Safety and Efficacy of Two Trabecular Micro-Bypass Stents as the Sole Procedure in Japanese Patients with Medically Uncontrolled Primary Open-Angle Glaucoma: A Pilot Case Series

Purpose. To evaluate efficacy and safety of a trabecular micro-bypass stent system when used as the sole procedure in Japanese patients with medically uncontrolled primary open-angle glaucoma (POAG). Design. Prospective nonrandomized interventional pilot study. Methods. Ten eyes of 10 Japanese patie...

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Main Authors: Daisuke Shiba, Shingo Hosoda, Saori Yaguchi, Naoki Ozeki, Kenya Yuki, Kazuo Tsubota
Format: Article
Language:English
Published: Hindawi Limited 2017-01-01
Series:Journal of Ophthalmology
Online Access:http://dx.doi.org/10.1155/2017/9605461
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spelling doaj-54001fe3cb56457bbd8ef8bc716a40342020-11-24T20:42:21ZengHindawi LimitedJournal of Ophthalmology2090-004X2090-00582017-01-01201710.1155/2017/96054619605461Safety and Efficacy of Two Trabecular Micro-Bypass Stents as the Sole Procedure in Japanese Patients with Medically Uncontrolled Primary Open-Angle Glaucoma: A Pilot Case SeriesDaisuke Shiba0Shingo Hosoda1Saori Yaguchi2Naoki Ozeki3Kenya Yuki4Kazuo Tsubota5Department of Ophthalmology, Keio University School of Medicine, Tokyo, JapanDepartment of Ophthalmology, Keio University School of Medicine, Tokyo, JapanDepartment of Ophthalmology, Keio University School of Medicine, Tokyo, JapanDepartment of Ophthalmology, Keio University School of Medicine, Tokyo, JapanDepartment of Ophthalmology, Keio University School of Medicine, Tokyo, JapanDepartment of Ophthalmology, Keio University School of Medicine, Tokyo, JapanPurpose. To evaluate efficacy and safety of a trabecular micro-bypass stent system when used as the sole procedure in Japanese patients with medically uncontrolled primary open-angle glaucoma (POAG). Design. Prospective nonrandomized interventional pilot study. Methods. Ten eyes of 10 Japanese patients with medically uncontrolled POAG taking three ocular hypotensive medications were treated using only the implantation of two iStent trabecular micro-bypass stents. Each patient continued to take the same ocular hypotensive medications used preoperatively throughout the study. Intraocular pressure (IOP) and endothelial cell density (ECD) were determined at baseline and at 1, 3, and 6 months postoperatively. Best-corrected visual acuity (BCVA) was measured at baseline and 6 months after surgery. Results. Mean IOP was 22.0±3.0 mmHg at baseline and 16.9±3.6 mmHg at 6 months, which represented a mean reduction of 5.1 mmHg or 23.2%. No significant changes were observed in the ECD and BCVA. Complications that occurred during the early postoperative period included hyphema, peripheral anterior synechiae, and occlusion of the stent by the iris. Conclusion. Implantation of two trabecular micro-bypass stents as the sole procedure in Japanese POAG patients effectively reduced IOP and exhibited a favorable safety profile. Clinical Trials Registration number is UMIN000004002.http://dx.doi.org/10.1155/2017/9605461
collection DOAJ
language English
format Article
sources DOAJ
author Daisuke Shiba
Shingo Hosoda
Saori Yaguchi
Naoki Ozeki
Kenya Yuki
Kazuo Tsubota
spellingShingle Daisuke Shiba
Shingo Hosoda
Saori Yaguchi
Naoki Ozeki
Kenya Yuki
Kazuo Tsubota
Safety and Efficacy of Two Trabecular Micro-Bypass Stents as the Sole Procedure in Japanese Patients with Medically Uncontrolled Primary Open-Angle Glaucoma: A Pilot Case Series
Journal of Ophthalmology
author_facet Daisuke Shiba
Shingo Hosoda
Saori Yaguchi
Naoki Ozeki
Kenya Yuki
Kazuo Tsubota
author_sort Daisuke Shiba
title Safety and Efficacy of Two Trabecular Micro-Bypass Stents as the Sole Procedure in Japanese Patients with Medically Uncontrolled Primary Open-Angle Glaucoma: A Pilot Case Series
title_short Safety and Efficacy of Two Trabecular Micro-Bypass Stents as the Sole Procedure in Japanese Patients with Medically Uncontrolled Primary Open-Angle Glaucoma: A Pilot Case Series
title_full Safety and Efficacy of Two Trabecular Micro-Bypass Stents as the Sole Procedure in Japanese Patients with Medically Uncontrolled Primary Open-Angle Glaucoma: A Pilot Case Series
title_fullStr Safety and Efficacy of Two Trabecular Micro-Bypass Stents as the Sole Procedure in Japanese Patients with Medically Uncontrolled Primary Open-Angle Glaucoma: A Pilot Case Series
title_full_unstemmed Safety and Efficacy of Two Trabecular Micro-Bypass Stents as the Sole Procedure in Japanese Patients with Medically Uncontrolled Primary Open-Angle Glaucoma: A Pilot Case Series
title_sort safety and efficacy of two trabecular micro-bypass stents as the sole procedure in japanese patients with medically uncontrolled primary open-angle glaucoma: a pilot case series
publisher Hindawi Limited
series Journal of Ophthalmology
issn 2090-004X
2090-0058
publishDate 2017-01-01
description Purpose. To evaluate efficacy and safety of a trabecular micro-bypass stent system when used as the sole procedure in Japanese patients with medically uncontrolled primary open-angle glaucoma (POAG). Design. Prospective nonrandomized interventional pilot study. Methods. Ten eyes of 10 Japanese patients with medically uncontrolled POAG taking three ocular hypotensive medications were treated using only the implantation of two iStent trabecular micro-bypass stents. Each patient continued to take the same ocular hypotensive medications used preoperatively throughout the study. Intraocular pressure (IOP) and endothelial cell density (ECD) were determined at baseline and at 1, 3, and 6 months postoperatively. Best-corrected visual acuity (BCVA) was measured at baseline and 6 months after surgery. Results. Mean IOP was 22.0±3.0 mmHg at baseline and 16.9±3.6 mmHg at 6 months, which represented a mean reduction of 5.1 mmHg or 23.2%. No significant changes were observed in the ECD and BCVA. Complications that occurred during the early postoperative period included hyphema, peripheral anterior synechiae, and occlusion of the stent by the iris. Conclusion. Implantation of two trabecular micro-bypass stents as the sole procedure in Japanese POAG patients effectively reduced IOP and exhibited a favorable safety profile. Clinical Trials Registration number is UMIN000004002.
url http://dx.doi.org/10.1155/2017/9605461
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