Commercialization of microwave thermokeratoplasty

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，使角膜基质（中间）层在瞳孔周围以环形图案收缩，以响应温度升高;因此，中央角膜收缩，从而矫正近视。大约50%的美国人口需要矫正近视。这种新的方法具有优势，最常见的手术治疗近视，激光辅助原位角膜磨镶术（LASIK）。具体而言，MTK：  不涉及中央角膜的手术干预。  不需要一段时间的愈合。  不使用昂贵的设备。  只需要一次2秒的治疗。  通过冷却系统保护角膜上皮。  避免LASIK的干眼并发症特征。 我们将改进现有的MTK系统，包括一个反馈系统，以实现精确的结果和一个光学定心系统，以帮助放置在角膜上。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善。在I期，我们将在5名受试者中进行体内急性研究。在II期，我们将进行一项为期3个月的体内慢性研究。这项工作将支持我们向FDA申请研究器械豁免。

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.