ENDOCAPSULAR VORTEX EMULSIFICATION CATARACT REMOVAL

囊内涡旋乳化白内障摘除术

• 批准号: 6194078
• 负责人: SOHEILA MIRHASHEMI
• 金额: $ 35.25万
• 依托单位: NEOMEDIX CORPORATION
• 依托单位国家: 美国
• 财政年份: 1996
• 资助国家: 美国
• 起止时间: 1996-05-01 至 2001-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6194078
• 关键词: animal tissue; biological models; biomaterial development /preparation; biomedical equipment development; cataract surgery; clinical biomedical equipment; evaluation /testing; eye prosthesis; injection /infusion; method development; model design /development; polymers; technology /technique

DESCRIPTION: In recent years, major emphasis has been placed on developing a biopolymer material, which could be injected into the natural lens capsule following cataract extraction. In order to fill the natural lens capsule with such a biopolymer lens substitute, the diseased cataract must first be removed via an endocapsular cataract extraction. The phacoemulsification procedure requires destruction (removal) of the anterior lens capsule, precluding use of future biopolymer lens refilling technologies. Optex has developed an innovative proprietary Endocapsular Vortex Emulsification (EVE) technology for endocapsular cataract removal. EVE is the first technology to offer the potential of providing a user-friendly, fast, economical and commercially viable procedure for performing endocapsular cataract removal. Scientific studies have demonstrated that lens material can be removed from the lens capsule via a 1.25-1.5 mm hole in less than 5 minutes (generally 1-3 minutes) using the EVE technology. Therefore, use of the EVE technology for cataract removal would allow the lens capsule to be basically intact so it can be filled with a biopolymer after cataract removal. The specific aims of this proposed research for advancing the EVE technology for cataract removal toward commercialization are as follows: 1) Develop clinical instrument system design including disposable (sterile, single use), responsible (limited reuse), and reusable (extended use) components. This clinical instrument system will serve as the basis for regulatory submissions to FDA and clinical studies. 2) Fabricate clinical instrument system, 3) Develop excised cadaver eye model, 4) Perform experimental studies to select and optimize clinical instrument system operating parameters, and 5) Demonstrate safety and efficacy and ease-of-use of the clinical instrument. PROPOSED COMMERCIAL APPLICATION: NOT AVAILABLE

描述：近年来，人们重点关注 开发一种生物聚合物材料，可以将其注入 白内障摘除后的自然晶状体囊。 为了填补 具有这种生物聚合物晶状体替代品的天然晶状体囊， 患病白内障必须首先通过囊内白内障摘除 萃取。 超声乳化手术需要破坏 （去除）晶状体前囊，排除未来的使用 生物聚合物镜片再填充技术。 Optex 开发了一种 创新专有的囊内涡旋乳化 (EVE) 囊内白内障摘除技术。 EVE是第一个 技术提供了提供用户友好、快速、 经济且商业上可行的囊内手术程序 白内障摘除。科学研究表明，镜片 可通过 1.25-1.5 毫米的孔从晶状体囊中取出材料 使用EVE技术不到5分钟（一般1-3分钟）。 因此，使用 EVE 技术去除白内障将允许 晶状体囊基本完好，因此可以填充 白内障摘除后的生物聚合物。 本提案的具体目标 研究推进 EVE 去除白内障技术 商业化工作如下： 1）开发临床仪器系统 设计包括一次性（无菌、一次性使用）、负责任（有限 重用）和可重用（扩展使用）组件。 本临床 仪器系统将作为监管提交的基础 FDA 和临床研究。 2）制造临床仪器系统，3） 开发离体尸体眼睛模型，4) 进行实验研究 选择和优化临床仪器系统操作参数，以及 5) 证明临床的安全性、有效性和易用性 乐器。 拟议的商业应用：不可用