Five-year extension of a clinical trial comparing the EX-PRESS glaucoma filtration device and trabeculectomy in primary open-angle glaucoma

Leo de Jong1, Antoine Lafuma2, Anne-Sophie Aguad&eacute;2, Gilles Berdeaux3,41Academic Medical Centre, Ophthalmology Department, Amsterdam, The Netherlands, 2Cemka-Eval, Bourg la Reine, Paris, France, 3Alcon France, Rueil-Malmaison, Paris, France, 4Conservatoire National des Arts et M&am...

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Autores principales:	de Jong L, Lafuma A, Aguad&eacute; A-S, Berdeaux G
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2011
Materias:	Ophthalmology RE1-994
Acceso en línea:	https://doaj.org/article/cdd199bdaa244b4da18f2c9377b231f1
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spelling	oai:doaj.org-article:cdd199bdaa244b4da18f2c9377b231f12021-12-02T06:12:59ZFive-year extension of a clinical trial comparing the EX-PRESS glaucoma filtration device and trabeculectomy in primary open-angle glaucoma1177-54671177-5483https://doaj.org/article/cdd199bdaa244b4da18f2c9377b231f12011-04-01T00:00:00Zhttp://www.dovepress.com/five-year-extension-of-a-clinical-trial-comparing-the-ex-press-glaucom-a7289https://doaj.org/toc/1177-5467https://doaj.org/toc/1177-5483Leo de Jong1, Antoine Lafuma2, Anne-Sophie Aguad&eacute;2, Gilles Berdeaux3,41Academic Medical Centre, Ophthalmology Department, Amsterdam, The Netherlands, 2Cemka-Eval, Bourg la Reine, Paris, France, 3Alcon France, Rueil-Malmaison, Paris, France, 4Conservatoire National des Arts et M&eacute;tiers, Paris, FranceBackground: This study compared the efficacy of the EX-PRESS&reg; glaucoma filtration device and trabeculectomy in primary open-angle glaucoma up to five years after surgery.Methods: Patients from a previously reported randomized, open-label, parallel-arm clinical trial in which 78 patients received either the EX-PRESS glaucoma filtration device or underwent a trabeculectomy were followed for up to an additional four years (five total) beyond the original study (39 eyes per treatment group). Risk-benefit data were obtained for up to five years after glaucoma surgery. Outcome variables were intraocular pressures and intraocular pressure medications. Complete success was denoted by intraocular pressure values &le; 18 mmHg without medication.Results: The EX-PRESS glaucoma filtration device controlled intraocular pressure more effectively without medication for more patients from year 1 (86.8% versus 61.5%, P = 0.01) to year 3 (66.7% versus 41.0%, P = 0.02) than trabeculectomy. At year 1, only 12.8% of patients required intraocular pressure medication after EX-PRESS implantation, compared with 35.9% after trabeculectomy. The proportions became closer at year 5 (41% versus 53.9%). The responder rate was higher with EX-PRESS and time to failure was longer. In addition, surgical interventions for complications were fewer after EX-PRESS implantation.Conclusion: This five-year analysis confirmed and extended the results reported after one year. Compared with trabeculectomy, EX-PRESS provided better intraocular pressure control in the first three years, and patients required fewer intraocular pressure medications and fewer surgical interventions during the five-year study period. For patients with primary open-angle glaucoma, the EX-PRESS glaucoma filtration device, implanted under a superficial scleral flap, produced significantly higher success rates than trabeculectomy. EX-PRESS is an effective device for long-term treatment of primary open-angle glaucoma.Keywords: glaucoma filtration device, trabeculectomy, primary open-angle glaucoma, intraocular pressure, medicationde Jong LLafuma AAguad&eacute; A-SBerdeaux GDove Medical PressarticleOphthalmologyRE1-994ENClinical Ophthalmology, Vol 2011, Iss default, Pp 527-533 (2011)
institution	DOAJ
collection	DOAJ
language	EN
topic	Ophthalmology RE1-994
spellingShingle	Ophthalmology RE1-994 de Jong L Lafuma A Aguad&eacute; A-S Berdeaux G Five-year extension of a clinical trial comparing the EX-PRESS glaucoma filtration device and trabeculectomy in primary open-angle glaucoma
description	Leo de Jong1, Antoine Lafuma2, Anne-Sophie Aguad&eacute;2, Gilles Berdeaux3,41Academic Medical Centre, Ophthalmology Department, Amsterdam, The Netherlands, 2Cemka-Eval, Bourg la Reine, Paris, France, 3Alcon France, Rueil-Malmaison, Paris, France, 4Conservatoire National des Arts et M&eacute;tiers, Paris, FranceBackground: This study compared the efficacy of the EX-PRESS&reg; glaucoma filtration device and trabeculectomy in primary open-angle glaucoma up to five years after surgery.Methods: Patients from a previously reported randomized, open-label, parallel-arm clinical trial in which 78 patients received either the EX-PRESS glaucoma filtration device or underwent a trabeculectomy were followed for up to an additional four years (five total) beyond the original study (39 eyes per treatment group). Risk-benefit data were obtained for up to five years after glaucoma surgery. Outcome variables were intraocular pressures and intraocular pressure medications. Complete success was denoted by intraocular pressure values &le; 18 mmHg without medication.Results: The EX-PRESS glaucoma filtration device controlled intraocular pressure more effectively without medication for more patients from year 1 (86.8% versus 61.5%, P = 0.01) to year 3 (66.7% versus 41.0%, P = 0.02) than trabeculectomy. At year 1, only 12.8% of patients required intraocular pressure medication after EX-PRESS implantation, compared with 35.9% after trabeculectomy. The proportions became closer at year 5 (41% versus 53.9%). The responder rate was higher with EX-PRESS and time to failure was longer. In addition, surgical interventions for complications were fewer after EX-PRESS implantation.Conclusion: This five-year analysis confirmed and extended the results reported after one year. Compared with trabeculectomy, EX-PRESS provided better intraocular pressure control in the first three years, and patients required fewer intraocular pressure medications and fewer surgical interventions during the five-year study period. For patients with primary open-angle glaucoma, the EX-PRESS glaucoma filtration device, implanted under a superficial scleral flap, produced significantly higher success rates than trabeculectomy. EX-PRESS is an effective device for long-term treatment of primary open-angle glaucoma.Keywords: glaucoma filtration device, trabeculectomy, primary open-angle glaucoma, intraocular pressure, medication
format	article
author	de Jong L Lafuma A Aguad&eacute; A-S Berdeaux G
author_facet	de Jong L Lafuma A Aguad&eacute; A-S Berdeaux G
author_sort	de Jong L
title	Five-year extension of a clinical trial comparing the EX-PRESS glaucoma filtration device and trabeculectomy in primary open-angle glaucoma
title_short	Five-year extension of a clinical trial comparing the EX-PRESS glaucoma filtration device and trabeculectomy in primary open-angle glaucoma
title_full	Five-year extension of a clinical trial comparing the EX-PRESS glaucoma filtration device and trabeculectomy in primary open-angle glaucoma
title_fullStr	Five-year extension of a clinical trial comparing the EX-PRESS glaucoma filtration device and trabeculectomy in primary open-angle glaucoma
title_full_unstemmed	Five-year extension of a clinical trial comparing the EX-PRESS glaucoma filtration device and trabeculectomy in primary open-angle glaucoma
title_sort	five-year extension of a clinical trial comparing the ex-press glaucoma filtration device and trabeculectomy in primary open-angle glaucoma
publisher	Dove Medical Press
publishDate	2011
url	https://doaj.org/article/cdd199bdaa244b4da18f2c9377b231f1
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Five-year extension of a clinical trial comparing the EX-PRESS glaucoma filtration device and trabeculectomy in primary open-angle glaucoma

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