COLLABORATIVE OBSERVATIONAL STUDY OF MYOPIA IN COMET CHILDREN

彗星儿童近视的合作观察研究

• 批准号: 7026966
• 负责人: RUTH E MANNY
• 金额: $ 19.33万
• 依托单位: UNIVERSITY OF HOUSTON
• 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/7026966
• 关键词: adolescence (12-20); clinical research; clinical trials; cooperative study; disease /disorder onset; human subject; human therapy evaluation; longitudinal human study; 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 Houston, College of Optometry (UHCO) 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). A total of four hundred children, 6-12 years of age with myopia (-1.25 to -4.50 D) in both eyes, who meet specific inclusion and exclusion criteria will be enrolled in the 4 participating centers. One hundred twelve children will be identified in Houston. These children will be recruited primarily from the University Eye Institute (UEI - the Clinic at UHCO). 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. A additional outcome measure is axial elongation as measured by A-scan ultrasonography. These outcome measures will be obtained by masked examiners. This application documents the ability of UHCO to recruit at least 112 children within one academic year, and to retain them for at least three years. Documentation is also provided that UHCO 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 UHCO, the other clinical centers are located at Colleges of Optometry in Boston, Birmingham, and Philadelphia, with the Study Chair in Boston and the Coordinating Center at Stony Brook NY.

描述：（申请人的摘要）本提案是为大学 休斯顿，验光学院（UHCO）作为四个临床之一， 近视矫正评估试验（COMET） 彗星是一 前瞻性随机临床试验，旨在评估 渐进式多焦点镜片（PAL）可以减缓青少年发病的进展， 近视，与传统的单视镜片（SV）相比。 总共四 100名6-12岁儿童，近视（-1.25至-4.50 D）， 符合特定入选和排除标准的患眼将入组 四个参与中心。 112名儿童将被确认 在休斯顿。 这些儿童将主要从大学招募 眼科研究所（UEI -UHCO诊所）。 所有符合条件的儿童将 在基线时和每隔6个月检查一次，持续至少3年， 测量屈光不正的变化并更新处方。 一 所有四个中心都将使用标准化的共同方案。 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。 将获得这些结果指标 戴面具的考官 本申请文件证明UHCO能够 在一个学年内招收至少112名儿童，并保留他们 至少三年 还提供了文件，说明UHCO拥有人员、设备和 根据COMET手册， 程序（MOP）。 COMET原理、设计和 《议定书》中载列了各种方法，该议定书与 研究主席和协调中心申请。 除了UHCO， 其它临床中心位于波士顿的验光学院， 伯明翰和费城，在波士顿和 纽约斯托尼布鲁克协调中心。