PURPOSE: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: The safety profile of combined cataract surgery and CyPass microstent implantation is acceptable and patients also showed a decrease in IOP and medication use.
PURPOSE: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: The safety profile of combined cataract surgery and CyPass microstent implantation is acceptable and patients also showed a decrease in IOP and medication use.