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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

基本信息

批准号：
10606524
负责人：
DAVID A BERNTSEN
金额：
$ 30.58万
依托单位：
UNIVERSITY OF HOUSTON
依托单位国家：
美国
项目类别：
财政年份：
2014
资助国家：
美国
起止时间：
2014-04-01 至 2025-03-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10606524
关键词：
11 year old Adherence Affect Binding Biological Markers Biometry Certification Child Childhood Clinical Contact Lenses Data Data Collection Data Coordinating Center Enrollment Ensure Environment Environmental Risk Factor Equipment Exposure to Eye Focal Adhesions Goals Grant Growth Human Resources Light Manuals Measurement Measures Mediating Methods Myopia Optometry Outcome Outcome Study Participant Persons Policies Procedures Protocols documentation Publications Pupil Quality Control Randomized Refractive Errors Retinal Ganglion Cells Risk Study Subject Testing Thick Thinness Time Training United States Universities Vision Visit clinical center clinical practice college design experience follow-up human subject protection lens longitudinal dataset patient subsets randomized, clinical trials recruit response risk minimization side effect standard of care treatment effect treatment group

项目摘要

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.

项目摘要这项建议是为休斯顿大学验光学院（UHCO）作为两个临床之一，近视儿童双焦点镜片2（BLINK 2）研究中心，该研究将继续跟踪儿童入组最初的BLINK研究随机临床试验。BLINK 2的主要目标是确定使用生物标志物的非侵入性测量（脉络膜厚度和内在光敏视网膜神经节细胞（ipRGC）介导的瞳孔功能）和室外光暴露，孩子如果多焦点隐形眼镜与单焦点隐形眼镜相比，在BLINK研究期间，BLINK 2还将回答有关后果的重要问题以及治疗效果的机制，例如多焦点接触透镜佩戴是否改变了功能以及治疗益处是否是短暂的。具体而言，BLINK 2将调查是否多焦点接触透镜的配戴可以减缓或仅仅延迟近视的发展，在停用多焦点接触镜后，近视发生进展，进展速度增加。 BLINK 2将通过确定哪些近视儿童将从近视控制中受益最大最有可能取得进展的人，从而最大限度地提高受益潜力，并最大限度地降低风险。BLINK 2将通过研究对最重要的眼部和环境疾病进展的影响来实现这一目标。风险因素最近假设控制眼睛的生长。该项目将收集最广泛的儿童近视眼脉络膜厚度的纵向研究。BLINK 2将测试以下重要问题：户外时间和光照是否影响发病后的近视进展，以及这些影响是否由ipRGC介导。如果软性多焦点角膜接触镜显示有临床意义的近视减缓，在BLINK研究期间，BLINK 2还将回答许多重要的问题，临床医生：儿童多年配戴多焦点接触透镜是否影响调节; 多焦点隐形眼镜是否减缓或仅仅延迟近视进展;以及在停用软性多焦点接触透镜配戴后增加。 BLINK 2旨在最大限度地提高受益，同时降低因近视而配戴多焦接触透镜的风险控制，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临床中心的能力，招收儿童从 BLINK研究将继续跟踪他们三年。申请书还记载， UHCO拥有成功开展本研究所需的人员、经验、设备和设施，根据研究程序手册（MOP）。关于研究原理的完整详细信息，设计和方法包含在MOP中，该MOP与研究椅申请一起提交。