Implantable Optical Intraocular Pressure Sensor for Improved Glaucoma Treatment

描述（由申请人提供）： Brockman-Hastings LLC旨在通过创建一种简单、准确且临床上可接受的用于监测眼内压（IOP）的传感器来减少青光眼患者的视力丧失。趋势表明，到2020年，全世界约有8000万人患有青光眼，其中1100万人将完全失明。IOP升高仍然是青光眼的关键风险因素和治疗症状，眼科医生在门诊访视期间常规测量IOP。然而，不频繁的单点测量不足以完全表征和管理疾病，并且不频繁的测量使得难以评估药物或手术治疗的有效性。为了解决这个问题，几个研究小组已经开发了植入式眼内压传感器;然而，这些设备已经被证明太大、复杂、不准确和/或高风险，无法快速临床应用。与这些器械相比，Brockman-Hastings传感器概念不包括任何植入的微电子电路或外部或内部电源。相反，该系统依赖于从传感器的活动区域（小于一平方毫米）反射的光。手持或眼镜安装的读出单元发射并捕获从传感器反射的红外信号以测量IOP。我们的传感器的简单性最大限度地减少了其物理尺寸，提供了一个美观的植入物，并允许一个简单和可逆的植入程序。该项目的长期目标是通过为医生提供高度准确的长期IOP测量值来减少视力丧失，并以此作为治疗决策和评估治疗有效性的基础。我们的第一阶段假设是，植入兔眼前房的光学IOP传感器将为青光眼管理提供足够准确的IOP测量，并且在植入一个月期间耐受良好。我们的具体目标是（1）在模拟生理环境中证明<1 mmHg的传感精度，以及（2）在兔青光眼模型中证明<2 mmHg的传感精度和一个月的耐受性。成功实现这些目标将为第二阶段奠定基础，第二阶段是在更长期（1-2年）和更大规模的动物研究中评估传感器的准确性和耐受性，并沿着FDA临床前测试。这种装置的成功商业化最终可以使数百万青光眼患者受益，特别是那些可以立即将传感器植入与另一种基于非激光的眼科手术联合收割机结合的患者。即使是这个狭窄的市场，仅在美国每年也有约100，000名青光眼患者。 公共卫生相关性： 趋势表明，到2020年，全球将有8000万青光眼患者，其中1100万人将失明。如果青光眼患者和他们的医生能够更频繁和更长期地进行眼内压监测，视力丧失可能会减少。在这项SBIR中，Brockman- Hastings LLC将验证一种简单、可逆植入式传感器的准确性和耐受性，该传感器允许进行此类测量，从而为青光眼管理提供更好的数据。

DESCRIPTION (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-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 &#8776; 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.