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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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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