ABSTRACT
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.
Subject(s)
Glaucoma Drainage Implants , Glaucoma, Open-Angle/diagnosis , Glaucoma, Open-Angle/surgery , Minimally Invasive Surgical Procedures/instrumentation , Aged , Equipment Failure Analysis , Female , Germany , Humans , Intraocular Pressure , Male , Miniaturization , Minimally Invasive Surgical Procedures/methods , Prosthesis Design , Treatment OutcomeABSTRACT
This study in sixty healthy volunteers investigated the effect of a single drop of either 0.5% timolol ophthalmic solution, 0.5% betaxolol ophthalmic solution, or placebo on corneal sensitivity as measured by the Cochet-Bonnet anesthesiometer. Corneal sensitivity was measured immediately prior to the drop and then 1, 3, 6, 10, 15 and 30 minutes after drop instillation. The timolol treated eyes showed a significant decrease at one minute after instillation. An increase in sensitivity occurred in the placebo group at 15 and 30 minutes. In the eyes treated with betaxolol, a significant reduction in corneal sensitivity was seen at every time point through the 10-minute measurement.