Randomized Clinical Trial for Early Postoperative Complications of Ex-PRESS Implantation versus Trabeculectomy: Complications Postoperatively of Ex-PRESS versus Trabeculectomy Study (CPETS).
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ABSTRACT:
SUBMITTER: Arimura S
PROVIDER: S-EPMC4869117 | biostudies-other | 2016
REPOSITORIES: biostudies-other
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Project description:We compared complications between Ex-PRESS implantation and trabeculectomy for 2 years after surgery. Sixty-four open-angle glaucoma eyes were randomly assigned to treatment with trabeculectomy (n?=?32) or Ex-PRESS implantation (n?=?32). The primary outcomes were postoperative complications, including reduction of the endothelial cell density (ECD) of the cornea, cataract progression and the frequency of other late postoperative complications. The Ex-PRESS group had significantly greater reduction of postoperative corneal ECD than the trabeculectomy group did at 2 years after surgery (P?=?0.026). Among the corneal areas measured using specular microscopy, the superior area, where the Ex-PRESS tube was inserted, had significantly more severe corneal ECD reduction than the inferior area after 2 years (-17.6% in superior area and -11.7% in inferior area, P?=?0.04). More cataract progression occurred in the trabeculectomy group than in the Ex-PRESS group (P?=?0.04). Twelve eyes (37.5%) in the trabeculectomy group and 4 eyes (12.5%) in the Ex-PRESS group underwent cataract surgery (P?=?0.019). The total number of other postoperative complications between 3 months and 2 years was significantly higher in the trabeculectomy group than in the Ex-PRESS group (P?=?0.02). Although Ex-PRESS implantation might be associated with an increased rate of corneal endothelial cell loss compared with trabeculectomy, it is beneficial for preventing cataract progression after filtering surgery.
| S-EPMC6212395 | biostudies-literature
Project description:ObjectiveTo evaluate the efficacy and safety of Ex-PRESS implantation (Ex-PRESS) compared to trabeculectomy in the treatment of patients with open-angle glaucoma (OAG).MethodsA comprehensive literature search using the Cochrane Methodology Register to identify randomized controlled clinical trials (RCCTs) comparing Ex-PRESS to trabeculectomy in patients with OAG. Efficacy estimates were measured by weighted mean difference (WMD) for the percentage intraocular pressure reduction (IOPR%) from baseline to end-point, and odds ratios (OR) for the complete success rate and postoperative interventions. Safety estimates were measured by OR for postoperative complications. Statistical analysis was performed using the RevMan 5.1 software.ResultsA total of four RCCTs were selected for this meta-analysis, including 215 eyes of 200 patients (110 eyes in the Ex-PRESS group, 105 eyes in the trabeculectomy group). There was no significant difference between Ex-PRESS and trabeculectomy in the IOPR% (WMD = 3.15; 95% confidence interval (CI), -6.17-12.47; P = 0.51). The pooled OR comparing Ex-PRESS to trabeculectomy for the complete success rate at one year after surgery were in favor of Ex-PRESS (OR = 2.93; 95% CI, 1.39-6.16; P = 0.005). The Ex-PRESS procedure was found to be associated with lower number of postoperative interventions (OR = 0.23; 95% CI, 0.07-0.81; P = 0.02) and with a significantly lower frequency of hyphema than trabeculectomy (OR = 0.21; 95% CI, 0.05-0.85; P = 0.03), whereas other complications did not differ statistically.ConclusionIn OAG, Ex-PRESS and trabeculectomy provided similar IOP control, but Ex-PRESS was more likely to achieve complete success, with fewer postoperative interventions. Complication rates were similar for the two types of surgery, except for a lower frequency of hyphema in the Ex-PRESS group.
| S-EPMC3900454 | biostudies-literature
Project description:PurposeTo evaluate the efficacy and safety of EX-PRESS implantation compared with trabeculectomy for uncontrolled open-angle glaucoma.MethodsPertinent randomized controlled trials were identified through systematic searches of the PubMed, EMBASE, and Cochrane Library. The efficacy measures utilized were the weighted mean differences (WMDs) for the intraocular pressure reduction (IOPR), the reduction in glaucoma medications, the change of visual acuity, and the relative risks (RRs) for operative success rates. The safety measures utilized were RRs for postoperative complications. The pooled effects were calculated using the random-effects model.ResultsFour randomized controlled trials of 292 eyes were included in this meta-analysis. The WMDs of the IOPR comparing the EX-PRESS with trabeculectomy were -0.25 (95% Cl: -3.61 to 3.11) at 6 month, 0.053 (-4.31 to 4.42) at 12 months, 0.81 (-4.06 to 5.67) at 24 months, and 0.20 (-2.11 to 2.51) at final follow-up. There was no statistically significance for IOPR at any point after surgery. There were also no significant differences in the reduction in glaucoma medications or visual acuity between the groups. The pooled relative risks comparing EX-PRESS with Trabeculectomy were 1.36 (1.11 to 1.66) for the complete operative success rate and 1.05 (0.94 to 1.17) for the qualified operative success rate. EX-PRESS and Trabeculectomy were associated with similar incidences in most complications with the exception of hyphema, with pooled RR being 0.18 (0.046 to 0.66).ConclusionsEX-PRESS implantation and trabeculectomy have similar efficacy in IOP-lowering, medication reduction, vision recovery, and qualified operative success rates. EX-PRESS associated with higher rates of complete operative success and fewer hyphema than with Trabeculectomy. However, these should be interpreted with caution because of the inherent limitations of the included studies.
| S-EPMC4074054 | biostudies-literature
Project description:PurposeAccumulating studies comparing the efficacy and safety of trabeculectomy and EX-PRESS implantation in open-angle glaucoma (OAG) report inconsistent findings. Thus, we conducted the updated meta-analysis to clarify the issue.MethodsRandomized controlled trials (RCTs) were selected through search of databases PubMed, Web of Science, Embase, and the Cochrane Library from their inception up until November 2018. The pooled mean difference (MD) for intraocular pressure reduction (IOPR) and antiglaucoma medication reduction, odds ratio (OR) for operative success, complication, and postoperative intervention was calculated using the random effects model.Results8 RCTs were enrolled, including 223 eyes in the EX-PRESS group and 217 eyes in the trabeculectomy group. EX-PRESS device implantation had a better IOPR% at 12 months postoperatively (MD = 8.9, 95% confidence interval (CI) = 2.5-15.3, P=0.006). There was no statistically significant difference in the antiglaucoma medication reduction (MD = 6.01, 95% CI = -4.13-16.15, P=0.25) and qualified success (P > 0.05). Statistically higher complete success at 1 year postoperatively was found in the EX-PRESS group (OR = 3.26, 95% CI = 1.24-8.55, P=0.02). EX-PRESS was associated with a lower frequency of increased IOP (OR = 0.15, 95% CI = 0.03-0.93, P=0.04) and hyphema (OR = 0.20, 95% CI = 0.05-0.74, P=0.02). Less postoperative intervention was needed in the EX-PRESS group (OR = 0.43, 95% CI = 0.20-0.94, P=0.04).ConclusionFor OAG patients, EX-PRESS implantation provided better efficacy in IOP control and complete success at 1 year postoperatively, with fewer increased IOP and hyphema as well as postoperative interventions. EX-PRESS device and trabeculectomy were similar in the qualified success and antiglaucoma medication reduction.
| S-EPMC6778870 | biostudies-literature
Project description:The aim of this study was to compare surgical and refractive outcomes between phacotrabeculectomy (P-Trab) and phaco with Ex-PRESS (P-Ex-PRESS) for glaucoma at a 6-month follow-up. This prospective randomized controlled trial included 81 eyes; 43 eyes (53%) and 38 eyes (47%) were assigned to the P-Ex-PRESS and P-Trab groups, respectively. Refraction, intraocular pressure (IOP), and best-corrected visual acuity were measured. Refractive change was analyzed using the cylinder's magnitude, and polar analysis assessed the change in the trend of astigmatism [with-the-rule, against-the-rule (ATR), oblique (OBL)], evaluating mean astigmatism in centroid form. All patients showed a statistically significant postoperative decrease in IOP (P < 0.05). There were no differences between the groups in terms of postoperative IOP and visual outcomes or in astigmatism preoperatively or postoperatively (P = 0.61, P = 0.74). In both groups, the mean preoperative and postoperative astigmatism were ATR and OBL, respectively. Preoperative and postoperative centroids in the P-Ex-PRESS group were 0.44 ± 1.32 D at 177° and 0.35 ± 1 D at 8°, respectively, (P = 0.5) and in the P-Trab group were 0.16 ± 1.5 D at 141° and 0.39 ± 1.38 D at 29°, respectively (P = 0.38). Both P-Ex-PRESS and P-Trab showed comparable antihypertensive efficacy in treating open-angle glaucoma over 6 months. Preoperative and postoperative astigmatism did not differ between groups. The groups showed comparable results for final visual acuity.
| S-EPMC7865719 | biostudies-literature
Project description:BackgroundTo compare the efficacy of Ex-PRESS implantation versus trabeculectomy combined with phacoemulsification.MethodsA retrospective 12-month study on patients with coincident primary open-angle glaucoma (POAG) and cataract. The patients underwent combined phacoemulsification and Ex-PRESS implant (Phaco-ExPRESS, n = 35) or phacotrabeculectomy (Phaco-Trab, n = 35). The morphological structures of the filtering bleb were examined by slit-lamp, anterior segment optical coherence tomography (AS-OCT) and in vivo confocal microscopy (IVCM). Complete success was defined as postoperative intraocular pressure (IOP) < 18 mmHg without the use of anti-glaucoma medication. Qualified success was defined as postoperative IOP < 18 mmHg with or without anti-glaucoma medications. The data were collected preoperatively and postoperatively at 2 weeks, 1 month, 3 months, 6 months, and 12 months.ResultsNo significant difference in the variables such as age, IOP and perimetry was found between the groups of Phaco-ExPRESS and Phaco-Trab. At the one-year postoperative visit for filtering blebs, Phaco-ExPRESS increased the mean area of epithelial microcysts significantly from 0.10 ± 0.05 to 0.20 ± 0.09 μm2 per μm2, while Phaco-Trab decreased the mean area significantly from 0.08 ± 0.04 to 0.04 ± 0.06 μm2 per μm2. Notably, the hyperreflective dots detected by IVCM decreased by 84.9% in Phaco-ExPRESS but increased by 36.3% in Phaco-Trab. The hyperreflective dots were further identified as neutrophil- and monocyte-like cells. The number of these cells were negatively correlated with the microcysts area (r = - 0.7, P < 0.01) but positively associated with the grade of connective tissue (r = 0.5, P < 0.01). By creating different microstructural changes in the filtering blebs, Phaco-ExPRESS produced a higher complete success rate (84.9% vs. 41.2%, P < 0.01) and significant decrease in the number of anti-glaucoma medications (P < 0.01) when compared with those in Phaco-Trab. However, the qualified success showed no significant difference between the two groups (100.0% vs. 91.2%, P = 0.24).ConclusionsAt the one-year follow-up, Phaco-ExPRESS generated better filtering bleb with larger area of microcysts, looser connective tissues, and less inflammation than that of Phaco-Trab, providing adequate IOP control and less IOP-lowering medications. These findings indicate that Phaco-ExPRESS could be more preferred than Phaco-Trab for the treatment of patients with coincident POAG and cataract.
| S-EPMC8841063 | biostudies-literature
Project description:PurposeTo compare intraocular pressure (IOP) over time after standard trabeculectomy vs Ex-PRESS implantation in patients with bilateral primary open-angle glaucoma (POAG).DesignProspective, randomised study.Patients and methodsThis study included adult patients with bilateral POAG necessitating surgery. Each patient underwent trabeculectomy in one eye and Ex-PRESS implantation under a scleral flap in the other eye according to randomised contralateral allocations. Efficacy was assessed by IOP values and success rates (IOP threshold and/or need for topical glaucoma medication) during 30 months. Statistical analysis included Generalised Estimate Equation and Cox Survival models, and paired t-tests.ResultsThirty eyes of 15 patients were studied for a mean of 23.6 months (SD, ± 6.9). At the last follow-up visit, mean pre-operative IOP decreased from 31.1 (± 14.2) to 16.2 (± 1.5) mm Hg after trabeculectomy, and from 28.1 (± 9.0) to 15.7 (± 1.8) mm Hg after Ex-PRESS implantation (P=0.001). The mean number of anti-glaucoma medicines prescribed at the last follow-up decreased from 3.7 pre-operatively (both groups) to 0.9 after trabeculectomy vs 0.3 after Ex-PRESS implantation (P=0.001). Complete success rates (5<IOP<18 mm Hg without medications) were higher with Ex-PRESS compared with trabeculectomy (P=0.0024). Postoperative complications were more frequent after trabeculectomy (33%) compared with Ex-PRESS (20%), with four trabeculectomy eyes (27%) needing postoperative interventions, compared with none with Ex-PRESS.ConclusionsTrabeculectomy and Ex-PRESS implantation provided similar IOP control, but the Ex-PRESS group had a lower rate of complications, fewer postoperative interventions, and needed less glaucoma medications.
| S-EPMC3351049 | biostudies-literature
Project description:PurposeTo describe postoperative complications encountered in the Primary Tube Versus Trabeculectomy (PTVT) Study during 5 years of follow-up.DesignMulticenter randomized clinical trial.ParticipantsA total of 242 eyes of 242 patients with medically uncontrolled glaucoma and no previous incisional ocular surgery, including 125 patients in the tube group and 117 patients in the trabeculectomy group.MethodsPatients were enrolled at 16 clinical centers and randomly assigned to treatment with a tube shunt (350-mm2 Baerveldt glaucoma implant) or trabeculectomy with mitomycin C (MMC, 0.4 mg/ml for 2 minutes).Main outcome measuresSurgical complications, reoperations for complications, visual acuity, and cataract progression.ResultsEarly postoperative complications occurred in 24 patients (19%) in the tube group and 40 patients (34%) in the trabeculectomy group (P = 0.013). Late postoperative complications developed in 27 patients (22%) in the tube group and 32 patients (27%) in the trabeculectomy group (P = 0.37). Serious complications producing vision loss and/or requiring a reoperation were observed in 3 patients (2%) in the tube group and 9 patients (8%) in the trabeculectomy group (P = 0.11). Cataract progression was seen in 65 patients (52%) in the tube group and 52 patients (44%) in the trabeculectomy group (P = 0.30). Surgical complications were not associated with a higher rate of treatment failure (P = 0.61), vision loss (P = 1.00), or cataract progression (P = 0.77) CONCLUSIONS: A large number of surgical complications were observed in the PTVT Study, but most were transient and self-limited. The incidence of early postoperative complications was higher following trabeculectomy with MMC than with tube shunt surgery. The rates of late postoperative complications, serious complications, and cataract progression were similar with both surgical procedures after 5 years of follow-up. Surgical complications did not increase the risk of treatment failure, vision loss, or cataract progression.
| S-EPMC9691562 | biostudies-literature
Project description:AimTo compare the effectiveness of postoperative adjunctive use of subconjunctival bevacizumab in altering the outcome of primary trabeculectomy in terms of sustained lowering of intraocular pressure (IOP) and reduction of postoperative bleb vascularization and fibrosis.MethodsA prospective, one center, randomized, placebo-control study. Fifty-nine patients (59 eyes) with uncontrolled IOP under maximal tolerated medical treatment (MTMT) were recruited. A primary trabeculectomy with mitomycin C (MMC) was done and the patients were randomized to either postoperative subconjunctival injection of bevacizumab (1.25 mg/0.05 mL) or balanced salt solution (BSS). Forty-seven patients (47 eyes) completed at least one year of follow up and were included in the study. The main outcome measure was the IOP, and secondary outcome measures include bleb morphology, vascularization, and fibrosis, as well as the need for glaucoma medications and 5-fluorouracil (5-FU) needling.ResultsAt 1-year follow up, there was no significant difference between groups for IOP (P=0.65), bleb morphology (P=0.65), and the need for glaucoma medications (P=0.65) or 5-FU needling requirements (P=0.11). However, the bevacizumab group had a higher rate of success results, lower use of glaucoma medications after surgery, and optimal bleb aspect in more patients, but more 5-FU needling procedures required.ConclusionA bigger sample size is needed in order to determine whether the differences found in the bevacizumab group are statistically significant.
| S-EPMC6796091 | biostudies-literature
Project description:BackgroundTo evaluate the effectiveness of neuromuscular electrical stimulation (NMES) in early rehabilitation of patients with postoperative complications after cardiovascular surgery.Methods37 patients (25 men and 12 women) aged 45 to 70 years with postoperative complications after cardiovascular surgery were included in the study. Eighteen patients underwent NMES daily since postoperative day 3 until discharge in addition to standard rehabilitation program (NMES group), and 19 patients underwent standard rehabilitation program only (non-NMES group). The primary outcome was the knee extensors strength at discharge in NMES group and in control. Secondary outcomes were the handgrip strength, knee flexor strength, and cross-sectional area (CSA) of the quadriceps femoris in groups at discharge.ResultsBaseline characteristics were not different between the groups. Knee extensors strength at discharge was significantly higher in the NMES group (28.1 [23.8; 36.2] kg on the right and 27.45 [22.3; 33.1] kg on the left) than in the non-NMES group (22.3 [20.1; 27.1] and 22.5 [20.1; 25.9] kg, respectively; P < .001). Handgrip strength, knee flexor strength, quadriceps CSA, and 6 minute walk distance at discharge in the groups had no significant difference.ConclusionsThis pilot study shows a beneficial effect of NMES on muscle strength in patients with complications after cardiovascular surgery. The use of NMES showed no effect on strength of non-stimulated muscle, quadriceps CSA, and distance of 6-minute walk test at discharge.Further blind randomized controlled trials should be performed with emphasis on the effectiveness of NEMS in increasing muscle strength and structure in these patients.
| S-EPMC7572009 | biostudies-literature