Glaucoma is primarily treated by the reduction of intraocular pressure (IOP). After failure of conservative therapy, trabeculectomy with or without antimetabolites is used to lower IOP. Trabeculectomy is a time-consuming surgical procedure that requires significant surgical and post-operative finesse to achieve success. It is subject to a host of complications such as hypotony maculopathy or filtering bleb related endophthalmitis. In addition, cataract formation is accelerated and visual recovery post-operatively can be slow. Ophthalmologists are currently calling for innovative, alternative therapies for the surgical treatment of glaucoma. This Phase 1 STTR proposal, a collaborative effort between Glaukos Corporation and Caltech, will allow us to build upon the clinical success of our first generation Trabecular Bypass Stent by developing an active pumping mechanism that may be incorporated in an implantable device to lower IOP to previously unachievable levels. The first generation stent, which will hit the European market this Fall, has already been implanted in over 150 patients over the last 2 1/2 years, and has not exhibited any signs of dislodging from the trabecular meshwork, or closing up due to healing of the trabecular meshwork. Based upon preliminary work on the development of small valveless, frictionless impedance pumps, we will design and characterize a micro-impedance pump that is small enough to be implanted into the trabecular meshwork in a similar fashion as the first generation stent. This Phase I study will involve a thorough characterization of the fluid mechanics associated with the micropump and a demonstration of its performance in human corneal rim tissue.
