DEVELOPMENT OF A NOVEL GLAUCOMA IMPLANT

描述（由申请人提供）：青光眼是世界上主要的致盲原因之一。青光眼是一种复杂的疾病，有许多潜在的原因。目前，唯一有效的治疗方法是将眼内压（IOP）降低到临床安全范围。相当一部分青光眼患者需要手术干预来阻止进行性视神经损伤。目前难治性青光眼的手术选择包括小梁切除术和青光眼引流植入物的使用。尽管抗代谢药提高了小梁切除术的成功率，但其使用与不可预测的血流控制、低眼压、伤口渗漏、囊膜纤维化和感染有关。青光眼管植入物已经越来越受欢迎，但所有目前市售的装置都受到纤维化反应的困扰，纤维化反应最终限制了这些装置的流出设施并防止较低的IOP。此外，纤维囊增加了眼睑运动障碍和下垂的风险，并最终限制了这些青光眼植入物的滤过寿命。改变对传统植入物的纤维化反应的尝试在很大程度上是不成功的。最近已经尝试使用各种生物相容性膜开发新一代青光眼植入物，但成功有限。我们成功地证明了使用一种特殊的生物相容性膜与一种经过验证的青光眼管植入物在我们的第一阶段SBIR资助结束时有利地调节纤维化反应的可行性。对于该II期应用，我们提出了一种独特的植入物设计，该设计由生物相容性材料组成，在动物和人体中表现出有利的流动和组织特性。我们建议将现有植入物与新材料结合以提高性能。该设备将在兔子模型系统中进行测试，然后在人体中进行测试。将在家兔研究中分析植入物的组织学、安全性和有效性。此后，人类最终原型的制造将开始，同时沿着最终产品的大规模制造系统的开发。随着该植入物长期性能的改善，手术器械的使用可能会显著增加。开发这种安全有效的青光眼引流装置将大大提高减少这种常见疾病失明的能力。本项目旨在通过开发一种新的青光眼引流装置来预防青光眼患者失明。

DESCRIPTION (provided by applicant): Glaucoma is one of the leading causes of blindness in the world. Glaucoma is a complex disease with many underlying causes. Currently, the only effective treatment is reducing intraocular pressure (IOP) to a clinically safe range. A significant portion of individuals with glaucoma will require surgical intervention to stop progressive optic nerve damage. Current surgical options for refractory glaucomas include trabeculectomy and the use of glaucoma drainage implants. Although antimetabolites have improved success rates for trabeculectomy, their use is associated with unpredictable control of flow, hypotony, wound leaks, capsular fibrosis and infection. Glaucoma tube implants have been gaining popularity, but all current commercially available devices are plagued with a fibrotic response that ultimately limits the outflow facility of these devices and prevents lower IOP. In addition, the fibrous capsule increases the risk of motility disturbances and drooping of the eyelid and ultimately limits the filtration life of these glaucoma implants. Attempts to modify the fibrotic response to conventional implants have largely been unsuccessful. There have been recent attempts to develop newer generation glaucoma implants using various biocompatible membranes with limited success. We successfully demonstrated the feasibility of using a particular biocompatible membrane with a proven glaucoma tube implant to favorably modulate the fibrotic response at the conclusion of our Phase I SBIR grant. For this Phase II application we propose a unique implant design consisting of a biocompatible material that demonstrates advantageous flow and tissue characteristics in animals and humans. We propose to integrate an existing implant with new material to improve performance. The device will be tested in a rabbit model system, and then in humans. The histology, safety, and effectiveness of the implants will be analyzed in the rabbit study. Thereafter, manufacturing of the final prototype for humans will begin along with the development of a mass manufacturing system for the final product. With improved long-term performance of this implant, use of surgical devices would likely increase significantly. Development of this safe and effective glaucoma drainage device will greatly improve the ability to reduce blindness from this common disorder. This project aims to prevent blindness in glaucoma patients through the development of a new glaucoma drainage device.