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.
abstract: 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.
authors.affiliation: Department of Ophthalmology, Keio University School of Medicine, Tokyo, Japan.
authors.forename: Daisuke
authors.identifier: 0000-0002-0366-9418
authors.initials: D
authors.lastname: Shiba
authors.affiliation: Department of Ophthalmology, Keio University School of Medicine, Tokyo, Japan.
authors.forename: Shingo
authors.initials: S
authors.lastname: Hosoda
authors.affiliation: Department of Ophthalmology, Keio University School of Medicine, Tokyo, Japan.
authors.forename: Saori
authors.initials: S
authors.lastname: Yaguchi
authors.affiliation: Department of Ophthalmology, Keio University School of Medicine, Tokyo, Japan.
authors.forename: Naoki
authors.identifier: 0000-0003-4730-2279
authors.initials: N
authors.lastname: Ozeki
authors.affiliation: Department of Ophthalmology, Keio University School of Medicine, Tokyo, Japan.
authors.forename: Kenya
authors.identifier: 0000-0002-3985-7824
authors.initials: K
authors.lastname: Yuki
authors.affiliation: Department of Ophthalmology, Keio University School of Medicine, Tokyo, Japan.
authors.forename: Kazuo
authors.identifier: 0000-0002-8874-7111
authors.initials: K
authors.lastname: Tsubota