Ophthalmology and Therapy最新文献

{"title":"Characterizing the Modern Interventional Glaucoma Treatment Paradigm: The Newton Registry.","authors":"Andrew M Williams, Anne L Coleman, Brian Stagg, Eric Newton, Deborah Ristvedt","doi":"10.1007/s40123-026-01524-9","DOIUrl":"https://doi.org/10.1007/s40123-026-01524-9","url":null,"abstract":"<p><strong>Introduction: </strong>We aim to describe the development of the Newton Registry which characterizes the frequency and nature of interventional glaucoma (IG) procedures used for treatment in the USA between 2022 and 2025.</p><p><strong>Methods: </strong>The Newton Registry contains International Classification of Disease Tenth Edition (ICD-10) codes and Current Procedural Terminology (CPT) codes from encounters with patients with glaucoma and providers in ophthalmology practices in the USA. Each practice provided a window of data 18-36 months in duration that captured all glaucoma patient and procedure encounters of the practice's providers. Robust data cleaning techniques were applied. Analyses were descriptive in nature and included a qualitative description of the dataset and its structure, the types and severity of glaucoma included, the duration of follow-up and lapse rate, and the frequency and nature of therapeutic IG.</p><p><strong>Results: </strong>The Registry contains data from 724,728 encounters between 157,246 patients with glaucoma and 605 providers at 35 practices. Most patients had open-angle glaucoma (82.1%) or were glaucoma suspects (10.5%). The glaucoma was coded as mild in 51.8% of patients, moderate in 13.5%, and severe in 17.8%. The mean follow-up duration was 15.4 (10.7) months with 56.3% having a > 12-month lapse in glaucoma care during the 18-36 month observation window. The glaucoma procedures rate (≥ 1 procedure during the observation window) was 12.2%; common procedures included selective laser trabeculoplasty (44.4%), stent implantation (25.7%), canaloplasty (12.3%), and goniotomy (12.1%), as well as traditional filtering surgeries (4.5%).</p><p><strong>Conclusions: </strong>The Newton Registry provides important information on current glaucoma treatment practice patterns. In subsequent analyses, this dataset may reveal the current status of the use of IG, provide insight into how IG is currently being deployed, supply a standard against which practices can compare when examining their own treatment patterns, and establish a baseline against which future changes in practice patterns can be measured.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":""},"PeriodicalIF":4.2,"publicationDate":"2026-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149207428","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":"Combined Light-Heavy Silicone Oil Endotamponade Compared with Heavy or Light Silicone Oil Endotamponade for Complex Rhegmatogenous Retinal Detachment: A Randomized Controlled Trial.","authors":"Haomin Lu, Xingguo Zhang, Yuege Zhang, Yi Peng, Minghao Sun, Jiajing Zhu, Yanan Shen, Pan Fan, Su Dong, Dawei Sun, Bo Jiang","doi":"10.1007/s40123-026-01508-9","DOIUrl":"https://doi.org/10.1007/s40123-026-01508-9","url":null,"abstract":"<p><strong>Introduction: </strong>To compare the clinical outcomes and postoperative complications of combined light-heavy silicone oil (L-HSO), heavy silicone oil (HSO), and light silicone oil (LSO) endotamponade for complex rhegmatogenous retinal detachment (RRD) with superior and inferior retinal breaks.</p><p><strong>Methods: </strong>In this prospective randomized controlled trial, 90 patients with primary complex RRD involving superior and inferior retinal breaks and proliferative vitreoretinopathy (PVR) grade C or higher were randomized to receive L-HSO, HSO, or LSO endotamponade after pars plana vitrectomy. Ultimately, 74 patients (74 eyes) completed the 12-month follow-up and were included in the final statistical analysis. The primary outcome was primary anatomical success rate. Secondary exploratory outcomes included best-corrected visual acuity (BCVA), intraocular pressure (IOP), and postoperative complications.</p><p><strong>Results: </strong>During the follow-up period, no statistically significant differences in primary anatomical success rates were observed among the three groups, although the combined L-HSO group showed a numerically higher primary anatomical success rate (100.0%). In addition, exploratory analyses suggested better BCVA in the combined L-HSO group than in the HSO group before removal of silicone oil (ROSO) and at 6 months after ROSO than in the LSO group at 6 months after ROSO (P < 0.05); no significant differences were observed at 12 months after ROSO. Regarding postoperative complications, the combined L-HSO group showed lower incidences of cataract progression, emulsified silicone oil droplets adhering to the posterior capsule, silicone oil emulsification in the vitreous cavity, anterior PVR, and elevated IOP than the HSO group (all P < 0.05).</p><p><strong>Conclusions: </strong>Combined L-HSO endotamponade may represent a potential endotamponade strategy for complex RRD with superior and inferior retinal breaks. Although the combined L-HSO group showed a numerically higher primary anatomical success rate and potentially favorable functional and safety findings, these results should be interpreted as exploratory and require confirmation in adequately powered studies.</p><p><strong>Clinical trial registration: </strong>Chinese Clinical Trial Registry identifier: ChiCTR2600132242.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":""},"PeriodicalIF":4.2,"publicationDate":"2026-10-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149183750","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":"Infraorbital Skin Application of Menthol Emulsion for Dry Eye Disease: A Randomized Clinical Trial.","authors":"Yixuan Gu, Ao Li, Yifei Wu, Yanlin Wei, Xianggen Wu, Lei Tian, Ying Jie","doi":"10.1007/s40123-026-01521-y","DOIUrl":"https://doi.org/10.1007/s40123-026-01521-y","url":null,"abstract":"<p><strong>Introduction: </strong>We aim to evaluate the short-latency tear-secretory effects and symptom responses of infraorbital menthol emulsion in dry eye disease (DED) without intentional ocular-surface instillation.</p><p><strong>Methods: </strong>In this randomized, participant- and assessor-masked, vehicle-controlled trial, 128 adults with DED were assigned to bilateral infraorbital application of vehicle (0% menthol), 2% menthol, or 4% menthol emulsion four times daily for 3 weeks. Follow-up measurements were obtained 10 min after supervised application. The available analysis population comprised 95 participants (32, 32, and 31, respectively), and efficacy analyses used the right eye. The primary endpoint was baseline-to-week-3 change in the Schirmer I test without topical anesthesia. Baseline-adjusted mixed models for repeated measures estimated treatment contrasts with 95% confidence intervals (CIs) and Dunnett-adjusted P-values.</p><p><strong>Results: </strong>Mean (standard deviation) week-3 Schirmer changes were 1.90 (7.41), 8.56 (7.95), and 8.72 (6.42) mm/5 min in the vehicle, 2%, and 4% groups, respectively. Adjusted differences versus vehicle were 6.69 mm/5 min for 2% menthol (95% CI 2.59-10.80; P< 0.001) and 6.43 mm/5 min for 4% menthol (95% CI 2.23-10.64; P = 0.002). Corresponding tear meniscus height differences were 0.08 mm (95% CI 0.04-0.13; P< 0.001) and 0.09 mm (95% CI 0.05-0.13; P< 0.001). Fluorescein tear break-up time did not meet the adjusted significance threshold. Exploratory dryness visual analog scale (VAS) scores also favored 2% and 4% menthol, with adjusted differences versus vehicle of -22.07 mm (95% CI -32.56 to -11.58) and -26.09 mm (95% CI -36.72 to -15.47), respectively, although subjective outcomes may have been influenced by functional unmasking. No serious adverse events occurred; one participant developed mild periocular erythema that resolved after treatment discontinuation.</p><p><strong>Conclusions: </strong>In the available analysis population, infraorbital 2% and 4% menthol produced clinically measurable short-latency increases in Schirmer values and tear meniscus height compared with vehicle, supporting further investigation of infraorbital stimulation of endogenous aqueous tear secretion without intentional ocular-surface instillation. The study does not establish persistence of benefit between applications, and confirmation is needed in trials with complete randomized-population follow-up and appropriately designed pre-dose assessments.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":""},"PeriodicalIF":4.2,"publicationDate":"2026-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149148373","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":"Characteristics and Factors of Incision-Related Descemet Membrane Detachment During Cataract Surgery: A Prospective Study.","authors":"Wenfei Guo, Ranyi Ding, Can Zhao, Xiaofeng Li, Xi Lu, Xiaowei Zhong, Weiyun Shi, Jijun Sun, Ting Wang","doi":"10.1007/s40123-026-01519-6","DOIUrl":"https://doi.org/10.1007/s40123-026-01519-6","url":null,"abstract":"<p><strong>Introduction: </strong>Incision-related Descemet membrane detachment (DMD) can arise at different stages of cataract surgery, but its real-time intraoperative characteristics and associated factors remain incompletely understood. This study aimed to characterize incision-related DMD in 2.65 mm clear corneal incisions and to identify factors associated with its occurrence using intraoperative optical coherence tomography (iOCT).</p><p><strong>Methods: </strong>A total of 179 patients (179 eyes) with cataracts underwent coaxial 2.65 mm clear corneal incision phacoemulsification with intraocular lens implantation. iOCT was used for real-time scanning of the corneal main incision, recording DMD occurrence and extent at each procedural step. The full cohort was used for descriptive analyses and to evaluate associations between baseline factors and DMD detected at any intraoperative stage. Irrigation/aspiration (I/A)-related exposures were evaluated in the primary I/A analysis cohort, comprising the 145 eyes that remained DMD-free at I/A initiation. The primary outcome was newly detected DMD, defined as the first detection of DMD during I/A or at any subsequent intraoperative stage. A new parameter, I/A incision-deformation time, was defined as the cumulative duration of instrument-incision engagement accompanied by visible incision deformation during the I/A stage.</p><p><strong>Results: </strong>Intraoperative DMD was detected in 109 of 179 eyes (60.9%) and was first observed most frequently during I/A (43.1%). In the primary I/A analysis cohort (n = 145), longer I/A incision-deformation time (adjusted odds ratio [aOR] = 1.23; 95% CI, 1.12-1.36; P < 0.001) and greater nuclear hardness (aOR = 4.20; 95% CI, 2.08-8.50; P < 0.001) were independently associated with the occurrence of DMD. I/A incision-deformation time and nuclear hardness showed similar discrimination (area under the curve [AUC], 0.728 and 0.726, respectively), while their exploratory combination yielded an optimism-corrected AUC of 0.800.</p><p><strong>Conclusions: </strong>Longer I/A incision-deformation time and greater nuclear hardness were independently associated with DMD occurrence. I/A incision-deformation time may offer a reproducible quantitative measure of instrument-incision interactions during cataract surgery.</p><p><strong>Trial registration: </strong>ChiCTR2100042379.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":""},"PeriodicalIF":4.2,"publicationDate":"2026-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149148522","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":"Study Design for ELARA, a Phase 3b Trial of Aflibercept 8 mg in Previously Treated Patients With Neovascular Age-Related Macular Degeneration or Diabetic Macular Edema.","authors":"David M Brown, Rohini Rao, Alyson J Berliner, Disha Patel, Yenchieh Cheng, Zhanying Bai, Charles C Wykoff","doi":"10.1007/s40123-026-01499-7","DOIUrl":"https://doi.org/10.1007/s40123-026-01499-7","url":null,"abstract":"<p><strong>Introduction: </strong>Aflibercept 8 mg at extended dosing intervals demonstrated functional and anatomic improvements in a large majority of patients with neovascular age-related macular degeneration (nAMD) or diabetic macular edema (DME) in pivotal trials. Although a subset of patients may require frequent injections to maintain disease control, the efficacy and safety of monthly dosing with aflibercept 8 mg had not been extensively assessed. The ELARA trial evaluated the tolerability and measures of efficacy of aflibercept 8 mg every 4 weeks, as well as the feasibility of dosing interval extension following 6 monthly doses of aflibercept 8 mg, in previously treated patients with nAMD or DME.</p><p><strong>Methods: </strong>ELARA was a multicenter, open-label, 96-week, phase 3b trial. Previously treated patients with nAMD or DME who received ≥ 3 intravitreal anti-vascular endothelial growth factor injections within 5 months before the first trial visit were eligible to participate. Patients received monthly injections of aflibercept 8 mg through week 24. Beginning at week 24, a treat-and-extend regimen was implemented based on dose regimen modification (DRM) criteria assessing disease activity and response to treatment to reflect treatment patterns of retina specialists in clinical practice. Dosing intervals were modified in patients who met DRM criteria for extension or shortening from week 24 through 96. The minimum dosing interval was every 4 weeks.</p><p><strong>Planned outcomes: </strong>The primary outcome was the incidence of ocular and non-ocular treatment-emergent adverse events through week 24. Exploratory outcomes included the change from baseline in best-corrected visual acuity and central subfield thickness at weeks 24 and 96.</p><p><strong>Trial registration: </strong>NCT06491914.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":""},"PeriodicalIF":4.2,"publicationDate":"2026-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149149269","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":"Correction: Long-Term Evolution of Treatment Outcomes with Once-Daily Ciclosporin A 0.1% Cationic Emulsion in Patients with Dry Eye Disease and Severe Keratitis.","authors":"Andrea Leonardi, Pasquale Aragona, Maite Sainz de la Maza, Aleksei Seleznev, Edward Wylegala, Edoardo Villani, Christophe Baudouin","doi":"10.1007/s40123-026-01512-z","DOIUrl":"https://doi.org/10.1007/s40123-026-01512-z","url":null,"abstract":"","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":""},"PeriodicalIF":4.2,"publicationDate":"2026-10-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149137920","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":"Association of Topical Therapy and Surgical Management with Corneal Parameters in Congenital PAX6-Related Classical Aniridia: a Cross-Sectional Study.","authors":"Yubo Li, Clara Grünauer-Kloevekorn, Mária Csidey, Annamária Náray, Anita Csorba, Fabian Norbert Fries, Klaudia Kéki-Kovács, Erika Maka, Marta Corton, Kálmán Tory, Eszter Jávorszky, Zoltán Zsolt Nagy, Achim Langenbucher, Márk Bérchegyi, Szilárd Váncsa, Nóra Szentmáry","doi":"10.1007/s40123-026-01520-z","DOIUrl":"https://doi.org/10.1007/s40123-026-01520-z","url":null,"abstract":"<p><strong>Introduction: </strong>This study aimed to investigate associations of topical therapy and surgical management with the severity of aniridia-associated keratopathy (AAK), limbal stem cell deficiency (LSCD) and corneal microstructural alterations in patients with PAX6-related congenital aniridia (CA).</p><p><strong>Methods: </strong>This cross-sectional study included eyes with genetically confirmed CA. Medical history, including preservative-free artificial tears, antiglaucoma medications (beta-blockers, brimonidine, carbonic anhydrase inhibitors, prostaglandin analogues), and ocular surgery was recorded. AAK and LSCD were graded. Anterior segment optical coherence tomography (AS-OCT) assessed epithelial and total corneal thickness, while in vivo confocal microscopy (IVCM) assessed subbasal nerve plexus parameters, Langerhans cell density (LCD), and stromal keratocyte density. Associations were analyzed using generalized estimating equations.</p><p><strong>Results: </strong>Sixty-one eyes of 31 patients were analyzed. More advanced AAK and LSCD were associated with more frequent preservative-free artificial tear use. Antiglaucoma medications were associated with differences in corneal thickness, keratocyte and Langerhans cell densities, and subbasal nerve plexus parameters. Prostaglandin analogue use was associated with a heterogeneous pattern, including higher corneal nerve fiber density and length, higher middle stromal keratocyte density, and lower LCD. Previous ocular surgery showed limited associations with corneal microstructural parameters but was associated with lower corneal nerve network complexity. All findings were exploratory and hypothesis-generating.</p><p><strong>Conclusions: </strong>Topical therapy use is associated with differences in corneal structural and cellular parameters in congenital aniridia. Preservative-free artificial tear use is associated with more advanced AAK and LSCD, while antiglaucoma medications are associated with differences in corneal thickness, keratocyte and Langerhans cell densities, and corneal nerve parameters. Prostaglandin-treated eyes show a heterogeneous pattern of associations with corneal microstructural parameters. Given the cross-sectional design, whether these treatment-associated differences reflect medication effects, underlying disease severity, treatment selection, concomitant therapies, or residual confounding cannot be determined. These findings require longitudinal confirmation.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":""},"PeriodicalIF":4.2,"publicationDate":"2026-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149112818","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":"Correction: STudy of Atropine to Reduce (STAR) Myopia Progression in Children: 24-Month Results of a Randomized, Double-Masked, Vehicle-Controlled Trial of Atropine Sulfate 0.01% and 0.03.","authors":"Michael Korenfeld, Maria Hurcikova, Kay Tatsuoka, Dana Tomciková, Janet Cheetham, Marek Kacerik","doi":"10.1007/s40123-026-01515-w","DOIUrl":"https://doi.org/10.1007/s40123-026-01515-w","url":null,"abstract":"","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":""},"PeriodicalIF":4.2,"publicationDate":"2026-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149112904","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":"Post Hoc MRI Analysis of Orbital Soft Tissue Volumes Pre- and Post-Teprotumumab in Patients with Chronic, Low-Activity Thyroid Eye Disease.","authors":"Shoaib Ugradar, Ada Kumar, Michael Karon, Zhenxun Wang, Prem S Subramanian, Sara T Wester","doi":"10.1007/s40123-026-01516-9","DOIUrl":"https://doi.org/10.1007/s40123-026-01516-9","url":null,"abstract":"<p><strong>Introduction: </strong>A previous phase 4 trial (Chronic) evaluated teprotumumab treatment in patients with chronic, low-activity thyroid eye disease (TED). In the current study, volumetric changes in the orbital soft tissues, lacrimal glands, and full facial fat were evaluated following teprotumumab in a subset of patients from this chronic TED trial who underwent magnetic resonance imaging (MRI).</p><p><strong>Methods: </strong>This post hoc exploratory MRI analysis examined volumetric changes of extraocular muscles (EOMs), orbital fat (OF), lacrimal glands, and full facial fat pre- and post-teprotumumab (week 24) in patients from the phase 4 Chronic trial at one preselected trial site. Patients had a TED duration of 2-10 years, diagnosis of chronic, low-activity TED (clinical activity score ≤ 1), and received eight teprotumumab infusions administered once every 3 weeks. The study (more proptotic) and fellow orbit were evaluated separately and together via MRI.</p><p><strong>Results: </strong>Of the six patients (female n = 5, male n = 1) undergoing MRI at baseline and week 24, the mean age and TED duration was 45.2 and 5.5 years, respectively. At baseline, patients had a mean proptosis of 25.25 mm (study orbits) and 24.00 mm (fellow orbits). Mean (%) changes from baseline (CFB) in total EOM and OF volumes in combined study and fellow orbits after 24 weeks of teprotumumab were - 1107.3 mm³ (- 25.0%) and - 5017.1 mm³ (- 34.6%), respectively. Mean (%) CFB in full facial fat and study and fellow lacrimal gland volumes were - 12,175.9 mm³ (- 6.6%), - 116.7 mm³ (- 21.9%), and - 150.5 mm³ (- 26.4%), respectively. Proptosis response was observed in 100% (6/6) of study and 66.7% (4/6) of fellow orbits.</p><p><strong>Conclusion: </strong>MRI demonstrated that teprotumumab effectively reduces orbital soft tissue, facial fat, and lacrimal gland volumes in study and fellow orbits of patients with chronic, low-activity TED.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifier NCT04583735.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":""},"PeriodicalIF":4.2,"publicationDate":"2026-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149112956","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":"Effects and Safety of Grape Skin Enzyme Fermentation Extract for Eye Fatigue and Dry Eye Symptoms: An Exploratory Randomized Controlled Trial.","authors":"Hoon Kim, Hyun Pil Yang, Yuli Park, Kyongjin Cho","doi":"10.1007/s40123-026-01509-8","DOIUrl":"https://doi.org/10.1007/s40123-026-01509-8","url":null,"abstract":"<p><strong>Introduction: </strong>Dry eye disease impairs visual function and quality of life. This trial evaluated the efficacy and safety of grape skin enzyme fermentation extract (KL-GEFE; Nunaezone, Kitto Life Co., Ltd., Pyeongtaek, Republic of Korea), a grape skin enzyme fermentation extract, in adults with ocular fatigue and dry-eye-related symptoms.</p><p><strong>Methods: </strong>In this 12-week, randomized, double-blind, placebo-controlled trial at Dankook University Hospital, 68 adults were allocated 1:1 to KL-GEFE (400 mg/day) or placebo. The study protocol specified the Schirmer I test, adapted Eye Strain Questionnaire (ESQ), noninvasive break-up time (NIBUT), fluorescein tear break-up time (TBUT), ocular-surface staining, critical flicker fusion frequency (CFF), and Ocular Surface Disease Index (OSDI) as efficacy outcomes but did not assign them a formal hierarchy. The protocol-specified efficacy analysis used baseline-adjusted analysis of covariance (ANCOVA) in the per-protocol set (PPS; n = 65), with supportive analysis in the full analysis set (FAS; n = 68) using last observation carried forward (LOCF).</p><p><strong>Results: </strong>At week 12, the adjusted KL-GEFE-minus-placebo difference was 4.46 mm for the Schirmer I test (95% CI 2.96-5.95; P < 0.001) and -4.29 points for the adapted ESQ total score (95% CI -8.39 to -0.19; P = 0.041). The corresponding FAS-LOCF estimates were 4.36 mm (95% CI 2.92-5.80; P < 0.001) and -4.56 points (95% CI -8.57 to -0.56; P = 0.026), respectively. The week 12 OSDI difference was not statistically significant, and no statistically significant week 12 between-group differences were observed for NIBUT, fluorescein TBUT, CFF, or ocular-surface staining. Two mild adverse events unrelated to the study product occurred; no serious adverse events occurred.</p><p><strong>Conclusion: </strong>KL-GEFE supplementation was associated with week 12 between-group differences in Schirmer I test values and adapted ESQ total scores, whereas no statistically significant week 12 between-group differences were observed for the other efficacy outcomes. Given the absence of a prospectively defined outcome hierarchy and multiplicity-control framework, these findings should be considered exploratory and require confirmation in prospectively designed trials.</p><p><strong>Trial registration: </strong>Clinical Research Information Service (CRIS; https://cris.nih.go.kr ), KCT0012279, registered on 14 July 2026; retrospectively registered.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":""},"PeriodicalIF":4.2,"publicationDate":"2026-10-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149112927","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}