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      Comparison of a second-generation trabecular bypass (iStent inject) to ab interno trabeculectomy (Trabectome) by exact matching

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          Abstract

          Purpose

          To achieve a highly balanced comparison of trabecular bypass stenting (IS2, iStent inject) with ab interno trabeculectomy (T, Trabectome) by exact matching.

          Methods

          Fifty-three IS2 eyes were matched to 3446 T eyes. Patients were matched using exact matching by baseline intraocular pressure (IOP), the number of glaucoma medications, and glaucoma type, and using nearest neighbor matching by age. Individuals without a close match were excluded. All surgeries were combined with phacoemulsification.

          Results

          A total of 78 eyes (39 in each group) could be matched as exact pairs with a baseline IOP of 18.3 ± 5.1 mmHg and glaucoma medications of 2.7 ± 1.2 in each. IOP in IS2 was reduced to 14.6 ± 4.2 mmHg at 3 months and in T to a minimum of 13.1 ± 3.2 mmHg at 1 month. In IS2, IOP began to rise again at 6 months, eventually exceeding baseline. At 24 months, IOP in IS2 was 18.8 ± 9.0 mmHg and in T 14.2 ± 3.5 mmHg. IS2 had a higher average IOP than T at all postoperative visits ( p < 0.05 at 1, 12, 18 months). Glaucoma medications decreased to 2.0 ± 1.5 in IS2 and to 1.5 ± 1.4 in T.

          Conclusion

          T resulted in a larger and sustained IOP reduction compared with IS2 where a rebound occurred after 6 months to slightly above preoperative values.

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          Most cited references38

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          Randomized evaluation of the trabecular micro-bypass stent with phacoemulsification in patients with glaucoma and cataract.

          To assess the safety and efficacy of the iStent trabecular micro-bypass stent (Glaukos Corporation, Laguna Hills, CA) in combination with cataract surgery in subjects with mild to moderate open-angle glaucoma. Prospective, randomized, open-label, controlled, multicenter clinical trial. A total of 240 eyes with mild to moderate open-angle glaucoma with intraocular pressure (IOP) ≤24 mmHg controlled on 1 to 3 medications were randomized to undergo cataract surgery with iStent implantation (treatment group) or cataract surgery only (control). Fifty additional subjects were enrolled to undergo cataract surgery with iStent implantation under protocol expansion. Data in this report are based on the first 240 eyes enrolled. Implantation of the iStent trabecular micro-bypass stent in conjunction with cataract surgery or cataract surgery only. The primary efficacy measure was unmedicated IOP ≤21 mmHg at 1 year. A secondary measure was unmedicated IOP reduction ≥20% at 1 year. Safety measures included best-corrected visual acuity (BCVA), slit-lamp observations, complications, and adverse events. The study met the primary outcome, with 72% of treatment eyes versus 50% of control eyes achieving the criterion (P<0.001). At 1 year, IOP in both treatment groups was statistically significantly lower from baseline values. Sixty-six percent of treatment eyes versus 48% of control eyes achieved ≥20% IOP reduction without medication (P = 0.003). The overall incidence of adverse events was similar between groups with no unanticipated adverse device effects. Pressure reduction on fewer medications was clinically and statistically significantly better 1 year after stent plus cataract surgery versus cataract surgery alone, with an overall safety profile similar to that of cataract surgery alone. Copyright © 2011 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.
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            Cem: Coarsened Exact Matching in Stata

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              Prospective, Randomized, Controlled Pivotal Trial of iStent inject Trabecular Micro-Bypass in Primary Open-Angle Glaucoma and Cataract: Two-Year Results

              Evaluate the safety and effectiveness of an ab interno implanted (iStent inject) Trabecular Micro-Bypass System (Glaukos Corporation, San Clemente, CA) in combination with cataract surgery in subjects with mild to moderate primary open-angle glaucoma (POAG).
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                Author and article information

                Contributors
                loewen.nils@gmail.com
                Journal
                Graefes Arch Clin Exp Ophthalmol
                Graefes Arch Clin Exp Ophthalmol
                Graefe's Archive for Clinical and Experimental Ophthalmology
                Springer Berlin Heidelberg (Berlin/Heidelberg )
                0721-832X
                1435-702X
                22 September 2020
                22 September 2020
                2020
                : 258
                : 12
                : 2775-2780
                Affiliations
                [1 ]GRID grid.8379.5, ISNI 0000 0001 1958 8658, Department of Ophthalmology, , University of Würzburg, ; Josef-Schneider-Straße, 11 97080 Würzburg, Germany
                [2 ]GRID grid.412581.b, ISNI 0000 0000 9024 6397, Department of Ophthalmology, , University Witten/Herdecke, ; Wuppertal, Germany
                Author information
                http://orcid.org/0000-0001-7167-1213
                Article
                4933
                10.1007/s00417-020-04933-z
                7677264
                32960322
                fd248caa-8979-48ca-8ade-ac8293bfe5a4
                © The Author(s) 2020

                Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.

                History
                : 1 December 2019
                : 7 September 2020
                : 10 September 2020
                Funding
                Funded by: University of Wuerzburg
                Award ID: Departmental Grant
                Categories
                Glaucoma
                Custom metadata
                © Springer-Verlag GmbH Germany, part of Springer Nature 2020

                Ophthalmology & Optometry
                glaucoma surgery,istent,trabecular bypass stent,trabectome,ab interno trabeculectomy,exact matching

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