角膜塑形用硬性透气接触镜临床试验设计中的重点关注问题

Key Attention in Clinical Trial Design of Rigid Gas Permeable Contact Lenses for Orthokeratology

角膜塑形用硬性透气接触透镜(rigid gas permeable contact lenses for orthokeratology)是一种可逆性非手术的物理矫正屈光不正的治疗方法。近年来,角膜塑形用硬性透气接触透镜的使用在我国快速增长,申报首次注册的产品逐年增多。在新版医疗器械注册管理办法出台后,境内或进口的此类产品在注册申报时均有可能需要在国内进行规范的临床试验,此类产品如何进行科学的临床试验设计是企业和临床试验机构共同关注的问题。

Rigid gas permeable contact lenses for orthokeratology is a reversible non-surgical physical correction of ametropia treatment. In recent years, with the rapid growth of the use of rigid gas permeable contact lenses for orthokeratology in our country, the registration of products increased year by year. In the new version of the provisions for medical device registration, the domestic or import of such products in the registration declaration may need to complete a clinical trial in the country. How to carry out scientific clinical trials of the product design is the common concern of enterprises and clinical trial institutions.