Reporte de incidentes serios en productos sanitarios usados en cirugía intraocular. Proponiendo ideas / Reporting serious incidents in medical devices used in intraocular surgery: Proposing ideas

La entrada en vigor del reglamento sobre productos sanitarios obliga a los clínicos a identificar y reportar a las autoridades sanitarias los posibles incidentes serios derivados de su utilización. Dadas las dudas que pueden suscitarse sobre qué puede o no considerarse incidente serio, un grupo de trabajo, creado por miembros de la Sociedad Española de Retina y Vitreo (SERV) y el clúster de oftalmología y ciencias de la visión (Cluster4Eye), han elaborado un documento que pretende orientar a los oftalmólogos sobre algunos de los incidentes que, en la experiencia del equipo de trabajo, no son habituales o pueden causar un serio daño a la función del paciente. (AU)

The entry into force of the regulation on medical devices obliges clinicians to identify and report to the Health Authorities possible serious incidents arising from their use. In view of the doubts that may arise as to whether or not it may be considered a serious incident, a working group, set up by members of the Spanish Society of Retina and Vitreous (SERV) and the cluster of ophthalmology and vision sciences (Cluster4Eye) have prepared a document that aims to guide ophthalmologists about some of the incidents that, in the experience of the work team, are not common or can cause serious damage to the patient's function. (AU)

Reporting serious incidents in medical devices used in intraocular surgery: Proposing ideas.

The entry into force of the regulation on medical devices obliges clinicians to identify and report to the Health Authorities possible serious incidents arising from their use. In view of the doubts that may arise as to whether or not it may be considered a serious incident, a working group, set up by members of the Spanish Society of Retina and Vitreo and the cluster of ophthalmology and vision sciences (Cluster4Eye) have prepared a document that aims to guide ophthalmologists about some of the incidents that, in the experience of the work team, are not common or can cause serious damage to the patient's function.

Respuesta de los autores: «Maculopatía por poppers» en España. Una nueva enfermedad oftalmológica / Author's reply: «Poppers maculopathy?» in Spain. A new ophthalmological disease

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'Maculopatía por poppers' en España. Una nueva enfermedad oftalmológica / 'Poppers maculopathy?' in Spain. A new ophthalmological disease

INTRODUCCIÓN: El término 'poppers' se refiere a productos a base de nitritos de alquilo utilizados con fines recreativos. CASO CLÍNICO: Varón de 40 años de edad, consumidor habitual de 'popper' que refiere visión borrosa en ambos ojos y fotofobia. La agudeza visual fue 0,63/1 en ambos ojos. Se apreció una lesión macular amarillenta de aspecto viteliforme bilateral en la funduscopia y una interrupción de la línea IS/OS en la tomografía de coherencia óptica. DISCUSIÓN: Este es el primer caso de 'maculopatía por poppers' registrada en España. Los hallazgos y síntomas clínicos son similares a los casos anteriores reportados

INTRODUCTION: The term 'poppers' refers to products made of volatile alkyl nitrites used for recreational practices. Clinical case: 40 year old man reported blurred vision in both eyes and photophobia, and admitted regular use of 'poppers'. Best corrected visual acuity was 0.63/1 in both eyes. Bilateral yellowish vitelliform macular lesions were present in both eyes in the funduscopy, as well as a disruption of the IS/OS line in the optical coherence tomography. DISCUSSION: This is the first case of 'poppers maculopathy' registered in Spain. Clinical findings and symptoms are similar to previous reported cases

«Poppers maculopathy?¼ in Spain. A new ophthalmological disease. / «Maculopatía por poppers¼ en España. Una nueva enfermedad oftalmológica.

INTRODUCTION: The term «poppers¼ refers to products made of volatile alkyl nitrites used for recreational practices. CLINICAL CASE: 40 year old man reported blurred vision in both eyes and photophobia, and admitted regular use of «poppers¼. Best corrected visual acuity was 0.63/1 in both eyes. Bilateral yellowish vitelliform macular lesions were present in both eyes in the funduscopy, as well as a disruption of the IS/OS line in the optical coherence tomography. DISCUSSION: This is the first case of «poppers maculopathy¼ registered in Spain. Clinical findings and symptoms are similar to previous reported cases.

Un paciente con artritis idiopática juvenil / A patient with Juvenile idiophatic arthritis

La artritis idiopática juvenil, a pesar de su baja incidencia, es la enfermedad reumática inflamatoria crónica más frecuente en la infancia. Ahora disponemos de criterios precisos y sencillos para diagnosticarla en Atención Primaria, ya que son criterios fundamentalmente clínicos. El diagnóstico de mono- o poliartritis, en ausencia de síntomas infecciosos generales y con radiografías normales, debe hacernos sospecharla en pacientes menores de 16 años. También nos hará pensar en ella su persistencia durante más de seis semanas. Las distintas formas clínicas serán diagnosticadas por el reumatólogo, pero la sospecha de la misma se debe establecer en Atención Primaria. El objetivo es conocer el tratamiento inicial para controlar el dolor y la inflamación, mantener la función y favorecer un crecimiento normal. No hay que olvidar las posibles complicaciones oculares. Enviar a Oftalmología en el momento del diagnóstico y realizar revisiones anuales así como al presentar cualquier síntoma que afecte a la cámara anterior (AU)

The Juvenile idiophatic arthritis in spite of his low frequency, is the most frequent rheumatic inflammatory chronic disease in the infancy. Now we have precise and simple criteria to diagnose her in Primary care since they are criteria fundamentally clinical and spread on the time. The diagnosis of monkey or polyarthritis, in absence of infectious general symptoms and with normal X-ray photographies, must make us suspect her in 16-year-old minor patients. Also it will make us think about her his persistence of more than 6 weeks. The different clinical forms will be diagnosed by the reumatólogo. But the suspicion of the same one must establish it the doctor of Primary care or the pediatrician of the Center of Health. The aim is to know the initial treatment that controls the pain and the inflammation, to support the function and to favor a normal growth. It is not necessary to forget the possible ocular complications. To send to ophthalmology in the moment of the diagnosis and to realize annual reviews as well as on having presented any symptom that concerns the previous chamber (AU)

Relationship between inflammation and microalbuminuria in prehypertension.

Inflammation is a pathogenic factor for target-organ damage (TOD) in hypertension. This study examined the relationship between inflammatory parameters and urinary albumin excretion (UAE) in prehypertension. A total of 65 prehypertensive subjects (blood pressure (BP) 120-139/80-89 mm Hg) and 26 healthy volunteers with BP <120/80 mm Hg were included. High-sensitivity C-reactive protein (hs-CRP), and serum and urinary tumor necrosis factor-α (TNF-α) were measured as inflammatory markers. Prehypertensive individuals had higher levels of inflammatory parameters and UAE than healthy subjects. Analyses carried out in prehypertensive participants showed that BP was similar between individuals with normoalbuminuria or microalbuminuria (MAB) (UAE between 30 and 299 mg per day). However, serum hs-CRP and urinary TNF-α excretion were higher in prehypertensives with MAB. Multiple regression analysis showed that systolic blood pressure (r=0.29, P<0.01), hs-CRP (r=0.20, P<0.001), and urinary TNF-α (r=0.69, P<0.001) were independently correlated with UAE (adjusted R(2)=0.73, P<0.001). Finally, logistic regression analysis performed in the prehypertensive group with the absence or presence of MAB as the dependent variable demonstrated that hs-CRP (3.92 (1.45-10.58), P=0.007) and urinary TNF-α (1.69 (1.20-2.37), P=0.002) were independent risk factors for the presence of MAB. Inflammatory parameters are significantly and independently associated with UAE in prehypertensive subjects, suggesting that inflammation may be a pathogenic factor for the early vascular or TOD in these individuals.

Delay in treating age-related macular degeneration in Spain is associated with progressive vision loss.

PURPOSE: To assess the impact on visual acuity of delays between diagnosis and treatment in patients with subfoveal neovascular age-related macular degeneration (NV-AMD) and to evaluate NV-AMD patients' emotional status before therapy initiation. METHODS: This retrospective, multicenter, epidemiological study included newly diagnosed NV-AMD patients registered in the Spanish national health system and referred to regional health centers for evaluation/treatment by a retinal specialist from 09/2005 to 03/2006. Records were reviewed and data abstracted at referring physicians' offices (diagnosis visit) and regional health centers (treatment visit). Treatment was at physicians' discretion. The Hospital Anxiety and Depression Scale was administered at the treatment visit (before therapy). RESULTS: Median time from the diagnosis to treatment visit was 2.3 months (95% confidence interval: 0.2-10.8 months). Vision loss had progressed at the treatment visit with a doubling in the percentage of patients with a visual acuity of 20/400 or worse (from 12.4 to 24.7%). The decrease in visual acuity from the diagnosis to the treatment visit was highly statistically significant (P<0.0001) as was the correlation between months to treatment and visual acuity change (r=0.5234, P<0.0001). Time from the diagnosis to the treatment visit remained a significant predictor of progressive vision loss when visual acuity at diagnosis and change in lesion size between diagnosis and treatment were controlled (P<0.0001). Patients with more severe vision loss prior to treatment tended to report more depression. CONCLUSIONS: Delayed treatment of patients newly diagnosed with NV-AMD is associated with substantial visual acuity loss.

Valoración evolutiva de fracturas de calcáneo mediante el análisis biomecánico de la marcha. Análisis de resultados / Follow-up assessment of calcaneus fractures by means of biomechanical gait analysis. Results

Introducción: En el vol. 10, n. °4 de esta revista presentamos la metodología del proyecto realizado en colaboración con la Clínica FREMAP de Rehabilitación de Valencia sobre la valoración de la marcha en pacientes con fractura de calcáneo. En este artículo se presentan y discuten los resultados obtenidos. Material y métodos: Con una muestra inicial de 16 pacientes y a partir de magnitudes biomecánicas se definieron y calcularon indicadores objetivos de calidad de la marcha mediante análisis estadístico avanzado. Resultados y discusión: Parámetros relacionados con la distribución asimétrica de presiones plantares, velocidad de progresión, longitud de zancada, asimetrías temporales, descarga asimétrica y discrepancia respecto al patrón de fuerzas en población sana son variables capaces de capturar de forma fiable y objetiva las variaciones que se operan en el patrón de marcha durante la rehabilitación. La distribución asimétrica de presiones en el antepié medida antes del alta clínica, permite predecir en la mayoría de los casos el resultado del sujeto desde el punto de vista biomecánico. Conclusiones: Se sugiere la posibilidad de utilizar plantillas instrumentadas principalmente, y plataformas dinamométricas de forma auxiliar, para predecir la evolución de fracturas de calcáneo y para asistir en la toma de decisiones en estadios tempranos de su rehabilitación (AU)

[Validation of a questionnaire for the diagnosis of dry eye]. / Validación cuestionario para diagnóstico de ojo seco.

PURPOSE: To develop and evaluate a questionnaire for diagnosis and follow-up of patients with symptoms suggestive of eye surface pathology. To evaluate the efficacy of dry eye treatment. METHODS: Samples were chosen among dry eye patients (n=44). A control group was chosen among the healthy population. The questionnaire was filled in at the beginning and end of the treatment with carbopol + polyvinyl alcohol (Siccafluid, Thea, Spain) four times a day. Initial and final punctuation was established and confronted with other classic diagnostic tests; fluorescein tear break up time, Schirmer test and Rose Bengal staining. RESULTS: Red eyes, lid inflammation, discharge, dry eye, sandy and foreign body sensations, burning, itching, discomfort, pricking, tearing and photophobia got significantly better after treatment (p<0.05). Lid reddening, lid inflammation, flakes in lashes, sticky eyes in the morning, teary eyes, transitory blurring vision and heavy sensation didn't improve (p>0.05). Total punctuation was significantly reduced at one month of treatment (p<0.01). Validation of the test was done against other standard tests (Schirmer test and Rose Bengal). We found a sensitivity of 76% and specificity of 71.5% for Schirmer test and a sensibility of 77% and specificity of 65% if gold standard was Rose Bengal. Predictive value (positive and negative), global value of the test and likelihood ratios were also assessed. CONCLUSION: This questionnaire is useful for diagnosis and follow-up of patients with dry eyes and other ocular surface symptoms. Carbopol + polyvinyl alcohol is useful for the treatment of patients with secretor tear insufficiency.

Validación cuestionario para diagnóstico de ojo seco / Validation of a questionnaire for the diagnosis of dry eye

Objetivo: Validar un cuestionario para diagnóstico y seguimiento de pacientes con síntomas de enfermedad de superficie ocular. Evaluar la eficacia del tratamiento en ojo seco. Método: Elegimos la muestra estudio entre pacientes diagnosticados de ojo seco (n=44). El grupo control estaba constituido por sujetos sanos (n=92). El cuestionario fue cumplimentado al inicio y final del tratamiento con carbopol + alcohol polivinílico (Siccafluid®, Thea, España) cuatro veces al día. Se estableció una puntuación inicial y final, y una valoración frente a las pruebas diagnósticas clásicas: tiempo ruptura película lagrimal, Rosa Bengala y test de Schirmer. Resultados: Enrojecimiento ocular, legaña, sensación de sequedad, arenilla, cuerpo extraño, ardoz y quemazón, picor, malestar, pinchazos, lagrimeo y fotofobia son más frecuentes en pacientes con ojo seco y mejoran significativamente (<0,05) tras tratamiento. Borde párpado rojo, inflamación, espuma y escamas en borde palpebral, ojos pegados al levantarse, ojos llorosos, borrosidad transitoria y sensación de pesadez no mejoraron (p<0,05). La puntuación total disminuyó significativamente en un mes (p<0,01). En la validación frente a otros estándares para ojo seco resultó una sensibilidad del 76 por ciento y especificidad del 71,5 por ciento siendo patrón oro el test de Schirmer; y para Rosa de Bengala resultó una sensibilidad de 77 por ciento y especificidad 65 por ciento. Valoramos también valor predictivo positivo y negativos, valor global de la prueba, y razones de verosimilitud. Conclusiones: Este cuestionario es válido para diagnóstico y control de los pacientes con ojo seco. El carbopol + alcohol polivinílico es útil en el tratamiento de los pacientes con insuficiencia lagrimal secretora.. (AU)

Chromosome 11q13 and atopic asthma.

Asthma is a complex syndrome in which bronchial inflammation and smooth muscle hyperactivity lead to labile airflow obstruction. The commonest form of asthma is that due to atopy, which is an immune disorder where production of IgE to inhaled antigens leads to bronchial mucosal inflammation. The ultimate origins of asthma are interactive environmental and genetic factors. The genetics is acknowledged to be heterogeneous, and one chromosomal region of interest and controversy has been 11q13. To clarify the nature of the chromosome 11q13 effect in atopy and asthma, we conducted a genetic association study in subjects with marked atopic asthma and matched controls, which incorporated the study of 13 genetic variants over a distance of 10-12 cM and which took account of detailed immune and clinical phenotyping. Association with high IgE levels was limited to the interval flanked by D11S1335 and CD20 in a 0.8-Mb interval and was greatest for variants of Fc epsilonRIbeta and HTm4; these variants also associated with asthma (recurrent wheeze with labile airflow obstruction and need for regular inhaler treatment). At the more telomeric marker, D11S480, variants associated with asthma, but not with high IgE levels. The data might support the possibility of multiple loci relevant to atopic asthma on chromosome 11q13.