Update on Intraocular Lens Power Calculation Study Protocols The Better Way to Design and Report Clinical Trials
Update on Intraocular Lens Power Calculation Study Protocols The Better Way to Design and Report Clinical Trials
复制标题
DOI：
10.1016/j.ophtha.2020.07.005
复制
发表时间：
2021-10-20
期刊：
影响因子：
13.7
通讯作者：
Savini, Giacomo
中科院分区：
文献类型：
--
作者：
Hoffer, Kenneth J.;Savini, Giacomo
大约在40年前，其中一位作者（K.J.H.）发表了一套有组织的系统，用于量化人工晶状体（IOL）度数计算公式、方法和仪器的准确性。在《美国眼科杂志》（American Journal of Ophthalmology）编辑的要求下，IOL Power Club（以及一位统计学家）在2015年发表了一篇社论，对这些研究的适当方案进行了现代化和量化。在过去的十年中，引入了许多新的光学生物计，公式和方法（其准确性尚未完全测试），我们被要求再次现代化和更新这些指南，以帮助其他人设计和正确报告2020年人工晶状体度数计算和生物计量的临床研究结果。我们评估了入组患者的指南，包括最低视力要求、双侧眼排除、样本量问题、人口统计学（年龄、性别和种族），以及此类研究是否不应使用与开发测试公式相同的数据进行。我们显示了对不断优化的绝对需要，这些公式应该进行比较、折射测量（测试距离）、预测误差分析（绝对误差中位数和平均值、标准差、误差范围、预测在+/- 0.25屈光度[D]、+/- 0.50 D、+/- 0.75 D和+/- 1.00 D内的眼睛百分比以及四分位数显示）和统计分析方法的测试。我们提出了排名公式准确性的方法，包括新的Haigis IOL公式性能指数。我们还指出了谁编写了被测公式的问题，研究中使用的所有公式都必须被引用，研究中使用的所有仪器的软件版本号都应该清楚地说明。前房深度的定义是指从角膜上皮到晶状体的距离。我们希望这些建议能够帮助研究人员提高研究的有效性和准确性，最终达到提高人工晶状体度数计算的准确性。(C) 2020年美国眼科学会
It was almost 40 years ago when one of the authors (K.J.H.) published an organized system to quantify the accuracy of intraocular lens (IOL) power calculation formulas, methods, and instruments. At the behest of the editor of the American Journal of Ophthalmology, the IOL Power Club (along with a statistician) published an editorial in 2015 modernizing and quantifying the proper protocols for these studies. Over the past decade, so many new optical biometers, formulas, and methods (whose accuracies have yet to be completely tested) have been introduced that we were asked to modernize and update these guidelines yet again to help others design and report correctly the results of clinical studies on IOL power calculation and biometry for 2020. We evaluated guidelines to enroll patients, including visual acuity minimums, exclusion of bilateral eyes, sample size issues, demographics (age, gender, and ethnicity), and whether such studies should not be performed using the same data that were used to develop the formula being tested. We showed the absolute need for constant optimization, which formulas should be tested for comparison, refraction measurement (testing distance), as well as the analysis of the prediction error (median and mean absolute errors; standard deviation; range of errors; percentage of eyes with a prediction within +/- 0.25 diopter [D], +/- 0.50 D, +/- 0.75 D, and +/- 1.00 D; and interquartile displays) and statistical methods of analyses. We present methods of ranking formula accuracy, including the new Haigis IOL Formula Performance Index. We also point out the issues of who programmed the formulas being tested, that all formulas used in the study must be referenced, and the software version number of all instruments used in the study should be stated clearly. The definition of anterior chamber depth should be stated as measured from the corneal epithelium to the lens. We hope that these recommendations will help researchers to improve the validity and accuracy of their studies with the ultimate goal to improve the accuracy of IOL power calculation. (C) 2020 by the American Academy of Ophthalmology