This research will assess the technical feasibility of developing a new and unique miniature ophthalmic lOP sensor, to be retrofitted into the cannula of a conventional Glaucoma Drainage Device and surgically implanted under the sclera for the purpose of continuous measurement and transmission of these lOP readings to a remote receiver. With this technology, physicians will have the ability to measure the effects that medications and other life-style factors have on the lOP of their patients in a real-time and continuous mode. Current technology does not allow for real-time, continuous (24/7, diurnal and nocturnal readings) monitoring of intraocular pressure (lOP) to enable physicians to study, diagnose and more clearly understand the response mechanism relating to lOP that can lead to more effective development and titration of glaucoma medications or other timely therapeutic options. Elevated and fluctuating (lOP) over a 24/7 period is an independent and proven risk factor for eye damage in the short term and glaucoma progressions in the long term, which if left unchecked or unmanaged could lead to blindness. This research is dedicated to developing technologies that assist physicians to more effectively treat the glaucoma patient. With regard to glaucoma, Brian Francis, MD, of the Doheny Eye Institute, has stated that: """"""""lntraocular Pressure (lOP) is the only treatable risk factor known. Three (3) recent NIH clinical trials have shown the importance of IOP control, even in the normal tension glaucoma patient. These are the 1) Normal Tension Glaucoma Study, the 2) Advanced Glaucoma Intervention Study, part 7, and 3) The Ocular Hypertension Treatments Study. The Importance of lOP has been clearly established, and is the gauge by which all current drug and surgical treatments are measured."""""""" The initial stage of research and development delineated here will consist of proving the proposed concept by means of a """"""""breadboard design"""""""". An original MEMS lOP sensor chip will be designed and fabricated which will employ a capacitive resonance and resistance effect, and the interface electronics materials and electronic chip (ASIC) and other items which form the telemetry signal will be outsourced. Advanced work will involve bonding an lOP MEMS sensor to the electronic chip (ASIC) and integrating it into a conventional Glaucoma Drainage Device (GDD) for implantation into humans. For this project, a computer designed silicon, piezoelectric pressure sensor and computer simulation of the lOP sensor and process will be developed along with a bench-top proof-of-concept prototype and functional process of 1) the lOP sensor, 2) the ASIC chip signal processor, and 3) the remote hand control device. Validations will be performed in the computer simulation of the MEMS pressure sensor chip and its ability to detect the pressure over the expected eye pressure ranges (0-40 mm Hg) from a remote distance of 4-6 feet. The bench-top model will demonstrate three functions, which will be initiated and activated remotely, A) intraocular pressure sensing, B) signal processing of those pressures using an inductance energy field, and C) transmission of the pressure readings to a remote device. Two extensive reports will be generated, i) a pressure sensor design, ASIC design, and MEMS lOP specification sheet with drawings, and I1)documentation of the experiment using the prototype configuration and commonly accepted intraocular testing rigs used to calibrate commercially available tonometers, that can lead researchers to develop more effective pharmaceuticals or therapeutic protocols for the glaucoma patent.
