Ab interno trabecular bypass surgery with Schlemm´s canal microstent (Hydrus) for open angle glaucoma.

BACKGROUND: Glaucoma is a leading cause of irreversible blindness. A number of minimally-invasive surgical techniques have been introduced as a treatment to prevent glaucoma from progressing; ab interno trabecular bypass surgery with the Schlemm's canal Hydrus microstent is one of them. OBJECTIVES: To evaluate the efficacy and safety of ab interno trabecular bypass surgery with the Hydrus microstent in treating people with open angle glaucoma (OAG). SEARCH METHODS: On 7 May 2019, we searched CENTRAL (2019, Issue 5), which contains the Cochrane Eyes and Vision Trials Register; Ovid MEDLINE; Ovid Embase; the ISRCTN registry; ClinicalTrials.gov; and the WHO ICTRP. SELECTION CRITERIA: We searched for randomised controlled trials (RCTs) of the Hydrus microstent, alone or with cataract surgery, compared to other surgical treatments (cataract surgery alone, other minimally-invasive glaucoma device techniques, trabeculectomy), laser treatment, or medical treatment. DATA COLLECTION AND ANALYSIS: A minimum of three authors independently extracted data from reports of included studies, using a data collection form and analysed data, based on standard Cochrane methods. MAIN RESULTS: We included three published studies, with 808 people randomised. Two studies had multiple international recruitment centres in the USA and other countries. The third study had several sites based in Europe. All three studies were sponsored by the Hydrus manufacturer Ivantis Inc. All studies included participants with mainly mild or moderate OAG (mean deviation between -3.6 dB (decibel) and -8.4 dB in all study arms), which was controlled with medication in many participants (mean medicated intraocular pressure (IOP) 17.9 mmHg to 19.1 mmHg). There were no concerns regarding allocation concealment bias, but masking of outcome assessors was high or unclear risk in all studies; masking of participants was achieved, and losses to follow-up were not a concern. Two studies compared the Hydrus microstent combined with cataract surgery to cataract surgery alone, in participants with visually significant cataracts and OAG. We found moderate-certainty evidence that adding the Hydrus microstent to cataract surgery increased the proportion of participants who were medication-free from about half to more than three quarters at 12-month, short-term follow-up (risk ratio (RR) 1.59, 95% confidence interval (CI) 1.39 to 1.83; 2 studies, 639 participants; I² = 0%; and 24-month, medium-term follow-up (RR 1.63, 95% CI 1.40 to 1.88; 2 studies, 619 participants; I² = 0%). The Hydrus microstent combined with cataract surgery reduced the medium-term mean change in unmedicated IOP (after washout) by 2 mmHg more compared to cataract surgery alone (mean difference (MD) -2.00, 95% CI -2.69 to -1.31; 2 studies, 619 participants; I² = 0%; moderate-certainty evidence), and the mean change in IOP-lowering drops (MD -0.41, 95% CI -0.56 to -0.27; 2 studies, 619 participants; I² = 0%; low-certainty evidence). We also found low-certainty evidence that adding a Hydrus microstent to cataract surgery reduced the need for secondary glaucoma surgery from about 2.5% to less than 1% (RR 0.17, 95% CI 0.03 to 0.86; 2 studies, 653 participants; I² = 27%; low-certainty evidence). Intraocular bleeding, loss of 2 or more visual acuity (VA) lines, and IOP spikes of 10 mmHg or more were rare in both groups; estimates were imprecise, and included both beneficial and harmful effects. There were no cases of endophthalmitis in either group. No data were available on the proportion of participants achieving IOP less than 21 mmHg, 17 mmHg, or 14 mmHg; health-related quality of life (HRQOL), or visual field progression. One study provided short-term data for the Hydrus microstent compared with the iStent trabecular micro-bypass stent (iStent: implantation of two devices in a single procedure) in 152 participants with OAG (148 in analyses). Use of the Hydrus increased the proportion of medication-free participants from about a quarter to about half compared to those who received iStent, but this estimate was imprecise (RR 1.94, 95% CI 1.21 to 3.11; low-certainty evidence). Use of the Hydrus microstent reduced unmedicated IOP (after washout) by about 3 mmHg more than the iStent (MD -3.10, 95% CI -4.17 to -2.03; moderate-certainty evidence), and the use of IOP-lowering medication (MD -0.60, 95% CI -0.99 to -0.21; low-certainty evidence). Both devices achieved a final IOP < 21 mmHg in most participants (Hydrus microstent: 91.8%; iStent: 84%; RR 1.09, 95% CI 0.97 to 1.23; low-certainty evidence). None of the participants who received the Hydrus microstent (N = 74) required additional glaucoma surgery; two participants who received the iStent (N = 76) did. Few adverse events were found in either group. No data were available on the proportion of participants achieving IOP less than 17 mmHg or 14 mmHg, or on HRQOL. AUTHORS' CONCLUSIONS: In people with cataracts and generally mild to moderate OAG, there is moderate-certainty evidence that the Hydrus microstent with cataract surgery compared to cataract surgery alone, likely increases the proportion of participants who do not require IOP lowering medication, and may further reduce IOP at short- and medium-term follow-up. There is moderate-certainty evidence that the Hydrus microstent is probably more effective than the iStent in lowering IOP of people with OAG in the short-term. Few studies were available on the effects of the Hydrus microstent, therefore the results of this review may not be applicable to all people with OAG, particularly in selected people with medically uncontrolled glaucoma, since IOP was controlled with medication in many participants in the included studies. Complications may be rare using the Hydrus microstent, as well as the comparator iStent, but larger studies are needed to investigate its safety.

Minimally Invasive Glaucoma Surgical Techniques for Open-Angle Glaucoma: An Overview of Cochrane Systematic Reviews and Network Meta-analysis.

IMPORTANCE: Glaucoma affects more than 75 million people worldwide. Intraocular pressure (IOP)-lowering surgery is an important treatment for this disease. Interest in reducing surgical morbidity has led to the introduction of minimally invasive glaucoma surgeries (MIGS). Understanding the comparative effectiveness and safety of MIGS is necessary for clinicians and patients. OBJECTIVE: To summarize data from randomized clinical trials of MIGS for open-angle glaucoma, which were evaluated in a suite of Cochrane reviews. DATA SOURCES: The Cochrane Database of Systematic Reviews including studies published before June 1, 2021. STUDY SELECTION: Reviews of randomized clinical trials comparing MIGS with cataract extraction alone, other MIGS, traditional glaucoma surgery, laser trabeculoplasty, or medical therapy. DATA EXTRACTION AND SYNTHESIS: Data were extracted according to Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines by one investigator and confirmed by a second. Methodologic rigor was assessed using the AMSTAR 2 appraisal tool and random-effects network meta-analyses were conducted. MAIN OUTCOMES AND MEASURES: The proportion of participants who did not need to use medication to reduce intraocular pressure (IOP) postsurgery (drop-free). Outcomes were analyzed at short-term (<6 months), medium-term (6-18 months), and long-term (>18 months) follow-up. RESULTS: Six eligible Cochrane reviews were identified discussing trabecular bypass with iStent or Hydrus microstents, ab interno trabeculotomy with Trabectome, subconjunctival and supraciliary drainage devices, and endoscopic cyclophotocoagulation. Moderate certainty evidence indicated that adding a Hydrus safely improved the likelihood of drop-free glaucoma control at medium-term (relative risk [RR], 1.6; 95% CI, 1.4 to 1.8) and long-term (RR, 1.6; 95% CI, 1.4 to 1.9) follow-up and conferred 2.0-mm Hg (95% CI, -2.7 to -1.3 mm Hg) greater IOP reduction at long-term follow-up, compared with cataract surgery alone. Adding an iStent also safely improved drop-free disease control compared with cataract surgery alone (RR, 1.4; 95% CI, 1.2 to 1.6), but the short-term IOP-lowering effect of the iStent was not sustained. Addition of a CyPass microstent improved drop-free glaucoma control compared with cataract surgery alone (RR, 1.3; 95% CI, 1.1 to 1.5) but was associated with an increased risk of vraision loss. Network meta-analyses supported the direction and magnitude of these results. CONCLUSIONS AND RELEVANCE: Based on data synthesized in Cochrane reviews, some MIGS may afford patients with glaucoma greater drop-free disease control than cataract surgery alone. Among the products currently available, randomized clinical trial data associate the Hydrus with greater drop-free glaucoma control and IOP lowering than the iStent; however, these effect sizes were small.

Endoscopic band ligation versus propranolol for the primary prophylaxis of variceal bleeding in cirrhotic patients with high risk esophageal varices.

BACKGROUND: Gastroesophageal variceal bleeding is a common complication of portal hypertension. Current guidelines recommend thorn-blockers for primary prophylaxis. However, evidence suggests that endoscopic variceal ligation (EVL) reduce bleeding episodes. AIMS: To compare endoscopic EVL with propranolol (PPL) for primary prophylaxis of variceal bleeding. METHODS: We conducted a randomized controlled trial. Over a 9-year period, 75 patients with cirrhosis and high-risk esophageal varices (HREV) were recruited and allocated to EVL (n=39) or PPL (n=36). Primary outcome was variceal bleeding. Secondary outcomes were survival, source of bleeding and serious adverse events. Analyses were made by intention-to-treat. RESULTS: Baseline characteristics were similar. Medium follow-up was 1647+/-1096 days. complete follow-up was achieved in 85% of patients. Variceal bleeding occurred in 12% of EVL and in 25% of PPL group (p=0.17). The actuarial risks of bleeding after 2 years were similar in both groups. Overall mortality was 51% in EVL and 33% in PPL group (p=0.17). Patients in the EVL group showed a lower rate of esophageal variceal bleeding (5.1% v/s 25%, p=0.027) and a higher rate of subcardial variceal bleeding compared with PPL group (7.7% v/s 0%, p=0.027). Serious adverse events related to EVL occurred in 2 patients, including 1 death. CONCLUSIONS: The present study supports that PPL should be considered the first choice in primary prophylaxis of variceal bleeding offering similar effects and lower severe adverse events compared with EVL.

Non-alcoholic fatty liver disease and its association with obesity, insulin resistance and increased serum levels of C-reactive protein in Hispanics.

BACKGROUND: Non-alcoholic fatty liver disease (NAFLD) is a metabolic disorder of the liver, which may progress to fibrosis or cirrhosis. Recent studies have shown a significant impact of ethnicity on susceptibility to steatosis-related liver disease. AIMS: To estimate the prevalence of NAFLD among Chilean Hispanics as well as the clinical and biochemical variables associated with the disease. METHODS: Population-based study among Chilean Hispanics. The diagnosis of NAFLD was made on the basis of ultrasound evidence of fatty liver and absence of significant alcohol consumption and hepatitis C virus infection. RESULTS: A total of 832 Hispanic subjects were included. Ultrasound findings revealed diffuse fatty liver in 23% of the subjects. Variables associated with fatty liver in multivariate analysis were body mass index >26.9 [odds ratio (OR) 6.2; 95% confidence interval (CI) 3.3-11.5], abnormal aspartate aminotransferase levels (OR 14; 95% CI 8.2-23.7), presence of insulin resistance as measured by homoeostasis model assessment-insulin resistance (OR 3; 95% CI 1.8-4.8) and serum levels of high-sensitivity C-reactive protein (hs-CRP) greater than 0.86 mg/L (OR 2.9; 95% CI 1.6-5.2). Among subjects with NAFLD, levels of hs-CRP were similar regardless of the alanine aminotransferase (ALT) level. CONCLUSIONS: Chilean Hispanics exhibit a high prevalence of NAFLD. Obesity, insulin resistance, abnormal aminotransferase levels and elevated hs-CRP were independently associated with the presence of NAFLD. ALT elevation underestimates the presence of ultrasonographical fatty liver, whereas hs-CRP is a sensitive independent marker of NAFLD, which may be useful for detecting fatty liver in the general population.

Optimal length of triple therapy for H pylori eradication in a population with high prevalence of infection in Chile.

AIM: To compare the efficacy of 7-d versus 14-d triple therapy for the treatment of H pylori infection in Chile, with a prevalence of 73% in general population. METHODS: H pylori-infected patients diagnosed by rapid urease test, with non-ulcer dyspepsia or peptic ulcer disease were randomized to receive omeprazole 20 mg bid, amoxicillin 1 g bid, and clarithromycin 500 mg bid for 7 (OAC7) or 14 (OAC14) d. Primary outcome was eradication rate 6 wk after the treatment. Subgroup analysis was carried out considering the eradication rate among patients with or without peptic ulcer disease and eradication rate among smokers or non-smokers. RESULTS: One hundred and thirty-one patients were randomized to OAC7 (n = 69) or OAC14 (n = 62). The overall eradication rate (intention-to-treat) was 78.3% in OAC7 and 85.5% in OAC14 groups, without a significant difference (P =0.37). No significant difference in the eradication rate was found among the patients with peptic ulcer disease (n = 31) between the OAC7 group (85.7%) and OAC14 group (87.5%). However, smokers had an obviously lower eradication rate compared to non-smokers, particularly in the OAC7 group (57.1% in smokers vs 83.6% in non-smokers; P = 0.06). Adverse effects rate were similar between both groups. CONCLUSION: Short-term efficacy of triple therapy with OAC for 7 d is comparable to 14 d in this high-prevalence population. Longer follow-up, and studies focused to some subgroups of patients (smokers and non-ulcer patients) are necessary to support widespread use of 7-d instead of 10-14-d triple therapy in a developing country like Chile.

Course of Glaucomatous Visual Field Loss Across the Entire Perimetric Range.

IMPORTANCE: Identifying the course of glaucomatous visual field (VF) loss that progresses from normal to perimetric blindness is important for treatment and prognostication. OBJECTIVE: To model the process of glaucomatous VF decay over the entire perimetric range from normal to perimetric blindness. DESIGN, SETTING, AND PARTICIPANTS: A post hoc, retrospective analysis was performed using data from the Advanced Glaucoma Intervention Study and the UCLA (University of California, Los Angeles) Jules Stein Eye Institute Glaucoma Division. Patients with open-angle glaucoma and VFs obtained from reliable examinations (defined as <30% fixation losses, <30% false-positive rates, and <30% false-negative rates) were recruited. All tests were performed with standard automated perimetry and a 24-2 test pattern. Linear, exponential, and sigmoid regression models were used to assess the pattern of threshold sensitivity deterioration at each VF location as a function of time. Visual field locations of interest included those with a mean of the initial 2 sensitivities of 26 dB or greater and a less than 10-dB mean of the final 2 sensitivities. Root mean squared error (RMSE) was used to evaluate goodness of fit for each regression model. The error was defined as the difference between the sensitivities modeled by the function and the observed sensitivities. The Advanced Glaucoma Intervention Study was conducted from 1998 to 2006; the present post hoc analysis was conducted from March 1, 2014, to March 1, 2015. MAIN OUTCOMES AND MEASURES: The RMSE of the residuals (fitted minus observed values) for the 3 regression models was used to evaluate goodness of fit. RESULTS: A total of 798 eyes from 583 patients (mean [SD] age, 64.7 [10.7] years; 301 [51.6%] women) who had more than 6 years of follow-up and underwent more than 10 VF examinations were included in this analysis. Mean (SD) follow-up time was 8.7 (2.2) years, and each eye had a mean of 15.2 (4.9) VF tests. For the VF locations with an initial sensitivity of 26 dB or greater and final sensitivity of less than 10 dB (309 locations), the sigmoid best-fit regression model had the lowest RMSE in 248 (80.3%) of the locations, the exponential function in 39 (12.6%), and the linear function in 22 (7.1%). The means (SDs) of RMSE were sigmoid, 4.1 (1.9); exponential, 6.0 (1.5); and linear 5.8 (1.6). CONCLUSIONS AND RELEVANCE: Pointwise sigmoid regression had a better ability to fit perimetric decay into a subset of locations that traverse the entire range of perimetric measurements from near normal to near perimetric blindness compared with linear and exponential functions. These results support the concept that the measured behavior of glaucomatous VF loss to perimetric blindness is nonlinear and that its course of deterioration may change with the course of disease.

The Fast Component of Visual Field Decay Rate Correlates With Disc Rim Area Change Throughout the Entire Range of Glaucomatous Damage.

PURPOSE: We investigated the longitudinal relationships between the changes in neuroretinal rim area (RA) and the slow (SC) and fast (FC) components of visual field (VF) decay at various stages of glaucoma. METHODS: We divided 465 eyes of 338 patients into glaucoma suspect, and preperimetric, early, and moderate/advanced glaucoma. All patients had a minimum of 3 confocal scanning laser ophthalmoscopic examinations and 4 VF tests with follow-up of 4 or more years. A pointwise exponential regression was used to perform trend analyses on thresholds at each VF test location, which was partitioned into SC and FC. A mixed effects linear model was used to explore the associations of RA change with mean deviation (MD), visual field index (VFI), SC, and FC. RESULTS: Decreased RA was associated with lower mean threshold sensitivities of FC regardless of baseline severity of glaucoma (P ≤ 0.03). The mean threshold sensitivities in SC were not correlated with RA change at any stage. Decreased RA was correlated with worse MD in preperimetric, early, and moderate/advanced glaucoma (P < 0.05). Decreased RA was correlated with worse VFI in preperimetric and early glaucoma only (P ≤ 0.04). CONCLUSIONS: A decrease in rim area was significantly correlated with the fast VF component regardless of the baseline severity of glaucoma. Mean deviation and VFI correlated with change of rim area only in certain stages of glaucoma. The identification of the fast component seems a more robust and useful measure of glaucomatous change than MD or VFI.

Models of glaucomatous visual field loss.

PURPOSE: To evaluate and compare the ability of pointwise linear, exponential, and logistic functions, and combinations of functions, to model the longitudinal behavior of visual field (VF) series and predict future VF loss in patients with glaucoma. METHODS: Visual field series from 782 eyes (572 patients) with open-angle glaucoma had greater than 6 years of follow-up and 12 VFs performed. Threshold sensitivities from the first 5 years at each location were regressed with linear, exponential, and logistic functions to estimate model parameters. A multiple-model approach applied the model with the lowest root mean square error (RMSE) at each location as the preferred model for future predictions. Predictions for each model were compared at 1, 2, 3, and 5 years after the last VF used to determine model parameters. RESULTS: There were no clinically important differences between any of the models tested for fit; however, the logistic function had the lowest average RMSE (P < 0.001). For predictions, the exponential model consistently had the lowest average prediction RMSE for all time intervals (P < 0.001); the multiple-model approach did not perform better than the exponential model (P < 0.001). CONCLUSIONS: While the logistic model best fit glaucomatous VF behavior over a long time period, the exponential model provided the best average predictions. A multiple-model approach for VF predictions was associated with a greater prediction error than with the best-performing single-model approach. A model's goodness of fit is not indicative of its predictive ability for measurements of glaucomatous VFs.

Audición del paciente hipertenso crónico controlado / Hearing in controlled chronic hypertensive patient

Estudios epidemiológicos postulando una presunta relación entre hipertensión arterial e hipoacusia habrían sido ratificados por diversas investigaciones experiementales en ratas hipertensas genéticamente. Este hecho generó el interés en determinar la verdadera magnitud del compromiso auditivo en seres humanos con hipertensión arterial crónica. Se realizó estudio audiométrico completo en pacientes hipertensos crónicos controlados en centros especializados. Se descartó a todo portador de patología de oído medio o interno de etiología o causa precisable, o con antecedentes de exposición laboral a ruidos intensos, diabetes, lue, drogas ototóxicas, barnizadores o hipertensión de antiguedad inferior a 3 años. Los resultados obtenidos en 217 pacientes hipertensos crónicos controlados fueron promediados, configurando diversos perfiles audiométricos de acuerdo a grupos de edad de éstos y comparándose con una población sana suburbana y rural, calificada como grupo control. El análisis comparativo de los resultados de ambos grupos no reveló diferencias significativas, permitiendo postular que el perfil audiométrico en población hipertensa crónica controlada es similar al de la población general. Por consiguiente, estos hallazgos discrepan con recientes trabajos experimentales que pretenden vincular hipertensión arterial e hipoacusia. Factores predisponentes individuales (estructurales o metabólicos) podrían, en casos aislados, provocar pérdida auditiva, no representando la evolución habitual en pacientes hipertensos crónicos

Disfonía funcional: variables clínicas y terapéuticas / Functional dysphonia: clinical and therapeutic variables

Se ha observado en los últimos años, en el Hospital del Trabajador de Santiago, un incremento en el número de pacientes aquejados de patología funcional de la voz. Con el objetivo de optimizar su tratamiento, se analizaron las características sociodemográficas y clínicas de una muestra de pacientes con disfonía funcional y su posible relación con la respuesta terapéutica. Se estudiaron retrospectivamente 77 pacientes mujeres, con diagnóstico de disfonía funcional, derivadas a la unidad de salud mental del Hospital del Trabajador. El tratamiento fue ambulatorio e incluyó evaluaciones periódicas por otorrinolaringólogo, sesiones de foniatría y, la evaluación y tratamiento de salud mental cuando se estimó necesario. La muestra estuvo constituida en un 87 por ciento por profesores. Presentaron diagnóstico psiquiátrico el 74 por ciento de las pacientes, predominando los trastornos adaptativos y personalidades vulnerables. Los conflictos más frecuentes fueron de origen laboral y familiar. Se discute el rol de variables sociodemográficas y clínicas en el tratamiento y la evolución de la disfonía funcional.