Ophthalmology and Therapy最新文献

{"title":"Patient-Reported Outcomes of Visual Disturbances with a Trifocal Intraocular Lens: A Meta-Analysis.","authors":"Dagny Zhu, Suyen Karki, Mukesh Dhariwal, Erkki Soini, Christian Asseburg","doi":"10.1007/s40123-024-01085-9","DOIUrl":"10.1007/s40123-024-01085-9","url":null,"abstract":"<p><strong>Introduction: </strong>Diffractive trifocal intraocular lenses (IOLs) provide good vision at distance, intermediate, and near, but can also cause positive dysphotopsias. This meta-analysis pooled published evidence on visual disturbances after bilateral implantation of the PanOptix (TFNTXX) IOL for patients undergoing cataract surgery.</p><p><strong>Method: </strong>A systematic literature search was conducted in PubMed and congress presentations from April 2021 to December 2022 to identify studies with patient-reported outcomes on the incidence of visual disturbances (starbursts, halos, glare) post bilateral implantation of PanOptix IOL during cataract surgery. Random-effects meta-analysis was performed to generate pooled proportions for patient-reported visual disturbances with a 95% confidence interval [CI].</p><p><strong>Results: </strong>Eleven unique studies were included, spanning 580 patients with bilateral implantation of PanOptix IOL from 10 countries with 1 to 12 months follow-up. In summary, 33.6% of patients with bilateral PanOptix implantation experienced glare, 43.9% experienced halos, and 30.4% experienced starbursts. Among these patients, small percentages reported severe glare (2.9%), severe halos (5.4%), and severe starbursts (3.4%). Only 0.8%, 1.4%, and 2.6% of patients found glare, halos, and starbursts, respectively, to be very bothersome.</p><p><strong>Conclusion: </strong>Halos are the most frequently reported visual disturbances. However, the likelihood of experiencing severe and/or very bothersome visual disturbances (halos, glare, starbursts) is approximately 5% and 3%, respectively, after bilateral implantation of PanOptix IOL. These findings should inform clinical decision-making and treatment choices when selecting the most appropriate IOL implant for cataract surgery.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":"379-390"},"PeriodicalIF":2.6,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11754775/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142882613","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":"Capsular Bag Performance of a Novel Hydrophobic Single-Piece Intraocular Lens.","authors":"Klemens Waser, Klaus Straßmair, Leon Pomberger, Haidar Khalil, Peter Laubichler, Matthias Bolz, Nino Hirnschall","doi":"10.1007/s40123-024-01075-x","DOIUrl":"10.1007/s40123-024-01075-x","url":null,"abstract":"<p><strong>Introduction: </strong>We conducted an evaluation of capsular bag performance of the Clareon CNA0T0 intraocular lens (IOL), focusing on postoperative anterior chamber depth (ACD), IOL tilt, and IOL decentration.</p><p><strong>Methods: </strong>Inclusion criteria were bilateral age-related cataract and the ability to provide informed consent. Exclusion criteria were prior surgeries, combined surgeries, and conditions posing a risk for postoperative capsular bag instability. Preoperative and 8-week postoperative assessments included optical biometry and high-resolution anterior segment optical coherence tomography (OCT). Subjective refraction was conducted only at 8 weeks postoperative visit.</p><p><strong>Results: </strong>In the first analysis, 49 right eyes of 49 patients were included. Mean preoperative and postoperative ACD were 3.10 and 4.69 mm, respectively. Mean preoperative tilt was 4.77°, increasing to 5.06° postoperatively. Preoperative decentration was 0.16 mm, increasing to 0.26 mm postoperatively. Absolute refractive error (ARE) was + 0.31D, with 81% of eyes within ± 0.5D limits. In analysis II (98 eyes of 49 patients), both eyes showed a moderate correlation in IOL tilt (Pearson correlation coefficient: 0.27, p = 0.061) and a low correlation in IOL decentration (Pearson correlation coefficient: 0.02, p = 0.892) and ARE (Spearman: 0.15, p = 305) between right and left eyes of the same patient.</p><p><strong>Conclusions: </strong>The Clareon CNA0T0 IOL demonstrated high mechanical stability, with low postoperative tilt and decentration values, resulting in excellent refractive outcomes and visual acuity. These findings confirm the IOL's high stability within the capsular bag and effectiveness in minimizing postoperative refractive error, requiring only minor A-constant adjustments for optimal cataract surgery outcomes.</p><p><strong>Trial registration: </strong>NCT06595693.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":"295-308"},"PeriodicalIF":2.6,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11754762/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142812987","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 Relevance and Potential Role of Orbital Fat in Inflammatory Orbital Diseases: Implications for Diagnosis and Treatment.","authors":"Prince Dadson, Peter Ngum, Luis Eduardo Juarez-Orozco, Michael Ntodie, Piotr Loba","doi":"10.1007/s40123-024-01079-7","DOIUrl":"10.1007/s40123-024-01079-7","url":null,"abstract":"<p><p>The orbit is an important structure within the skull that houses the eye, optic nerve, and extraocular muscles. It also contains adipose/fat tissue, which provides a protective cushion for these components. Inflammatory orbital disease can affect any or all components of the orbit, often arising from various underlying pathologic conditions, including autoimmune, infectious, and vascular diseases. Typical signs and symptoms of orbital inflammation include swelling, redness, pain, discomfort, and potential loss of function. The role of orbital fat in the pathogenesis of inflammatory orbital diseases has not been fully explored. This review aims to provide a comprehensive description of orbital fat, its relevance and the potential role in inflammatory diseases of the orbit, and the use of radiologic imaging studies for evaluating this fat depot in cases of as inflammatory orbital diseases. Additionally, this review discusses the various procedures available for the treatment and management of these conditions. A range of interventions, including pharmacotherapy and surgical procedures, will be evaluated as promising therapeutic options. This review also explores the characteristics and potential applications of orbital fat-derived stem cells, with an emphasis on their regenerative abilities and anti-inflammatory effects. Understanding the role of orbital fat and its contribution to inflammatory orbital diseases is essential for optimizing diagnostic and treatment strategies.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":"247-281"},"PeriodicalIF":2.6,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11754589/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142829494","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":"Patient Characteristics, Diagnoses, and Management in a Combined Uveitis-Rheumatology Clinic.","authors":"Jason Shawver, Amit K Reddy, Alan G Palestine, Jason R Kolfenbach","doi":"10.1007/s40123-024-01090-y","DOIUrl":"10.1007/s40123-024-01090-y","url":null,"abstract":"<p><strong>Introduction: </strong>Combined uveitis-rheumatology clinics (combined clinics) are a relatively recent clinical care model. Here we report the demographics, ocular and systemic disease characteristics, and medications utilized in patients seen in a combined clinic at a tertiary care hospital in the USA.</p><p><strong>Methods: </strong>Medical records were reviewed of patients seen at the Combined Clinic at the University of Colorado Hospital between January 1, 2016 and November 1, 2023. Data including age, sex, referral indication, ocular and systemic inflammatory disease diagnosis, and therapies utilized were obtained.</p><p><strong>Results: </strong>A total of 171 patients were included in the study, of which 122 were diagnosed with a systemic inflammatory disease, the most common of which were spondyloarthritis and rheumatoid arthritis. Nearly half of patients referred to the combined clinic with a known ocular inflammatory disease (OID) and suspicion for a systemic process were eventually diagnosed with a systemic disease. The most common associations in patients with both OID and systemic disease were anterior uveitis with spondyloarthritis, and scleritis with rheumatoid arthritis. The most common systemic immunomodulatory therapies (IMT) used were adalimumab, methotrexate, and rituximab. Over 40% of patients underwent a change in IMT during their first evaluation.</p><p><strong>Conclusions: </strong>Most patients seen in the combined clinic had both ocular and systemic inflammatory disease and were treated with IMT. Many patients were diagnosed with a systemic inflammatory disease upon evaluation in the combined clinic, and nearly half were recommended to initiate or change IMT at their first visit. This highlights the utility of a combined clinic in the management of these complex patients, in addition to providing logistical benefits to patients and educational opportunities for trainees.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":"461-469"},"PeriodicalIF":2.6,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11754547/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142922319","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":"Replacing Theories with Evidence Around the Axes of the Eye in Intraocular Lens Selection: A Review for the Clinician.","authors":"Joaquín Fernández, Filomena Ribeiro, Noemi Burguera, Neus Burguera-Giménez, Manuel Rodríguez-Vallejo","doi":"10.1007/s40123-025-01092-4","DOIUrl":"https://doi.org/10.1007/s40123-025-01092-4","url":null,"abstract":"<p><p>The prevailing narrative in scientific literature has long overemphasized the role of ocular axes in intraocular lens (IOL) implantation, perpetuating misconceptions that have led to unnecessary exclusions of patients. Historical assumptions, coupled with inconsistent terminology and statistical inaccuracies, have muddled clinical decision-making. This review delves into these misconceptions, offering a critical reassessment of their relevance. Drawing from a non-systematic search across PubMed, the IOLEvidence App Database, and additional sources through snowballing, the review includes diverse studies exploring the relationship between ocular axes (angles, chords, kappa, alpha, lens, …) and IOL implantation. The findings reveal widespread confusion in terminology, particularly the interchangeable use of terms like 'angles' and 'chords', and highlight device-specific variability in parameters such as Chord-mu, Chord-alpha, and Chord-lens. Despite these inconsistencies, no robust evidence supports using these measures as grounds for excluding patients from IOL procedures. Interestingly, postoperative IOL centration (Chord-iol) emerged as a more critical factor for visual outcomes than preoperative ocular axes. The evidence suggests that values for Chord-mu, Chord-alpha, and Chord-lens should prompt further evaluation of atypical cases but are not reliable exclusion criteria. Moreover, a shift in focus toward aligning the IOL slightly temporal to the vertex normal appears to optimize visual acuity and minimize photic phenomena, challenging the established paradigm of knowledge about IOL centration.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2025-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143028980","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":"Changes in Retinal Oxygen Saturation 1 Month After Femtosecond LASIK Treatment in Chinese Adults with Myopia.","authors":"Xiaoqi Ma, Shanshan Ge, Xinwei Yang, Yuehua Zhou","doi":"10.1007/s40123-024-01091-x","DOIUrl":"https://doi.org/10.1007/s40123-024-01091-x","url":null,"abstract":"<p><strong>Introduction: </strong>This study aimed to compare changes in retinal oxygen saturation 1 month after femtosecond-assisted laser in situ keratomileusis (FS-LASIK) in Chinese adults with myopia using retinal oximetry.</p><p><strong>Methods: </strong>In this prospective, observational, single-center cohort study, Chinese adults aged 18-45 years with myopia were categorized into four groups according to spherical equivalent (SE), with 66 eyes characterized as low myopia (LM -3.00D < SE ≤ -0.50D), 68 eyes as moderate myopia (MM -6.00D < SE ≤ -3.00D), 68 eyes as high myopia (HM -9.00D < SE ≤ -6.00D), and 65 eyes as super-high myopia (SHM: SE ≤ -9.00D). The following were measured before and 1 month after FS-LASIK: SE, intraocular pressure (IOP), average keratometry (Km), and axial length (AL). Other ocular biological parameters included retinal arterial oxygen saturation (SaO₂) and retinal venous oxygen saturation (SvO₂); parameter difference values are expressed as ∆.</p><p><strong>Results: </strong>Of the 267 participants, 63.30% were female and 36.70% were male. The mean SE, AL, SaO₂, and SvO₂ were -5.93 ± 3.24 D, 26.01 ± 1.35 mm, 93.49% ± 1.67%, and 62.97% ± 4.52%, respectively. Before FS-LASIK, SaO₂ was significantly correlated with AL and SE (r_s = -0.305, P < 0.001; r_s = 0.385, P < 0.001). Significant differences were found in SaO₂ across myopia categories (P < 0.001). The changes in the retinal arterial oxygen saturation decreased significantly after FS-LASIK (F = 24.948, P < 0.001). After surgery, SaO₂ demonstrated a statistically significant but weak negative relationship with refractive correction (ΔSE) (r_s = -0.380, P < 0.001) and axial length (r_s = -0.404, P < 0.001), a significant but weak positive correlation with average keratometry cutting value (ΔKm) (r_s = 0.354, P < 0.001), and no correlation with the change in IOP (ΔIOP) (P > 0.05).</p><p><strong>Conclusion: </strong>Ruling out the influence of refractive error, SaO₂ was significantly decreased 1 month after FS-LASIK, while there was no significant change in SvO₂. We conjecture that retinal amplification may affect differences in retinal oxygen saturation.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2025-01-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143009197","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":"Third-Generation Trabecular Micro-Bypass Implantation with Phacoemulsification for Glaucoma.","authors":"Zachary Vest, Nadia Alinaghizadeh, Connor Prendergast","doi":"10.1007/s40123-024-01087-7","DOIUrl":"https://doi.org/10.1007/s40123-024-01087-7","url":null,"abstract":"<p><strong>Introduction: </strong>This retrospective, consecutive, real-world case series assessed the efficacy and safety of third-generation trabecular micro-bypass stent implantation (iStent infinite) with phacoemulsification in patients with mild-to-moderate primary open-angle glaucoma (POAG).</p><p><strong>Methods: </strong>Patients underwent phacoemulsification combined with implantation of iStent infinite (containing three stents) by a single U.S. glaucoma surgeon. Outcomes through 12 months included mean intraocular pressure (IOP) and medications; proportions of eyes with IOP ≤ 18 mmHg, ≤ 15 mmHg, or ≤ 12 mmHg; proportions of eyes on 0, 1, 2, or ≥ 3 topical glaucoma medications; adverse events; and secondary glaucoma procedures. Data are presented for the observed cohort of all available eyes at each time point and the consistent cohort of eyes with data at 12 months postoperative.</p><p><strong>Results: </strong>A total of 121 eyes with mild (66.1%) or moderate (33.9%) POAG underwent iStent infinite implantation between February 2023 and June 2024. In eyes with 12-month follow-up data (n = 32), mean IOP reduced from 18.1 ± 3.3 mmHg preoperatively to 13.8 ± 3.4 mmHg at 12 months (23.8% reduction, p < 0.001), while mean number of medications reduced from 1.38 ± 0.91 to 1.06 ± 1.13 medications (23.2% reduction, p = 0.023). The proportions of eyes achieving IOP ≤ 18/15/12 mmHg increased from 53.1%/21.9%/3.1% preoperatively to 87.5%/75.0%/43.8% at 12 months, respectively (all p < 0.01). Adverse events were largely mild and transient; three eyes (< 3%) had secondary laser or micro-invasive glaucoma interventions due to IOP and/or medications above goal.</p><p><strong>Conclusions: </strong>iStent infinite implantation with cataract surgery resulted in clinically and statistically significant IOP and medication reductions through 12 months postoperative, with favorable safety. This cohort constitutes one of the first and largest published datasets for this device in combination with cataract surgery in real-world usage.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2025-01-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142984425","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":"Surgical Parameters and Prognostic Factors in Persistent Fetal Vasculature: Insights from a Retrospective Cohort Study.","authors":"Fatima AlGhazal, Valmore A Semidey, Marcos J Rubio-Caso, Sulaiman M AlSulaiman, Gorka Sesma","doi":"10.1007/s40123-024-01088-6","DOIUrl":"https://doi.org/10.1007/s40123-024-01088-6","url":null,"abstract":"<p><strong>Introduction: </strong>Persistent fetal vasculature (PFV) is a congenital anomaly associated with significant surgical challenges, including a high risk of postoperative retinal detachment (RD). This study aimed to evaluate the impact of surgical approach and axial length (AL) on RD risk and visual outcomes in pediatric PFV management.</p><p><strong>Methods: </strong>A retrospective cohort study was conducted involving 76 eyes of 74 patients who underwent cataract surgery for PFV between 2014 and 2022. Patients were categorized by RD status postoperatively (14 with RD, 62 without RD). Key predictors, including surgical approach (corneal vs. pars plicata), AL, and age at surgery, were analyzed. The primary outcomes were RD incidence and final best-corrected visual acuity (BCVA).</p><p><strong>Results: </strong>Compared to the pars plicata approach, the corneal approach was associated with a significantly lower risk of RD, as indicated by a multivariate odds ratio of 0.08 (95% CI 0.01-0.6, P = 0.011). A shorter AL increased the risk of RD (median 17 vs. 20 mm, P = 0.002). The RD group showed poorer visual outcomes (P < 0.001), with a 71% loss of light perception. Surgery before 3 months improved outcomes, regardless of RD. Visible ciliary processes were strongly correlated with RD (P < 0.001).</p><p><strong>Conclusions: </strong>Corneal surgical approach and longer AL are associated with a lower RD risk in PFV cataract surgery. Early intervention and thorough preoperative assessment of the AL and ciliary processes are crucial for optimal outcomes.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2025-01-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142984419","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":"Risk Factors and Characteristics Associated with Visual Impairment and Eye Diseases in Moyamoya Disease: Insights from a National Database.","authors":"Youyi Song, Xin Yang, Hongzhu Yang, Hongyun Mei, Xuedan Lu, Hao Xie, Qinfeng Yang, Wenbin Duan","doi":"10.1007/s40123-024-01052-4","DOIUrl":"10.1007/s40123-024-01052-4","url":null,"abstract":"<p><strong>Introduction: </strong>This study aims to investigate the incidence and risk factors of visual impairment and eye diseases in patients with moyamoya disease (MMD), a rare cerebrovascular disorder. Understanding these associations is crucial for improving patient management and outcomes.</p><p><strong>Methods: </strong>This study utilized International Classification of Diseases (ICD) codes from both the 9th edition (ICD-9-CM) and 10th edition (ICD-10-CM) to define diagnoses, complications, and procedures within the National Inpatient Sample (NIS) Database. Data elements were extracted from discharge summaries. Statistical analysis was performed using IBM SPSS Statistics software version 25. Chi-square tests were employed for univariate analysis to assess the relationships between visual impairment, eye diseases, and MMD. Subsequently, multivariate logistic regression was utilized to calculate odds ratios (OR) and their corresponding 95% confidence intervals (CI) over a 10-year period to further investigate these relationships.</p><p><strong>Results: </strong>The incidence of visual impairment and eye diseases in MMD was 3.7%. Visual impairment and eye diseases in MMD were associated with Asian or Pacific Islander race (OR = 1.538, 95% CI 1.058-2.237), self-pay insurance (OR = 1.796, 95% CI 1.503-3.061), and hospitalization in the Midwest or North Central region (OR = 1.466, 95% CI 1.035-2.076). Visual impairment and eye diseases in moyamoya disease were associated with ischemic stroke (OR = 2.001, 95% CI 1.564-2.560), hypertension (OR = 1.508, 95% CI 1.089-2.088), headache (OR = 2.834, 95% CI 1.968-4.081), migraine (OR = 2.156, 95% CI 1.544-3.011), memory loss (OR = 3.866, 95% CI 1.493-10.012), and dizziness (OR = 1.322, 95% CI 0.549-3.182).</p><p><strong>Conclusions: </strong>Our analysis of a large, population-based sample in the US reveals a notable association between MMD and the presence of visual impairment and eye diseases.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":"183-196"},"PeriodicalIF":2.6,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11724827/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142695764","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 Multicenter Safety Analysis of Lupin's Intravitreal Biosimilar Ranibizumab (Ranieyes) in Chorioretinal Vascular Diseases.","authors":"Debdulal Chakraborty, Tushar Kanti Sinha, Sourav Sinha, Aniruddha Maiti, Angshuman Mukherjee, Krishnendu Nandi, Sudipta Das, Saptorshi Majumdar, Dinesh Rungta, Ranabir Bhattacharya","doi":"10.1007/s40123-024-01065-z","DOIUrl":"10.1007/s40123-024-01065-z","url":null,"abstract":"<p><strong>Introduction: </strong>This study aims to evaluate the ocular and systemic safety profiles of intravitreal biosimilar ranibizumab Ranieyes (Lupin Pharmaceuticals, Mumbai, India) in real-world clinical settings across multiple chorioretinal vascular diseases, including neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), and retinal vein occlusion (RVO) in adults.</p><p><strong>Methods: </strong>We conducted a retrospective, consecutive, interventional, uncontrolled multicenter study using data from three hospital networks in India. A total of 1401 eyes received 2194 injections of Ranieyes between June 2022 and November 2023. Patients were followed for a minimum of 6 months, and data on ocular and systemic adverse events (AEs) were collected and analyzed.</p><p><strong>Results: </strong>The study population included 636 male patients and 533 female patients, with a mean age of 58.63 ± 11.54 years. The average number of injections per eye was 1.49 ± 0.23, with the highest frequency in the nAMD group (mean of 2.3 ± 0.23 injections per eye) over 6 months. Non-serious adverse events (nsAEs) were observed in 26.83% of injections, with mild ocular pain and transient blurring of vision being the most common. Serious ocular adverse events were rare, occurring in 0.85% of eyes, with retinal pigment epithelial tear (RPE TEAR) being the most frequent. Systemic adverse events were noted in 5.03% of patients, and all but one were non-serious. One patient developed non-fatal myocardial infarction, the causal relationship of which, however, was not established with the intravitreal agent used. No cases of endophthalmitis were observed.</p><p><strong>Conclusions: </strong>This large-scale, real-world study demonstrates that Ranieyes is a safe intravitreal antivascular endothelial growth factor (anti-VEGF) agent across various chorioretinal vascular diseases. The safety profile of Ranieyes is consistent with that of the reference product, making it a viable option in resource-constrained settings.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":"129-139"},"PeriodicalIF":2.6,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11724808/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142668562","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}