Research Project
9199545
PROJECT SUMMARY/ABSTRACT Brockman-Hastings LLC seeks to reduce vision loss for glaucoma sufferers by creating a simple, accurate, and clinically acceptable system for monitoring intraocular pressure (IOP). Trends indicate that by 2020, approximately 80 million people worldwide will have glaucoma, 11 million of whom will become 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 often insufficient to fully manage glaucoma, 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; however, these devices have thus far proven too large, complex, inaccurate, and/or high risk for rapid clinical adoption. In contrast, Brockman-Hastings? sensor 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), and a hand held or eye-glass-mounted readout unit captures an infrared image to measure IOP. The simplicity of our sensor minimizes its physical size, providing for an aesthetic implant and allowing a simple, lower-risk implantation procedure. In Phase I we established feasibility of the technology by achieving both specific aims: (1) sub-1 mmHg sensing accuracy in a simulated physiological environment and (2) sub 2-mmHg precision and one month tolerability in the rabbit eye. Our phase II hypothesis is that the optical IOP monitoring system, based around a refined anterior chamber implant, will provide measurements sufficiently accurate for glaucoma management and will satisfy preclinical requirements for an investigational device exemption. To establish this, we propose two specific aims: (1) Demonstrate that the optical IOP monitoring system meets preclinical performance requirements (1 mmHg accuracy) under real-time, accelerated aging, and in-vivo (rabbit eye) conditions, and (2) Demonstrate that the optical IOP monitoring system satisfies preclinical (mechanical, dimensional, biocompatibility, and sterility) safety requirements. Successful commercialization of this device could ultimately benefit millions of glaucoma patients, especially those that could immediately combine the sensor implantation with another eye surgery. Even this narrower market encompasses ~100,000 glaucoma patients per year in the U.S. alone. Ultimately, the system will reduce the human and financial cost of glaucoma-related vision loss by providing physicians with accurate, long-term IOP data on which to base treatment decisions and assess treatment effectiveness.
