Soft Bifocal Contact Lens Myopia Control - Data Coordinating Center

描述（由申请人提供）：本提案是为软性双焦点隐形眼镜近视控制研究数据协调中心提交的，这是一项多中心随机临床试验，旨在回答与近视儿童眼睛生长减慢有关的3个重要问题。我们将确定软性双焦点隐形眼镜是否会减缓儿童近视的进展。软性双焦点隐形眼镜将在近视受试者中产生广泛分布的外周离焦，这将使我们能够确定外周离焦的数量是否与近视进展缓慢有关。在不戴隐形眼镜的情况下测量周围屈光不正可以让我们监测眼睛形状的变化，从而确定周围离焦主要是改变局部眼睛生长还是影响整个眼睛的生长。在这项试验中，294名儿童衰老

DESCRIPTION (provided by applicant): This proposal is for the Data Coordinating Center for the Soft Bifocal Contact Lens Myopia Control Study, a mulfl-center, randomized clinical trial designed to answer 3 important issues related to slowing eye growth in myopic children. We will determine whether soft bifocal contact lenses slow myopia progression in children. The soft bifocal contact lenses will create a wide distribution of peripheral defocus in myopic subjects, which will allow us to determine whether the amount of peripheral myopic defocus is related to slower myopia progression. Measuring the peripheral refractive error without contact lenses will allow us to monitor changes in eye shape to determine whether peripheral defocus primarily changes local eye growth or affects the growth of the entire eye. In this trial, 294 children aged 7 to 11 years with myopia will be randomly assigned to wear soft bifocal (either Biofinity Multifocal with +2.50 D add or with +1.50 add; Cooper Vision, Fairfield, NY) or single vision (Biofinity; Cooper Vision, Fairfield, NY) contact lenses. A comparison of the myopia progression experienced by the treatment groups will determine if the soft bifocal lenses slow myopia, while peripheral findings will provide additional information about the regulation of peripheral eye growth. As the Data Coordinating Center for the Soft Bifocal Contact Lens Myopia Control Study, we will complete the following Specific Aims: 1.) implement the protocol as designed by the Soft Bifocal Contact Lens Myopia Control Study Executive Committee; 2) implement data collection procedures via electronic data capture systems that ensure high-quality data in a secured fashion; and 3) analyze the data using appropriate statistical methodology and ensure that the results are accurately reported.