结合结构和功能评估青光眼进展：对临床试验设计的影响。
Combining structure and function to evaluate glaucomatous progression: implications for the design of clinical trials.
机构信息
Hamilton Glaucoma Center and Department of Ophthalmology, University of California, San Diego, USA; Federal University of São Paulo, Department of Ophthalmology, Brazil.
出版信息
Curr Opin Pharmacol. 2013 Feb;13(1):115-22. doi: 10.1016/j.coph.2012.10.010. Epub 2012 Dec 4.
Abstract
The selection of a suitable method for assessment of glaucomatous progression and estimation of rates of change is an essential component of the design of clinical trials investigating neuroprotective therapies for the disease. Due to the limitations of currently available tests, approaches combining structural and functional tests are essential in order to provide reliable detection of endpoints. This could also potentially enable shorter clinical trials with relatively smaller sample size requirements. A recent approach for estimating rates of retinal ganglion cell loss using a combination of structural and functional tests has been shown to perform better than isolated parameters from conventional tests for diagnosing, staging and detecting glaucoma progression and may prove useful as an outcome measure in clinical trials of the disease.
摘要
选择合适的方法来评估青光眼的进展并估计变化率是研究疾病神经保护疗法的临床试验设计的重要组成部分。由于目前可用的测试方法存在局限性，因此需要结合结构和功能测试的方法，以便可靠地检测终点。这还有可能使临床试验相对减少样本量要求。最近，一种使用结构和功能测试相结合的方法来估计视网膜神经节细胞损失的速度已被证明优于传统测试中用于诊断、分期和检测青光眼进展的孤立参数，并且可能作为疾病临床试验的一种结果测量方法证明有用。
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