Commercialization of microwave thermokeratoplasty

微波热角膜移植术的商业化

• 批准号: 6943228
• 负责人: B STUART TREMBLY
• 金额: $ 37.26万
• 依托单位: AVEDRO, INC.
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-09-01 至 2006-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6943228
• 关键词: cats; keratoplasty; microwave radiation; myopia; optics; radiation dosage; technology /technique development

DESCRIPTION (provided by applicant): Microwave Thermokeratoplasty (MTK) shrinks the stromal (middle) layer of the cornea in a ring pattern around the pupil in response to elevation of temperature by absorption of microwave energy; the central cornea flattens as a result, thus correcting for myopia. About 50% of the U.S. population requires correction for myopia. This novel method has advantages over the most common surgical treatment for myopia, laser assisted in-situ keratomileusis (LASIK). Specifically, MTK:  Involves no surgical intervention in the central cornea.  Requires no period of healing.  Does not use expensive equipment.  Involves only a single, 2-second treatment.  Spares the corneal epithelium through its cooling system.  Avoids the dry eye complication characteristic of LASIK. We will improve the existing MTK system by incorporating a feedback system to achieve precise results and an optical centering system to assist placement on the cornea. We will evaluate the redesigned system in ex vivo and in vivo corneas and quantify the improvement in predictability and repeatability of refractive effect. In Phase I, we will perform an in vivo acute study in five subjects. In Phase II, we will perform an in vivo chronic study with a 3- month follow-up period. This work will support our application to the FDA for an Investigational Device Exemption.

描述（由申请人提供）： 微波热角膜成形术 (MTK) 通过吸收微波能量来响应温度升高，使瞳孔周围的角膜基质（中）层收缩成环形；结果，中央角膜变平，从而矫正近视。大约 50% 的美国人口需要矫正近视。这种新颖的方法比最常见的近视手术治疗激光辅助原位角膜磨镶术（LASIK）具有优势。具体来说，联发科： 不涉及中央角膜的手术干预。 无需愈合期。 不使用昂贵的设备。 仅涉及一次 2 秒的治疗。 通过其冷却系统保护角膜上皮。 避免 LASIK 特有的干眼并发症。 我们将改进现有的 MTK 系统，加入反馈系统以实现精确结果，并引入光学定心系统以协助放置在角膜上。我们将在离体和体内角膜中评估重新设计的系统，并量化屈光效果的可预测性和可重复性的改进。在第一阶段，我们将对五名受试者进行体内急性研究。在第二阶段，我们将进行一项为期 3 个月随访的体内慢性研究。这项工作将支持我们向 FDA 申请研究设备豁免。