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

近视进展及后果的检验以及软性多焦点隐形眼镜近视控制的机制 - 数据协调中心

• 批准号: 10600988
• 负责人: LISA A Jordan
• 金额: $ 33.63万
• 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 2025-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10600988
• 关键词: 11 year old; Address; Affect; Binding; Biological Markers; Biometry; Caring; Child; Childhood; Clinical; Clinical Trials Design; Cohort Studies; Conduct Clinical Trials; Contact Lenses; Data; Data Collection; Data Coordinating Center; Enrollment; Ensure; Environment; Environmental Risk Factor; Exposure to; Eye; Focal Adhesions; Goals; Growth; Health Care Costs; Light; Literature; Measurement; Measures; Mediating; Methodology; Monitor; Myopia; National Eye Institute; Optics; Outcome; Outcome Study; Participant; Patients; Peripheral; Persons; Positioning Attribute; Procedures; Protocols documentation; Pupil; Quality of life; Randomized; Refractive Errors; Reporting; Research Design; Retinal Ganglion Cells; Risk; Role; Safety; Secure; Shapes; Specific qualifier value; Study Subject; Testing; Thick; Thinness; Time; United States; Vision; Visit; cohort; data management; data quality; design; efficacy evaluation; electronic data capture system; follow-up; improved; lens; longitudinal dataset; negative affect; protocol development; quality assurance; randomized, clinical trials; response; risk minimization; side effect; standard of care; treatment effect; treatment group

This is the proposal for the Data Coordinating Center for the BLINK2 Study, whose primary goal 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, we 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, we 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. The study 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. The study will test the important question of whether time outdoors and light exposure influence myopia progression after onset in addition to whether these affects 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, the study will also answer many important questions asked routinely by our clinical colleagues. We will know the accommodative effect of multiple years of multifocal contact lens wear in children; we will know if multifocal contact lenses slow or simply delay myopia progression; and we will know whether myopia progression increases following discontinuation of soft multifocal contact lens wear. Answers to the questions addressed by this proposal could improve the care for the 60 million myopic children in the United States. While the consequences of ordinary amounts of myopia are rarely sight- threatening, the quality of life for all myopic patients is negatively affected and the health care costs to treat myopia are high (approximately $4.6 billion in 1990). The National Eye Institute recognizes the need to "evaluate the efficacy of potential treatments for delaying the onset or for slowing the progression of myopia, such as lenses that alter peripheral defocus." 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, a problem that affects a large proportion of people.

这是BLINK 2研究数据协调中心的建议，其主要目标是 使用生物标志物（脉络膜）的非侵入性测量来确定近视进展的相关性 厚度和内在光敏视网膜神经节细胞介导的瞳孔功能）和室外光 儿童接触。如果多焦点隐形眼镜能将近视的进展速度减缓30%或更多， 在BLINK研究期间，我们还将回答有关单光隐形眼镜的重要问题， 治疗效果的后果和机制，例如多焦点接触透镜配戴是否改变 是否具有治疗功能以及治疗获益是否是短暂的。具体来说，我们将调查 多焦点接触透镜配戴是否减缓或仅仅延迟近视进展，以及是否存在 多焦点接触停止后近视进展的“反弹”，进展率增加 眼镜. 这项研究将确定哪些近视儿童最能从近视控制中受益， 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。这项研究将检验一个重要的问题 户外时间和光照是否会影响发病后的近视进展， 这些影响是由内在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，该研究还将回答 我们的临床同事经常会问到很多重要的问题。我们就能知道 儿童配戴多焦点接触透镜多年;我们将知道多焦点接触镜片是否会减慢或 简单地延迟近视进展;我们将知道近视进展是否会在以下情况下增加 停止配戴软性多焦点接触透镜。 这项提案所提出的问题的答案可以改善6000万近视患者的护理 在美国的孩子们。虽然普通近视的后果很少看到- 威胁，所有近视患者的生活质量都会受到负面影响，治疗的医疗保健费用也会增加 近视率很高（1990年约为46亿美元）。国家眼科研究所认识到， “评估延迟近视发作或减缓近视进展的潜在治疗方法的疗效， 例如改变周边散焦的透镜。“BLINK 2旨在最大限度地提高效益，同时降低风险， 佩戴多焦点接触透镜以控制近视，同时回答关于以下方面的重要科学和临床问题： 近视发展的后果和机制，这是一个影响大部分人的问题。