Collaborative Observational Study of Myopia in COMET Children 2-Coordinating Ctr

描述（由申请人提供）：COMET儿童近视的合作观察性研究（COSMICC）是一项纵向研究，对参加近视矫正评价试验（COMET.目前，在平均年龄为17岁时，该队列中仅42%的受试者的近视停止进展。这组不同种族的近视受试者有7-8年的标准化、可靠的屈光不正和眼部成分测量，保持率高达93%。因此，该队列提供了一个独特的机会来表征近视的进展和稳定，并了解它们如何受到从COMET和文献中确定的遗传和环境因素的影响。通过对这一队列再进行5年的研究，COSMICC 2旨在实现以下目标。 目标1：使用Gompertz和其他函数来表征COSMICC队列中58%的进行性近视患者的近视病程，并基于先前确定的内在风险因素（年龄、种族和父母近视）开发预测模型。我们期望发现，根据Gompertz函数拟合数据确定的近视稳定性将与使用临床定义的稳定性相当，并且轴向伸长的结果将与近视进展的结果相似。目标二：在这一特征明确的近视患者队列中，检验与近视进展和稳定的环境风险因素相关的4个假设，目的3：为了检验与COSMICC受试者中IOP、CCT和黄斑厚度与眼轴伸长变化和近视进展相关的3个假设。本申请寻求对协调中心活动的持续支持，自COMET成立以来，它已成功地发挥了这一作用，并将继续类似于COSMICC。协调中心的主要职责是：1）为COSMICC 2的设计、实施和分析提供流行病学和生物统计学专业知识; 2）制定和实施统计分析计划; 3）协作制定、修改和分发表格、文件和方案; 4）负责数据管理、处理和分析; 5）准备报告以监测招募、数据收集和数据质量; 6）协调和记录临床中心之间的沟通; 7）负责质量保证程序; 8）合作准备结果的出版物。COSMICC 2的其他新目标是处理和分析与近视和眼轴长度相关的IOP、CCT和黄斑厚度和体积的新测量数据。研究主席和4家临床中心各自提交了单独的申请。

DESCRIPTION (provided by applicant): The Collaborative Observational Study of Myopia in COMET Children (COSMICC) is a longitudinal study that has followed the cohort of children who participated in the Correction of Myopia Evaluation Trial (COMET. Currently, at an average age of 17 years, myopia has stopped progressing in only 42% of the subjects in this cohort. This group of ethnically diverse myopic subjects has 7-8 years of standardized, reliable measurements of refractive error and ocular components, with outstanding retention of 93%. Thus, this cohort provides a unique opportunity to characterize progression and stabilization of myopia and to learn how they are influenced by genetic and environmental factors identified from COMET and from the literature. By studying this cohort for an additional 5 years, COSMICC2 seeks to accomplish the following aims. Aim 1: To use the Gompertz and other functions to characterize the course of myopia in the 58% of the COSMICC cohort with progressing myopia and to develop predictive models based on previously identified, intrinsic risk factors (age, ethnicity, and parental myopia). We expect to find that myopia stabilization determined from Gompertz functions fit to the data will be comparable to stabilization using a clinical definition and that results for axial elongation will be similar to those for myopia progression. Aim 2: To test 4 hypotheses related to environmental risk factors for myopia progression and stabilization in this well-characterized cohort of myopes Aim 3: To test 3 hypotheses related to the association of IOP, CCT, and macular thickness with changes in axial elongation and myopia progression in COSMICC subjects This application seeks continued support for the activities of the Coordinating Center, which has successfully served in this role since COMET began and will remain similar to COSMICC. The major responsibilities of the Coordinating Center are to: 1) provide epidemiologic and biostatistical expertise to the design, conduct and analysis of COSMICC2; 2) develop and implement the statistical analysis plan; 3) collaborate in the development, modification and distribution of forms, documents and protocols; 4) be responsible for data management; processing and analysis; 5) prepare reports to monitor recruitment, data collection, and data quality; 6) coordinate and document communications among clinical centers; 7) be responsible for quality assurance procedures; and 8) collaborate in preparing publications of the results. Additional new aims for COSMICC2 are to process and analyze data concerning new measurements of IOP, CCT and macular thickness and volume as they relate to myopia and axial length. Separate applications have been submitted by the Study Chair and each of the 4 clinical centers.