Randomized Clinical Trial for Early Postoperative Complications of Ex-PRESS Implantation versus Trabeculectomy: Complications Postoperatively of Ex-PRESS versus Trabeculectomy Study (CPETS).
ABSTRACT: We compared early postoperative complications between trabeculectomy and Ex-PRESS implantation. Enrolled patients with 39 primary open-angle or 25 exfoliative glaucoma were randomly assigned to receive trabeculectomy (trabeculectomy group) or Ex-PRESS implantation (Ex-PRESS group). Primary outcomes were early postoperative complications, including postoperative anterior chamber inflammation, frequencies of hyphema, flat anterior chamber, choroidal detachment, hypotonic maculopathy, and the change of visual acuity. The postoperative flare values in trabeculectomy group were higher than those in the Ex-PRESS group (overall, P = 0.004; and 10 days, P = 0.02). Hyphema occurred significantly more frequently in the trabeculectomy group (P = 0.0025). There were no significant differences of the other primary outcomes between the two groups. Additionally, duration of anterior chamber opening was significantly shorter in the Ex-PRESS group (P = 0.0002) and the eyes that had iris contact with Ex-PRESS tube had significantly shallower anterior chambers than did the eyes without the iris contact (P = 0.013). The Ex-PRESS implantation prevented early postoperative inflammation and hyphema in the anterior chamber and shortened the duration of anterior chamber opening. Iris contact with the Ex-PRESS tube occurred more frequently in eyes with open-angle glaucoma and shallow anterior chambers.
Project description:<h4>Objective</h4>To evaluate the efficacy and safety of Ex-PRESS implantation (Ex-PRESS) compared to trabeculectomy in the treatment of patients with open-angle glaucoma (OAG).<h4>Methods</h4>A 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.<h4>Results</h4>A 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.<h4>Conclusion</h4>In 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.
Project description:Purpose:Accumulating 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. Methods:Randomized 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. Results:8 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). Conclusion:For 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.
Project description:PURPOSE: To evaluate the efficacy and safety of EX-PRESS implantation compared with trabeculectomy for uncontrolled open-angle glaucoma. METHODS: Pertinent 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. RESULTS: Four 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). CONCLUSIONS: EX-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.
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.
Project description:To compare intraocular pressure (IOP) over time after standard trabeculectomy vs Ex-PRESS implantation in patients with bilateral primary open-angle glaucoma (POAG).Prospective, randomised study.This 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.Thirty 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.Trabeculectomy 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.
Project description:Trabeculectomy has been the traditional primary surgical therapy for open-angle glaucoma. While trabeculectomy is effective in lowering intraocular pressure, complications associated with the procedure have motivated the development of alternative techniques and devices, including the EX-PRESS Glaucoma Filtration Device. This review describes the efficacy, safety, complication rates, and potential advantages and disadvantages of the EX-PRESS Glaucoma Filtration Device. EX-PRESS implantation is technically simpler compared with that of trabeculectomy, with fewer surgical steps. Vision recovery has been more rapid after EX-PRESS implantation compared with trabeculectomy. Intraocular pressure variation is lower during the early postoperative period, indicating a more predictable procedure. While efficacy of the EX-PRESS implant has been comparable to trabeculectomy, postoperative complications appear less common after EX-PRESS implantation compared with trabeculectomy. The EX-PRESS Glaucoma Filtration Device appears to be safe and effective in the surgical management of open-angle glaucoma.
Project description:To compare effectiveness of fornix- and limbal-based conjunctival flaps in trabeculectomy surgery.Systematic review.Setting: CENTRAL, MEDLINE, LILACS, ISRCTN registry, ClinicalTrials.gov, WHO, and ICTRP were searched to identify eligible randomized controlled trials (RCTs).RCTs in which benefits and complications of fornix- vs limbal-based trabeculectomy for glaucoma were compared in adult glaucoma patients.We followed Cochrane methodology for data extraction.Proportion of failed trabeculectomies at 24 months, defined as the need for repeat surgery or uncontrolled intraocular pressure (IOP) >22 mm Hg, despite topical/systemic medications.The review included 6 trials with a total of 361 participants, showing no difference in effectiveness between fornix-based vs limbal-based trabeculectomy surgery, although with a high level of uncertainty owing to low event rates. In the fornix-based and limbal-based surgery, mean IOP at 12 months was similar, with ranges of 12.5-15.5 mm Hg and 11.7-15.1 mm Hg, respectively. Mean difference was 0.44 mm Hg (95% CI -0.45 to 1.33) and 0.86 mm Hg (95% CI -0.52 to 2.24) at 12 and 24 months of follow-up, respectively. Mean number of postoperative glaucoma medications was similar between the 2 groups. Mean difference was 0.02 (95% CI -0.15 to 0.19) at 12 months. As far as postoperative complications, an increased risk of shallow anterior chamber was observed in the limbal-based group.Similar efficacy of trabeculectomy surgery with respect to bleb failure or IOP control was observed in both types of conjunctival flap incisions. A significant difference was detected in the risk of postoperative shallow anterior chamber, which was increased in the limbal-based group.
Project description:We assess the efficacy and safety of canaloplasty and trabeculectomy for treatment of glaucoma. We searched the China National Knowledge Infrastructure, PubMed, Web of Science, and WanFang databases for potentially eligible studies. Pooled risk ratio (RR) with 95% confidence interval (CI) was calculated using random- or fixed-effect models if appropriate. Eight studies were included for meta-analysis. There was no difference in intraocular pressure at 6 months (WMD = 0.97, 95%CI: -0.48-2.41). Intraocular pressure in canaloplasty group 12 months after operation was higher than in trabeculectomy group (WMD = 1.90, 95%CI: 0.12-3.69), P < 0.05). The canaloplasty group showed higher success rate than trabeculectomy group (RR = 0.86, 95%CI: 0.77-0.97). The canaloplasty group was more likely to have hyphema (RR = 2.96, 95%CI: 1.51-5.83), P < 0.05) than trabeculectomy group (RR = 0.24, 95, CI(0.06-0.89), P < 0.05]. The incidence of and hypotony and postoperative choroid abnormalities in canaloplasty group was significantly lower than that in trabeculectomy group (RR = 0.30, 95%CI: 0.11-0.83; RR = 0.24, 95%CI: 0.09-0.66), P < 0.05). Both trabeculectomy and canaloplasty can significantly reduce the intraocular pressure in glaucoma patients at 12 months after operation, trabeculectomy leads a more marked IOP decrease than canaloplasty at the cost of a higher complication rate and more demanding for postoperative care.
Project description:The Uveitis Glaucoma Hyphema (UGH) syndrome is a triad that in the new era of phacoemulsification cataract surgeries is considered uncommon. One of the risk factor for this complication is implant a one piece intra ocular lens in the anterior chamber. We present a case of one piece intraocular lens that was implanted in the anterior chamber and caused to UGH. The lens chafing the iris and created an unusual appearance of iris transillumination defects in the shape of intra ocular lens.
Project description:INTRODUCTION: The present study aimed to evaluate the effects of intravitreal ranibizumab (IVR) as adjunctive treatment for trabeculectomy with mitomycin C (TMC) in neovascular glaucoma (NVG). METHODS: This is a prospective study of 15 eyes from 14 consecutive patients with NVG carried out between December 2008 and December 2009. Each eye received IVR (0.5 mg/0.05 ml) 1 week before TMC. Trabeculectomy was performed with fornix-based conjunctival flap method. After TMC, additional panretinal photocoagulation (PRP), subconjunctival five fluorouracil injection, and bleb needling may be performed if indicated. The primary outcome measures were post-TMC intraocular pressure (IOP) and numbers of anti-glaucoma medication. The secondary outcome measures included of the recurrence of neovascularization at iris (NVI) and complications. RESULTS: Six eyes underwent adequate PRP before IVR but iris rubeosis still persisted. All eyes showed regression of NVI within 1 week after IVR. After TMC, mean IOP was significantly decreased from 37.9 mmHg preoperatively to 15.6 mmHg postoperatively (P < 0.001). Intraoperative hyphema was observed in four eyes. Thirteen eyes had controlled IOP (<21 mmHg) at last visit among which only one eye needed anti-glaucoma medication. Two eyes were considered as failure and needed further intervention. Visual acuity was maintained or improved in eight eyes. Recurrent NVI was not detected. All patients were symptom-free at last visit. Mean follow-up was 39 weeks. CONCLUSION: IVR is an effective treatment adjunctive to TMC for NVG. The occurrence of intraoperative complications was low and the short-term outcomes after trabeculectomy were favorable.