CORRECTION OF MYOPIA EVALUATION TRIAL--CHAIR APPLICATION

描述：（申请人的摘要）近视矫正评估 试验（COMET）是一项多中心、随机、双盲临床试验 旨在评估渐进多焦镜片（PAL）是否会减缓 与传统的单一近视相比， 视觉镜片（SV）。 四个参与的临床中心，在学院 波士顿、伯明翰、费城和休斯顿的验光师将招收一名 研究共450名双眼近视（-1.25 D至-4.5 D）儿童， 6-12岁，符合特定的入选和排除标准。 他们 将主要从小学视力筛查中识别， 验光学院临床病历。 所有符合条件的儿童将 在基线时和每隔6个月进行一次检查，至少持续3年 以测量屈光不正的变化并更新处方。 一 所有中心将使用标准化的通用方案。 主 结果测量是近视的进展，如通过睫状肌麻痹剂测量的。 自动验光 另外的结果测量是轴向伸长， 通过A扫描超声测量。 这些将通过蒙面获得 考官 除了一般性地介绍COMET研究之外，本申请还寻求 支持新英格兰大学的研究主席办公室 验光 COMET原理、设计和方法的完整细节如下： 载于所附《程序手册》。 资源中心 COMET是位于马萨诸塞州波士顿的研究主席办公室， 位于纽约州斯托尼布鲁克的中心。

DESCRIPTION: (Applicant's Abstract) The Correction of Myopia Evaluation Trial (COMET) is a multi-center, randomized, double-masked clinical trial designed to assess whether progressive addition lenses (PAL's) slow the progression of juvenile-onset myopia, as compared to conventional single vision lenses (SV). Four participating clinical centers, at Colleges of Optometry in Boston, Birmingham, Philadelphia, and Houston, will enroll a study total of 450 children with myopia (-1.25 D to -4.5 D) in both eyes, 6-12 years old, who meet specific inclusion and exclusion criteria. They will be identified primarily from elementary school vision screenings and College 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 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. In addition to presenting the COMET study in general, this application seeks support for the Study Chair's Office at the New England College of Optometry. Complete details of the COMET rationale, design, and methods are contained in the attached Manual of Procedures. Resource centers for the COMET are the Study Chair's Office in Boston, MA, and the Coordinating Center in Stony Brook, NY.