EVALUATION TRIAL--COORDINATING CENTER

近视矫正评估试验(COMET)是一个多中心的项目， 随机、双掩蔽临床试验，旨在评估 渐进式附加镜片(PAL‘s)延缓青少年的进展- 发作性近视，与传统的单视镜(SV)相比。 主要的结果衡量标准是近视的进展，通过 睫状肌麻痹的自发性屈光。另一个衡量结果的指标是轴向。 伸长率，由A超测得。次要目标 彗星的作用是描述青少年近视的自然病史 在接受常规治疗或PAL治疗的一组儿童中。 在一年的时间内，这项研究将招募450名6-12岁的儿童 岁，双眼近视(-1.25D至-4.5D)，谁相遇 具体的纳入和排除标准。参与者将是 主要从小学视力筛查和 验光诊所学院。符合条件的儿童将接受检查 根据以基准和六个月为间隔的标准方案， 至少三年，以测量屈光不正的变化和 来更新处方。 提出的彗星是一项合作努力，涉及四个 波士顿、伯明翰验光学院的临床中心， 费城和休斯顿，波士顿的一个研究会主席办公室， 马萨诸塞州和位于纽约州石溪的协调中心(CC)。 一个独立的数据安全和监测委员会将审查 每年至少一次评估隐形眼镜的风险和好处的数据 任务。此应用程序寻求对 CC.CC的主要职责是：1)提供流行病学和 组织、设计、实施和实施生物统计学专业知识 试验分析；2)合作开发和 分发表格、文件和协议；3)开发、实施 并监控随机化过程；4)对数据负责 管理、处理和分析；5)编制监控报告 征聘、数据收集、安全问题、终点和数据 质量；6)协调和记录研究会议和交流 中心之间；7)负责质量保证程序； 8)合作准备成果出版物。

The Correction of Myopic Evaluation Trial (COMET) is a multi-center, randomized, double-masked clinical trial that aims to assess whether progressive addition lenses (PAL's) slow the progression of juvenile- onset myopia, as compared to conventional single vision lenses (SV). The primary outcome measure is progression of myopia, as measured by cycloplegic autorefraction. An additional outcome measure is axial elongation, as measured by A-scan ultrasonography. The secondary aim of COMET is to describe the natural history of juvenile-onset myopia in a group of children receiving conventional treatment or PAL's. Within a one-year period, the study will enroll 450 children, 6-12 years old, with myopia (-1.25D to -4.5D) in both eyes, who meet specific inclusion and exclusion criteria. Participants will be identified primarily from elementary school vision screening and College of Optometry clinics. Eligible children will be examined according to a standard protocol at baseline and six-month intervals, for at least three years, to measure changes in refractive error and to update prescriptions. The proposed COMET is a collaborative effort that involves four clinical centers at Colleges of Optometry in Boston, Birmingham, Philadelphia and Houston, a study chair's office in Boston, Massachusetts and a coordinating center (CC) in Stony Brook, New York. An independent Data Safety and Monitoring Committee will review the data at least once a year to assess the risks and benefits of the lens assignment. This application seeks support for the activities of the CC. The major CC responsibilities are to: 1) provide epidemiologic and biostatistical expertise to the organization, design, conduct and analysis of the trial; 2) collaborate in the development and distribution of forms, documents and protocols; 3) develop, implement and monitor the randomization process; 4) be responsible for data management, processing and analysis; 5) prepare reports to monitor recruitment, data collection, safety issues, endpoints and data quality; 6) coordinate and document study meetings and communications among centers; 7) be responsible for quality assurance procedures; and 8) collaborate in preparing publications of the results.