Soft Bifocal Contact Lens Myopia Control

描述（由申请人提供）：本提案旨在将休斯顿大学视光学学院（UHCO）作为软性双焦点接触透镜近视对照研究的两个临床中心之一，该研究是一项随机临床试验，旨在回答与近视儿童眼睛生长缓慢相关的3个重要问题。第一个问题的答案将决定市售软性双焦点隐形眼镜是否能减缓儿童近视的进展。第二和第三个问题的答案将确定软性双焦点隐形眼镜如何影响眼睛的生长，以最终优化减缓儿童近视进展的信号。将招募符合研究入选和排除标准的294名近视儿童（7至11岁）。休斯顿大学临床中心将招收147名儿童。这些儿童将被随机分配配戴单视软性角膜接触镜或中心距软性双焦点角膜接触镜，并将使用临床中心之间标准化的方案进行至少三年的随访。主要结果是通过睫状肌麻痹自动验光测量的近视变化。次要结局包括在远距离和近距离佩戴隐形眼镜时的周边散焦、不佩戴隐形透镜时的周边屈光不正（眼睛形状）以及中心和周边眼长。该申请详细说明了UHCO临床中心在15个月内招募147名近视儿童的能力，并保留这些儿童至少三年的随访。我们还记录了UHCO拥有根据研究程序手册（MOP）成功开展本研究所需的人员、经验、设备和设施。关于研究原理、设计和方法的完整详细信息见MOP，该MOP与研究椅申请一起提交。其他临床中心、研究主席和数据协调中心位于俄亥俄州州立大学。

DESCRIPTION (provided by applicant): This proposal is for the University of Houston College of Optometry (UHCO) to serve as one of two clinical centers for the Soft Bifocal Contact Lens Myopia Control Study, a randomized clinical trial designed to answer 3 important issues related to slowing eye growth in myopic children. The answer to the first question will determine whether commercially available soft bifocal contact lenses slow myopia progression in children. Answers to the second and third questions will determine how soft bifocal contact lenses affect growth of the eye, in order to ultimately optimize signals that slow myopia progression in children. A total of 294 myopic children (7 to 11 years old) meeting the study's inclusion and exclusion criteria will be enrolled. The University of Houston Clinical Center will enroll 147 children. The children will be randomly assigned to wear either single-vision soft contact lenses or center-distance soft bifocal contact lenses and will be followed for at least three years using protocols standardized between the clinical centers. The primary outcome is the change in myopia as measured by cycloplegic auto refraction. Secondary outcomes include peripheral defocus while wearing contact lenses at distance and near, peripheral refractive error without a contact lens (eye shape), and central and peripheral eye length. This application details the UHCO Clinical Center's ability to recruit 147 myopic children in 15 months and to retain the children for at least three years of follow-up. We also document that UHCO has the personnel, experience, equipment, and facilities needed to successfully conduct this study in accordance with the study Manual of Procedures (MOP). Complete details regarding the study rationale, design, and methods are contained in the MOP, which is submitted with the Study Chair application. The other Clinical Center, Study Chair, and Data Coordinating Center are located at The Ohio State University.