CORRECTION OF MYOPIA TRIAL--CLINICAL CENTER

描述：(申请人摘要)本提案是为加州大学提供的 休斯顿验光学院(UHCO)将成为四家临床医院之一 以近视矫正评估试验(COMET)为中心。彗星是一颗 前瞻性随机临床试验旨在评估 渐进式人工晶状体(PAL‘s)延缓青少年发病的进展 近视，与传统的单视镜(SV)相比。总共有四个 100名6-12岁近视儿童(-1.25至-4.50D) 符合特定纳入和排除标准的Eyes将参加 4个参赛中心。112名儿童将被确认身份 在休斯顿。这些孩子将主要从大学招收 眼科研究所(UEI-UHCO诊所)。所有符合条件的儿童都将 至少三年内每六个月进行一次基线检查，以 测量屈光不正的变化并更新处方。一个 所有四个中心都将使用标准化的通用协议。初级阶段 通过睫状肌麻痹来衡量近视的进展情况。 自动折射。另一个衡量结果的指标是轴向伸长，如 经A超测量。将获得这些结果衡量标准 蒙面审查员。此应用程序记录了UHCO能够 在一个学年内招收至少112名儿童，并留住他们 至少三年了。 还提供了UHCO拥有人员、设备和 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UHCO外， 其他临床中心设在波士顿的验光学院， 伯明翰和费城，研究主席在波士顿和 纽约石溪协调中心。

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.