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.

«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.

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.

[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.

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.