Waring G O, Moffitt S D, Gelender H, Laibson P R, Lindstrom R L, Myers W D, Obstbaum S A, Rowsey J J, Safir A, Schanzlin D J, Bourque L B
Ophthalmology. 1983 Jan;90(1):40-58. doi: 10.1016/s0161-6420(83)34603-0.
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.
一项关于近视放射状角膜切开术的为期五年的多中心合作临床试验正在九个临床中心开展。该研究由国家眼科研究所资助，正在招募约500名年龄在21岁及以上、生理性近视度数在-2.00至-8.00屈光度且符合其他明确规定入选标准的患者。外科医生使用钻石刀片微米刀在前角膜上做八个放射状切口。中央透明区的直径由近视度数决定，切口深度通过术中超声测厚法确定。除外科医生外的研究人员收集所有术前和术后数据。检查包括使用标准化视力表测量视力、由第二名观察者核实验光结果、通过角膜曲率计和光角膜镜测量角膜曲率、使用眩光测试仪定量眩光以及使用计算机数字化仪从镜面显微镜照片测量单个内皮细胞的大小。使用正式的心理测量问卷来评估患者的主观反应。医师监督员在现场访视期间确保遵守方案，数据与安全监测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。
