COLLABORATIVE OBSERVATIONAL STUDY OF MYOPIA IN COMET CHILDREN

描述：（申请人的摘要）本提案针对新英格兰 视光学学院（NEWENCO）作为临床中心， 近视矫正评估试验（COMET）。 COMET是一个前瞻性的， 一项随机临床试验，旨在评估 与传统的人工晶状体相比， 传统的单视镜片（SV）。 750名6-12岁儿童 双眼近视（-1.25至-4.5 D），符合特定 入选标准和缺乏特定排除标准的患者将入组。 他们将主要从小学视力筛查中识别出来。 所有符合条件的儿童将在基线和6个月时接受检查 间隔至少三年随访，以测量 屈光不正和更新处方。 一个标准化的，通用的 将在所有四个中心使用该方案。 主要结局指标是 近视进展，通过睫状肌麻痹自动验光测量。 一个 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 申请文件证明了NEWENCO筛查约7700名儿童的能力 为可能的资格，招募至少188名儿童在一个 一学年，并保留他们至少三年的后续行动。 文件还提供了NEWENCO拥有的人员，设备， 根据《彗星手册》， 程序（MOP）。 COMET原理、设计和 方法包含在MOP中，该MOP与 研究椅和协调中心的应用。 除了NEWENCO， 其他的临床中心都设在视光学学院， 伯明翰、休斯顿和费城，波士顿有研究椅， 纽约州斯托尼布鲁克的协调中心。

DESCRIPTION: (Applicant's Abstract) This proposal is for the New England College of Optometry (NEWENCO) to serve as a clinical center in the Correction of Myopia Evaluation Trial (COMET). COMET is a prospective, randomized clinical trial designed to assess whether progressive addition lenses (PALs) 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 criteria and lack specific exclusion criteria will be enrolled. They will be identified primarily from elementary school vision screenings. All eligible children will be examined at baseline and at six-month intervals for at least three years of follow up 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 NEWENCO to screen about 7700 children for possible eligibility, to recruit at least 188 children within one academic year and to retain them for at least three years of follow up. Documentation is also provided that NEWENCO 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 NEWENCO, the other clinical centers are located at Colleges of Optometry in Birmingham, Houston, and Philadelphia, with the Study Chair in Boston and the Coordinating Center at Stony Brook, NY.