An Implantable Intraocular Pressure Control System - Phase II

植入式眼压控制系统 - 第二阶段

• 批准号: 8842631
• 负责人: THOMAS C DELAHANTY
• 金额: $ 28.48万
• 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 2018-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8842631
• 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; Health; 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; 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）：青光眼是一种广泛存在的慢性疾病，是致盲的主要原因，与视网膜神经节细胞死亡有关。在原发性开角型青光眼（POAG）中，眼压升高是视网膜细胞丧失的最常见危险因素。大型临床试验结果表明，青光眼患者IOP降低可延缓视力丧失的发展。即使眼压在正常范围内的青光眼患者也能从降低眼压中获益。目前，许多药物和手术方法被用来降低青光眼患者的IOP。然而，药物治疗的患者往往不适应，难治和/或遭受不良反应。目前的外科植入物是被动装置，不能检测或响应IOP的变化，经常失败。无论采用哪一种方法，都需要患者到办公室就诊，由医生通过眼压计手动验证IOP控制。我们建议制造一种既能感知IOP又能通过打开和关闭一个微型瓣膜来调节IOP的植入物。植入物的电源将是独立的，带有一个能够发送和接收外部命令的收发器。最终形式的植入物将监测和调节IOP，并能够记录IOP数据和有关瓣膜功能的信息，并通过数字设备（如PC）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截止/电磁阀，并附带遥测和数据采集系统。2)进行瓣膜的短期和长期体外试验，验证正常和病理压差范围内IOP的检测、反应和控制。3)在清醒、活动的正常IOP家兔上植入瓣膜并进行急性和慢性试验，以确定其安全性和有效性。