four Japanese men whose medical charts were reviewed and analyzed retrospectively.</p><p><strong>Results: </strong>All patients declined decimal visual acuity to 0.1, 0.2, 0.4, 0.6, and 0.8. Their fundus appearances were generally normal, except for one patient who displayed faint white dots in the upper macular region. Two patients showed dye leakage from retinal vessels during fluorescein angiography. Optical coherence tomography (OCT) results revealed abnormalities in all patients: three had a disrupted ellipsoid zone (EZ) and hyper-reflective nodules at the retinal pigment epithelium line, while one patient presented with a blurred EZ. The patients had myopia ranging from -4.5 to -7.5 diopters. They were diagnosed with syphilitic outer retinopathy based on the findings from the fundus examination, OCT, and serologic tests and were treated with oral amoxicillin, resulting in improved vision.</p><p><strong>Conclusions: </strong>The OCT findings are typical for diagnosing syphilitic outer retinopathy. Myopia was prevalent in the four patients, indicating a need for further research on refractive errors in patients with syphilitic outer retinopathy.</p>","PeriodicalId":14563,"journal":{"name":"Japanese Journal of Ophthalmology","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2025-04-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144024592","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":"Long-term outcomes and the association between early detection of retinal pigment epithelial atrophy and remission after loading dose in eyes with retinal angiomatous proliferation.","authors":"Wataru Kikushima, Yoichi Sakurada, Daphne Viel Tsuru, Kenji Kashiwagi","doi":"10.1007/s10384-025-01189-0","DOIUrl":"https://doi.org/10.1007/s10384-025-01189-0","url":null,"abstract":"<p><strong>Purpose: </strong>To investigate the association between early detection of retinal pigment epithelial (RPE) atrophy after anti-vascular endothelial growth factor (VEGF) treatment and the long-term treatment outcomes in eyes with retinal angiomatous proliferation (RAP).</p><p><strong>Study design: </strong>A retrospective observational study METHODS: All patients with treatment-naive RAP initially received three monthly anti-VEGF administration with or without photodynamic therapy (PDT), followed by as-needed anti-VEGF administration. At 12 months post-injection, they were divided into two groups depending on the presence or absence of RPE atrophy. The visual and anatomic outcomes, and the incidence of 12-month remission were investigated within a 48-month follow-up.</p><p><strong>Results: </strong>Thirty-seven eyes of 37 patients were included. The mean age was 80.4 ± 7.0 years, 54% were women. In the atrophy (+) group, 58.3% of patients achieved 12-month remission, significantly higher than the atrophy (-) group (p = 0.04). During the study period, best corrected visual acuity in the atrophy (+) group deteriorated from 0.50 ± 0.43 logMAR to 0.66 ± 0.47 logMAR (p = 0.14), while in the atrophy (-) group, it deteriorated significantly from 0.48 ± 0.27 logMAR to 0.76 ± 0.42 logMAR (p = 6.7×10^-3). The mean additional injections in the atrophy (+) group were significantly smaller compared with the atrophy (-) group at 3.5 ± 4.7 versus 15.3 ± 4.3, respectively (p = 9.0×10^-6).</p><p><strong>Conclusion: </strong>Early detection of RPE atrophy was associated with the incidence of 12-month remission and reduced number of additional injections. The formation of RPE atrophy might suggest a decrease in the disease activity of RAP.</p>","PeriodicalId":14563,"journal":{"name":"Japanese Journal of Ophthalmology","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2025-04-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143810974","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":"Comparative analysis of axial length measurement method for eyes with submacular hemorrhage.","authors":"Masakazu Nagayama, Shuhei Kimura, Mio Morizane Hosokawa, Yusuke Shiode, Ryo Matoba, Tetsuro Morita, Keisuke Kanenaga, Yuki Morizane","doi":"10.1007/s10384-024-01147-2","DOIUrl":"10.1007/s10384-024-01147-2","url":null,"abstract":"<p><strong>Purpose: </strong>To identify a method for comparing preoperative axial length (AL) measurements with postoperative AL in submacular hemorrhage (SMH).</p><p><strong>Study design: </strong>Retrospective.</p><p><strong>Methods: </strong>This study included 30 patients who underwent vitrectomy for SMH (January 2016-January 2023) with preoperative and postoperative AL data. Preoperative AL was obtained using ultrasonography for the affected eye (aUS-AL) and compared to those measured using optical biometry (OB) for the affected and fellow eyes (aOB-AL and fOB-AL, respectively). Postoperative AL (aPost-AL) was defined as the AL of the affected eye by OB. The absolute differences between the preoperative AL (aUS-AL, aOB-AL, and fOB-AL) and aPost-AL were assessed.</p><p><strong>Results: </strong>aUS-AL, aOB-AL, and fOB-AL values were 23.50 ± 1.41 mm, 23.32 ± 1.40 mm, and 23.66 ± 1.45 mm, respectively, correlating strongly with aPost-AL (23.54 ± 1.37 mm) (all R > 0.95). fOB-AL exceeded aPost-AL significantly (P = 0.02). In all 30 eyes, absolute differences between preoperative AL and aPost-AL were 0.19 ± 0.18 mm, 0.28 ± 0.32 mm, and 0.21 ± 0.22 mm, respectively, which were not significantly different from each other (all P > 0.05). In nine eyes with SMH height > 1000 μm or unmeasurable, the absolute difference between aOB-AL and aPost-AL (0.42 ± 0.33 mm) exceeded that of aUS-AL and aPost-AL (0.10 ± 0.09 mm) (P = 0.003).</p><p><strong>Conclusion: </strong>Although aUS-AL, aOB-AL, and fOB-AL correlated well with postoperative AL in patients with SMH, fOB-AL may be measured longer and aOB-AL shorter in some cases. Therefore, aUS-AL may be considered primarily in determining IOL power of cataract surgery performed in combination with SMH displacement.</p>","PeriodicalId":14563,"journal":{"name":"Japanese Journal of Ophthalmology","volume":" ","pages":"196-202"},"PeriodicalIF":2.1,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143005422","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":"Two-year randomized controlled trial of circumferential versus segmental ab externo angle surgery in patients with primary open angle glaucoma.","authors":"Ahmed Samy Elwehidy, Nader Hussein Lotfy Bayoumi, Mostafa A S Elwehidy, Nashaat Shawky Zaky, Sherein M Hagras, Nader H L Bayoumi","doi":"10.1007/s10384-024-01150-7","DOIUrl":"10.1007/s10384-024-01150-7","url":null,"abstract":"<p><strong>Purpose: </strong>To compare the surgical outcomes of visco-circumferential-suture-trabeculotomy (VCST) and rigid probe segmental viscotrabeculotomy (VT) in primary open-angle glaucoma (POAG).</p><p><strong>Study design: </strong>A prospective randomized controlled study.</p><p><strong>Patients and methods: </strong>Patients presenting with POAG and operated upon in Mansoura Ophthalmic Center in Mansoura, Egypt between February 2017 and September 2021 were enrolled. Study eyes were randomized to either VCST or VT and follow up extended for 24 months. Success was defined as an intra ocular pressure (IOP)≤18 mmHg with a 40% reduction from baseline. Complications were noted.</p><p><strong>Results: </strong>The study enrolled 166 (82 in the circumferential group) eyes of 107 patients. There were no statistically significant differences between both groups in any demographic or preoperative clinical characteristics. The IOP trend demonstrated marked initial reduction (from 32.3±2.4 and 31.8±2.6 mmHg preoperatively in VCST and VT groups respectively) followed by a slow gradual rise over subsequent follow-up settling at lower IOP values in the circumferential (12.4±1.2 mmHg) than in the segmental group (15.5±0.9 mmHg) (p<0.001), both settling at significantly lower levels than preoperative values. The survival curve demonstrates complete success rates at 12, 15, 18, and 24 months were 98.8%, 96.4%, 95.1%, and 85.4% in the circumferential group and 98.8%, 92.9%, 91.7%, 79.8% in the segmental group respectively. Minimal self-limiting hyphema was universal in all study eyes.</p><p><strong>Conclusions: </strong>Angle procedures -segmental and circumferential- are effective in lowering the IOP for at least 2 years in eyes with POAG, with circumferential angle surgery providing a greater reduction of IOP and requiring fewer subsequent glaucoma procedures.</p>","PeriodicalId":14563,"journal":{"name":"Japanese Journal of Ophthalmology","volume":" ","pages":"279-286"},"PeriodicalIF":2.1,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12003612/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143023119","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":"Safety and aesthetic outcomes of silicone buckles as an implant for anophthalmic sockets: a decade of experience in Japan.","authors":"Rikako Iwasaki, Yoshiyuki Kitaguchi, Takeshi Morimoto, Hiroshi Shimojo, Takahiro Fujino, Shimpei Komoto, Kohji Nishida","doi":"10.1007/s10384-025-01164-9","DOIUrl":"10.1007/s10384-025-01164-9","url":null,"abstract":"<p><strong>Purpose: </strong>To investigate the safety and aesthetic outcomes of silicone buckle #506 for anophthalmic socket reconstruction.</p><p><strong>Study design: </strong>Retrospective cohort study.</p><p><strong>Methods: </strong>Patients who underwent enucleation or evisceration at the Osaka University Hospital were retrospectively analyzed. Patients under 18 years old, with < 3 months follow-up, without a prosthesis, or with bilateral surgery were excluded. Aesthetic outcomes were assessed using standardized photographs taken 3 months postoperatively, scored by five independent ophthalmologists for upper eyelid sulcus deepening asymmetry. Scoring was categorized as 0: no noticeable side difference, 1: slight asymmetry, and 2: marked asymmetry characterized by upper eyelid sulcus deepening.</p><p><strong>Results: </strong>Fifty-nine patients (60 sockets) were analyzed. Thirty-three received silicone buckle implants (1-4 buckles). Implant exposure occurred in two patients (6.1%). Aesthetic scores were assessed in 48 patients. Mean aesthetic scores were 0.97 (no implant), 0.78 (one buckle), 0.68 (two buckles), and 0.42 (three/four buckles) (p = 0.123).</p><p><strong>Conclusions: </strong>Silicone buckle #506 appears to be a safe and feasible option for anophthalmic socket reconstruction. Further studies are needed to optimize aesthetic outcomes and determine the ideal number of buckles.</p>","PeriodicalId":14563,"journal":{"name":"Japanese Journal of Ophthalmology","volume":" ","pages":"214-220"},"PeriodicalIF":2.1,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12003588/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143364682","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":"Efficacy and safety of ROH-101 (0.15% ganciclovir gel) for cytomegalovirus corneal endotheliitis: an open-label, uncontrolled, phase 3 study in Japan.","authors":"Noriko Koizumi, Dai Miyazaki, Seiichiro Sugita, Chie Sotozono, Tsutomu Inatomi, Hiroshi Goto, Atsushi Shiraishi, Shuichiro Eguchi, Shin-Ichiro Ito, Yuichi Hori, Eiichi Uchio, Takeshi Soma, Takeo Fukuchi, Ken Hayashi, Yusuke Takeuchi, Yoshitsugu Inoue","doi":"10.1007/s10384-025-01168-5","DOIUrl":"10.1007/s10384-025-01168-5","url":null,"abstract":"<p><strong>Purpose: </strong>Cytomegalovirus (CMV) corneal endotheliitis often causes severe visual impairment owing to irreversible corneal endothelial dysfunction. Given the side effects of systemic antiviral therapy, development of an approved topical antiviral agent for CMV corneal endotheliitis is desirable. This study evaluated the efficacy and safety of topical 0.15% GCV gel, ROH-101, in the treatment of CMV corneal endotheliitis in Japanese patients.</p><p><strong>Study design: </strong>Open-label, multicenter, uncontrolled, phase 3 study (jRCT2051210064).</p><p><strong>Methods: </strong>The study was conducted from August 2021 to December 2022, with a 2-week run-in period with 0.1% fluorometholone eye drops alone, a 12-week treatment period with additional ROH-101, and a 24-week post-treatment observation period after discontinuation of ROH-101. The primary endpoint was the proportion of patients achieving a CMV DNA copy number in the aqueous humor of less than 10³ copies/mL at week 12. The clinical findings and safety were assessed over the treatment and post-treatment observation periods.</p><p><strong>Results: </strong>Twelve eyes of 12 patients with PCR-proven CMV corneal endotheliitis were enrolled. Treatment was discontinued in 1 eye owing to an adverse event. The other 11 eyes completed 12 weeks of treatment with 63.6% achieving the primary endpoint. The clinical findings, such as corneal edema, coin-shaped lesions, and anterior chamber inflammation, improved in all 11 eyes and did not worsen in 8 eyes that completed the post-treatment observation period. Endothelial cell density was well maintained, and none of the 11 eyes showed corneal endothelial dysfunction. Mild adverse drug reactions were reported in 3 eyes (8.3%).</p><p><strong>Conclusion: </strong>ROH-101 was a safe and efficacious treatment in Japanese patients diagnosed with CMV corneal endotheliitis.</p>","PeriodicalId":14563,"journal":{"name":"Japanese Journal of Ophthalmology","volume":" ","pages":"296-307"},"PeriodicalIF":2.1,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12003522/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143810739","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}