SBIR-STTR Award

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-term goal 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, implanted in 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 <1 mmHg sensing accuracy in a simulated physiological environment and (2) to demonstrate <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 ≈80 million 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.

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 vis its. 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.

Public Health Relevance Statement:
PUBLIC HEALTH RELEVANCE Trends indicate that by 2020 there will be ?80 million 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 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.

NIH Spending Category:
Aging; Assistive Technology; Bioengineering; Eye Disease and Disorders of Vision; Neurodegenerative; Neurosciences

Project Terms:
5 year old; Address; Adoption; Aging; Algorithms; anterior chamber; base; Biocompatible Materials; biomaterial compatibility; blind; Blindness; Cataract Extraction; Clinical; Clinical Trials; clinically relevant; commercial application; commercialization; Complex; Compliance behavior; cost; Data; Devices; Diagnosis; Effectiveness; Electronics; Elements; Ensure; Environment; Esthetics; Event; experience; Eye; Failure; Feedback; Financial cost; Glass; Glaucoma; Goals; Hand; Health; high intraocular pressure; high risk; Human; Image; image processing; Implant; implantation; Implantation procedure; implanted sensor; improved; In Vitro; in vivo; Intraocular lens implant device; Investments; Knowledge; Lasers; Light; Marketing; Measurement; Measures; Mechanics; meetings; millimeter; Monitor; Office Visits; Operative Surgical Procedures; Ophthalmologic Surgical Procedures; Ophthalmologist; optical sensor; Optics; Oryctolagus cuniculus; Outcome; Patients; Performance; performance tests; Pharmacologic Substance; Phase; Physicians; Physiologic Intraocular Pressure; Physiological; Power Sources; pre-clinical; preclinical safety; Preclinical Testing; prototype; Recovery; Research; Research Design; Risk; Risk Factors; Safety; sensor; Small Business Innovation Research Grant; Software Design; Specialist; Sterility; success; symptom treatment; System; Systems Analysis; Technology; Testing; Third-Party Payer; Time; Treatment Effectiveness; trend; Visual; Visual impairment