Soft Bifocal Contact Lens Myopia Control - Data Coordinating Center

描述（由申请人提供）：本提案针对软性双焦点接触透镜近视对照研究数据协调中心，该研究是一项多中心、随机临床试验，旨在回答与近视儿童眼睛生长缓慢相关的3个重要问题。我们将确定软性双焦点隐形眼镜是否能减缓儿童近视的进展。软性双焦点接触镜将在近视受试者中产生广泛的周边散焦分布，这将使我们能够确定周边近视散焦量是否与近视进展较慢有关。在没有接触镜的情况下测量周边屈光不正将使我们能够监测眼睛形状的变化，以确定周边散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， 7 - 11岁的近视患者将被随机分配配戴软性双焦点（Biocompatible Multifocal +2.50 D add或+1.50 add;库珀Vision，Fairfield，NY）或单光（Biocompatible;库珀Vision，Fairfield，NY）角膜接触镜。比较治疗组经历的近视进展将确定软性双焦点镜片是否减缓近视，而周边发现将提供关于周边眼生长调节的额外信息。 作为软性双焦点接触透镜近视控制研究的数据协调中心，我们将完成以下具体目标：1.）实施软性双焦点接触透镜近视控制研究执行委员会设计的方案; 2）通过电子数据采集系统实施数据收集程序，确保以安全的方式获得高质量数据; 3）使用适当的统计方法分析数据，并确保准确报告结果。

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.