CORRECTION OF MYOPIA EVALUATION TRIAL--CLINICAL CENTER

近视矫正评估试验--临床中心

• 批准号: 6363150
• 负责人: WENDY L MARSH-TOOTLE
• 金额: $ 20.37万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 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/6363150
• 关键词: adolescence (12-20); clinical research; clinical trials; cooperative study; human subject; human therapy evaluation; longitudinal human study; mass screening; 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 Alabama School of Optometry (UABSO) 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). 750 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 UABSO to screen 7500 children for possible eligibility, to recruit at least 188 children within one academic year, and to retain them for at least three years. Documentation is also provided that UABSO 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 UABSO, the other clinical centers are located at Colleges of Optometry in Boston, Houston, and Philadelphia, with the Study Chair in Boston and the Coordinating Center at Stony Brook.

（申请人摘要）本提案拟提交给北京大学