Ophthalmology and Therapy最新文献

{"title":"Transepithelial Versus Conventional PRK: A Randomized Controlled Study.","authors":"Robert Edward T Ang","doi":"10.1007/s40123-025-01167-2","DOIUrl":"10.1007/s40123-025-01167-2","url":null,"abstract":"<p><strong>Introduction: </strong>Transepithelial photorefractive keratectomy (t-PRK) is an updated maneuver based on the proven surgical procedure of conventional photorefractive keratectomy (PRK) for the correction of ametropia. Unlike conventional PRK, which is a two-step process involving the physical removal of the corneal epithelium prior to excimer laser treatment of the stroma, t-PRK uses the excimer laser to complete both activities in a single-step procedure.</p><p><strong>Methods: </strong>This was a prospective, randomized, controlled, contralateral, masked, single-surgeon study of adult subjects with myopia with a manifest residual spherical equivalent (MRSE) of ≤ 1.5 D or hyperopia with an MRSE of ≥  + 1.5 D, conducted at a single center in the Philippines. Eligible subjects were randomized to undergo conventional PRK in one eye and t-PRK in the other. The follow-up was for 6 months. The primary endpoint evaluated the absolute refractive predictability at 3 months. Secondary endpoints during the 6-month follow-up included safety, manifest refraction, visual acuity, halos and glare, slit-lamp examinations, and patient-reported outcomes.</p><p><strong>Results: </strong>A total of 35 subjects (70 eyes) were enrolled (63% female, 94% Asian, mean age 30 years). The mean (standard deviation [SD]) absolute prediction error was 0.26 D (0.23) for conventional PRK and 0.34 D (0.32) for t-PRK, meeting the threshold for demonstration of noninferiority (p = 0.2253). There were no statistically significant differences between conventional PRK and t-PRK for manifest sphere, manifest cylinder, MRSE, or uncorrected or corrected visual acuity at 6 months. All subjects were satisfied with both procedures and there was no preference for one treatment over the other.</p><p><strong>Conclusions: </strong>Both conventional and t-PRK are equally safe and effective, and result in favorable outcomes for subjects with ametropia. The efficiency of the t-PRK procedure versus conventional PRK should be considered when PRK is indicated.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov, NCT04698174.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":"1567-1579"},"PeriodicalIF":2.6,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12167193/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144187550","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":"Advancing Ocular Safety Profile Assessment: A Novel Grading Scale for Ocular Adverse Reactions Associated with Bemarituzumab.","authors":"Asim V Farooq, Savreet Kaur, Pradeep Hundal, Maureen Burke, Rosilin Sulaiman, Anita Zahlten-Kümeli, Sumera Raoof, Zhezhen Li, Telma Murias Dos Santos, Xiaojun Jacqueline Huang, Kathryn Colby","doi":"10.1007/s40123-025-01139-6","DOIUrl":"10.1007/s40123-025-01139-6","url":null,"abstract":"<p><p>Targeted cancer therapies have transformed the landscape of cancer treatments but are often associated with off-target adverse drug reactions due to overlapping molecular pathways in healthy tissues, including those in the eye. Fibroblast growth factor receptors (FGFRs), expressed across various parts of the eye, can become unintended targets of FGFR inhibitors such as erdafitinib, infigratinib, and pemigatinib, leading to ocular adverse events (AEs) affecting the ocular surface and retina. AEs across clinical trials are graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), which may not completely capture the ocular sequelae resulting from the use of emerging therapies. As CTCAE grading is mainly through the description of symptoms and their impact on visual acuity, it is imperative to use a tool that relies more on objective findings from ophthalmologic evaluations. The novel ocular adverse reaction severity grading scale developed by Amgen in collaboration with expert ophthalmologists, accounts for the anatomical regions impacted by ocular adverse reactions and anchors each severity grade to objective observable criteria from ophthalmologic evaluations. This grading scale is being used across the clinical development program for bemarituzumab to precisely characterize the ocular safety profile, enabling cross-specialty collaboration between oncologists and eye care providers to implement appropriate management strategies. This commentary article highlights the efforts led by Amgen in collaboration with regulatory, medical, and academic fields to develop tools that facilitate early recognition of adverse reactions and appropriate interventions for patient care.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":"1349-1356"},"PeriodicalIF":2.6,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12167182/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144037583","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":"Outer Retinal Tubulation and Geographic Atrophy: A Natural History Analysis of Sham Observed Eyes from the OAKS and DERBY Trials.","authors":"Srinivas Sadda, Kensington A Hatcher, Birva K Shah, Srinivas Sai Kondapalli, Chao Li, Caroline R Baumal","doi":"10.1007/s40123-025-01156-5","DOIUrl":"10.1007/s40123-025-01156-5","url":null,"abstract":"<p><strong>Introduction: </strong>Retrospective, longitudinal analysis of sham observed eyes from the phase 3 OAKS and DERBY trials evaluated the relationship between geographic atrophy (GA) growth and the presence or absence of outer retinal tubulation (ORT).</p><p><strong>Methods: </strong>Prevalence rates of ORT were calculated, and analysis of GA growth was performed using fundus autofluorescence and optical coherence tomography (OCT).</p><p><strong>Results: </strong>ORT prevalence rates were 32%, 37.5%, and 43% at baseline, month 12, and month 24, respectively. Eyes with a fully formed ORT at baseline had 23.6% less GA area growth over 24 months compared with GA without ORT present at baseline.</p><p><strong>Conclusion: </strong>The presence of ORT at baseline on OCT may be reflective of slower growth of GA, irrespective of GA location, as was noted in this series. The potential diagnostic impact of ORT should be considered when designing clinical studies for GA and when analyzing the results of such studies.</p><p><strong>Trial registration: </strong>OAKS: ClinicalTrials.gov identifier NCT03525613 (registered May 15, 2018); EudraCT identifier 2018-001435-52 (registered September 27, 2018).</p><p><strong>Derby: </strong>ClinicalTrials.gov identifier NCT03525600 (registered May 15, 2018); EudraCT identifier 2018-001436-22 (registered September 21, 2018).</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":"1611-1619"},"PeriodicalIF":2.6,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12167419/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144094496","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":"Dry Eye Disease: From Causes to Patient Care and Clinical Collaboration-A Narrative Review.","authors":"Pasquale Aragona, Stefano Barabino, Antonio Di Zazzo, Giuseppe Giannaccare, Edoardo Villani, Francesco Aiello, Elena Antoniazzi, Stefano Bonini, Emilia Cantera, Gianpaolo Carlini, Chiara Chierego, Rossella Colabelli, Romina Fasciani, Antonella Franch, Giovanna Gabbriellini, Caterina Maria Rita Gagliano, Andrea Leonardi, Angelo Macrì, Rita Mencucci, Luigi Mosca, Vincenzo Orfeo, Antonio Pinna, Augusto Pocobelli, Romolo Protti, Paolo Rama, Laura Rania, Miguel Rechichi, Pierangela Rubino, Andrea Russo, Vincenzo Scorcia, Leopoldo Spadea, Marco Trentadue, Salvatore Troisi, Piera Versura, Maurizio Rolando","doi":"10.1007/s40123-025-01161-8","DOIUrl":"10.1007/s40123-025-01161-8","url":null,"abstract":"<p><p>Dry eye disease (DED) is a common condition of the ocular surface that affects tens of millions of people worldwide. It is often characterized by decreased tear production or increased evaporation, resulting in a wide range of signs and symptoms. This review provides a comprehensive analysis of the literature related to DED, detailing causes, diagnostic tests, and medical management. Several mechanisms contribute to the maintenance of the physiological integrity of the ocular surface, and their dysfunction may result in noticeable symptoms. Accurate diagnosis is therefore essential, even when physiological function is only minimally impaired or no clear pathological signs are present. The review emphasizes the importance of addressing the underlying causes through a combination of treatment options, lifestyle changes, and enhanced communication between patients and healthcare providers to break the cycle of inflammation and tear instability. It aims to raise awareness among patients, healthcare professionals, and researchers regarding the diagnosis and treatment of DED, while also highlighting recent advancements and future challenges in its management.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":"1411-1428"},"PeriodicalIF":2.6,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12167426/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144160756","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":"Real-World Outcomes of Brolucizumab Treatment in Japanese Patients with Neovascular Age-Related Macular Degeneration: A 12-Month, Multicenter Study.","authors":"Masayuki Ohnaka, Yoichi Sakurada, Atsushi Hayashi, Kazuaki Kadonosono, Hitoshi Ohno, Ryusaburo Mori, Hidetaka Matsumoto, Ippei Nagamori, Yuki Murata, Tina Maio-Twofoot, Helene Karcher, Hidenori Takahashi","doi":"10.1007/s40123-025-01159-2","DOIUrl":"10.1007/s40123-025-01159-2","url":null,"abstract":"<p><strong>Introduction: </strong>The aim of this study was to evaluate the real-world outcomes of brolucizumab use in Japanese patients with neovascular age-related macular degeneration (nAMD).</p><p><strong>Methods: </strong>PHEASANT was a retrospective, multicenter, single-arm cohort study. The study included 438 patients, of whom 123 were treatment-naïve and 315 were pre-treated. The primary outcome was retinal fluid (subretinal fluid [SRF] and intraretinal fluid [IRF]) resolution at month 12, with change in visual and retinal anatomy parameters and safety assessed as key secondary outcomes.</p><p><strong>Results: </strong>At baseline in the treatment-naïve cohort, 10.1% (n = 7/69) of patients were free of retinal fluid, increasing to 62.3% (n = 43/69) at month 12. In the pre-treated cohort, 14.9% (n = 30/201) of patients were free of retinal fluid at baseline, increasing to 43.8% (n = 88/201) at month 12. The median (interquartile range [IQR]) injection interval for pre-treated patients at month 12 was extended by 21 (7.0-35.0) days. The overall intraocular inflammation rate (including the rate of retinal vasculitis/retinal occlusive vasculitis of 0.46% [2/438]) was 8.4% (n = 37/438).</p><p><strong>Conclusion: </strong>In a real-world clinical setting, brolucizumab was effective at drying the retina in treatment-naïve and pre-treated Japanese nAMD patients and therefore has the potential to reduce the treatment burden by prolonging injection intervals. Safety outcomes support the overall favorable benefit/risk profile of brolucizumab.</p><p><strong>Clinicaltrials: </strong></p><p><strong>Gov identifier: </strong>NCT06699914.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":"1551-1565"},"PeriodicalIF":2.6,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12167219/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144160760","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":"Clinical and Biological Evaluation of NAAGA Versus Azelastine Eye Drops in Patients with Allergic Conjunctivitis and Tear Film Dysfunction: A Randomized Controlled Trial.","authors":"Mario Troisi, Salvatore Troisi, Diego Strianese, Michele Rinaldi, Maria Vittoria Turco, Ciro Costagliola","doi":"10.1007/s40123-025-01171-6","DOIUrl":"10.1007/s40123-025-01171-6","url":null,"abstract":"<p><strong>Introduction: </strong>Allergic conjunctivitis is a common ocular condition characterized by discomfort, itching, and redness, which significantly impacts quality of life. Its frequent overlap with dry eye disease (DED) complicates diagnosis and management, as both conditions share inflammation and tear film dysfunction as underlying mechanisms. Effective treatments must address both the inflammatory and tear film aspects of these conditions. While traditional therapies include antihistamines and mast cell stabilizers, innovative approaches focus on agents with dual anti-inflammatory and antiallergic properties. N-acetyl-aspartyl-glutamate (NAAGA) has shown potential in alleviating symptoms of both allergic conjunctivitis and DED through mechanisms involving mast cell stabilization, inhibition of inflammatory mediators, and improvement of tear film stability. This study compares the efficacy of NAAGA and azelastine hydrochloride, an established antihistamine, in improving symptoms and clinical markers of tear film dysfunction in patients with allergic conjunctivitis.</p><p><strong>Methods: </strong>This randomized, single-blind study included 134 patients with atopy and mild to moderate tear film dysfunction. Participants received either NAAGA (49 mg/ml, four times daily) or azelastine hydrochloride (0.05%, twice daily) for 4 weeks. The primary endpoint was the change in Ocular Surface Disease Index (OSDI) scores. Secondary endpoints included tear osmolarity, Schirmer test results, tear break-up time (TBUT), fluorescein staining, and matrix metalloproteinase-9 (MMP-9) levels.</p><p><strong>Results: </strong>Both treatments improved all parameters significantly over 4 weeks. NAAGA reduced OSDI scores from 26.12 ± 4.70 to 11.84 ± 3.43, compared to azelastine's improvement from 24.57 ± 4.70 to 15.54 ± 4.36 (p < 0.001). NAAGA showed superior reductions in tear osmolarity (from 320.99 ± 4.35 to 312.33 ± 3.25 mOsm/l) compared to azelastine (from 320.13 ± 3.46 to 318.57 ± 3.46 mOsm/l, p < 0.001), and greater enhancements in Schirmer test results (6.51 ± 1.95 mm to 10.08 ± 1.88 mm) and TBUT (4.10 ± 1.70 to 7.91 ± 1.79 s).</p><p><strong>Conclusions: </strong>NAAGA outperformed azelastine in alleviating symptoms and improving clinical markers of tear film dysfunction in allergic conjunctivitis. Its dual action on inflammation and tear stability highlights its therapeutic potential. Further studies are warranted to confirm these findings and explore additional applications.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifier, NCT12345678.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":"1581-1595"},"PeriodicalIF":2.6,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12167221/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144199767","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":"Surgical Outcomes of Retropupillary Iris-Claw Intraocular Lens Implantation for Various Indications.","authors":"Hyo Song Park, Sung Chul Park, Jin Ha Kim, Young Hoon Ohn, Tae Kwann Park, Jung Woo Han","doi":"10.1007/s40123-025-01153-8","DOIUrl":"10.1007/s40123-025-01153-8","url":null,"abstract":"<p><strong>Introduction: </strong>The retropupillary iris-claw intraocular lens (RP-IOL) offers a sutureless solution to complications like aphakia, intraocular lens (IOL) dislocation, and opacification post-cataract surgery. Unlike time-consuming, complication-prone traditional methods, RP-IOL potentially reduces surgical time and complications. This study evaluates RP-IOL's clinical outcomes to assess its efficacy and safety.</p><p><strong>Methods: </strong>This single-center retrospective case series reviewed medical records of 68 eyes from 68 patients who underwent RP-IOL implantation between January 2017 and May 2023. Preoperative and postoperative data, including visual acuity (VA), intraocular pressure (IOP), and spherical equivalent (SE), were analyzed.</p><p><strong>Results: </strong>The mean uncorrected VA improved significantly from 1.25 ± 0.73 (logarithm of the minimum angle of resolution) preoperatively to 0.42 ± 0.47 at 1 month postoperatively (P < 0.001). The mean IOP decreased significantly from 17.69 ± 5.01 mmHg preoperatively to 16.09 ± 4.23 mmHg 1 month postoperatively (P = 0.041). Postoperative complications occurred in 35.3% of cases, with the most common being IOP elevation (13.2%), cystoid macular edema (11.8%), and disenclavation of IOL (7.4%). Most complications were successfully managed. The study also included a subanalysis of seven patients with IOL opacification, showing improved VA postoperatively, although without statistical significance due to the small sample size.</p><p><strong>Conclusions: </strong>RP-IOL implantation is an effective and safe option for secondary IOL implantation or exchange in cases of aphakia, IOL dislocation, and IOL opacification. The procedure offers significant improvements in visual acuity and a reduction in intraocular pressure, with manageable postoperative complications. While the study supports the use of RP-IOL as a viable option, further research with larger sample sizes and prospective designs is recommended to establish its long-term efficacy and safety compared to traditional methods.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":"1491-1501"},"PeriodicalIF":2.6,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12167421/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144064313","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":"Peripheral Neuropathy Symptoms and Ocular Surface Lesions in Patients with Type 2 Diabetes Mellitus and Dry Eye: A Clinical Correlational Study.","authors":"Yanling Liu, Dapeng Sun, Qianqian Kong, Dongfang Li, Rui Wang, Jia Yin, Lixin Xie, Yanling Dong, Yangyang Zhang","doi":"10.1007/s40123-025-01150-x","DOIUrl":"10.1007/s40123-025-01150-x","url":null,"abstract":"<p><strong>Introduction: </strong>Reduced corneal sensation in individuals with type 2 diabetes mellitus (T2DM) leads to a dissociation between dry eye disease (DED) signs and symptoms, thereby affecting diagnostic accuracy. This study aimed to investigate the correlation between ocular surface signs and diabetic peripheral neuropathy (DPN) symptoms in patients with T2DM-associated DED.</p><p><strong>Methods: </strong>The Michigan Neuropathy Screening Instrument Questionnaire (MNSIQ) was used to categorize patients with T2DM into MNSIQ-DPN and non-DPN groups. Ocular irritation symptoms were evaluated using the Ocular Surface Disease Index (OSDI) questionnaire. Ocular surface lesions were assessed via Cochet-Bonnet esthesiometry, corneal fluorescein staining (CFS), the Schirmer I tear test (SIT), tear meniscus height (TMH), noninvasive keratography break-up time (NIKf-BUT), and the meibomian gland loss (MGL) grade detected by OCULUS. Corneal nerve fiber parameters were evaluated using in vivo confocal microscopy (IVCM).</p><p><strong>Results: </strong>A total of 116 patients with T2DM, comprising 76 non-DPN patients and 40 MNSIQ-DPN patients, along with 51 age-matched participants without diabetes, were enrolled. Although OSDI scores were equivalent between MNSIQ-DPN patients and non-DPN patients, MNSIQ-DPN patients presented significantly more severe CFS (p < 0.001), meibomian gland dysfunction (MGD) (p < 0.001), corneal nerve fiber loss (p < 0.001), sensory dysfunction (p = 0.02), and corneal microneuromas (p < 0.001). The MNSIQ score was significantly positively correlated with CFS (p < 0.001); MGD (p < 0.01); corneal nerve fiber loss, including corneal nerve fiber density and length and branch density, in the paracentral (all p < 0.001) and inferior-whorl areas (p < 0.01, p < 0.05 and p < 0.01, respectively); and corneal microneuromas, characterized by increased microneuroma numbers (p < 0.001) and areas (p < 0.001) in these regions.</p><p><strong>Conclusion: </strong>MNSIQ scores were significantly and robustly correlated with the presence of corneal epithelial defects, MGD, and nerve fiber loss in patients with T2DM. These findings suggest that DPN is a critical factor in diabetic ocular surface complications, highlighting the importance of the MNSIQ for assessing these conditions.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":"1503-1519"},"PeriodicalIF":2.6,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12167187/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144079187","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":"Pooled Analysis of Three MicroShunt Studies in Primary Open-Angle Glaucoma Evaluating Different Concentrations of Applied Mitomycin C.","authors":"Julián Garcia-Feijoo, Juan F Batlle, Florent Aptel, Yves Lachkar, Isabelle Riss, Omar Sadruddin, Tuan Nguyen, Henny J M Beckers","doi":"10.1007/s40123-025-01149-4","DOIUrl":"10.1007/s40123-025-01149-4","url":null,"abstract":"<p><strong>Introduction: </strong>The PRESERFLO MicroShunt is an 8.5-mm-long (70-µm lumen) controlled ab externo filtration surgery device made from poly[styrene-block-isobutylene-block-styrene] (SIBS). Three prospective, open-label clinical trials (ClinicalTrials.gov Identifiers: NCT00772330; NCT01563237; NCT02177123) evaluated the 2-year effectiveness and safety of MicroShunt implantation plus mitomycin C (MMC). This pooled analysis compared outcomes in patients receiving 0.2 or 0.4 mg/ml MMC during MicroShunt implantation.</p><p><strong>Methods: </strong>Patients aged 18-85 years with primary open-angle glaucoma (intraocular pressure [IOP] 18-35 mmHg) uncontrolled on maximal tolerated medical therapy and/or where glaucoma progression warranted surgery who underwent MicroShunt implantation with/without cataract surgery, and with adjunctive use of 0.2 or 0.4 mg/ml MMC. Two-year outcomes included changes in IOP and glaucoma medications, complete success rates (IOP ≥ 6 to < 14 mmHg or ≥ 20% reduction, without medications), and rates of procedure/device-related adverse events (AEs) and serious AEs (SAEs).</p><p><strong>Results: </strong>Of the 125 included patients, 58 received 0.2 mg/ml MMC and 67 received 0.4 mg/ml MMC). Mean percent reduction in IOP was significantly greater in patients receiving 0.4 than 0.2 mg/ml MMC (- 40.9% vs. - 34.5%, P < 0.05). Mean glaucoma medication use was reduced to a lower level between baseline and year 2 in the 0.4 than in the 0.2 mg/ml MMC group. At year 2, the percentage of medication-free patients (85.2% vs. 58.0%, P < 0.01) and the complete success rates (71.6% vs. 48.3%, P < 0.01) were significantly higher in the 0.4 than in the 0.2 mg/ml MMC group. Rates of procedure/device-related AEs and SAEs did not differ significantly in the two groups (P > 0.05).</p><p><strong>Conclusions: </strong>IOP and glaucoma medication use at year 2 were lower, and complete success rate was higher, in patients administered 0.4 mg/ml than 0.2 mg/ml MMC. Although there is no consensus on the optimal concentration of MMC, these findings may guide surgeons until further evidence from controlled trials becomes available.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":"1533-1549"},"PeriodicalIF":2.6,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12167400/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144128362","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":"Multiwavelength Photobiomodulation Improves Multiple Aspects of Visual Function in Early-Stage Dry Age-Related Macular Degeneration.","authors":"Cem Küçükerdönmez, Stephanie E Tedford","doi":"10.1007/s40123-025-01183-2","DOIUrl":"https://doi.org/10.1007/s40123-025-01183-2","url":null,"abstract":"<p><strong>Introduction: </strong>This study aimed to evaluate the safety and efficacy of multiwavelength photobiomodulation (PBM) treatment (Tx) in earlier stages of nonexudative (dry) age-related macular degeneration (AMD).</p><p><strong>Methods: </strong>Participants were enrolled with a diagnosis of dry AMD. Participants were treated with a single or repeated series of multiwavelength PBM treatment (LumiThera Valeda^® Light Delivery System; 590, 660, and 850 nm) delivered three times per week over 3-5 weeks every 4 months with follow-up extending out to 16 months. Outcomes analyzed included visual acuity (VA), contrast sensitivity (CS), and electroretinography (ERG).</p><p><strong>Results: </strong>A total of 41 eyes (27 participants) were evaluated after single (1 series of Tx, n = 41 eyes) and repeat (2-4 series of Tx, n = 26 eyes) PBM treatment with up to 16 months of follow-up. Participants were mostly female (n = 22, 81.5%) with a mean time since AMD diagnosis of 5.6 years. Participants enrolled had earlier stage dry AMD with better vision (~ 20/32 Snellen) and a mean baseline VA of 76.5 letters. Single and repeated PBM Tx improved VA, CS, multi-luminance ERG, and fixed luminance ERG parameters. No significant visual decline was noted in any outcome measure or signs of phototoxicity.</p><p><strong>Conclusions: </strong>PBM treatment of patients with earlier stage dry AMD showed improvements on multiple visual outcome measures and no adverse effects. Earlier stage AMD populations may not show robust magnitude effects as their starting vision does not show serious deficits, however; as a result of the degenerative and progressive nature of the disease, repeat treatment and continued monitoring of these outcomes are of interest. These beneficial effects were improved with repeated PBM treatment series.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2025-06-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144476226","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}