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: 10382456
• 负责人: Donald O. Mutti
• 金额: $ 53.57万
• 依托单位: OHIO STATE UNIVERSITY
• 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/10382456
• 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; Ohio; 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

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.

本提案旨在让俄亥俄州州立大学（OSU）作为双焦点的两个临床中心之一 近视儿童2（BLINK 2）研究，该研究将继续跟踪参加原始研究的儿童。 BLINK随机临床试验。BLINK 2的主要目标是确定近视进展的相关性 使用生物标志物（脉络膜厚度和固有光敏视网膜色素）的非侵入性测量 神经节细胞介导的瞳孔功能）和儿童户外光照。如果多焦点隐形眼镜慢 在BLINK研究期间，与单视角膜接触镜相比，近视进展30%或更多， BLINK 2还将回答有关治疗效果的后果和机制的重要问题， 例如多焦点接触透镜佩戴是否改变了矫正功能以及治疗是否 利益是短暂的。具体而言，BLINK 2将研究近视进展是否减缓或仅仅是 多焦点接触透镜佩戴延迟以及近视进展是否存在“反弹”， 停用多焦点角膜接触镜后的进展率。 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会影响发病后的近视进展， 这些作用是由固有光敏视网膜神经节细胞介导的。如果软性多焦点隐形眼镜 在BLINK研究期间显示具有临床意义的近视进展减缓，BLINK 2也将回答 我们的临床同事经常问到许多重要的问题：调节是否受到 儿童配戴多焦点接触透镜多年;多焦点接触镜片是否会减慢或简单 延迟近视进展;以及在停用软性药物后近视进展是否增加 多焦点接触透镜磨损。 BLINK 2旨在最大限度地发挥益处，同时降低因近视而佩戴多焦点隐形透镜的风险 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。本申请详细说明了俄勒冈州立大学临床中心的能力，以登记和继续以下 BLINK研究中的近视儿童进行了额外三年的研究。该申请还表明，OSU已 成功开展本研究所需的人员、经验、设备和设施， 研究程序手册（MOP）。关于研究原理、设计和 方法包含在MOP中，该MOP与研究主席的申请一起提交。