OPHTHALMIC VISCOELASTIC FLUID SYSTEM
OPHTHALMIC VISCOELASTIC FLUID SYSTEM
批准号:
3496894
负责人:
JOHN M BLACKMORE
金额:
$4.98万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
1989
资助国家:
美国
项目状态:
已结题
起止时间:
1989-09-30 至 1990-06-30
中文摘要
需要一种合成的、透明的粘弹性流体用于
成本更低,使用更方便,
透明质酸钠的手术效果与之相当
MDR Group,Inc.正在开发一种眼用粘弹性液体系统
它既用于手术中的眼部局部使用,也用于眼内
以传统的方式。眼内液体可能会使角膜最小化
术后眼球肿胀和眼压升高。时事新闻
液体将提供卓越的角膜保湿和外科医生
手术中视觉化,延缓干燥的强烈效果
来自操作显微镜灯光的热量。
外用液体可能只需要每八到十分钟涂抹一次
在手术过程中与30秒的应用间隔进行比较
平衡盐溶液,目前唯一使用的局部解决方案。时事新闻
和眼内解决方案有望共同努力,提供
角膜上皮细胞和内皮细胞的高级保护
做手术。
第一阶段的目标是完成产品的开发
系统,并有资格在美国FDA下进行人体临床试验
调查设备豁免。
在开发粘弹性材料方面存在创新的潜力
为特定外科应用量身定做的流变性
低成本、易获得的合成材料。
英文摘要
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.
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