中国屈光手术安全性和有效性的多中心协同研究初步分析

目的针对多中心协同开展屈光手术研究的＂十五＂国家科技攻关计划,分析其成果及其对屈光手术安全性和有效性研究的贡献,探索与之相关的研究形式和完成机制。方法温州医学院附属眼视光医院等19家医院多中心联合开展屈光手术的临床研究,在统一标准和规范的前提下,开展屈光手术的临床调查和资料收集工作,手术类型包括准分子激光屈光性角膜切削术（photorefractive kera-tectomy,PRK）、准分子激光原位角膜磨镶术（laser in situkeratomileusis,LASIK）、眼内晶状体屈光手术（phakic intraoc-ular lens,PIOL）。研究分三个层面进行：①单个中心屈光手术后视觉功能的临床基础研究。②多中心开展屈光手术情况的一般资料收集和分析。③多中心前瞻性调查研究设计的安全性和有效性临床研究。结果从以不同角度设计的临床基础研究中总结出与视觉功能有关的参数,主要有视敏度和对比敏感度视力、调节和辐辏功能参数、眼球像差、角膜形态参数。②多中心屈光手术开展的一般资料提示,屈光手术在经历上升期后趋于平稳发展状态,手术方式以LASIK为主,屈光矫正以近视矫正为主,医疗人员和设备已相对完善。③多中心协同研究共收集屈光手术总例数2188例,其中LASIK病例达到1754例;LASIK总安全性参数和有效性参数分别达到1.007和1.003。结论屈光手术安全性和有效性的研究焦点体现了手术期望的综合指数,具有重要的临床应用和推广价值。多中心研究成功运行的关键在于课题的合理设计和各中心之间的协同和科学管理,目前国内屈光手术有效性和安全性达到相对理想状态。

Primary analysis on the safety and efficacy study of refractive surgery through multi-centers cooperative investigation

Objective Based on the completion of the refractive surgery research project from the Chinese National Key Technologies R＆D Program, the outcome contribute to the safety and efficacy of refractive surgery was analyzed, and the way for making its success was explored. Methods The Hospital of Optometry and Oph- thamology, at Wenzhou Medical College, along with 19 refractive surgery centers, conducted clinical study of refractive surgery of laser in situ keratomileusis （LASIK）, photorefractive keratomileusis （PRK） and phakic intraocular lens （PIOL）. Under the established standards and procedures, multi-centers refractive surgery investiga- tion and data collection were made in three parts studies conse- quently： ① Clinical basic study on visual function after refractive surgery was done at Wenzhou. ② General data about refractive surgery were collected among 12 units. ③Longitudinal clinical in- vestigation on safety and efficacy in multi -center was conducted. Results ①The critical visual functional related parameters for fine outcome of refractive surgery were summarized in the part I. And they were visual acuity, contrast sensitivity function, accommodation and vergence, ocular optical aberration and corneal topography. ② From the general data collection, the volume of refractive surgery was in the development curve from sharp up to flat up trend, LASIK was the domain one. Myopes took account of the majority. Faculty and facility were well equipped. ③Two thousand one hun- dred and eighty-eight cases were enrolled and kept for scheduled followe up. Among which, there were 1754 LASIK cases. Among the LASIK cases at the 6th month follow up, the safety and effica- cy factors were 1.007 and 1.003 respectively. Conclusion The safety and efficacy factors of refractive surgery reflected the expect- ed comprehensive outcome which has clinical significance and ap- plication. The success of multi -centers research investigation de- pends on the project design, friendly cooperation and good manage-