Soft Bifocal Contact Lens Myopia Control

描述（由申请人提供）：本提案为休斯顿大学视光学院（UHCO）作为软双焦点隐形眼镜近视控制研究的两个临床中心之一，这是一项随机临床试验，旨在回答与近视儿童眼睛生长减慢有关的三个重要问题。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。第二个和第三个问题的答案将决定软性双焦点隐形眼镜如何影响眼睛的生长，从而最终优化减缓儿童近视进展的信号。共有294名符合研究纳入和排除标准的近视儿童（7 - 11岁）被纳入研究。休斯顿大学临床中心将招募147名儿童。这些儿童将被随机分配佩戴单视力软性隐形眼镜或中距软性双焦点隐形眼镜，并将按照临床中心之间标准化的协议进行至少三年的随访。主要的结果是近视的改变，由单眼麻痹性自屈光测量。次要结果包括远近佩戴隐形眼镜时外周离焦、不佩戴隐形眼镜时外周屈光不正（眼形）以及眼中央和外周长度。这份申请详细说明了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。我们还证明，UHCO拥有按照研究程序手册（MOP）成功开展这项研究所需的人员、经验、设备和设施。关于研究基本原理、设计和方法的完整细节包含在MOP中，该MOP与研究主席申请一起提交。另一个临床中心、研究主席和数据协调中心位于俄亥俄州立大学。

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.