CORRECTION OF MYOPIA EVALUATION TRIAL--CHAIR APPLICATION

描述：(申请者摘要)近视矫正评估 试验(COMET)是一项多中心、随机、双盲临床试验 旨在评估渐进式附加镜片(PAL‘s)是否会减缓 与传统单眼相比，青少年发作性近视的进展 视觉透镜(SV)。四个参与的临床中心，在学院 在波士顿、伯明翰、费城和休斯顿的验光，将招收 对450名双眼近视(-1.25D至-4.5D)的儿童进行研究， 6-12岁，符合特定的纳入和排除标准。他们 将主要从小学视力筛查和 验光学院临床病历。所有符合条件的儿童都将 至少在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 所有中心都将使用标准化、通用的协议。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。这些信息将通过MASTED获得 主考人。 除了呈现彗星研究的一般情况外，该应用程序还寻求 对新英格兰学院研究教席办公室的支持 验光。Comet的基本原理、设计和方法的完整细节如下 载于所附的《程序手册》。的资源中心 Comet是位于马萨诸塞州波士顿的研究主席办公室和协调中心 位于纽约州石溪的中心

DESCRIPTION: (Applicant's Abstract) The Correction of Myopia Evaluation Trial (COMET) is a multi-center, randomized, double-masked clinical trial designed to assess whether progressive addition lenses (PAL's) slow the progression of juvenile-onset myopia, as compared to conventional single vision lenses (SV). Four participating clinical centers, at Colleges of Optometry in Boston, Birmingham, Philadelphia, and Houston, will enroll a study total of 450 children with myopia (-1.25 D to -4.5 D) in both eyes, 6-12 years old, who meet specific inclusion and exclusion criteria. They will be identified primarily from elementary school vision screenings and College 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 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. In addition to presenting the COMET study in general, this application seeks support for the Study Chair's Office at the New England College of Optometry. Complete details of the COMET rationale, design, and methods are contained in the attached Manual of Procedures. Resource centers for the COMET are the Study Chair's Office in Boston, MA, and the Coordinating Center in Stony Brook, NY.