Implantable Optical Intraocular Pressure Sensor for Improved Glaucoma Treatment
Department of Health and Human Services
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Small Business Information
6003 TWO SPRINGS LN, LOUISVILLE, KY, 40207-2369
Socially and Economically Disadvantaged:
AbstractDESCRIPTION (provided by applicant): Brockman-Hastings LLC seeks to reduce vision loss for glaucoma sufferers by creating a simple, accurate, and clinically acceptable sensor for monitoring intraocular pressure (IOP). Trends indicate that by 2020, approximately 80 million people worldwide will have glaucoma, 11 million of whom will become completely blind. Elevated IOP remains the key risk factor and treated symptom for glaucoma, and ophthalmologists routinely measure IOP during office visits. However,infrequent, single point measurements are insufficient to fully characterize and manage the disease, and infrequent measurements make it difficult to assess the effectiveness of pharmaceutical or surgical treatments. To address this problem several research groups have developed implantable intraocular pressure sensors; yet, these devices have proven too large, complex, inaccurate, and/or high risk for rapid clinical adoption. In contrast to these devices, the Brockman-Hastings sensor concept does not include any implanted microelectronic circuitry or external or internal power sources. Instead, the system relies on the reflection of light from the sensor s active region (smaller than one square millimeter). A hand held or eye-glass-mounted readout unit emits and captures an infrared signal that is reflected off the sensor to measure IOP. The simplicity of our sensor minimizes its physical size, providing for an aesthetic implant, and allowing for a simple and reversible implantation procedure. The long-termgoal of the project is to reduce vision loss by providing physicians with highly accurate, long-term IOP measurements on which to base treatment decisions and assess treatment effectiveness. Our Phase I hypothesis is that an optical IOP sensor, implantedin the anterior chamber of the rabbit eye, will provide IOP measurements with sufficient accuracy for glaucoma management and will be well tolerated during implantation for one month. Our specific aims are (1) to demonstrate lt 1 mmHg sensing accuracy in asimulated physiological environment and (2) to demonstrate lt 2 mmHg sensing precision and one month tolerability in a rabbit model of glaucoma. Successfully accomplishing these aims will lay the foundation for Phase II, an evaluation of sensor accuracy and tolerability in a longer term (1-2 year) and larger scale animal study, along with FDA pre-clinical testing. Successful commercialization of such a device could ultimately benefit millions of glaucoma patients, especially those that could immediately combine the sensor implantation with another non-laser based eye surgery. Even this narrower market encompasses ~100,000 glaucoma patients per year in the U.S. alone. PUBLIC HEALTH RELEVANCE: Trends indicate that by 2020 there will be and#8776; 80million people worldwide with glaucoma, 11 million of whom will become blind. Vision loss could be reduced if more frequent and longer term intraocular pressure monitoring were available to glaucoma patients and their physicians. In this SBIR Brockman- Hastings LLC will validate the accuracy and tolerability of a simple, reversibly implantable sensor that allows such measurements, and thus provide better data for managing glaucoma.
* information listed above is at the time of submission.