COLLABORATIVE OBSERVATIONAL STUDY OF MYOPIA IN COMET CHILDREN

描述：(申请人摘要)这项提案是针对宾夕法尼亚州的 视光学院(PCO)将成为中国四大临床中心之一 近视矫正评估试验(COMET)。彗星是一颗有前景的， 随机临床试验旨在评估渐进性相加 镜片(PAL‘s)延缓青少年近视的进展，与 传统的单视镜(SV)。750名6-12岁的儿童 双眼近视(-1.25至-4.5D)的年龄，谁会遇到特定的 纳入和排除标准将被纳入。他们将被识别出来 主要来自小学视力检查和验光学院 临床病历。所有符合条件的儿童将在 基线和至少三年每隔六个月进行一次测量 屈光不正的变化和更新处方。一个标准化的， 所有四个中心都将使用共同的协议。主要结果是 测量近视的进展，通过睫状肌麻痹的自动屈光来测量。 另一个测量结果的指标是通过A扫描测量的轴向伸长 超声波检查。这些证书将由蒙面考官获得。这 申请证明PCO有能力对7500名儿童进行筛查 可能的资格，在学业上至少招收188名儿童 一年，并保留至少三年。文档还包括 只要PCO有人员、设备和设施进行 这项研究是根据COMET程序手册(MOP)进行的。完成 彗星的基本原理、设计和方法的详细信息包含在 《议定书》，与研究主席和协调机构单独提交 居中应用程序。除了PCO，其他临床中心还有 位于波士顿、休斯顿和伯明翰的验光学院，拥有 波士顿的研究教席和石溪的协调中心。

DESCRIPTION: (Applicant's Abstract) This proposal is for the Pennsylvania College of Optometry (PCO) 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). Seven hundred fifty 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 PCO to screen 7500 children for possible eligibility, to recruit at least 188 children within on academic year, and to retain them for at least three years. Documentation is also provided that PCO 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 PCO, the other clinical centers are located at Colleges of Optometry in Boston, Houston, and Birmingham, with the Study Chair in Boston and the Coordinating Center at Stony Brook.