OPHTHALMIC VISCOELASTIC FLUID SYSTEM

眼科粘弹性流体系统

• 批准号: 3496894
• 负责人: JOHN M BLACKMORE
• 金额: $ 4.98万
• 依托单位: MDR GROUP, INC.
• 依托单位国家: 美国
• 财政年份: 1989
• 资助国家: 美国
• 起止时间: 1989-09-30 至 1990-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3496894
• 关键词: biomaterial compatibility; biomedical equipment safety; blood viscosity; body fluid viscosity; cataract surgery; clinical biomedical equipment; cytotoxicity; fluorescent dye /probe; intraocular fluid; intraocular pressure; laboratory rabbit; nonblood rheology

There is a need for a synthetic, clear visoelastic fluid for use in ophthalmic surgery which is lower in cost, more convenient to use and comparable in surgical performance o sodium hyaluronate MDR Group, Inc. is developing an ophthalmic viscoelastic fluid system which is used both topically on the eye during surgery and intraocularly in the conventional fashion. The intraocular fluid may minimize corneal swelling and intraocular pressure rises post-operatively. The topical fluid will provide superior corneal moisturization and surgeon visualization during surgery, delaying the drying effects of the intense heat from the operating microscope light. The topical fluid may need only be applied every eight to ten minutes during surgery compared to the interval of 30 second applications with balanced salt solution, the only topical solution now used. The topical and intraocular solutions are expected to work together to provide superior corneal epithelial and endothelial cell protection during surgery. The objective of phase I is to complete the development of the product system and qualify it for human clinical trials under a U.S. FDA Investigational Device Exemption. The potential for innovation exists in developing viscoelastics with "tailored" rheologic properties for specific surgical applications from low cost readily available synthetic materials.

需要一种合成的，清晰的玻璃弹性流体以便在 眼科手术的成本较低，使用更方便 外科手术性能o透明质酸钠 MDR Group，Inc。正在开发眼科粘弹性流体系统 在手术期间和眼内局部使用 以传统方式。眼内液可以最大程度地减少角膜 术后肿胀和人工压力上升。局部 液体将提供优质的角膜保湿和外科医生 手术期间的可视化，延迟了强烈的干燥作用 从操作显微镜发出热量。 局部液体可能只需要每8到十分钟一次 手术期间与30秒应用的间隔相比 平衡盐溶液，现在使用的唯一局部解决方案。局部 并期望眼内解决方案共同提供 上等角膜上皮和内皮细胞保护 外科手术。 第一阶段的目的是完成产品的开发 系统并将其符合美国FDA的人类临床试验的资格 调查设备豁免。 创新的潜力是开发与 针对特定手术应用的“量身定制”流变特性 低成本容易获得的合成材料。