Grisanti S, Margolina E, Hoeh H, Rau M, Erb C, Kersten-Gomez I, Dick H B, Grisanti S
Ophthalmologe. 2014 Jun;111(6):548-52. doi: 10.1007/s00347-013-2927-6.
The suprachoroidal CyPass micro-stent is designed to be implanted into the supraciliary space to facilitate aqueous outflow along the uveoscleral pathway in patients with open-angle glaucoma (OAG). This study assessed the safety of micro-stent implantation in patients undergoing cataract surgery.
In this multicenter study the CyPass microstent was implanted in patients with OAG undergoing cataract surgery. The implantation was performed using a minimally invasive, conjunctiva-sparing, ab interno intervention. Primary endpoints were safety aspects of the implant, secondary endpoints were the reduction of intraocular pressure (IOP) and topical medication.
There were no severe adverse events during or after surgery in any of the patients. In patients with controlled glaucoma (IOP < 21 mmHg) the average IOP remained constant throughout the 24 month follow-up period but mean medication use decreased from 2.0 at baseline to 1.1 postoperative. In patients with IOP of ≥ 21 mmHg the pressure was reduced by 37 % postoperatively and mean medication decreased from 2.2 at baseline to 1.0.
The safety profile of combined cataract surgery and CyPass microstent implantation is acceptable and patients also showed a decrease in IOP and medication use.
脉络膜上腔CyPass微支架旨在植入睫状体上腔,以促进开角型青光眼(OAG)患者房水沿葡萄膜巩膜途径流出。本研究评估了微支架植入在接受白内障手术患者中的安全性。
在这项多中心研究中,CyPass微支架被植入接受白内障手术的OAG患者体内。植入采用微创、保留结膜的眼内介入方式进行。主要终点是植入物的安全性方面,次要终点是眼压(IOP)降低和局部用药情况。
所有患者在手术期间或术后均未发生严重不良事件。在青光眼得到控制(眼压<21 mmHg)的患者中,在整个24个月的随访期内平均眼压保持恒定,但平均用药量从基线时的2.0降至术后的1.1。在眼压≥21 mmHg的患者中,术后眼压降低了37%,平均用药量从基线时的2.2降至1.0。
白内障手术联合CyPass微支架植入的安全性是可接受的,患者的眼压和用药量也有所降低。