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      Ex-PRESS Implantation Versus Trabeculectomy in Uncontrolled Glaucoma: A Meta-Analysis

      1 , 1 , 1 , 1 , *

      PLoS ONE

      Public Library of Science

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          Abstract

          Objective

          To evaluate the efficacy and tolerability of Ex-PRESS implantation (Ex-Press) compared with trabeculectomy (Trab) in the treatment of patients with uncontrolled glaucoma.

          Methods

          A comprehensive literature meta-analysis was performed according to the Cochrane Collaboration methodology to identify controlled clinical trials comparing Ex-Press with Trab. Efficacy estimates were measured by weight mean difference (WMD) for the percentage intraocular pressure (IOP) reduction from baseline to end-point, odds ratio (OR) for complete success, and qualified success rates. Tolerability estimates were measured by OR for adverse events. All outcomes were reported with a 95% confidence interval (CI). Data were synthesized by Stata 11.0 SE for Windows.

          Results

          Eight controlled clinical trials meeting the predefined criteria were included in the meta-analysis. A total of 605 eyes from 559 patients with medically uncontrolled glaucoma were included. The weighted mean difference of the percentage IOP reduction from baseline was 2.33 (95% confidence interval: −2.59–7.24) when comparing Ex-Press with Trab. Ex-Press was associated with numerically greater, but nonsignificant, IOP lowering efficacy than Trab. The pooled odds ratio comparing Ex-Press with Trab were 0.93 (0.39, 2.23) for the complete success rate and 1.00 (0.39, 2.56) for the qualified success rate. Ex-Press was associated with a significantly lower frequency of hypotony and hyphema than Trab, with pooled ORs of 0.29 (0.13, 0.65) and 0.36 (0.13, 0.97), respectively.

          Conclusion

          Ex-Press was associated with equivalent efficacy to Trab in lowering IOP. Comparable proportions of patients reached the IOP target with Ex-Press and Trab. Ex-Press was better tolerated than Trab.

          Related collections

          Most cited references 17

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          Novel glaucoma procedures: a report by the American Academy of Ophthalmology.

          To review the published literature and summarize clinically relevant information about novel, or emerging, surgical techniques for the treatment of open-angle glaucoma and to describe the devices and procedures in proper context of the appropriate patient population, theoretic effects, advantages, and disadvantages. Devices and procedures that have US Food and Drug Administration clearance or are currently in phase III clinical trials in the United States are included: the Fugo blade (Medisurg Ltd., Norristown, PA), Ex-PRESS mini glaucoma shunt (Alcon, Inc., Hunenberg, Switzerland), SOLX Gold Shunt (SOLX Ltd., Boston, MA), excimer laser trabeculotomy (AIDA, Glautec AG, Nurnberg, Germany), canaloplasty (iScience Interventional Corp., Menlo Park, CA), trabeculotomy by internal approach (Trabectome, NeoMedix, Inc., Tustin, CA), and trabecular micro-bypass stent (iStent, Glaukos Corporation, Laguna Hills, CA). Literature searches of the PubMed and the Cochrane Library databases were conducted up to October 2009 with no date or language restrictions. These searches retrieved 192 citations, of which 23 were deemed topically relevant and rated for quality of evidence by the panel methodologist. All studies but one, which was rated as level II evidence, were rated as level III evidence. All of the devices studied showed a statistically significant reduction in intraocular pressure and, in some cases, glaucoma medication use. The success and failure definitions varied among studies, as did the calculated rates. Various types and rates of complications were reported depending on the surgical technique. On the basis of the review of the literature and mechanism of action, the authors also summarized theoretic advantages and disadvantages of each surgery. The novel glaucoma surgeries studied all show some promise as alternative treatments to lower intraocular pressure in the treatment of open-angle glaucoma. It is not possible to conclude whether these novel procedures are superior, equal to, or inferior to surgery such as trabeculectomy or to one another. The studies provide the basis for future comparative or randomized trials of existing glaucoma surgical techniques and other novel procedures. Copyright © 2011 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.
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            Comparison of trabeculectomy with Ex-PRESS miniature glaucoma device implanted under scleral flap.

            To evaluate the Ex-PRESS miniature implant (Model R 50) placed under partial-thickness scleral flap compared with standard trabeculectomy. In this retrospective comparative series of 100 eyes, we compared 50 eyes in 49 patients treated with the Ex-PRESS miniature glaucoma implant under a scleral flap with 50 matched control eyes in 47 patients treated with trabeculectomy. Success was defined as intraocular pressure (IOP) > or =5 mm Hg and < or =21 mm Hg, with or without glaucoma medications, without further glaucoma surgery or removal of implant. Early postoperative hypotony was defined as IOP <5 mm Hg during the first postoperative week. The average follow-up was 10.8 months (range 3.5 to 18) for the Ex-PRESS group and 11.2 months (range 3 to 15) for the trabeculectomy group. Although the mean IOP was significantly higher in the early postoperative period in the Ex-PRESS group compared with the trabeculectomy group, the reduction of IOP was similar in both groups after 3 months. The number of postoperative glaucoma medications in both groups was not significantly different. Kaplan-Meier survival curve analysis showed no significant difference in success between the 2 groups (P=0.594). Early postoperative hypotony and choroidal effusion were significantly more frequent after trabeculectomy compared with Ex-PRESS implant under scleral flap (P<0.001). The Ex-PRESS implant under a scleral flap had similar IOP-lowering efficacy with a lower rate of early hypotony compared with trabeculectomy.
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              Implantation of a miniature glaucoma device under a scleral flap.

              To test the safety and efficacy of the Ex-PRESS miniature glaucoma device when it is implanted under a scleral flap instead of under the conjunctiva as it was originally suggested. Between November 2000 and February 2003, the Ex-PRESS implant was inserted in 24 eyes of 23 patients with severe open angle glaucoma. Sixteen eyes of the 24 (66%) had had previous failed filtering surgery. The remaining 8 eyes (33%) were high risk for failures cases. A 5 x 5 mm limbal-based, 50% depth, scleral flap was raised into clear cornea. The Ex-PRESS implant was inserted into the anterior chamber under the scleral flap at the limbus. The scleral flap was securely sutured back, as is done in trabeculectomy operations. The intraocular pressure was significantly reduced from 27.2 +/- 7.1 mm Hg pre-operatively to 14.5 +/- 5.0 mm Hg at 12 months (n = 21) and 14.2 +/- 4.2 mm Hg at 24 months (n = 8). Postoperatively, only two patients needed anti-glaucoma medications to keep the IOP below 21 mm Hg. The Ex-PRESS device was found to be safe and effective with few complications when it is implanted under a scleral flap even in the high-risk patients studied.
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                Author and article information

                Contributors
                Role: Editor
                Journal
                PLoS One
                PLoS ONE
                plos
                plosone
                PLoS ONE
                Public Library of Science (San Francisco, USA )
                1932-6203
                2013
                31 May 2013
                : 8
                : 5
                Affiliations
                [1 ]Zhongshan Ophthalmic Center, State Key Laboratory of Ophthalmology, Sun Yat-Sen University, Guangzhou, People's Republic of China
                Zhongshan Ophthalmic Center, China
                Author notes

                Competing Interests: The authors have declared that no competing interests exist.

                Conceived and designed the experiments: WW MWZ WBH XLZ. Performed the experiments: WW MWZ WBH XLZ. Analyzed the data: WW MWZ WBH XLZ. Contributed reagents/materials/analysis tools: WW MWZ WBH XLZ. Wrote the paper: WW MWZ.

                Article
                PONE-D-13-05862
                10.1371/journal.pone.0063591
                3669314
                23741296

                This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                Page count
                Pages: 6
                Funding
                This work was supported in whole or in part by the National Natural Science Foundation of China (81170849), Guangdong Provincial Natural Science Foundation (S2011020002401), and the Fundamental Research Funds of State Key Laboratory of Ophthalmology (2011C02). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
                Categories
                Research Article
                Mathematics
                Statistics
                Biostatistics
                Statistical Methods
                Medicine
                Clinical Research Design
                Meta-Analyses
                Statistical Methods
                Non-Clinical Medicine
                Health Care Policy
                Treatment Guidelines
                Ophthalmology
                Glaucoma
                Surgery
                Ophthalmology

                Uncategorized

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