{"title":"Incidentes graves de productos sanitarios en Oftalmología reportados a la AEMPS","authors":"L.C. Ramón-Carreira , E.M. Sobas , J.C. Pastor","doi":"10.1016/j.oftal.2024.12.002","DOIUrl":"10.1016/j.oftal.2024.12.002","url":null,"abstract":"<div><div>The implementation of the Medical Device Regulation and Royal Decree 192/2023 not only requires manufacturers to enhance safety measures in the production of medical devices but is also complemented by additional regulations impacting hospitals, clinics, and healthcare personnel. Among these is the requirement to identify and report serious incidents to the Spanish Agency of Medicines and Medical Devices (AEMPS). To establish a baseline and evaluate the dissemination efforts of these concepts at the level of scientific societies and other organizations, serious incidents involving ophthalmic medical devices reported to AEMPS since 2018 and subject to health alerts have been identified. Although the percentage remains minimal, it is notable that issues with software or equipment such as surgical microscopes and Optical Coherence Tomography (OCT) are now being reported.</div></div>","PeriodicalId":8348,"journal":{"name":"Archivos De La Sociedad Espanola De Oftalmologia","volume":"100 5","pages":"Pages 274-277"},"PeriodicalIF":0.0,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143903765","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
L.A. Oseguera Chávez, L.E. Salas Medina, C. Palacio Pastrana, W. Cedillo Suárez
{"title":"Cambios endoteliales en pacientes con y sin diabetes después de cirugía manual de catarata de pequeña incisión","authors":"L.A. Oseguera Chávez, L.E. Salas Medina, C. Palacio Pastrana, W. Cedillo Suárez","doi":"10.1016/j.oftal.2025.01.011","DOIUrl":"10.1016/j.oftal.2025.01.011","url":null,"abstract":"<div><h3>Background and objective</h3><div>In Mexico there is a high prevalence of diabetes, which is one of the most frequent etiologies of cataract. The impact of diabetes on postoperative corneal decompensation associated with MSICS has not been studied in our country. The objective of the study was to determine the difference in corneal endothelial changes between diabetic and non-diabetic patients by preoperative specular microscopy and at one month and 3 months after MSICS.</div></div><div><h3>Patients and methods</h3><div>Prospective, longitudinal, paired, non-randomized study with two groups; Group 1: Diabetic patients and Group 2: Non-diabetic patients. All patients had a complete ophthalmologic evaluation and preoperative and postoperative specular microscopy at one month and 3 months.</div></div><div><h3>Results</h3><div>119 eyes were included. The percentage of CD loss at 1 month was 11.1% in diabetic patients and 6.3% in non-diabetic patients. At 3 months the percentage of loss was 9.9% in diabetic patients and 5.4% in non-diabetic patients. The CV was higher in patients with diabetes and was significant at 1 month; however, at 3 months the values were comparable. The percentage of HEX decreased significantly in the first month in patients with diabetes.</div></div><div><h3>Conclusions</h3><div>There was a significant difference with greater CD loss, greater CV and less HEX in patients with diabetes vs. without diabetes at 1 month after the M-SICS procedure, however, it was not statistically significant at 3 months. This suggests greater endothelial stress, longer recovery time and remodeling of the corneal endothelium in patients with diabetes.</div></div>","PeriodicalId":8348,"journal":{"name":"Archivos De La Sociedad Espanola De Oftalmologia","volume":"100 5","pages":"Pages 246-253"},"PeriodicalIF":0.0,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143903762","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
S. Labay-Tejado , J. Laguna , M.J. Navarro-Angulo , L. Muñoz , M. Jodar , E. Milla
{"title":"XEN 63 en glaucoma refractario secundario a microftalmia y afaquia: a propósito de un caso","authors":"S. Labay-Tejado , J. Laguna , M.J. Navarro-Angulo , L. Muñoz , M. Jodar , E. Milla","doi":"10.1016/j.oftal.2024.11.010","DOIUrl":"10.1016/j.oftal.2024.11.010","url":null,"abstract":"<div><div>Microphthalmia (MO) predisposes to glaucoma and congenital cataracts (CC). Cataract removal in MO is characterized by several complications such as aphakic glaucoma.</div><div>We report the case of a 33-year-old male with MO, aphakia, and refractory glaucoma who underwent inferonasal ab-interno XEN 63 implantation, after posterior vitrectomy. Whole Exome Sequencing (WES) analysis was performed identifying the likely pathogenic variant c.197G>A (p.Cys66Tyr) in heterozygosity in the <em>PAX6</em> gene related to Peters anomaly (PA) and the variant of unclear significance c.353T>C (p.Leu118Pro) in heterozygosity in the <em>CRYBB3</em> gene, potentially related to CC. Until the 12-month follow-up, the patient maintained intraocular pressure between 16 and 18<!--> <!-->mmHg without medication or complications.</div><div>XEN 63, when combined with posterior vitrectomy may be an option in select cases, owing to its versatility. However, further investigation is required. Genetic analysis provides a pre-symptomatic diagnosis and may lead to a more personalised medicine.</div></div>","PeriodicalId":8348,"journal":{"name":"Archivos De La Sociedad Espanola De Oftalmologia","volume":"100 5","pages":"Pages 289-294"},"PeriodicalIF":0.0,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143903768","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
L. Gallardo Martin , B. Burgos-Blasco , B. Vidal-Villegas , J.I. Fernandez-Vigo , J. Garcia-Feijoo , J.M. Martinez-de-la-Casa
{"title":"Análisis de citocinas para evaluar la gravedad en el glaucoma primario de ángulo abierto y glaucoma pseudoexfoliativo","authors":"L. Gallardo Martin , B. Burgos-Blasco , B. Vidal-Villegas , J.I. Fernandez-Vigo , J. Garcia-Feijoo , J.M. Martinez-de-la-Casa","doi":"10.1016/j.oftal.2024.12.007","DOIUrl":"10.1016/j.oftal.2024.12.007","url":null,"abstract":"<div><h3>Purpose</h3><div>To analyze cytokines in tear and aqueous humour as biomarkers for evaluation of severity of glaucoma.</div></div><div><h3>Design</h3><div>Cross-sectional study.</div></div><div><h3>Subjects and methods</h3><div>Tear and aqueous humour samples were collected from 15 exfoliative glaucoma (XFG) patients, 43 primary open-angle glaucoma (POAG) patients and 33 controls (eligible for cataract surgery).</div><div>A total of 27 inflammatory cytokines were analyzed in the tear and aqueous humor samples by the Bio-Plex Pro Human Cytokine 27-Plex Immunoassay kit: interleukin (IL)-1b, IL-1ra, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, IL-12, IL-13, IL-15, IL-17, eotaxin, fibroblast growth factor (FGF) basic, granulocyte colony-stimulating factor, granulocyte-monocyte colony-stimulating factor, interferon-γ, interferon gamma-induced protein, monocyte chemo-attractant protein-1, macrophage inflammatory protein (MIP)-1a, MIP-1b, platelet-derived growth factor, regulated on activation normal T cell expressed and secreted, tumor necrosis factor-α and vascular endothelial growth factor.</div></div><div><h3>Results</h3><div>In the tear samples a statistically significant difference in IL-2, IL-4, IL-9, IL-12, IL-15 and FGF-basic between study groups was observed. In aqueous humor, a statistically significant difference of the following cytokines was observed: IL-5, IL-6, IL-12 and MCP-1. IL-4 and IL-15 differences correlate with the number of topical drugs, while IL-9 and IL-15 are associated with the visual field mean defect.</div></div><div><h3>Conclusion</h3><div>Inflammation is strongly associated with glaucoma and some cytokines may be related to glaucoma severity.</div></div>","PeriodicalId":8348,"journal":{"name":"Archivos De La Sociedad Espanola De Oftalmologia","volume":"100 5","pages":"Pages 254-263"},"PeriodicalIF":0.0,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143903763","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Desvelando el enigma: gigantesco adenocarcinoma ductal primario de novo pobremente diferenciado de la glándula lagrimal con características agresivas. Informe de un caso y revisión de la literatura","authors":"S. Malik, C. Ahluwalia, A. Aziz Khan","doi":"10.1016/j.oftal.2024.09.006","DOIUrl":"10.1016/j.oftal.2024.09.006","url":null,"abstract":"<div><div>Primary ductal adenocarcinoma (PDA) of the lacrimal gland is a rare and aggressive malignancy originating from ductal epithelial cells. Its rarity and diverse clinical presentations pose significant diagnostic challenges, emphasizing the need for accurate diagnosis and appropriate management strategies. The study presents an intriguing case of a 50-year-old man with a large de novo primary ductal adenocarcinoma of the lacrimal gland, initially misdiagnosed as a meningeal solitary fibrous tumor due to its atypical clinical presentation of «down and out» proptosis. The case underscores the importance of histopathology to achieve a correct diagnosis and guide management decisions. Despite aggressive treatment approaches, the prognosis of primary ductal adenocarcinoma patients remains grim due to its aggressive behavior and tendency for recurrence and metastasis. The present case study emphasizes that a differential of primary ductal adenocarcinoma should be considered despite the presence of anomalous clinical and radiological presentation.</div></div>","PeriodicalId":8348,"journal":{"name":"Archivos De La Sociedad Espanola De Oftalmologia","volume":"100 5","pages":"Pages 295-301"},"PeriodicalIF":0.0,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143903769","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
G. Yılmaz , G. Demirci , S. Karaman , M. Sargolzaeimoghaddam , E.S. Uluçam , A. Sarg
{"title":"Serie de casos del síndrome de Williams-Beuren con disminución de la fóvea central y del espesor corneal central","authors":"G. Yılmaz , G. Demirci , S. Karaman , M. Sargolzaeimoghaddam , E.S. Uluçam , A. Sarg","doi":"10.1016/j.oftal.2024.11.009","DOIUrl":"10.1016/j.oftal.2024.11.009","url":null,"abstract":"<div><h3>Background/aims</h3><div>To characterize the ocular signs of Williams-Beuren syndrome (WBS) in 3 cases examined at Istanbul Medipol University Ophthalmology Clinic.</div></div><div><h3>Methods</h3><div>Three patients with a diagnosis of WBS underwent comprehensive ophthalmic evaluation at the Istanbul Medipol University Ophthalmology, including best-corrected visual acuity, slit-lamp biomicroscopy, dilated fundus examination, optical coherence tomography, corneal topography and colour fundus imaging.</div></div><div><h3>Results</h3><div>All 3 cases had decreased best corrected visual acuity, decreased ILM-RNFL thicknesses with a persistence of inner retinal layers on the SD-OCT examinations, decreased central corneal thickness yet normal epithelial thickness measurements and retinal arteriolar tortuosity in fundus examination.</div></div><div><h3>Conclusion</h3><div>WBS is a complex multisystem genetic disorder. The ocular findings observed in these cases which are decreased corneal thickness with normal epithelial thickness, decreased ILM-RPE thicknesses, and retinal arteriolar tortuosity may provide future insight into systemic vascular findings affected by a microdeletion of chromosome 7q11.23 which also contains elastin gene in WBS.</div></div>","PeriodicalId":8348,"journal":{"name":"Archivos De La Sociedad Espanola De Oftalmologia","volume":"100 5","pages":"Pages 238-245"},"PeriodicalIF":0.0,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143903761","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
L. López Guajardo , F. Armadá Maresca , F. González del Valle
{"title":"Tratamiento del desprendimiento de retina regmatógeno primario. Importancia y necesidad de la cirugía escleral","authors":"L. López Guajardo , F. Armadá Maresca , F. González del Valle","doi":"10.1016/j.oftal.2025.01.007","DOIUrl":"10.1016/j.oftal.2025.01.007","url":null,"abstract":"","PeriodicalId":8348,"journal":{"name":"Archivos De La Sociedad Espanola De Oftalmologia","volume":"100 5","pages":"Pages 235-237"},"PeriodicalIF":0.0,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143903760","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
A.B. González Escobar, I.E. Molina Guilabert, R.M. García Herrera, I.M. Baquero Aranda, R. Luque Aranda, J.M. Galván Cano
{"title":"Retinopatía asociada a distrofia muscular facioescapulohumeral. A propósito de un caso tratado con implante intravítreo de dexametasona y fotocoagulación láser","authors":"A.B. González Escobar, I.E. Molina Guilabert, R.M. García Herrera, I.M. Baquero Aranda, R. Luque Aranda, J.M. Galván Cano","doi":"10.1016/j.oftal.2025.01.003","DOIUrl":"10.1016/j.oftal.2025.01.003","url":null,"abstract":"<div><div>Facioscapulohumeral muscular dystrophy (FSHMD) is a slowly progressive muscular dystrophy that affects especially the muscles of the face, shoulder girdle and upper arms. It may present extramuscular manifestations such as hearing loss and retinopathy. Up to 75% of patients may show alterations in the retinal vasculature such as vascular tortuosity, microaneurysms, telangiectasias, retinal ischemia and exudation, and in less than 1% of cases it may present as Coats-like syndrome. We present a 40-year-old male with FSHMD who, in an ophthalmologic examination, showed exudative retinopathy in his left eye (LE) with peripheral retinal ischemia treated with laser therapy, and macular edema (ME) treated with intravitreal dexamethasone injection (IDI).</div><div>We would like to emphasize the importance of performing an ophthalmological examination on all patients with FSHMD to rule out associated retinal pathology, and thus prevent loss of visual acuity (VA) with early treatment.</div></div>","PeriodicalId":8348,"journal":{"name":"Archivos De La Sociedad Espanola De Oftalmologia","volume":"100 5","pages":"Pages 283-288"},"PeriodicalIF":0.0,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143903767","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
J. González-Martín-Moro , A. Bravo-Nuevo , M.A. García-Cabezas
{"title":"El principio de Krogh, el glaucoma y el ojo «extremófilo» de las ballenas","authors":"J. González-Martín-Moro , A. Bravo-Nuevo , M.A. García-Cabezas","doi":"10.1016/j.oftal.2024.12.001","DOIUrl":"10.1016/j.oftal.2024.12.001","url":null,"abstract":"","PeriodicalId":8348,"journal":{"name":"Archivos De La Sociedad Espanola De Oftalmologia","volume":"100 4","pages":"Pages 165-166"},"PeriodicalIF":0.0,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143821011","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
F. López-Herrero, J.L. Sánchez-Vicente, M. Portillo-Martínez, J.V. Guijarro-Ambel, R. Barrera-Moyano, J. Suárez-Pérez
{"title":"Imagen multimodal en la hipertrofia congénita del epitelio pigmentario de la retina peripapilar","authors":"F. López-Herrero, J.L. Sánchez-Vicente, M. Portillo-Martínez, J.V. Guijarro-Ambel, R. Barrera-Moyano, J. Suárez-Pérez","doi":"10.1016/j.oftal.2024.11.007","DOIUrl":"10.1016/j.oftal.2024.11.007","url":null,"abstract":"<div><div>Congenital hypertrophy of the retinal pigment epithelium (CHRPE) is a benign congenital hamartoma of the RPE of generally indolent course. It is usually located outside the posterior pole, with peripapillary presentation being a very rare entity (less than 1% of CHRPE cases). It is a pigmented lesion that can evolve into a heterogeneous pigmented lesion with gaps in its interior and a halo of depigmentation.</div><div>We present the case of a 52-year-old patient with a peripapillary CHRPE in the left eye followed in our service for more than 12 years through a multimodal imaging study. The patient maintained a visual acuity of 1.0, showing a small increase in the size of the atrophic areas within the lesion. No complications were observed. The right eye did not present any alteration.</div></div>","PeriodicalId":8348,"journal":{"name":"Archivos De La Sociedad Espanola De Oftalmologia","volume":"100 4","pages":"Pages 209-212"},"PeriodicalIF":0.0,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143821481","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}