Examination of Myopia Progression and Consequences and Mechanism of Soft Multifocal Contact Lens Myopia Control - Clinical Center

这项提议是让俄亥俄州立大学(OSU)作为Bifocal的两个临床中心之一 近视儿童镜片2(BLINK2)研究，将继续跟踪最初登记的儿童 眨眼随机临床试验。BLINK2的主要目标是确定近视进展的相关因素 使用生物标志物(脉络膜厚度和固有的光敏视网膜)的非侵入性测量 神经节细胞介导的瞳孔功能)和儿童的户外光照。如果多焦隐形眼镜戴得慢 在眨眼研究中，近视的进展比单眼隐形眼镜高出30%或更多， BLINK2还将回答有关治疗效果的后果和机制的重要问题， 例如，多焦点隐形眼镜配戴是否改变调节功能，以及治疗是否 收益是短暂的。具体地说，BLINK2将调查近视进展是否放缓或只是 由于配戴多焦点隐形眼镜而延迟，近视进展是否出现反弹， 多焦点隐形眼镜停用后的进展率。 BLINK2将通过确定哪些近视儿童将从近视控制中受益最大 谁最有可能进步，从而最大限度地增加受益的潜力，并将风险降至最低。BLINK2将 通过研究最重要的眼部和环境因素对进展的影响来实现这一目标 风险因素最近被认为是控制眼睛生长的因素。该项目将收集最广泛的 儿童近视脉络膜厚度的纵向数据集。BLINK2将测试一个重要的问题 户外时间和光照是否影响近视发病后的进展 这些效应是由固有的感光性视网膜神经节细胞介导的。如果软性多焦点隐形眼镜 在BLINK研究期间显示出临床上有意义的近视进展减缓，BLINK2也将回答 我们的临床同事经常问的许多重要问题：住宿是否受到 儿童佩戴多焦点隐形眼镜多年；多焦点隐形眼镜戴得慢还是简单 延缓近视进展；以及停止软性治疗后近视进展是否增加 多焦点隐形眼镜佩戴。 Blink2寻求最大化益处，同时降低近视配戴多焦点隐形眼镜的风险 控制，同时回答重要的科学和临床问题的后果和机制 近视进展。此应用程序详细说明了俄亥俄州立大学临床中心的注册和继续跟踪的能力 来自BLINK研究的近视儿童再多学习三年。该应用程序还记录了OSU拥有 成功进行这项研究所需的人员、经验、设备和设施 与《程序研究手册》(MOP)保持一致。完成有关研究的基本原理、设计和 方法载于《议定书》，随研究主席的申请一起提交。

This proposal is for The Ohio State University (OSU) to serve as one of two clinical centers for the Bifocal Lenses In Nearsighted Kids 2 (BLINK2) study, which will continue to follow children enrolled in the original BLINK randomized clinical trial. The primary goal of BLINK2 is to determine correlates of myopia progression using non-invasive measurement of biomarkers (choroidal thickness and intrinsically photosensitive retinal ganglion cell-mediated pupil function) and outdoor light exposure in children. If multifocal contact lenses slow the progression of myopia by 30% or more compared to single vision contact lenses during the BLINK Study, BLINK2 will also answer important questions about the consequences and mechanism of the treatment effect, such as whether multifocal contact lens wear alters accommodative function and whether or not the treatment benefit is transient. Specifically, BLINK2 will investigate whether myopia progression is slowed or simply delayed by multifocal contact lens wear and whether there is a “rebound” in myopia progression, an increase in progression rate, after discontinuation of multifocal contact lenses. BLINK2 will identify the myopic children who will most benefit from myopia control by determining those who are most likely to progress, thereby maximizing the potential for benefit and minimizing risk. BLINK2 will accomplish this goal by investigating the effect on progression of the most important ocular and environmental risk factors recently hypothesized to control the growth of the eye. The project will collect the most extensive longitudinal dataset ever on choroidal thickness in childhood myopia. BLINK2 will test the important question of whether time outdoors and light exposure influence myopia progression after onset in addition to whether these effects are mediated by intrinsically photosensitive retinal ganglion cells. If soft multifocal contact lenses show a clinically meaningful slowing of myopia progression during the BLINK Study, BLINK2 will also answer many important questions asked routinely by our clinical colleagues: whether accommodation is affected by multiple years of multifocal contact lens wear in children; whether multifocal contact lenses slow or simply delay myopia progression; and whether myopia progression increases following discontinuation of soft multifocal contact lens wear. BLINK 2 seeks to maximize the benefit while lowering the risk of multifocal contact lens wear for myopia control while answering important scientific and clinical questions about the consequences and mechanism of myopia progression. This application details the OSU Clinical Center's ability to enroll and continue following myopic children from the BLINK study for three additional years. The application also documents that OSU 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's application.