Rationale for and design of the National Eye Institute Prospective Evaluation of Radial Keratotomy (PERK) Study.
Rationale for and design of the National Eye Institute Prospective Evaluation of Radial Keratotomy (PERK) Study.
复制标题
国家眼科研究所放射状角膜切开术 (PERK) 研究前瞻性评估的基本原理和设计。
DOI：
10.1016/s0161-6420(83)34603-0
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发表时间：
1983
期刊：
影响因子：
13.7
通讯作者：
Bourque,LB
中科院分区：
文献类型：
--
作者：
Waring3rd,GO;Moffitt,SD;Gelender,H;Laibson,PR;Lindstrom,RL;Myers,WD;Obstbaum,SA;Rowsey,JJ;Safir,A;Schanzlin,DJ;Bourque,LB
一项为期五年的多中心合作临床试验正在九个临床中心进行。该研究由国家眼科研究所资助，招募了大约500名年龄在21岁或以上的患者，他们患有-2.00至-8.00屈光度的生理性近视，并且符合其他明确定义的合格标准。外科医生用一把金刚石刀片的千分尺在角膜前部做八个放射状切口。中央透明区的直径由近视程度和术中超声角膜厚度测量的切口深度决定。除外科医生以外的研究者收集所有术前和术后数据。检查包括用标准视力表测量视力，由第二个观察者验证屈光度，用角膜曲率计和角膜光镜检查测量角膜曲率，用眩光测试仪定量眩光，用计算机化数字化仪从镜面显微照片测量单个内皮细胞的大小。一个正式的心理测量问卷被用来评估病人的主观反应。医生监查员确保在研究中心访视期间遵守方案，数据和安全性监查委员会成员监督研究进展。协调中心的生物统计学家确保完整的数据收集，处理数据，并协助解释结果。
A five-year, multicenter, collaborative clinical trial of radial keratotomy for myopia is being carried out at nine clinical centers. The study, funded by the National Eye Institute, is recruiting approximately 500 patients aged 21 years or older with −2.00 to −8.00 diopters of physiologic myopia who also meet other clearly defined eligibility criteria. Surgeons use a diamond-bladed micrometer knife to make eight radial incisions in the anterior cornea. The diameter of the central clear zone is determined by the amount of myopia and the depth of the incisions by intraoperative ultrasonic pachymetry. Investigators other than the surgeon gather all pre- and post-operative data. Examinations include measurement of visual acuity with standardized charts, verification of refractions by a second observer, measurement of corneal curvature by keratometry and photokeratoscopy, quantitation of glare with a glare tester, and measurement of the size of individual endothelial cells from specular photomicrographs with a computerized digitizer. A formal psychometric questionnaire is used to evaluate the patients' subjective response. Physician monitors insure adherence to the protocol during site visits and members of the Data and Safety Monitoring Board oversee the progress of the study. Biostatisticians at the Coordinating Center insure complete data collection, process the data, and assist in the interpretation of results.