Brockman-Hastings LLC — Department of Health and Human Services SBIR Phase II: NEI

Description

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 approximately million people worldwide will have glaucoma 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 sub mmHg sensing accuracy in a simulated physiological environment and sub 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 Demonstrate that the optical IOP monitoring system meets preclinical performance requirements mmHg accuracy under real time accelerated aging and in vivo rabbit eye conditions and 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 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 PUBLIC HEALTH RELEVANCE Trends indicate that by there will be million people worldwide with glaucoma 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 Phase II effort Brockman Hastings LLC will demonstrate the performance and safety of an intraocular pressure monitoring system based on a simple implantable optical sensor