Dispositivo medico, metodo e test di immunodosaggio per l’individuazione della retinopatia diabetica proliferante

La presente invenzione si riferisce a un dispositivo medico 20 (1) comprendente tre percorsi (3, 4, 5), in cui ciascun percorso è esteso tra una prima zona (6) destinata a ricevere un campione in forma liquida ed una zona terminale (7) avente una porzione assorbente, in cui ciascun percorso comprende, estese tra la prima zona e la zona terminale: 25 una zona di cattura (8) caricata con una prefissata quantità di una prefissata proteina, in cui la proteina è rispettivamente costituita da TNF-alfa, Lattoferrina e Lipocalina-1; una zona coniugata (9) disposta a monte della zona di cattura, caricata con un rispettivo anticorpo legato ad un mezzo indicatore, in cui l’anticorpo è specifico rispettivamente per le proteine TNF-alfa, Lattoferrina e Lipocalina-1; e una zona di controllo (10) disposta a valle della zona di cattura, caricata con un anticorpo specie-specifico anti-immunoglobuline, l’invenzione riguarda anche un metodo e un test di immunodosaggio delle proteine TNF-alfa, Lipocalina-1 e Lattoferrina per l’identificazione della retinopatia diabetica proliferante in un paziente

Dispositivo medico, metodo e test di immunodosaggio per l’individuazione della retinopatia diabetica proliferante

La presente invenzione si riferisce a un dispositivo medico 20 (1) comprendente tre percorsi (3, 4, 5), in cui ciascun percorso è esteso tra una prima zona (6) destinata a ricevere un campione in forma liquida ed una zona terminale (7) avente una porzione assorbente, in cui ciascun percorso comprende, estese tra la prima zona e la zona terminale: 25 una zona di cattura (8) caricata con una prefissata quantità di una prefissata proteina, in cui la proteina è rispettivamente costituita da TNF-alfa, Lattoferrina e Lipocalina-1; una zona coniugata (9) disposta a monte della zona di cattura, caricata con un rispettivo anticorpo legato ad un mezzo indicatore, in cui l’anticorpo è specifico rispettivamente per le proteine TNF-alfa, Lattoferrina e Lipocalina-1; e una zona di controllo (10) disposta a valle della zona di cattura, caricata con un anticorpo specie-specifico anti-immunoglobuline, l’invenzione riguarda anche un metodo e un test di immunodosaggio delle proteine TNF-alfa, Lipocalina-1 e Lattoferrina per l’identificazione della retinopatia diabetica proliferante in un paziente

Macular hole closure patterns associated with different internal limiting membrane flap techniques

To compare the anatomic and functional outcome of two variants of the inverted internal limiting membrane (I-ILM) flap technique for idiopathic macular holes (IMH) larger than 400 A mu m.Twenty-seven consecutive patients undergoing PPV for IMH were randomly assigned to different variants of I-ILM technique: the Cover group included 14 patients in which the I-ILM was folded upside-down over the MH as a single layer while the Fill group enrolled 13 patients in which the I-ILM was folded within the MH in multiple layers.MH closed in 12/14 Cover and in 13/13 Fill eyes (84.6 vs. 100%, p = 0.14; n.s.). Vision at 1 month was Snellen 0.44 +/- 0.17 vs. 0.28 +/- 0.21 (p = 0.05) and 0.48 +/- 0.20 vs. 0.37 +/- 0.25 (n.s.) at 3 months. IS/OS line interruption width was 463 +/- 385 vs. 602 +/- 210 A mu m, respectively, at 1 month (n.s.) and 602 +/- 210 vs. 563 +/- 209 A mu m at 3 months (n.s.). The Cover group showed outer retina cystic changes more often (p < 0.01). MH over 700 A mu m closed in 0/2 and in 2/2 cases, respectively, in the Cover and Fill groups (0.045).Cover and Fill I-ILM techniques allowed similar closure rates and post-operative vision at 3 months. The Cover group showed better anatomical restoration and vision at 1 month while the Fill technique might be more efficient in closing larger MHs

Macular hole closure patterns associated with different internal limiting membrane flap techniques

Purpose: To compare the anatomic and functional outcome of two variants of the inverted internal limiting membrane (I-ILM) flap technique for idiopathic macular holes (IMH) larger than 400 µm. Methods: Twenty-seven consecutive patients undergoing PPV for IMH were randomly assigned to different variants of I-ILM technique: the Cover group included 14 patients in which the I-ILM was folded upside-down over the MH as a single layer while the Fill group enrolled 13 patients in which the I-ILM was folded within the MH in multiple layers. Results: MH closed in 12/14 Cover and in 13/13 Fill eyes (84.6 vs. 100%, p = 0.14; n.s.). Vision at 1 month was Snellen 0.44 ± 0.17 vs. 0.28 ± 0.21 (p = 0.05) and 0.48 ± 0.20 vs. 0.37 ± 0.25 (n.s.) at 3 months. IS/OS line interruption width was 463 ± 385 vs. 602 ± 210 µm, respectively, at 1 month (n.s.) and 602 ± 210 vs. 563 ± 209 µm at 3 months (n.s.). The Cover group showed outer retina cystic changes more often (p < 0.01). MH over 700 µm closed in 0/2 and in 2/2 cases, respectively, in the Cover and Fill groups (0.045). Conclusions: Cover and Fill I-ILM techniques allowed similar closure rates and post-operative vision at 3 months. The Cover group showed better anatomical restoration and vision at 1 month while the Fill technique might be more efficient in closing larger MHs

Ocular perfusion pressure control during pars plana vitrectomy: testing a novel device

Purpose: To study the efficacy of a novel device intended to control infusion pressure based on mean ocular perfusion pressure (MOPP) during pars plana vitrectomy (PPV). Methods: An arm blood pressure cuff connected to a vitrectomy machine calculated mean arterial pressure (MAP), while a pressure sensor close to the infusion trocar measured intraocular pressure (IOP). MOPP was calculated in real time in 36 consecutive patients undergoing PPV, who were divided into two groups. The device lowered IOP every time that calculated MOPP fell below 30 mmHg in the Control ON group (18 patients), while no action was taken in the Control OFF group (18 patients). Results: Baseline IOP and blood pressure were similar between groups. The Control ON group had significantly lower average intraoperative IOP (30.5 ± 2.1 vs. 35.9 ± 6.9 mmHg; p = 0.002) and higher MOPP (56.4 ± 5.9 vs. 49.7 ± 6.1 mmHg) than the Control OFF group. The Control ON group also spent less time at MOPP < 10 mmHg and < 30 mmHg: 0 vs. 3.40 ± 2.38 min (p < 0.001) and 9.91 ± 7.15 vs. 16.13 ± 8.12 min (p = 0.02), respectively. Conclusions: The MOPP control device effectively maintained lower IOP and higher MOPP throughout surgery. It also helped avoid dangerous IOP peaks and MOPP dips, allowing patients to spend less time at MOPP of < 10 and < 30 mmHg

Telemedicine for screening diabetic retinopathy: The NO BLIND Italian multicenter study

Aims: Diabetic retinopathy (DR) represents the main cause of blindness among adults in the industrialized Countries. Use of telemedicine could offer an easy, smart specialist fundus oculi examination, as well as putting in a screening programme many patients who otherwise would be excluded. Materials and methods: The NO BLIND is a transversal, multicentre, observational study. Its pilot phase involved nine public outpatient clinics for 6 months. As endpoint of the study, we assessed the prevalence of DR by retinography in a subset of the Italian population. Patients' fundus oculi photos were performed by trained diabetologists through a digital smart ophthalmoscope. Results: According to our endpoint, in the final study population (n = 1461), obtained excluding patients for whom retinography was not able to provide any diagnosis, DR prevalence was equal to 15.5%. According to the receiver operating characteristic (ROC) curve performed, we can observe how retinography appears a highly accurate method to detect DR (AUROC 0.971, 95% confidence interval, 0.954-0.989), with a specificity of the 100% and a sensitivity of the 94.3%. Conclusions: Our findings, in an Italian setting, confirm main data in the literature about DR prevalence. Hence, telemedicine could represent an accurate, fast, and cheap method for screening of DR. © 2018 John Wiley &amp; Sons, Ltd.Aims. Diabetic retinopathy (DR) represents the main cause of blindness among adults in the industrialized Countries. Use of telemedicine could offer an easy, smart specialist fundus oculi examination, as well as putting in a screening program many patients who otherwise would be excluded. Materials and Methods. The NO Blind is a transversal, multicentre, observational study. Its pilot phase involved nine public outpatient clinics for six months. As endpoint of the study, we assessed the prevalence of DR by retinography in a subset of the Italian population. Patients’ fundus oculi photos were performed by trained diabetologists through a digital smart ophthalmoscope. Results. According to our endpoint, in the final study population (n=1461), obtained excluding patients for whom retinography was not able to provide any diagnosis, DR This article is protected by copyright. All rights reserved. prevalence was equal to 15.5%. According to the ROC Curve performed, we can observe how retinography appears a highly accurate method to detect DR (AUROC 0.971 95% C.I. 0.954-0.989), with a specificity of the 100% and a sensitivity of the 94.3%. Conclusions. Our findings, in an Italian setting, confirm main data in the literature about DR prevalence. Hence, telemedicine could represent an accurate, fast and cheap method for screening of DR

High HDL Cholesterol: a risk factor for Diabetic Retinopathy? Findings from NO BLIND study

Aims: To assess the correlation between diabetic retinopathy (DR) and potential risk factors, as well as the relationship between DR and the other complications of diabetes, in a real-life population of type 2 diabetes patients recruited in several centres in Italy. Methods: The NO BLIND is a cross-sectional, multicentre, observational study, which involved nine public outpatient clinics in Italy. The patients were assessed for eligibility from November 2016 till November 2017. Those enrolled underwent standard fundus oculi exam. Clinical and laboratory data were also collected. Results: 2068 T2DM underwent fundus oculi exam. 435 received diagnosis of diabetic retinopathy (21%). Diabetic retinopathy was independently associated with HDL cholesterol (O.R.: 1.042; 95% C.I.: 1.012–1.109; p = 0.004), Albumin Excretion Rate (AER) (O.R.: 1.001; 95% C.I.: 1.000–1.002; p = 0.034) and GFR (O.R.: 1.159; 95% C.I.: 1.039–1.294; p = 0.008). HDL cholesterol values were hence split in two classes according to a potential cut-off (40 mg/dL), as defined by the ROC curve. Following analysis confirmed the association between DR and high HDL values (p = 0.032). Somatic neuropathy and diabetic ulcer were independently related with DR (p &lt; 0.001 and p = 0.012, respectively). Conclusions: A novel relationship between high HDL cholesterol and DR was observed. © 2019 Elsevier B.V.Aims: To assess the correlation between diabetic retinopathy (DR) and potential risk factors, as well as the relationship between DR and the other complications of diabetes, in a real-life population of type 2 diabetes patients recruited in several centres in Italy. Methods: The NO BLIND is a cross-sectional, multicentre, observational study, which involved nine public outpatient clinics in Italy. The patients were assessed for eligibility from November 2016 till November 2017. Those enrolled underwent standard fundus oculi exam. Clinical and laboratory data were also collected. Results: 2068 T2DM underwent fundus oculi exam. 435 received diagnosis of diabetic retinopathy (21%). Diabetic retinopathy was independently associated with HDL cholesterol (O.R.: 1.042; 95% C.I.: 1.012–1.109; p = 0.004), Albumin Excretion Rate (AER) (O.R.: 1.001; 95% C.I.: 1.000–1.002; p = 0.034) and GFR (O.R.: 1.159; 95% C.I.: 1.039–1.294; p = 0.008). HDL cholesterol values were hence split in two classes according to a potential cut-off (40 mg/dL), as defined by the ROC curve. Following analysis confirmed the association between DR and high HDL values (p = 0.032). Somatic neuropathy and diabetic ulcer were independently related with DR (p &lt; 0.001 and p = 0.012, respectively). Conclusions: A novel relationship between high HDL cholesterol and DR was observed

Aspirin in a Diabetic Retinopathy Setting: insights from NO BLIND Study

Background and Aims Diabetic retinopathy (DR) is the most common microvascular complication of diabetes. Diabetic macroangiopathies, particularly cardiovascular (CV) diseases, seems closely related to diabetes microvascular complications. Aspirin represents the most prescribed compound in CV prevention. Aspirin impact on DR is still object of debate. As aspirin is already recommended among diabetics at high CV risk, aim of this study was to assess a potential relationship between DR and aspirin therapy, in a type 2 diabetes cohort of patients screened through telemedicine. Methods and Results NO Blind is a cross-sectional, multicenter, observational study, which involved nine Italian outpatient clinics. Primary endpoint was the assessment of relationship between aspirin treatment and DR. 2 068 patients were enrolled in the study, subsequently split into two subpopulations according to either presence or absence of DR. Overall, 995 subjects were under aspirin therapy. After adjusting for most common potential confounders, age and gender, aspirin was significantly associated with DR (OR: 1.72, 95%CI: 1.58–2.89, p=0.002) and proliferative DR (PDR) (OR: 1.89, 95%CI: 1.24-2.84, p=0.003). Association comes lost further adjusting for MACEs (OR: 1.28, 95%CI: 0.85–1.42, p=0.157) (Model 4) and eGFR (OR: 0.93; 95%CI: 0.71-1.22; p=0.591) (Model 5). Conclusion In this multicenter cross-sectional study including a large sample of outpatients with T2DM, we showed that aspirin was not associated with DR after adjustment for several cardio-metabolic confounders. However, as partially confirmed by our findings, and related to the well-known pro-hemorrhagic effect of aspirin, its use should be individually tailored, even by telemedicine tools