Correction of Myopia Evaluation Trial Phase II

描述（由申请人提供）：近视矫正评价试验（COMET），一项多中心、随机临床试验，旨在评价渐进多焦镜片（帕尔斯）与单光镜片（SVL）相比是否能减缓近视进展， 招募了469名近视儿童，这些儿童在3年的时间内每年通过睫状肌麻痹自动验光和眼轴长度进行标准化近视测量。保持良好，98.5%的儿童完成了3年的随访。4年随访访视将于2002年10月完成，此后不久，研究设计将从临床试验转向纵向研究。COMET队列提供了一个独特的机会来表征近视进展，以及它如何受到COMET第一阶段确定的因素以及家族性近视的新数据（包括遗传分析）的影响。更好地了解预测近视进展和稳定的因素也将有助于指导干预措施的选择和时机，并针对那些可能从治疗中受益最多的群体。COMET-第二阶段将通过再收集5年来自COMET儿童的数据来实现以下目标。目标1：根据COMET中的儿童队列，开发预测模型并确定9年内近视和眼轴长度变化的特征因素。目标二：完成COMET家系的确定，并从先前确定的高度近视开始，进行旨在调查青少年发病近视遗传位点的研究。目的3：评价长期效果（即，超过三年）已佩戴帕尔斯或SVL至少三年。本申请寻求继续支持协调中心的活动。协调中心的主要职责仍然是：1）为II期研究的设计、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，包括遗传分析; 3）合作制定、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。II期的其他目标是：1）模拟COMET儿童近视的进展和稳定; 2）跟踪研究中心之间父母/兄弟姐妹屈光不正和遗传数据的流动; 3）创建谱系结构，建立遗传数据库并进行连锁和其他遗传分析。

DESCRIPTION (provided by applicant): The Correction of Myopia Evaluation Trial (COMET), a multi-center, randomized clinical trial designed to evaluate whether progressive addition lenses (PALs) slow the progression of myopia compared to single vision lenses (SVLs), enrolled 469 myopic children who have been carefully followed with annual standardized measurements of myopia by cycloplegic autorefraction and axial length over a 3-year period. Retention has been excellent, with 98.5% of children completing 3-year follow-up visits. Four year follow up visits will be completed in October, 2002, and soon after that the study design will shift from a clinical trial to a longitudinal investigation. The COMET cohort provides a unique opportunity to characterize myopia progression and how it is influenced by factors identified in the first phase of COMET as well as new data on familial myopia, including genetic analyses. Better understanding of the factors predictive of myopia progression and stabilization also will help guide selection and timing of interventions as well as target those groups that may benefit most from treatment. COMET-Phase II will accomplish the following aims by collecting data from COMET children for an additional 5 years. Aim 1: To develop predictive models and identify factors that characterize changes over a 9 - year period in myopia and axial length, based on the cohort of children in COMET. Aim 2: To complete ascertainment of the pedigrees of COMET families and to conduct studies designed to investigate genetic loci for juvenile-onset myopia, beginning with those previously identified for high myopia. Aim 3: To evaluate the long term effect (i.e., beyond three years) of having worn either PALs or SVLs for at least three years. This application seeks continued support for the activities of the Coordinating Center. The major responsibilities of the Coordinating Center will continue to be to: 1) provide epidemiologic and biostatistical expertise to the design, conduct and analysis of Phase II; 2) develop and implement the statistical analysis plan including genetic analyses; 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 aims for Phase II are to: 1) model the progression and stabilization of myopia in COMET children; 2) track the flow of parental/sibling refractive error and genetic data among study centers; and 3) create the pedigree structure, establish the genetic database and conduct linkage, and other genetic analyses.