COLLABORATIVE OBSERVATIONAL STUDY OF MYOPIA IN COMET CHILDREN

彗星儿童近视的合作观察研究

• 批准号: 6718395
• 负责人: WENDY L MARSH-TOOTLE
• 金额: $ 17.26万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-03-01 至 2008-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6718395
• 关键词: adolescence (12-20); clinical research; clinical trials; cooperative study; human subject; human therapy evaluation; longitudinal human study; mass screening; middle childhood (6-11); mydriatic /cycloplegic; myopia; outcomes research; pathologic process; ultrasonography; vision aid; vision tests

DESCRIPTION: (Applicant's Abstract) This proposal is for the University of Alabama School of Optometry (UABSO) to serve as one of four clinical centers in the Correction of Myopia Evaluation Trial (COMET). COMET is a prospective, randomized clinical trial designed to assess whether progressive addition lenses (PAL's) slow the progression of juvenile-onset myopia, compared to conventional single vision lenses (SV). 750 children 6-12 years old with myopia (-1.25 to -4.5 D) in both eyes, who meet specific inclusion and exclusion criteria will be enrolled. They will be identified primarily from elementary school vision screenings and School of Optometry clinical patient records. All eligible children will be examined at baseline and at six-month intervals for at least three years to measure changes in refractive error and to update prescriptions. A standardized, common protocol will be used at all four centers. 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. These will be obtained by masked examiners. This application documents the ability of UABSO to screen 7500 children for possible eligibility, to recruit at least 188 children within one academic year, and to retain them for at least three years. Documentation is also provided that UABSO has the personnel, equipment, and facilities to conduct the study in accordance with the COMET Manual of Procedures (MOP). Complete details of the COMET rationale, design, and methods are contained in the MOP, which is submitted separately with the study chair and coordinating center applications. In addition to UABSO, the other clinical centers are located at Colleges of Optometry in Boston, Houston, and Philadelphia, with the Study Chair in Boston and the Coordinating Center at Stony Brook.

描述：（申请人的摘要）本提案是为大学 亚拉巴马视光学学院（UABSO）将作为四个临床中心之一 近视矫正评估试验（COMET） 彗星是一 前瞻性随机临床试验，旨在评估 渐进式多焦点镜片（PAL）可以减缓青少年发病的进展， 近视，与传统的单视镜片（SV）相比。 750名儿童 6-12双眼近视（-1.25至-4.5 D），符合特定 入选和排除标准。 他们将被识别 主要来自小学视力筛查和验光学校 临床患者记录。 所有符合资格的儿童将在 基线和每隔6个月至少三年测量 屈光不正的变化和更新处方。 一个标准化， 所有四个中心都将使用共同的方案。 主要结局 测量是近视的进展，如通过睫状肌麻痹自动验光测量的。 另一个结果指标是通过A扫描测量的轴向伸长 超声检查 这些将由蒙面检查员获得。 这 申请文件的能力UABSO筛选7500名儿童， 可能的资格，在一所学校内招收至少188名儿童， 一年，并保留至少三年。 文档也是 只要UABSO有人员、设备和设施进行 根据COMET程序手册（MOP）进行研究。 完成 COMET的基本原理、设计和方法的详细内容， MOP，与研究主席单独提交， 中心应用程序。 除了UABSO，其他临床中心是 位于波士顿，休斯顿和费城的验光学院， 波士顿的研究主席和斯托尼布鲁克的协调中心。