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.

描述：（申请人的摘要）该提案针对的是大学 阿拉巴马视光学院 (UABSO) 将成为四个临床中心之一 参与近视矫正评估试验（COMET）。 彗星是一个 前瞻性、随机临床试验旨在评估是否 渐进多焦点镜片（PAL）可减缓青少年发病的进展 近视，与传统单光镜片 (SV) 相比。 750 名儿童 6-12岁双眼近视（-1.25至-4.5D），符合特定条件的 将纳入纳入和排除标准。 他们将被识别 主要来自小学视力筛查和视光学院 临床患者记录。 所有符合条件的儿童都将在 基线并以六个月为间隔，持续至少三年进行测量 屈光不正的变化并更新处方。 一个标准化的、 所有四个中心都将使用共同协议。 主要结果 测量是近视的进展，通过散瞳自验来测量。 另一个结果测量是通过 A 扫描测量的轴向伸长率 超声检查。 这些将由蒙面审查员获得。 这 申请记录了 UABSO 对 7500 名儿童进行筛查的能力 可能的资格，在一个学院内招收至少 188 名儿童 一年，并保留至少三年。 文档也是 前提是 UABSO 拥有人员、设备和设施来开展 该研究按照 COMET 程序手册 (MOP) 进行。 完全的 COMET 的基本原理、设计和方法的详细信息包含在 MOP，与研究主席和协调员单独提交 中心应用程序。 除 UABSO 外，其他临床中心还有 位于波士顿、休斯顿和费城的视光学院， 波士顿的研究主席和石溪的协调中心。