An Implantable Intraocular Pressure Control System - Phase II

植入式眼压控制系统 - 第二阶段

• 批准号: 8707806
• 负责人: THOMAS C DELAHANTY
• 金额: $ 96.67万
• 依托单位: FORSYTHE TECHNOLOGIES WORLDWIDE, INC.
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-09-01 至 2016-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8707806
• 关键词: Adverse effects; Animals; Blindness; Cells; Cessation of life; Characteristics; Chronic Disease; Cicatrix; Clinical Trials; Computer software; Conscious; Data; Detection; Development; Devices; Disease; Electromagnetics; Eye; Glaucoma; Goals; Head; Hour; Housing; Implant; In Vitro; Inflammation; Left; Liquid substance; Magnetism; Measurable; Measures; Monitor; Neck; Normal Range; Office Visits; Operative Surgical Procedures; Oryctolagus cuniculus; Patients; Performance; Pharmaceutical Preparations; Phase; Physicians; Physiologic Intraocular Pressure; Physiological; Power Sources; Primary Open Angle Glaucoma; Recovery; Refractory; Retinal; Risk Factors; Safety; Silicones; Sterility; System; Techniques; Telemetry; Temperature; Testing; Time; Tissues; Twin Multiple Birth; Variant; Vision; base; data acquisition; design; digital; in vitro testing; in vivo; non-compliance; pressure; prototype; public health relevance; response; sensor; stem; tonometry

DESCRIPTION (provided by applicant): Glaucoma, a widespread, chronic disease, is a leading cause of blindness and is related to the death of retinal ganglionic cells. In the most prevalent form of glaucoma, primary open-angle glaucoma (POAG), increased intraocular pressure (IOP) is the most common risk factor associated with the loss of retinal cells. Results from large clinical trials indicate that decreasing IOP in glaucoma patients delays the development of vision loss. Even glaucoma patients with IOPs in the normal range benefit from decreasing their IOP. Currently, numerous pharmacological and surgical approaches are employed to reduce IOP in glaucoma patients. However, drug treated patients are frequently noncompliant, refractory and/or suffer from adverse effects. Current surgical implants are passive devices unable to detect or respond to changes in IOP and frequently fail. With either approach, a patient office visit is required for the physician to manually verify IOP control by tonometry. We propose to create an implant capable of both sensing IOP and regulating it through opening and closing a miniature valve. The implant's power supply will be self-contained, with a transceiver capable of sending and receiving external commands. In its final form the implant will monitor and regulate IOP and be capable of recording and sending IOP data and information concerning valve function to the physician and/or patient via a digital device such as a PC. The three specific, measurable objectives for Phase II are to: 1) Design and fabricate a miniature twin magnetic stop/electromagnetic valve with accompanying telemetry and data acquisition system. 2) Perform short and long-term in vitro tests of the valve to demonstrate detection, response and control of IOP in the normal and pathological pressure ranges. 3) Implant the valve and test it both acutely and chronically on conscious, active normal IOP rabbits to determine safety and efficacy.

描述（由申请人提供）：青光眼是一种广泛的慢性疾病，是致盲的主要原因，与视网膜神经节细胞的死亡有关。在最普遍的青光眼形式中，原发性开角型青光眼（POAG），眼内压（IOP）升高是与视网膜细胞损失相关的最常见的风险因素。来自大型临床试验的结果表明，降低青光眼患者的IOP可延迟视力丧失的发展。即使是IOP在正常范围内的青光眼患者也能从降低IOP中获益。目前，许多药理学和手术方法用于降低青光眼患者的IOP。然而，药物治疗的患者通常是不依从的、难治的和/或遭受不良反应。目前的外科植入物是无源装置，不能检测或响应IOP的变化，并且经常失效。无论采用哪种方法，医生都需要到患者办公室就诊，通过眼压测量手动验证IOP控制。我们建议创造一种植入物，能够通过打开和关闭微型阀来感知IOP并调节IOP。植入物的电源将是独立的，具有能够发送和接收外部命令的收发器。在其最终形式中，植入物将监测和调节IOP，并且能够记录IOP数据和关于瓣膜功能的信息，并通过数字装置（例如PC）将其发送给医生和/或患者。第二阶段的三个具体的、可测量的目标是：1）设计和制造一个微型双磁止动/电磁阀，并附带遥测和数据采集系统。2)对瓣膜进行短期和长期体外试验，以证明在正常和病理压力范围内IOP的检测、响应和控制。3)植入瓣膜，并在清醒、活动的正常IOP家兔上进行急性和慢性试验，以确定安全性和有效性。