Ophthalmology and Therapy最新文献

{"title":"Therapeutic Keratopigmentation: Cosmetic and Functional Outcomes.","authors":"Seyed Javad Hashemian, Sepehr Roozdar, Jorge L Alió","doi":"10.1007/s40123-025-01131-0","DOIUrl":"https://doi.org/10.1007/s40123-025-01131-0","url":null,"abstract":"<p><strong>Introduction: </strong>This work aimed to assess the safety and outcomes of femtosecond laser-assisted intrastromal keratopigmentation (FIK) and superficial automated keratopigmentation (SAK) using micronized mineral pigments (MMPs) as a therapeutic cosmetic tool.</p><p><strong>Methods: </strong>Keratopigmentation (KTP) was performed in 85 eyes of 85 patients with moderate-to-severe cosmetic disabilities (20/80 to no light perception) related to various etiologies causing corneal scarring or iris abnormalities. Thirty-six eyes were treated by FIK, 46 eyes by SAK, and three eyes using combined SAK + FIK. The cosmetic outcome, patient satisfaction, and occurrence of any related complications were recorded. The cosmetic or visual outcome was assessed through patient-reported feedback, while an independent observer evaluated the cosmetic appearance at the 6th month postoperatively. The mean follow-up period was 13.06 ± 9.9 months (6-53 months).</p><p><strong>Results: </strong>The study included 48 males and 37 females. The mean age was 37.8 ± 14.25 (14-77 years). An independent observer assessed the cosmetic outcome as excellent or good in 91.8% of cases. Excellent or good cosmetic outcome was reported by the independent observer in 91.4% of the SAK group, 91.5% of the FIK group, and 100% of SAK + FIK combined. Eighty percent of patients reported cosmetic satisfaction 3 weeks postoperative; 73.9% of SAK group, 86% of FIK group, and 100% of the combined SAK + FIK group were satisfied with their cosmetic outcome. Twelve eyes of SAK and five eyes of FIK group required additional KTP procedures because of color fading and cosmetic unsatisfaction. Post-operative symptoms were photophobia (28.2%), tearing (23.5%), and pain (8.2%). Post-operative complications were dry eye (5.8%), delayed epithelial healing (2.3%), and microbial keratitis (1.1%).</p><p><strong>Conclusions: </strong>This study confirms that FIK and SAK using micronized mineral pigments are safe and efficient surgical techniques for managing cosmetic and visual disabilities caused by iris abnormalities and cosmetic issues related to corneal scars.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2025-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143772831","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":"Bilateral Acute Iris Transillumination Following Systemic Moxifloxacin Intake in the Greek Population.","authors":"Efthymia Kalogera, Evangelos Spanos, Michael Karampelas, Ioannis Halkiadakis, Vasileios Peponis, Kallirroi Konstantopoulou","doi":"10.1007/s40123-025-01135-w","DOIUrl":"https://doi.org/10.1007/s40123-025-01135-w","url":null,"abstract":"<p><strong>Introduction: </strong>Bilateral acute iris transillumination (BAIT) is a recently described entity, usually following moxifloxacin intake or respiratory tract infections. Interest in the disease has increased since the COVID-19 pandemic; however, its etiopathogenesis remains unclear. This study presents five cases in Greece with symptoms and signs suggestive of BAIT after systemic moxifloxacin administration. Unusual clinical manifestations and differential diagnosis are highlighted.</p><p><strong>Case presentations: </strong>Five female patients presented to the Uveitis Department complaining of bilateral photophobia and redness following systemic moxifloxacin intake. Past ocular history was unremarkable. The median best corrected visual acuity (BCVA) was 7/10 (range 4/10-9/10) and mean intraocular pressure (IOP) was 17 mmHg, with one eye demonstrating increased IOP of 32 mmHg. Clinical findings included bilateral diffuse mid-peripheral iris transillumination, conjunctival hyperemia, unresponsive pupils, and pigment dispersion into the anterior chamber. Two cases presented blue-colored irides. Gonioscopy showed pigment deposition at the trabecular meshwork. Anterior segment optical coherence tomography (OCT) revealed a normal iris configuration in all cases.</p><p><strong>Discussion: </strong>In Greece, BAIT has been infrequently described, with the highest prevalence being reported in Türkiye. The etiopathogenesis remains unknown, but the typical geographical distribution raises suspicion of a genetic predisposition. BAIT could be considered a drug-related adverse event or an ocular manifestation of viral infections, such as COVID-19. Clinical findings may vary, though differential diagnosis can be quite challenging. In cases with elevated intraocular pressure, topical treatment is usually adequate, although surgical approaches have been reported in the literature. All of our cases fit the clinical features of BAIT. Interestingly, two of the patients had light blue iris color.</p><p><strong>Conclusion: </strong>Understanding the clinical manifestations of the disease and its geographic spread facilitates a prompt clinical diagnosis, preventing unnecessary diagnostic tests. Although BCVA is typically well preserved in BAIT, persistent photophobia may lead to severe visual impairment. Further research is necessary to elucidate the exact etiopathogenesis of BAIT and explore genetic factors that may predispose individuals to this condition.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2025-04-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143764424","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":"Correlation Between Relative Peripheral Refraction and Efficacy of Myopia Control After Wearing Multifocal Soft Contact Lenses in Children.","authors":"Mengyao Xu, Yuxin Yang, Fengju Zhang, Yushan Xu, Yuyan Huang, Linlu Zhang, Jie Wen","doi":"10.1007/s40123-025-01096-0","DOIUrl":"10.1007/s40123-025-01096-0","url":null,"abstract":"<p><strong>Introduction: </strong>This study investigated the relationship between relative peripheral refraction (RPR), retinal choroidal vessel, and the growth rate of axial length (AL) in children with myopia wearing multifocal soft contact lenses (MiSight CLs).</p><p><strong>Methods: </strong>Forty-four eyes of 44 children with myopia wearing MiSight CLs were included in the study. RPRs and retinal choroidal vessel were measured at baseline, 3 months, 6 months, and 1 year using multispectral refraction topography (MRT) and optical coherence tomography angiograghy (OCTA). MRT presented RPR at different fields of view and OCTA presented retinal choroidal vessel characteristics centered on the macula. The correlation between the changes of RPR (ΔRPRs) and the growth rate of AL was analyzed.</p><p><strong>Results: </strong>The baseline AL, spherical equivalent, age, and average growth rate of AL of children are 24.76 ± 0.95 mm,  - 3.22 ± 1.77 D, 11.25 ± 2.42 years, and 0.22 ± 0.17 mm/year. At 3 months, TRPR (RPR of the circular visual field of 53° centered on macular fovea) (p = 0.0007), RPR-15 (p = 0.0042), RPR-30 (p = 0.0012), RPR-45 (p = 0.0031), and RPR-I (p = 0.0082) of children with myopia wearing MiSight CLs were significantly lower than baseline. The ΔRPR was negatively correlated with the growth rate of AL (ΔTRPR, r = - 0.43, p = 0.003; ΔRPR-45, r = - 0.43, p = 0.004; ΔRPR-I, r = - 0.35, p = 0.02; ΔRPR-N, r = - 0.32, p = 0.04). At 1 year, there was a significant difference in the retina vessel volume index compared to baseline (p = 0.0002).</p><p><strong>Conclusion: </strong>RPR showed significant changes at 3 months after wearing multifocal soft contact lenses, but noticeable changes in retinal vessel volume index occurred only at 1 year. MRT demonstrates a higher efficacy in the early detection of the effectiveness of myopia control measures.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":"755-771"},"PeriodicalIF":2.6,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11920468/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143483735","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 Socioeconomic Burden of Retinal Diseases: Can Biosimilars Add Value? A Narrative Review.","authors":"Seenu M Hariprasad, Frank G Holz, Carl V Asche, Amine Issa, Oriol Mora, Simon Keady, Mourad F Rezk, Phil Sarocco, Steven Simoens","doi":"10.1007/s40123-025-01104-3","DOIUrl":"10.1007/s40123-025-01104-3","url":null,"abstract":"<p><p>Retinal diseases, such as neovascular age-related macular degeneration, diabetic retinopathy, and retinal vein occlusion, pose a significant global burden on individuals, families, and healthcare systems. Intravitreal anti-vascular endothelial growth factor (anti-VEGF) therapy has become the standard treatment for retinal diseases, improving clinical outcomes, while delaying disease progression. Although effective, biologics are associated with high costs, which can lead to underutilisation and, consequently, suboptimal patient treatment outcomes, further contributing to healthcare costs. Additionally, the expansion in the elderly population is predicted to significantly increase costs and burden on healthcare systems due to retinal diseases, requiring effective strategies and the utilisation of emerging technologies that are crucial public health priorities for tackling global vision impairment. Recently, anti-VEGF biosimilars have been approved and are expected to provide a cost-effective alternative, while providing equivalent efficacy and comparable safety, immunogenicity, and pharmacokinetic profiles as the reference product. The entry of biosimilars holds the promise of meeting some of these unmet needs, giving physicians and patients access to sustainable treatments that can provide cost-effective therapy, enabling savings to be reinvested into healthcare facilities. This article aims to review the impact of retinal diseases on clinical, social, and financial aspects of patient care, emphasising the potential value of biosimilars in ophthalmology.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":"621-641"},"PeriodicalIF":2.6,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11920568/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143502548","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":"Ocular Sticks for Routine Ophthalmic Surgery: A Randomized Controlled Monocentric Trial.","authors":"Isaak Fischinger, Manfred Tetz, Angela Odame, Heidi Kulas, Martin Abel","doi":"10.1007/s40123-025-01107-0","DOIUrl":"10.1007/s40123-025-01107-0","url":null,"abstract":"<p><strong>Introduction: </strong>Ocular sticks are used to absorb fluids during ophthalmic surgeries. Hence, this prospective study was conducted to evaluate the clinical performance, safety, and usability of Pro-optha^® Ocular Sticks in comparison to an alternative device under the conditions of routine ophthalmic surgeries.</p><p><strong>Methods: </strong>Patients requiring eye surgery were randomly allocated into two equal groups, with the investigational device, Pro-ophta^® Ocular Sticks, as the intervention group (IG) and the alternative stick as the comparator group (CG). Two types of surgery were performed. The study is also registered on the German Clinical Trials Register with ID DRKS00025690.</p><p><strong>Results: </strong>106 patients were included in the analyses. In both treatment groups, the investigator's/surgeon's general user satisfaction was rated as either \"good\" or \"very good.\" The non-inferiority hypothesis that the Pro-ophta^® Ocular Stick is not rated worse in satisfaction than the alternative device was confirmed with statistical significance (p = 0.0005). At least 98.12% were rated as \"good\" and \"very good\" in both treatment groups for the additional endpoints. Pro-ophta^® Ocular Stick was rated better for almost all the additional endpoints and within the surgery subgroups. The mean number of sticks and surgery duration were 3.5 ± 2.74 and 11.5 (± 8.88) min, respectively, with a positive correlation (r = 0.580) for the Pro-ophta^® Ocular Stick and 3.9 ± 2.45 and 9.5 (± 5.90) min, respectively, with a positive correlation (r = 0.025) for the alternative device. No device-related adverse events occurred.</p><p><strong>Conclusions: </strong>Effective ocular sticks play an instrumental role in the outcome of ophthalmic surgeries. The investigational device demonstrated efficiency, yielding good surgical results, usability, and an exceptionally good safety profile.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":"659-673"},"PeriodicalIF":2.6,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11920446/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143425588","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":"Performance and Safety of a Sodium Hyaluronate, Xanthan Gum, and Osmoprotectants Ophthalmic Solution in the Treatment of Dry Eye Disease: An Observational Clinical Investigation.","authors":"Mercedes Molero Senosiaín, Barbara Burgos-Blasco, Pilar Perez-García, Álvaro Sánchez-Ventosa, Marta Villalba-González, María Dolores López Pérez, José Carlos Díaz, Vanesa Díaz-Mesa, Alberto Villarrubia Cuadrado, Enrique Artiaga Elordi, Jose Manuel Larrosa Poves, Alejandro Blasco, Antonio Mateo, Claudine Civiale, Laura Bonino, Antonio Cano-Ortiz","doi":"10.1007/s40123-025-01099-x","DOIUrl":"10.1007/s40123-025-01099-x","url":null,"abstract":"<p><strong>Introduction: </strong>Dry eye disease (DED) is characterized by an imbalance in the tear film, resulting in symptoms such as dryness, redness, and discomfort. The management of DED involves tear supplements, medications, or surgery in severe cases. To evaluate the clinical performance and safety of a hypotonic ophthalmic solution containing sodium hyaluronate 0.2%, xanthan gum 0.2%, and osmoprotectants (glycine and betaine) for treating DED.</p><p><strong>Methods: </strong>This multicenter, prospective, observational clinical investigation included 35 subjects treated with one drop of the ophthalmic solution four times daily. Evaluations were conducted at baseline, on day 14, and at 1 and 3 months. The investigation assessed corneal and conjunctival fluorescein staining (NEI score), hyperemia index (Keratograph®), fluorescein tear film break-up time (TFBUT), best-corrected visual acuity, dry eye symptoms (SANDE), and quality of life (DEQS). Safety was monitored through adverse events, intraocular pressure measurements, and the Investigator Global Assessment of Safety.</p><p><strong>Results: </strong>Subjects were predominantly female (93.9%), with an average age of 59.9 ± 13.8 years. The ophthalmic solution significantly reduced keratitis lesions with global NEI score decreasing from baseline at 1 month (- 6.67 ± 4.6, p = 0.001) and 3 months (- 7.61 ± 4.0 points; p = 0.001). Conjunctival hyperemia improved significantly after 1 month (- 0.34 ± 0.7 points; p = 0.027), while fluorescein tear film stability increased significantly at 1 (1.85 ± 3.1 s; p = 0.002) and 3 months (1.98 ± 3.4 s; p = 0.001). Symptoms also improved significantly (p = 0.001) at 1 and 3 months (- 29.37 ± 22.2 points and - 26.41 ± 24.0 points, respectively), as did quality of life (- 20.81 ± 15.6 points at 1 month and - 18.43 ± 19.3 points at 3 months; p = 0.001 for both). The safety profile was very good, with no adverse events (only mild ocular discomfort reported in 14.3% of subjects).</p><p><strong>Conclusions: </strong>The ophthalmic solution effectively improved DED symptoms and signs, enhancing patients' quality of life while maintaining a good safety profile.</p><p><strong>Trial registration number: </strong>NCT05778942.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":"675-692"},"PeriodicalIF":2.6,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11920488/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143472762","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":"Early Effects of Perfluorohexyloctane Ophthalmic Solution on Patient-Reported Outcomes in Dry Eye Disease: A Prospective, Open-Label, Multicenter Study.","authors":"Jason Bacharach, Shane R Kannarr, Anthony Verachtert, Preeya K Gupta, Moataz Razeen, Megan E Cavet, Jason L Vittitow, Jacob Lang, Thomas M Chester, Jillian F Ziemanski, Darrell E White","doi":"10.1007/s40123-025-01097-z","DOIUrl":"10.1007/s40123-025-01097-z","url":null,"abstract":"<p><strong>Introduction: </strong>Perfluorohexyloctane ophthalmic solution (PFHO) is indicated for the treatment of signs and symptoms of dry eye disease (DED) and targets excessive tear evaporation. This study evaluated patient-reported outcomes early in treatment with PFHO.</p><p><strong>Methods: </strong>This prospective, multicenter, open-label, phase 4 study enrolled adults with a history of DED for ≥ 6 months. PFHO was instilled in both eyes four times daily for 14 days. Patients completed early outcome surveys during four clinic visits (day 1 [pretreatment; 5 and 60 min post-PFHO instillation] and days 3, 7, and 14). Symptom severity, symptom frequency, and treatment satisfaction were rated on visual analog scales (range 0-100). The primary endpoint was mean change from baseline in overall DED symptom severity at day 7. Secondary endpoints included change in severity of individual DED symptoms (eye dryness, blurred vision, eye irritation, light sensitivity, eye tiredness, burning/stinging, eye itching, eye pain); change in frequency (measured as percentage of time experienced) of the most bothersome symptom, awareness of dry eye symptoms, and fluctuation in quality of vision; and treatment satisfaction.</p><p><strong>Results: </strong>Ninety-nine patients enrolled (85.9% female; age range 35-81 years). The primary endpoint was met: mean (SD) overall symptom severity decreased significantly from 72.1 (17.0) at baseline to 27.8 (22.3) at day 7 (mean change, - 44.5; P < 0.0001). Mean (SD) percentage of time experiencing the most bothersome symptom decreased from 77.9% at baseline to 34.7% at day 14 (P < 0.0001). Significant reductions in severity and frequency also were observed for all symptoms at all postbaseline assessments (P < 0.0001). Median ratings of treatment satisfaction were 83.0 at day 3, 86.0 at day 7, and 90.0 at day 14.</p><p><strong>Conclusion: </strong>Early in the course of treatment with PFHO, patients with DED experienced significant reductions in dry eye symptom frequency and severity. Treatment satisfaction with PFHO was high.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifier NCT06309953.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":"693-704"},"PeriodicalIF":2.6,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11920460/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143476792","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":"A Systematic Review of Advances in AI-Assisted Analysis of Fundus Fluorescein Angiography (FFA) Images: From Detection to Report Generation.","authors":"Tao Yu, An Shao, Hongkang Wu, Zichang Su, Wenyue Shen, Jingxin Zhou, Xingxi Lin, Danli Shi, Andrzej Grzybowski, Jian Wu, Kai Jin","doi":"10.1007/s40123-025-01109-y","DOIUrl":"10.1007/s40123-025-01109-y","url":null,"abstract":"<p><p>Fundus fluorescein angiography (FFA) serves as the current gold standard for visualizing retinal vasculature and detecting various fundus diseases, but its interpretation is labor-intensive and requires much expertise from ophthalmologists. The medical application of artificial intelligence (AI), especially deep learning and machine learning, has revolutionized the field of automatic FFA image analysis, leading to the rapid advancements in AI-assisted lesion detection, diagnosis, and report generation. This review examined studies in PubMed, Web of Science, and Google Scholar databases from January 2019 to August 2024, with a total of 23 articles incorporated. By integrating current research findings, this review highlights crucial breakthroughs in AI-assisted FFA analysis and explores their potential implications for ophthalmic clinical practice. These advances in AI-assisted FFA analysis have shown promising results in improving diagnostic accuracy and workflow efficiency. However, further research is needed to enhance model transparency and ensure robust performance across diverse populations. Challenges such as data privacy and technical infrastructure remain for broader clinical applications.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":"599-619"},"PeriodicalIF":2.6,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11920566/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143468102","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":"The Impact of Disease Activity Criteria on Extending Injection Intervals in Real-World Patients with Neovascular Age-Related Macular Degeneration.","authors":"Bhairavi Bhatia, Sing Yue Sim, Evangelia Chalkiadaki, Georgios Koutsocheras, Luke Nicholson, Senthil Selvam, Sobha Sivaprasad, Bishwanath Pal, Josef Huemer, Pearse A Keane, Robin Hamilton, Praveen J Patel","doi":"10.1007/s40123-025-01108-z","DOIUrl":"10.1007/s40123-025-01108-z","url":null,"abstract":"<p><strong>Introduction: </strong>In clinical practice, intravitreal anti-vascular endothelial growth factor (anti-VEGF) injection intervals for patients with neovascular age-related macular degeneration (nAMD) are based on disease activity, with active or recurrent disease requiring more frequent injections. Injection interval modification criteria differ from those used in clinical trials, thereby potentially affecting treatment outcomes. This analysis evaluated the potential impact of applying disease activity criteria from recent clinical trials (TENAYA/LUCERNE; HAWK/HARRIER; PULSAR) on the decision to extend injection intervals in real-world patients commenced on faricimab after the loading phase of treatment and at 12 months.</p><p><strong>Methods: </strong>Data were analysed from 105 treatment-naïve patients with nAMD who received anti-VEGF injections at Moorfields Eye Hospital. Disease activity criteria from TENAYA/LUCERNE, HAWK/HARRIER and PULSAR clinical trials were applied to determine the hypothetical impact on the decision to modify injection intervals at week 12 (fourth injection) and 12-month real-world clinic visits.</p><p><strong>Results: </strong>At 12 weeks, 79% of patients had injection intervals extended in clinical practice compared to 80% when applying hypothetical TENAYA/LUCERNE disease activity criteria; 77% using HAWK/HARRIER and 96% using PULSAR. There was agreement between clinical practice and all clinical trials in 60% of eyes, and no agreement in 13%. At 12 months, fewer patients were inactive, with 55% of eyes quiescent in clinical practice, 58% when applying TENAYA/LUCERNE criteria and 67% using HAWK/HARRIER. Application of PULSAR disease activity criteria showed 96% of patients were classed as inactive. 34% of eyes showed agreement in disease activity status between clinical practice and all clinical trials at 12 months, with no agreement in 20%.</p><p><strong>Conclusions: </strong>Applying disease activity criteria from clinical trials to clinical practice can have a significant impact on hypothetical anti-VEGF injection intervals. Consideration should be paid to which criteria are used in real-world practice to help achieve treatment burden reductions and optimal treatment outcomes seen in clinical trials.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":"773-786"},"PeriodicalIF":2.6,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11920564/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143523932","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":"Hydroxypropyl-Methylcellulose and GlicoPro^® Eyedrops in the Treatment of Dry Eye Disease: In Vitro and Clinical Study.","authors":"Edoardo Villani, Giuseppe Campagna, Valentina Gentili, Elisa Imelde Postorino, Paola Genovese, Paola Palino, Gloria Maini, Alice Carbucicchio, Eleonora Ferioli, Paolo Nucci, Roberta Rizzo, Pasquale Aragona","doi":"10.1007/s40123-025-01101-6","DOIUrl":"10.1007/s40123-025-01101-6","url":null,"abstract":"<p><strong>Introduction: </strong>Artificial tear substitutes are key elements in the first-line treatment of dry eye disease (DED). We hypothesized that GlicoPro^®, a new multimolecular complex based on proteins, sulfured and unsulfured glycosaminoglycans and opiorphin, was able to significantly improve the effect of hydroxypropyl-methylcellulose (HPMC) eyedrops in treating DED.</p><p><strong>Methods: </strong>We performed an in vitro experiment and a clinical study, comparing an HPMC + GlicoPro^®-based to an HPMC-based ophthalmic formulation (similar kinematic viscosity and comparable HPMC concentration). An in vitro dry eye model was established by inducing hyperosmolarity in the base medium of human corneal epithelial cells HCE-2. After treatment with ophthalmic formulations, the expression levels of inflammatory cytokines and enzymes (IL-20, IL-1β, TNF-α, IL-6, IL-8, MMP-9, and MCP-1) was measured by real-time polymerase chain reaction. Moreover, we performed a single-blind randomized 1:1 clinical trial, aimed to compare the efficacy of the two formulations instilled four times per day (QID), in treating mild-to-moderate DED. Symptoms (Ocular Surface Disease Index and Symptom Assessment iN Dry Eye), clinical signs, and ocular surface imaging data were assessed at baseline and after 1 and 3 months of treatment.</p><p><strong>Results: </strong>In vitro experiment: under hyperosmotic conditions, corneal epithelial cells upregulated the expression of inflammatory cytokines IL-20, IL-1β, TNF-α, IL-6, and IL-8. Treatment with HPMC + GlicoPro^® significantly decreased the expression of all inflammatory markers tested, including cytokines, MMP-9, and MCP-1 (P < 0.05).</p><p><strong>Clinical study: </strong>the HPMC + GlicoPro^® formulation showed a significantly higher effect in improving symptoms (overall treatment effect: P < 0.001), tear film stability, and markers of inflammation on corneal confocal microscopy (P < 0.01).</p><p><strong>Conclusions: </strong>Both in vitro and clinical data provided evidence supporting the role of GlicoPro^® in improving the effect of HPMC in DED treatment.</p><p><strong>Clinical trial registration: </strong>NCT06726525.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":"787-803"},"PeriodicalIF":2.6,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11920458/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143537665","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}