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.

需要一种合成的透明粘弹性流体用于 眼科手术成本更低，使用更方便 手术性能与透明质酸钠相当 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。眼内液可能会最小化角膜 术后肿胀和眼压升高。话题性 液体将为外科医生提供卓越的角膜保湿效果 手术期间可视化，延迟强烈的干燥效果 来自手术显微镜光的热量。 局部液体可能只需每八到十分钟涂抹一次 与手术期间间隔 30 秒的应用相比 平衡盐溶液，目前唯一使用的局部溶液。话题性 和眼内解决方案预计将共同提供 优越的角膜上皮和内皮细胞保护 外科手术。 第一阶段的目标是完成产品的开发 系统并使其符合美国 FDA 的人体临床试验资格 研究设备豁免。 开发粘弹性材料具有创新潜力 针对特定手术应用的“定制”流变特性 低成本易得的合成材料。