COLLABORATIVE OBSERVATIONAL STUDY OF MYOPIA IN COMET CHILDREN

彗星儿童近视的合作观察研究

• 批准号: 7201566
• 负责人: Erik Matthew Weissberg
• 金额: $ 20.32万
• 依托单位: NEW ENGLAND COLLEGE OF OPTOMETRY
• 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 2008-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7201566
• 关键词: 12 year old; Adolescent; Boston; Child; Clinical; Clinical Trials Design; Documentation; Eligibility Determination; Enrollment; Equipment; Evaluation; Exclusion Criteria; Eye; Human Resources; Manuals; Masks; Measures; Methods; Myopia; New England; Observational Study; Optometry; Outcome Measure; Philadelphia; Procedures; Protocols documentation; Randomized; Recruitment Activity; Refractive Errors; Scanning; Ultrasonography; Update; Vision; Vision Screening; abstracting; college; cycloplegic; design; elementary school; follow-up; inclusion criteria; lens; prescription document; prescription procedure; prospective

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.

描述：(申请者摘要)这项建议是针对新英格兰的 视光学院(NEWENCO)将在美国 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)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 纳入标准和缺乏具体的排除标准将被录取。 他们将主要从小学视力检查中识别出来。 所有符合条件的儿童将在基线和六个月时接受检查 至少三年的跟踪间隔，以衡量 屈光不正和更新处方。一种标准化的、通用的 协议将在所有四个中心使用。主要结果衡量标准是 近视的进展，通过睫状肌麻痹的自发性屈光不正来衡量。一个 另一项测量结果是A超测量的轴向伸长率 超声波检查。这些证书将由蒙面考官获得。这 申请证明NEWENCO有能力对大约7700名儿童进行筛查 对于可能的资格，在一年内至少招收188名儿童 并将其保留至少三年。 还提供了NEWENCO拥有人员、设备、 以及根据《彗星手册》进行研究的设施 程序(拖把)。彗星的原理、设计和设计的完整细节 方法包含在MOP中，它与 研究主席和协调中心的申请。除了新文科， 其他临床中心位于#年的验光学院。 伯明翰、休斯顿和费城，研究主席在波士顿和 纽约石溪的协调中心。