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温度升高，在瞳孔周围形成环形的角膜基质(中间)层，从而使中央角膜变平，从而矫正近视。大约50%的美国人需要矫正近视。这种新的方法比最常见的近视手术-激光辅助原位角膜磨镶术(LASIK)具有优势。具体地说，MTK： 不涉及中央角膜的手术干预。 不需要一段时间的治疗。 不使用昂贵的设备。 只需要一次2秒的治疗。 通过其冷却系统使角膜上皮得以保留。 避免了LASIK特有的干眼并发症。 我们将改进现有的MTK系统，加入反馈系统以获得准确的结果，并加入光学中心系统以帮助放置在角膜上。我们将在体外和体内对重新设计的系统进行评估，并量化屈光效果的可预测性和重复性的改善。在第一阶段，我们将在五个受试者中进行体内急性研究。在第二阶段，我们将进行体内慢性研究，并进行3个月的随访期。这项工作将支持我们向FDA申请调查设备豁免。

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.