COLLABORATIVE OBSERVATIONAL STUDY OF MYOPIA IN COMET CHILDREN

彗星儿童近视的合作观察研究

• 批准号: 6717638
• 负责人: RUTH E MANNY
• 金额: $ 19.6万
• 依托单位: UNIVERSITY OF HOUSTON
• 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/6717638
• 关键词: adolescence (12-20); clinical research; clinical trials; cooperative study; disease /disorder onset; human subject; human therapy evaluation; longitudinal human study; 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 Houston, College of Optometry (UHCO) 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). A total of four hundred children, 6-12 years of age with myopia (-1.25 to -4.50 D) in both eyes, who meet specific inclusion and exclusion criteria will be enrolled in the 4 participating centers. One hundred twelve children will be identified in Houston. These children will be recruited primarily from the University Eye Institute (UEI - the Clinic at UHCO). 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. A additional outcome measure is axial elongation as measured by A-scan ultrasonography. These outcome measures will be obtained by masked examiners. This application documents the ability of UHCO to recruit at least 112 children within one academic year, and to retain them for at least three years. Documentation is also provided that UHCO 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 UHCO, the other clinical centers are located at Colleges of Optometry in Boston, Birmingham, and Philadelphia, with the Study Chair in Boston and the Coordinating Center at Stony Brook NY.

描述：（申请人的摘要）该提案针对的是大学 休斯敦视光学院 (UHCO) 将成为四个临床学院之一 近视矫正评估试验（COMET）中心。 彗星是一个 前瞻性随机临床试验旨在评估是否 渐进多焦点镜片（PAL）可减缓青少年发病的进展 近视，与传统单光镜片 (SV) 相比。 一共四个 百名 6-12 岁儿童患有近视（-1.25 至 -4.50 D） 符合特定纳入和排除标准的眼睛将被纳入 4个参与中心。 一百十二名儿童将被确认身份 在休斯顿。 这些孩子将主要从大学招募 眼科研究所（UEI - UHCO 诊所）。 所有符合资格的儿童都将 至少三年内以六个月为间隔进行基线检查，以 测量屈光不正的变化并更新处方。 一个 所有四个中心都将使用标准化的通用协议。 初级 结果测量是近视的进展，通过睫状肌麻痹测量 自动验光。 另一个结果指标是轴向伸长率 通过A扫描超声检查测量。 这些成果措施将获得 由蒙面考官进行。 该应用程序记录了 UHCO 的能力 一学年内至少招收 112 名儿童，并留住他们 至少三年。 还提供文件证明 UHCO 拥有人员、设备和 根据 COMET 手册进行研究的设施 程序（MOP）。 COMET 原理、设计和的完整详细信息 方法包含在 MOP 中，与 研究主席和协调中心申请。 除了 UHCO 之外， 其他临床中心位于波士顿验光学院， 伯明翰和费城，研究主席在波士顿， 纽约州石溪协调中心。