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

近视进展及后果的检查以及软性多焦点隐形眼镜近视控制的机制 - 临床中心

• 批准号: 10382262
• 负责人: DAVID A BERNTSEN
• 金额: $ 59.57万
• 依托单位: UNIVERSITY OF HOUSTON
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-04-01 至 2024-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10382262
• 关键词: 11 year old; Adherence; Affect; Biological Markers; Biometry; Child; Childhood; Clinical; Contact Lenses; Data; Data Collection; Data Coordinating Center; Enrollment; Ensure; Environment; Environmental Risk Factor; Equipment; Exposure to; Eye; Goals; Grant; Growth; Human Resources; Light; Manuals; Measurement; Measures; Mediating; Methods; Myopia; Optometry; Outcome; Outcome Study; Participant; Persons; Photosensitivity; Policies; Procedures; Protocols documentation; Publications; Pupil; Quality Control; Randomized; Randomized Clinical Trials; Refractive Errors; Retinal Ganglion Cells; Risk; Study Subject; Testing; Thick; Time; Training; United States; Universities; Vision; Visit; clinical center; clinical practice; college; design; experience; follow-up; human subject protection; lens; longitudinal dataset; patient subsets; recruit; response; risk minimization; side effect; standard of care; treatment effect; treatment group

Project Summary This proposal is for the University of Houston College of Optometry (UHCO) 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 Study randomized clinical trial. The primary goal of BLINK2 is to determine correlates of myopia progression using non-invasive measurements of biomarkers (choroidal thickness and intrinsically photosensitive retinal ganglion cell (ipRGC)-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 a “rebound” in myopia progression occurs, 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 and whether these effects are mediated by ipRGCs. 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 clinicians: 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. BLINK2 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 UHCO Clinical Center's ability to enroll children from the BLINK Study to continue following them for an additional three years. The application also documents 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.

项目摘要 这项提议是让休斯顿大学验光学院(UHCO)作为两个临床 近视儿童2双焦点透镜研究中心(BLINK2)，该研究将继续跟踪儿童 入选原BLINK研究随机临床试验。BLINK2的主要目标是确定 无创性测量生物标志物(脉络膜厚度和脉络膜厚度)与近视进展的相关性 固有光敏性视网膜神经节细胞(IpRGC)介导的瞳孔功能)和室外光照 孩子们。如果多焦点隐形眼镜使近视进展速度比单眼慢30%或更多 在BLINK研究期间，BLINK2还将回答有关后果的重要问题 以及治疗效果的机制，如多焦点隐形眼镜配戴是否改变了调节能力 功能，以及治疗益处是否短暂。具体而言，BLINK2将调查 近视进展因配戴多焦点隐形眼镜而延缓或只是延缓，以及近视是否出现反弹 停用多焦点隐形眼镜后，近视进展，进展率增加。 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，以及这些影响是否 是由ipRGC介导的。如果软性多焦点隐形眼镜显示出临床上有意义的近视减缓 在BLINK研究期间，BLINK2还将回答许多例行提出的重要问题 临床医生：儿童配戴多年多焦点隐形眼镜是否会影响调节； 多焦点隐形眼镜是否延缓或只是延缓近视进展；近视进展 随着软性多焦点隐形眼镜的停止佩戴而增加。 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UHCO临床中心是否有能力从 BLINK研究继续跟踪他们另外三年。该应用程序还记录了 UHCO拥有成功进行这项研究所需的人员、经验、设备和设施 根据《程序研究手册》(MOP)。关于研究基本原理的完整细节， 设计和方法载于随研究教席申请书一起提交的《议定书》。