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）该提议是针对大学的 阿拉巴马州验光学院（UABSO）作为四个临床中心之一 在修正近视评估试验（彗星）中。 彗星是一个 前瞻性，随机临床试验旨在评估是否 渐进式添加镜头（PAL）减慢了少年发作的进展 与传统的单视镜（SV）相比，近视。 750个孩子 两只眼睛的近视（-1.25至-4.5 d）6-12岁 纳入和排除标准将被录取。 他们将被确定 主要来自小学视觉放映和验光学院 临床患者记录。 所有合格的孩子将在 基线和六个月的间隔至少三年 折射错误的变化并更新处方。 标准化， 共同协议将在所有四个中心使用。 主要结果 测量是通过环形自动截图测量的近视的进展。 另一个结果是通过A-Scan测量的轴向伸长 超声检查。 这些将由蒙版检查员获得。 这 申请记录UABSO筛选7500名儿童的能力 可能的资格，在一个学术中招募至少188名儿童 一年，并保留至少三年。 文档也是 只要UABSO拥有人员，设备和设施来进行 根据彗星手册（MOP）的研究。 完全的 彗星原理，设计和方法的详细信息包含在 拖把，与学习椅分别提交并进行协调 中心申请。 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，与 波士顿的学习主席和Stony Brook的协调中心。