Intraocular pressure control after the implantation of a second Ahmed glaucoma valve.

The objective of this study is to evaluate the efficacy and safety of a second Ahmed glaucoma valve (AGV) in eyes with refractory glaucoma that had undergone prior Ahmed device implantation. This multicenter, retrospective study evaluated 58 eyes (58 patients) that underwent a second AGV (model S2-n = 50, model FP7-n = 8) due to uncontrolled IOP under maximal medical therapy. Outcome measures included IOP, visual acuity, number of glaucoma medications, and postoperative complications. Success was defined as IOP <21 mmHg (criterion 1) or 30 % reduction of IOP (criterion 2) with or without hypotensive medications. Persistent hypotony (IOP <5 mmHg after 3 months of follow-up), loss of light perception, and reintervention for IOP control were defined as failure. Mean preoperative IOP and mean IOPs at 12 and 30 months were 27.55 ± 1.16 mmHg (n = 58), 14.45 ± 0.83 mmHg (n = 42), and 14.81 ± 0.87 mmHg (n = 16), respectively. The mean numbers of glaucoma medications preoperatively at 12 and 30 months were 3.17 ± 0.16 (n = 58), 1.81 ± 0.2 (n = 42), and 1.83 ± 0.35 (n = 18), respectively. The reductions in mean IOP and number of medications were statistically significant at all time intervals (P < 0.001). According to criterion 1, Kaplan-Meier survival curves disclosed success rates of 62.9 % at 12 months and 56.6 % at 30 months. According to criterion 2, Kaplan-Meier survival curves disclosed success rates of 43.9 % at 12 months and 32.9 % at 30 months. The most frequent early complication was hypertensive phase (10.3 %) and the most frequent late complication was corneal edema (17.2 %). Second AGV implantation may effectively reduce IOP in eyes with uncontrolled glaucoma, and is associated with relatively few complications.

Efficacy and tolerability of fixed-combination bimatoprost/timolol versus fixed-combination dorzolamide/brimonidine/timolol in patients with primary open-angle glaucoma or ocular hypertension: a multicenter, prospective, crossover study.

BACKGROUND: Fixed-combination ocular hypotensives have multiple advantages, but triple-therapy dorzolamide/brimonidine/timolol (dorz/brim/tim) is only available in Latin and South America, and information on its relative efficacy is limited. This study compares the efficacy and tolerability of fixed-combination bimatoprost/timolol (bim/tim) and dorz/brim/tim in Mexican patients with primary open-angle glaucoma or ocular hypertension. METHODS: In this investigator-masked, crossover study, patients with unmet target intraocular pressure (IOP) on once-daily bim/tim or twice-daily dorz/brim/tim received the opposite medication for 3 months before returning to their pre-baseline medication for 3 months. IOP was evaluated before and after morning instillation at months 2, 3, 5 and 6. Primary endpoints were mean IOP change and Ocular Surface Disease Index© (OSDI) score at each visit. The intent-to-treat population was the a priori analysis population, but due to the number of discontinuations, the per-protocol and intent-to-treat populations were used for the primary efficacy and sensitivity analyses, respectively. RESULTS: Seventy-eight and 56 patients were included in the intent-to-treat and per-protocol populations, respectively. At month 3, statistically significant IOP reductions from baseline were observed in the bim/tim (P < 0.01) and dorz/brim/tim (P < 0.0001) groups, regardless of assessment time. At month 6, patients returned to bim/tim exhibited no significant IOP increase (regardless of assessment time), but patients returned to dorz/brim/tim exhibited a statistically significant IOP increase (P < 0.001) when assessed before instillation of study treatment. Results were similar in both intent-to-treat and per-protocol analysis populations. In the per-protocol analysis, 70% of patients on bim/tim at month 3 had an IOP <14 mm Hg, which declined to 58% (P = 0.0061) at month 6 (ie, after 3 months of dorz/brim/tim treatment). In patients receiving dorz/brim/tim at month 3, 38% had an IOP <14 mm Hg, which remained comparable after return to bim/tim. OSDI scores and incidence of adverse events were similar in both groups. CONCLUSIONS: In this first direct comparison of the efficacy of dorz/brim/tim and bim/tim, patients switched from dorz/brim/tim to bim/tim demonstrated improved/lower IOP; when returned to dorz/brim/tim, IOP increased to levels seen at study initiation, suggesting that once-daily bim/tim may have greater IOP-lowering efficacy. Both bim/tim and dorz/brim/tim were well tolerated with minimal ocular surface damage. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01737853 (registered October 9, 2012).

Comparison of Goldmann applanation and dynamic contour tonometry in a population of Mexican open-angle glaucoma patients.

To compare intraocular pressure (IOP) measurements obtained with Goldmann applanation (GAT) and dynamic contour tonometry (DCT) in a Mexican population. 40 glaucoma patients were included in this cross-sectional observational cohort study. IOP measurements were performed in the following order: DCT, ultrasonic pachymetry and GAT, with a 5-minute difference between each measurement, between 8 am and 2 pm. Only DCT measurements of good quality (Q ≤ 3) were accepted. GAT measurements were made three times with the same Goldmann tonometer, previously checked for calibration errors, and the mean was used for statistical purposes. The IOP (mean [standard deviation], 95 % confidence interval [CI]) measured with the Goldmann tonometer (13.2 [2.4], 12.4-14.0 mmHg) was significantly lower than that obtained with the DCT (18.4 [3.3], 17.0-19.2 mmHg), p < 0.0001. Pearson's correlation coefficients between CCT and IOP measured with GAT and DCT were (r = 0.24, 95 % CI = 0.07-0.52, p = 0.133) and (r = 0.13, 95 % CI = -0.19 to 0.43, p = 0.412), respectively. The concordance correlation coefficient between GAT and DCT was r c = 0.3, 95 % CI = 0.17-0.41). DCT seems to overestimate the IOP as compared to GAT. Additionally, although there was a good correlation between the IOP measurements assessed with either GAT or DCT, the agreement was poor.

Ambulatory surgery for chronic venous insufficiency using radiofrequency thermoablation: quality and satisfaction.

BACKGROUND: Chronic venous disease is a frequent and prevalent pathology. Its surgical treatment has been shown to be cost-effective. Thermal endoablation performed as major outpatient surgery (MAS) is the technique of choice. OBJECTIVE: To know the satisfaction of patients after MAS and the quality of care provided. METHOD: Observational, descriptive, cross-sectional study, carried out between January 2019 and March 2020. A survey was carried out on patients who underwent endovascular radiofrequency thermoablation in two hospitals in Spain, consisting of two questionnaires: one ad hoc and one another of satisfaction (SERCAL). Quality indices for MAS were measured. RESULTS: We analyzed 156 episodes. 145 interventions were carried out. We found 4 (2.8%) unscheduled admissions. 3 patients (2.1%) attended the emergency department. There was a 99.3% success rate. 100% of the patients had pre-surgical recommendations and informed consent. We obtained 48 surveys (response rate: 33.1%). All the patients gave a rating greater ≥ 8 in quality of care (x = 9.83) and would recommend this procedure to their relatives (x = 9.71). CONCLUSIONS: Endovascular radiofrequency thermoablation performed in MAS has a high success rate and a very low rate of admission and visit to the emergency room. Patient satisfaction is high.

ANTECEDENTES: La enfermedad venosa crónica es una patología frecuente y prevalente. Su tratamiento quirúrgico ha mostrado ser coste-efectivo. La endoablación térmica realizada como cirugía mayor ambulatoria (CMA) es la técnica de elección. OBJETIVO: Conocer la satisfacción de los pacientes tras CMA y la calidad de la atención brindada. MÉTODO: Estudio observacional, descriptivo y transversal, realizado entre enero de 2019 y marzo de 2020. Se realizó una encuesta a los pacientes intervenidos mediante termoablación endovascular por radiofrecuencia en dos hospitales de España, con dos cuestionarios: uno ad hoc y otro de satisfacción (SERCAL). Se midieron índices de calidad para CMA. RESULTADOS: Analizamos 156 episodios. Se realizaron 145 intervenciones. Encontramos 4 (2.8%) ingresos no programados. Tres pacientes (2.1%) acudieron a urgencias. Hubo una tasa de éxito del 99.3%. El 100% de los pacientes contaban con recomendaciones prequirúrgicas y consentimiento informado. Obtuvimos 48 encuestas (índice de respuesta: 33.1%). Todos los pacientes otorgaron una calificación ≥ 8 en calidad de atención (x = 9.83) y recomendarían este procedimiento a sus familiares (x = 9.71). CONCLUSIONES: La termoablación endovascular por radiofrecuencia realizada en CMA tiene una alta tasa de éxito y unas tasas de ingreso y visita a urgencias muy bajas. La satisfacción de los pacientes es elevada.

Prevalence of hypertensive phase and outcomes in patients with Ahmed valve implantation at one year of follow-up and evaluation of associated risk factors.

Purpose: To evaluate the prevalence of hypertensive phase (HP) and failure in patients who underwent Ahmed Glaucoma Valve (AGV) implantation and identify the possible risk factors for both HP and failure. Methods: A cross-sectional, observational study was conducted. Medical records of patients who underwent AGV implantation and had at least 1 year of follow-up were reviewed. HP was defined as an intraocular pressure (IOP) greater than 21 mmHg between the first week and the third postoperative month not attributable to other causes. Success was defined as an IOP between 6 and 21 mmHg, with preservation of light perception and no additional glaucoma surgeries. Statistical analysis was conducted to identify possible risk factors. Results: A total of 193 eyes of 177 patients were included. HP was present in 58%; a higher preoperative IOP and younger age were associated with HP. Pseudophakic or aphakic eyes had a lower HP rate. Failure was present in 29%; neovascular glaucoma, worse basal best corrected visual acuity (BCVA), higher baseline IOP, and postoperative complications were linked to a higher likelihood of failure. No difference in the HP rate between the failure and success groups was found. Conclusion: A higher baseline IOP and younger age are associated with HP development; pseudophakia and aphakia might be protective factors. Factors for AGV failure are a worse BCVA, neovascular glaucoma, postoperative complications, and a higher baseline IOP. At 1 year, a higher number of medications were needed to achieve IOP control in the HP group.

Real-world outcomes of micropulse cyclophotocoagulation in a Latin American population and analysis of the factors associated with the success rate.

OBJECTIVE: To report the outcomes of micropulse cyclophotocoagulation in a Latin American population with refractory glaucoma in a "real-world" setting and to evaluate the factors associated with success after a one-year follow-up. MATERIALS AND METHODS: Retrospective, multicenter study. The medical records of patients who underwent micropulse cyclophotocoagulation between September 2017 and October 2018 were reviewed. Treatment success was defined as an intraocular pressure of 5 to 21 mmHg or a 20% intraocular pressure reduction with or without additional glaucoma medical therapy. RESULTS: Eighty-three eyes from 83 patients were included, with a mean follow-up of 10.1 ± 3.1 months. The intraocular pressure and number of glaucoma medications significantly decreased at all postoperative visits from a mean of 21.9 ± 7.6 mmHg on 3.8 medications to 13.1 ± 3.5 mmHg on 2.8 medications at the 12-month follow-up. The mean intraocular pressure decreased 40.1% from baseline at 12 months. The cumulative success rate was 54.5% (95% CI, 44-67%) at 12-month follow-up. We identified a higher baseline intraocular pressure as a significant independent predictor of treatment success (p = 0.03). Late complications included 1 eye with corneal edema, 1 eye with prolonged anterior chamber inflammation and cystoid macular edema and 9 eyes (11%) with visual loss of 2 Snellen lines or more. CONCLUSIONS: Micropulse cyclophotocoagulation is an effective and safe treatment for Latin American patients and can provide intraocular pressure and medication reductions with a single treatment after a one-year follow-up. A high baseline intraocular pressure was the most significant predictor of treatment success.

Surgical outcomes of excisional goniotomy using the kahook dual blade in severe and refractory glaucoma: 12-month results.

OBJECTIVES: To describe the efficacy and safety of goniotomy with trabecular meshwork excision using the Kahook Dual Blade (KDB, New World Medical Inc., Rancho Cucamonga, CA) in patients with severe or refractory glaucoma. METHODS: This retrospective multicentre case series reports on 40 eyes with severe or refractory open-angle glaucoma that underwent standalone or combined KDB goniotomy and were followed for 12 months post-operatively in the United-States, Mexico and Switzerland. Surgical success was defined as an intraocular pressure (IOP) reduction ≥20% from baseline at 12 months, with fewer medications than preoperatively. Mean IOP and antiglaucoma medication reduction, probabilities of achieving an IOP ≤16 or 18 mmHg, and adverse events were also analysed. RESULTS: Mean IOP decreased from 18.1 ± 5.0 mmHg at baseline to 14.8 ± 3.7 mmHg at 12 months (18.2% reduction, P < 0.001). Concomitantly, the mean number of glaucoma medications decreased from 2.5 ± 1.4 to 1.7 ± 1.2 (32% reduction, P = 0.002). The proportion of eyes achieving an IOP reduction of more than 20% from baseline was 37.5% (n = 15) at 12 months. At 12 months, 67.5% and 82.5% achieved a medicated IOP ≤ 16 and ≤18 mmHg, respectively. No severe complications were reported. CONCLUSION: Excisional goniotomy with KDB achieves a statistically significant IOP and antiglaucoma medication reduction in severe or refractory glaucoma over a period of 12 months. While its efficacy decreases with time, its favourable safety profile makes it a potentially useful primary or adjunctive procedure in high-risk eyes.

Knowledge and awareness of glaucoma in Mexican patients with and without glaucoma diagnosis in an Ophthalmology Referral Center.

AIM: To assess and compare knowledge and awareness of glaucoma in subjects with and without glaucoma diagnosis attending an Ophthalmology Referral Center. METHODS: This cross-sectional study was conducted at Asociación Para Evitar la Ceguera in Mexico City, using a questionnaire formulated by a group of experts following the Delphi panel rules, and pre-tested in a pilot study. The questionnaire was applied and compared between: glaucoma patients, relatives of glaucoma patients and patients without glaucoma. Socio-demographic data was collected to assess correlation with the level of knowledge using Logistic regression models, estimating the odds ratios (OR), 95% confidence intervals, and P<0.05. RESULTS: Three hundred and ninety-four subjects were enrolled; with a median age of 61y. One hundred and thirty-four (34%) were patients with glaucoma, 152 (38.6%) patients without glaucoma, and 108 (27.4%) relatives of patients with glaucoma. Two hundred and ninety-one (73.9%) participants were aware of the term "glaucoma". Regarding knowledge 46.7% had moderate knowledge, 37.8% had poor knowledge, and 15.5% good knowledge. Overall, relatives of glaucoma patients had the highest scores, and patients without glaucoma got the lowest scores. A positive correlation was found between better knowledge and frequent ophthalmological examinations OR 2.24 (P=0.02), higher education level OR 4.17 (P=0.00) and having a family member with glaucoma OR 3.28 (P=0.00). CONCLUSION: Awareness and knowledge of glaucoma in subjects attending an Ophthalmology Referral Center is predominantly moderate or poor. This has important implications regarding attitudes that can result in lack of follow up in ophthalmological care.

Simple Tube Centrifugation Method for Platelet-Rich Plasma (PRP) Preparation in Catalonian Donkeys as a Treatment of Endometritis-Endometrosis.

The aim of this study was to standardize a simple, manual platelet-rich plasma (PRP) protocol in Catalonian donkeys using single-spin tube centrifugation as a treatment for jenny endometritis. The objective was to obtain a blood product with a moderate concentration of platelets (2 or 3 times baseline physiologic values) and a low WBC (White Blood Cells) concentration. Blood was drawn from six Catalonian donkeys using acid citrate dextrose (ACD) as an anticoagulant, and then processed by single centrifugation at 133× g for two different centrifugation times (10 and 15 min). The PRP samples were evaluated by flow cytometry, and TGF-ß1 (Transforming Growth Factor-Beta1) concentrations were determined by enzyme-linked immunosorbent assay (ELISA). The 10 min centrifugation protocol resulted in a slightly greater release of TGF-ß1 (6044.79 ng/mL), a 2.06-fold increase in platelet concentration, and a 15-fold reduction in leukocyte concentration when compared to the initial values. The 15 min centrifugation time resulted in a 2.44-fold increase in baseline platelet concentration, a reduction in WBC count by a factor of 20, and slightly lower TGF levels (5206 ng/mL). We conclude that both protocols are adequate for the obtention of PRP, and both may have an acceptable therapeutic potential for use in this species, although this needs to be further validated.

Long-term visual field changes after femtosecond laser-assisted cataract surgery in glaucoma patients, case series.

PURPOSE: To assess the short and long-term changes in Visual Field (VF) Mean Deviation (MD), Visual Field Index (VFI), and intraocular pressure (IOP) after femtosecond laser-assisted cataract surgery (FLACS) in glaucomatous eyes. MATERIALS AND METHODS: Interventional, prospective case series. Patients with glaucoma, who required cataract surgery were included. All patients underwent a complete ophthalmologic assessment and Visual Fields. FLACS was performed in all patients by a single experienced surgeon. IOP was measured during surgery immediately before and after pretreatment suction docking. Changes from baseline in VF MD and VFI, IOP, visual acuity (VA), and number of glaucoma medications were evaluated up to one-year follow-up. RESULTS: Fourteen eyes of 11 patients were included. Eighty-five percent were female, with a mean age of 74.2 ± 7.9 years. Nine (64.3%) and 5 (35.7%) were diagnosed with primary angle closure glaucoma (PACG) and primary open angle glaucoma (POAG), respectively. We found a slight IOP reduction after the docking phase during FLACS in both glaucoma subtype groups. No significant changes in visual field mean deviation (MD) and visual field index (VFI) were found from baseline to 12 months after surgery in both groups. A significant reduction in IOP values was found in all cases from baseline up to one year follow up. No significant changes were observed in BCVA and number of topical glaucoma medications after one year in both groups. CONCLUSION: In our patients, there was an IOP reduction immediately after suction docking FLACS pretreatment. Mean IOP at final follow-up showed a reduction from baseline. There was no change in VF MD and VFI from baseline to final one-year follow-up. FLACS appears to be well tolerated in early and moderate glaucoma and appears to be a safe tool for glaucoma patients undergoing cataract surgery. Similar results to traditional surgery can be obtained with the advantages of femtosecond laser precision.

Outcomes of trabeculectomy with polyvinylpyrrolidone collagen versus mitomycin in primary open angle glaucoma. 36-month follow-up. / Colágeno polivinilpirrolidona versus mitomicina C en trabeculectomía en pacientes con glaucoma primario de ángulo abierto. Seguimiento a 36 meses.

PURPOSE: Describe and compare the effects of intraoperative application of Polyvinylpyrrolidone Collagen (PVP) versus Mitomycin C (MMC) on the pattern of change in mean IOP reduction and mean number of medications over 36-months follow-up in patients with primary open angle glaucoma (POAG) undergoing trabeculectomy. METHODS: Prospective, randomized, comparative study. Twenty-six eyes of 26 patients with POAG and no previous incisional glaucoma surgery underwent trabeculectomy and were randomized to PVP or MMC and completed a 36-month follow-up. Main outcome measures were IOP and number of glaucoma medications. Multivariate longitudinal analysis was performed by fitting a linear trend model adjusting for baseline response for the IOP outcome and a log-linear regression model with within-subject associations for the number of hypotensive medications outcome. Sensitivity analysis was performed to assess lower and higher order polynomial trends over time in IOP. RESULTS: The univariate analysis revealed that the mean IOP reduction from baseline to 36 months was 7.62mmHg (3.05; 12.18) in the MMC group and 8.15mmHg (-0.64; 16.95) in the PVP group. Mean percentage IOP reduction from baseline was 37.09% (15.93; 58.17) and 36.08% (5.16; 67.20) in the PVP group. Mean change in number of medications from baseline to 36 months was -0.92 medications (-3.38; +1.54) for the MMC group and -1 medication (-3.12; +1.12) for the PVP group. Both groups had a statistically significant decline in mean IOP over the follow-up period (p<0.001) but there was no discernible difference between the two exposure groups in the rate of change in IOP (p=0.5975). Sensitivity analysis showed that a linear trend model is adequate to describe the IOP reduction over the follow-up period. Both groups had a statistically significant change in the number of hypotensive medications used between baseline and month 36 (p<0.05) but there was no discernible difference between exposure groups (p=0.2917). Both the PVP and MMC groups showed an initial reduction in number of medications until month 12 and a relatively linear increase towards month 36. A longer follow-up may be warranted to reveal differences in the number of medications between the two exposure groups. Postoperative complications were less frequent in the PVP group. CONCLUSIONS: The use of PVP during trabeculectomy achieves and maintains a statistically significant IOP reduction from baseline to 36 months and decreases the number of glaucoma medications. Secondary outcome measures showed a lower incidence of adverse events in the PVP group.

Tenon Cyst Patch Graft for Ahmed Glaucoma Valve Tube Exposure: Case Series Report.

PURPOSE: To report our experience using a Tenon cyst autograft in the management of tube exposure post Ahmed glaucoma valve (AGV) implantation. METHODS: This is a retrospective case series. RESULTS: Four patients who underwent tube exposure repair using Tenon cyst autograft were identified in our tertiary care center. The duration between initial AGV implantation and tube exposure ranged between 3 and 36 months with a mean of 16 months (±14.35 mo). All patients were followed postoperatively for a range of 4 to 24 months with a mean of 11.75 months (±9.03 o) and all remain exposure free at last follow-up. CONCLUSION: The use of a Tenon cyst autograft for the surgical repair of a tube exposure is valuable, as it involves using autologous scar tissue that is available in eyes that have undergone AGV implantation. The patch autograft is technically easy to harvest, and represents a significantly lower cost when compared with other available options.

Depression and Medical Treatment Adherence in Mexican Patients With Glaucoma.

PRECIS: The prevalence of depression in Mexican patients with glaucoma is higher than that reported in the general population. Depression prevalence and severity are directly associated with glaucoma severity and lower adherence to medical treatment. PURPOSE: To determine the prevalence of depression in patients with glaucoma and to describe the correlation between the severity of depression, glaucoma, and treatment adherence. PATIENTS AND METHODS: This cross-sectional study included 111 patients with glaucoma who answered the Beck Depression Inventory (BDI)-II and the Morisky-Green questionnaire that evaluated their depression severity and medical treatment adherence. Low treatment adherence was defined as having a score of >2 on the Morisky-Green questionnaire. Analysis of variance, Fisher exact test, and linear regression models were used for statistical analyses. The main outcomes were prevalence of depression, prevalence of depression according to glaucoma damage, and the association between depression severity, medical treatment adherence, and glaucoma damage. RESULTS: The average patient age was 67.6±13.8 years. The prevalence of depression was 50.4%. Analysis of variance revealed a statistically significant association between glaucoma severity of the "worse eye" and the BDI raw score. In the "better eye," there was no statistically significant difference in mean BDI raw scores across glaucoma severity categories. There was a statistically significant association between the presence of depression and the level of treatment adherence after adjusting for age, sex, type of glaucoma, and the glaucoma severity in both eyes. The risk of low treatment adherence in patients with depression was 38 times that of patients with no depression. CONCLUSION: Glaucoma is associated with a prevalence of depression nearly 10 times higher than that in the general population. Glaucoma, depression severity, and lower adherence to medical treatment are associated.

Refractive Outcomes of Cataract Surgery With or Without Endocyclophotocoagulation.

PRECIS: Surgeons that perform cataract surgery combined with endocyclophotocoagulation (ECP) should rely on their preferred intraocular lens (IOL) calculation formula. There is no need to perform any correction to the IOL power, as this procedure does not modify the refractive outcome. PURPOSE: The purpose of this study was to compare postoperative refractive outcomes in patients with glaucoma who underwent phacoemulsification and IOL implantation with or without ECP and the change in intraocular pressure (IOP) and number of antiglaucoma medications between groups. METHODS: A cross-sectional study in which the medical records of the patients with any type of glaucoma, who underwent phacoemulsification with IOL implantation in the capsular bag in addition to ECP or as a standalone procedure from June 2016 to August 2019 were analyzed. Clinical data collected included axial length, steep, flat, and mean keratometry values, target spherical equivalent (SE) estimated by the SRK/T formula, manifest refraction SE at the 1-month follow-up, IOP, and number of antiglaucoma medications before and 12 months after surgery. Primary and secondary outcome measures were the mean predictive error (MPE), the postoperative SE, and the change in IOP after surgery in both groups, respectively. Significance was assessed using the Student t test for all variables between groups according to data distribution. P-values <0.05 were considered to be statistically significant. RESULTS: A total of 196 eyes of 196 patients were included, 98 in the combined phacoemulsification-ECP group, and 98 in the non-ECP group. The observed MPE was -0.043±0.44, and 0.06±0.38 D MPE, respectively (P=0.079). Overall, 74.34% in the phacoemulsification-ECP group and 78.4% in the non-ECP group had a postoperative SE of ±0.50. The ECP group had lower IOP and a greater decrease in antiglaucoma medications at 12 months of follow-up. CONCLUSIONS: SRK/T formula performed well in both groups, with no statistically significant difference in the MPE and the percentage of eyes achieving postoperative SE of ±0.50. We consider it is unnecessary to perform any kind of correction to the IOL power calculation when performing ECP.

Surgical Outcomes of a Second Ahmed Glaucoma Valve Implant for the Treatment of Refractory Glaucoma.

PRéCIS:: In this article, the authors concluded that an additional Ahmed glaucoma valve (AGV) implantation after the failure of an initial AGV, even with the addition of glaucoma medications, maybe a good surgical treatment option for refractory glaucoma. PURPOSE: To evaluate the surgical outcomes of a second AGV implant in Hispanic patients with refractory glaucoma. MATERIALS AND METHODS: The medical records of patients who underwent a second AGV implant were reviewed retrospectively. Clinical outcome measures including intraocular pressure (IOP), visual acuity, and glaucoma medication use were collected from the preoperative visit and all follow-up visits up to 18 months after surgery. Failure was defined as one of the following: loss of light perception, sustained IOP >21 or <6 mm Hg, an IOP reduction of <20% from baseline, need for additional glaucoma surgery, including needling revision with subconjunctival adjuvant therapy, or valve extrusion. RESULTS: A total of 48 patients were included. In all cases, an S-2 model was implanted in the superonasal quadrant. Mean preoperative IOP was 24.3±7.9 mm Hg and was significantly reduced to 13.9±4.8 at 6 months (P<0.05), 15.4±7.2 at 12 months (P<0.05), and 12.9±2.0 at 18 months (P<0.05). Mean glaucoma medications were reduced from 2.8±1.1 preoperatively to 1.9±1.2 at 6 months (P<0.05), 2.4±1.2 at 12 months, and 2.2±1.1 at 18 months; however, the difference was no longer statistically significant after 6 months, and the success rate was 60% at the mean for survival time of 15 months (13.7 to 16.5). CONCLUSION: The findings of this study demonstrate that a second AGV can achieve a significant reduction in IOP for up to 18 months postoperatively.

COVID-19 and the eye: how much do we really know? A best evidence review.

To identify and classify available information regarding COVID-19 and eye care according to the level of evidence, within four main topics of interest: evidence of the virus in tears and the ocular surface, infection via the conjunctival route, ocular manifestations, and best practice recommendations. A structured review was conducted in PubMed, ScienceDirect, LILACS, SciELO, the Cochrane Library and Google Scholar on COVID-19 and ophthalmology. The Oxford Centre for Evidence Based Medicine 2011 Levels of Evidence worksheet was used for quality assessments. 1018 items were identified in the search; 26 records were included in the qualitative synthesis, which encompassed 6 literature reviews, 10 case series or cross-sectional studies, 4 case reports, and 6 intervention descriptions. Seventeen out of 26 records (65%) were categorized as level 5 within the Oxford CBME methodology grading system, the rest were level 4. The evidence generated on COVID-19 and ophthalmology to date is limited, although this is understandable given the circumstances. Both the possible presence of viral particles in tears and conjunctiva, and the potential for conjunctival transmission remain controversial. Ocular manifestations are not frequent and could resemble viral infection of the ocular surface. Most recommendations are based on the strategies implemented by Asian countries during previous coronavirus outbreaks. There is a need for substantive studies evaluating these strategies in the setting of SARS-CoV-2. In the meantime, plans for applying these measures must be implemented with caution, taking into account the context of each individual country, and undergo regular evaluation.

Clinical Evaluation of a Novel Electromechanical Topical Ocular Drug Delivery System: Two Phase 1 Proof of Concept Studies.

PURPOSE: Self-administration of topical ophthalmic therapies remains challenging for many patients as errors due to improper technique are common. The aim of the current studies was to evaluate a novel electromechanical topical ocular drug delivery device designed to facilitate precise dosing and accurate delivery with substantially lower drug exposure than conventional eye drops. PATIENTS AND METHODS: Two randomized Phase 1 studies were performed to evaluate the efficacy and safety of a single dose of a topical ophthalmic solution administered as a ~9 µL microfluid stream via the test device compared with a ~30-40 µL drop delivered via conventional dropper in healthy subjects (Trial 1) and glaucoma patients (Trial 2). In Trial 1, a 1% tropicamide/2.5% phenylephrine solution was administered via the test device in one eye and by conventional dropper in the contralateral eye. Pupil dilation was measured at 30 min intervals post-instillation and subject comfort was assessed using a visual analogue scale (range, 0-100). In Trial 2, patients were randomized to receive latanoprost 0.005% via the test device or conventional dropper. Intraocular pressure was measured at baseline and 4-8 hrs post-instillation. RESULTS: In Trial 1 (N=20), mean (SD) pupil diameter 30 mins post-instillation increased by 3.4 (0.9) and 3.5 (1.0) mm in the test and control eyes, respectively. The mean comfort score was 81.7 for the test device versus 57.3 for conventional dropper delivery. In Trial 2 (N=18), the mean change in intraocular pressure following administration of latanoprost was -5.0 (1.8) and -4.3 (3.3) mm Hg in the test and control groups, respectively. No serious adverse events were observed in either study. CONCLUSION: Administration of a single dose of topical ophthalmic therapy via an electromechanical drug delivery device resulted in comparable effects on pupil dilation and intraocular pressure with lower drug exposure and increased patient comfort compared with conventional dropper delivery.

The efficacy and safety of two fixed combinations: timolol-dorzolamide-brimonidine versus timolol-dorzolamide. A prospective, randomized, double-masked, multi-center, 6-month clinical trial.

We compared the efficacy and safety of a new fixed combination of timolol 0.5%/odorzolamide 20%/brimonidine 0.2% in ophthalmic solution versus a fixed combination of timolol 0.5%/dorzolamide 2% in patients with open-angle glaucoma or ocular hypertension. The fixed triple combination was significantly more efficient in mean intraocular pressure reduction from baseline throughout the six-month follow-up.

Results and complications of carotid endarterectomy in a hospital from Madrid, Spain.

OBJECTIVE: To study the incidence of cerebrovascular (transient ischemic attacks and stroke) and myocardial events (myocardial infarction) as well as early survival related to carotid endarterectomy. Our secondary aim is to establish possible risk factors associated with complications. METHOD: Retrospective observational case-control study within a cohort. All patients who underwent carotid endarterectomy by the angiology and vascular surgery service at the Hospital Universitario La Paz, in Madrid (Spain), in the period between January 2011 and December 2017 were included. Chi square was used to calculate differences. Kaplan-Meier and Cox regression was used for the survival analysis and patency. RESULTS: 111 procedures were performed on 108 patients, 95 (87,9%) male with an average age of 68.5 ± 8.75. The mean time of follow-up was 2.9 years. There was no 30-day post-surgical mortality, with a 30-day postoperative cerebral vascular event rate of 2.7%. Statistically significant correlation was found between the presence of 30-day postoperative cerebral vascular event and primary closure (p = 0.005) as well as between the smoking habit and 30-day postoperative myocardial infarction (p = 0.036) and restenosis (p = 0.008). In mid-term follow-up, the event rate for cerebral vascular events and myocardial infarction was 1.8%. CONCLUSION: carotid endarterectomy is the procedure of choice in carotid stenosis. The low rates of perioperative mortality, morbidity and complications have been demonstrated.

OBJETIVO: Conocer la incidencia de eventos cerebrovasculares y miocárdicos, y la supervivencia temprana, relacionados con la endarterectomía carotídea, y como objetivo secundario establecer los posibles factores de riesgo asociados a las complicaciones. MÉTODO: Estudio observacional de casos y controles anidado en una cohorte retrospectiva. Se incluyeron todos los pacientes que se sometieron a endarterectomía carotídea en el servicio de angiología y cirugía vascular del Hospital Universitario La Paz, de Madrid (España), en el periodo de enero de 2011 a diciembre de 2017. Para la estimación de diferencias se utilizó la prueba de ji al cuadrado. El análisis de supervivencia y permeabilidad se realizó mediante Kaplan-Meier y regresión de Cox. RESULTADOS: Se realizaron 111 procedimientos en 108 pacientes, 95 (87.9%) de ellos varones, con una edad media de 68.5 ± 8.75 años. La media de seguimiento fue de 2.9 años. No hubo mortalidad posquirúrgica a 30 días, y la tasa global de eventos vasculares cerebrales posoperatorios a 30 días fue del 2.7%. Se encontró asociación entre la presencia de eventos vasculares cerebrales posquirúrgicos a 30 días y el cierre arterial primario (p = 0.005), y del infarto agudo de miocardio posoperatorio a 30 días y la reestenosis carotídea con el hábito tabáquico (p = 0.036 y p = 0.008, respectivamente). En el seguimiento a mediano plazo se encontró una tasa de enfermedad vascular cerebral y de infarto agudo de miocardio del 1,8%. CONCLUSIÓN: La endarterectomía carotídea es el procedimiento de elección en la estenosis carotídea por enfermedad aterosclerótica. En nuestro estudio se demuestran sus bajas tasas de mortalidad, de morbilidad y de complicaciones perioperatorias.

A Phase III Randomized Clinical Trial of a 0.5% Timolol + 0.2% Brimonidine + 2.0% Dorzolamide Fixed Combination, Preservative-Free Ophthalmic Solution vs. 0.5% Timolol + 0.2% Brimonidine + 2.0% Dorzolamide Fixed Combination in Patients with Controlled Primary Open-Angle Glaucoma.

INTRODUCTION: The aim of this prospective crossover study was to evaluate the non-inferiority of PRO-122 (a preservative-free fixed combination) compared with 0.5% timolol + 0.2% brimonidine + 2.0% dorzolamide fixed combination (KOF) by evaluating its efficacy, tolerability and safety in subjects with controlled primary open-angle glaucoma (POAG) previously treated with KOF for at least 2 months. METHODS: In a prospective, crossover, randomized, double-masked multicenter study, patients previously treated with KOF were randomly assigned to receive either PRO-122 or KOF for 30 days. On day 31, the A sequence changed to KOF, while the B sequence received PRO-122. All patients remained in the protocol for 30 additional days for a total of 60 days. The main efficacy endpoint was maintaining the controlled intraocular pressure (IOP). The safety and tolerability of both products were assessed by the presence of adverse events (AEs), ocular findings, a questionnaire on ocular comfort and the VF-14 index. RESULTS: A total of 51 patients participated. After application of PRO-122 twice a day, its efficacy was demonstrated through maintenance of the controlled IOP in patients previously controlled with KOF. The crossover between PRO-122 and KOF and vice versa, after 30 days of use, did not affect IOP control. PRO-122 was shown not to be inferior to KOF in maintaining IOP at control levels. The safety of both drugs is similar, as neither presented drug-related AEs or differences regarding safety issues. The tolerability of the two medications-evaluated by ocular findings, the questionnaire on ocular comfort and the VF-14 index-was also determined to be similar. CONCLUSIONS: The controlled IOP in patients with controlled POAG treated with PRO-122 was maintained both in relation to the initial controlled IOP of the study and when compared with KOF in the B sequence. Finally, the treatment with PRO-122 demonstrated similar safety and tolerability to KOF. FUNDING: Laboratorios Sophia, S.A. de C.V. (Zapopan, Jalisco, México). TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03257813 (registered retrospectively).