A Real Time Monitoring System for IOP in Glaucoma

DESCRIPTION (provided by applicant): Assenti's enclosed NEI / SBIR proposal is intended to provide continuous, non-invasive 24 hour monitoring of Intra-Ocular Pressure (lOP) in patients with optic nerve damage from glaucoma. The project can be viewed as "assistive technology for prevention of blindness". Elevated lOP is thought to be the most important risk factor for the initiation and progression of glaucoma. The current therapeutic management of glaucoma, based on several clinical studies, aims to halt disease progression by reducing lOP to clinically acceptable levels using medical, laser or surgical treatments. The Ocular Hypertension Treatment Study (OHTS) has recently identified elevated lOP as an important predictor for the onset of glaucoma [9]. The Advanced Glaucoma Intervention Study demonstrated a protective role for low lOP in visual field deterioration detected in glaucomatous patients [10]. Even in NPG disease progression has been shown to be markedly reduced by the traditional intervention of lOP reduction [11,12]. Experimental studies using animal models of glaucoma support the clinical observations that lOP initiated factors are important for glaucomatous degeneration of the optic nerve. Collaborative research teams from the University of Louisville's Speed School of Engineering and the Department of Ophthalmology & Visual Sciences along with key industry partners have combined to form a corporation named Assenti LLC. Assenti will construct an integrated circuit (IC) pressure sensor with onboard telemetry that will be placed within the anterior chamber of the glaucomatous eye to record Lop between 10 and 40 mm Hg continuously over 24 hours. The telemetric circuit will be developed to provide power to the sensor IC as well as receive data from the sensor IC without requiring batteries or wires. The primary coil that provides power and receives data from the IC will be housed on spectacle frames, which can be worn by the subject. It is envisioned that all patients with established glaucoma in whom treatment has been initiated, either medical or surgical, would be candidates for the device. The three specific aims and for this potentially revolutionary treatment of glaucoma are as follows: 1. Fabricate 2 ultra-miniature MEMS pressure sensors based on a piezoresistive and capacitance designs. 2. Development of the telemetry circuitry for power and data communication. 3. Test the MEMS pressure sensors and telemetry circuitry under both in vitro and in vivo conditions.