EVALUATION TRIAL--COORDINATING CENTER

评估试验--协调中心

• 批准号: 6502336
• 负责人: LESLIE G HYMAN
• 金额: $ 75.11万
• 依托单位: STATE UNIVERSITY NEW YORK STONY BROOK
• 依托单位国家: 美国
• 财政年份: 1996
• 资助国家: 美国
• 起止时间: 1996-09-30 至 2003-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6502336
• 关键词: clinical research; cooperative study; data collection methodology /evaluation; diagnosis quality /standard; epidemiology; eye disorder diagnosis; human subject; human therapy evaluation; mass screening; medical rehabilitation related tag; middle childhood (6-11); myopia; statistics /biometry; ultrasonography; vision aid

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.

近视矫正评估试验（COMET）是一项多中心， 一项随机、双盲临床试验，旨在评估 渐进式多焦点镜片（PAL）减缓青少年的进展， 与传统单视镜片（SV）相比， 主要结果指标是近视的进展，如通过以下指标测量的： 睫状肌麻痹自动验光 一个额外的结果测量是轴向的 伸长，如通过A扫描超声检查测量的。 次要目的 COMET的目的是描述青少年近视的自然史 在一组接受常规治疗或PAL的儿童中。 在一年的时间里，这项研究将招募450名儿童，6-12岁， 岁，双眼近视（-1.25D至-4.5D），符合 具体的入选和排除标准。 参与者将被 主要从小学视力筛查中识别， 视光学学院诊所。 符合条件的儿童将接受检查 根据基线和六个月间隔的标准方案， 至少三年，以测量屈光不正的变化， 更新处方 拟议的彗星是一项合作努力，涉及四个 在波士顿、伯明翰、 费城和休斯顿，波士顿的一个研究所， 在马萨诸塞州和纽约的斯托尼布鲁克有一个协调中心（CC）。 一个独立的数据安全和监测委员会将审查 至少每年一次的数据，以评估透镜的风险和受益 派任 本申请寻求对 CC. CC的主要职责是：1）提供流行病学和 生物统计专业知识的组织，设计，进行， 试验分析; 2）合作开发， 分发表格、文件和议定书; 3）制定、执行 并监督随机化过程; 4）对数据负责 管理、处理和分析; 5）编写报告，以监测 招募、数据收集、安全性问题、终点和数据 质量; 6）协调和记录研究会议和沟通 （七）负责质量保证程序; 8)合作编写成果出版物。