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: 10240453
• 负责人: LISA A Jordan
• 金额: $ 25.85万
• 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/10240453
• 关键词: 11 year old; Address; Affect; 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; Goals; Growth; Health Care Costs; Light; Literature; Measurement; Measures; Mediating; Methodology; Monitor; Myopia; National Eye Institute; Optics; Outcome; Outcome Study; Participant; Patients; Peripheral; Photosensitivity; Positioning Attribute; Procedures; Protocols documentation; Pupil; Quality of life; Randomized; Randomized Clinical Trials; Refractive Errors; Reporting; Research Design; Retinal Ganglion Cells; Risk; Role; Safety; Secure; Shapes; Specific qualifier value; Study Subject; Testing; Thick; 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; response; risk minimization; side effect; standard of care; treatment effect; treatment group; 11 year old; Address; Affect; 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; Goals; Growth; Health Care Costs; Light; Literature; Measurement; Measures; Mediating; Methodology; Monitor; Myopia; National Eye Institute; Optics; Outcome; Outcome Study; Participant; Patients; Peripheral; Photosensitivity; Positioning Attribute; Procedures; Protocols documentation; Pupil; Quality of life; Randomized; Randomized Clinical Trials; Refractive Errors; Reporting; Research Design; Retinal Ganglion Cells; Risk; Role; Safety; Secure; Shapes; Specific qualifier value; Study Subject; Testing; Thick; 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; 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Blink2研究数据协调中心的建议，其主要目标是 使用非侵入性测量生物标志物（脉络膜）确定近视进展的相关性（脉络膜 厚度和本质上光敏的视网膜神经节细胞介导的瞳孔功能）和室外光线 儿童接触。如果多灶性隐形眼镜降低了近视的进展30％或以上 单一视觉隐形眼镜在眨眼研究期间，我们还将回答有关 治疗效果的后果和机制，例如多灶性隐形眼镜是否改变 适应性功能以及治疗益处是否是短暂的。具体来说，我们将调查 近视进展是放慢的还是简单地被多灶性隐形眼镜磨损延迟以及是否有 近视进展中的“反弹”，在中断多灶接触后的进展率增加 镜片。 这项研究将通过确定这些儿童来确定将最大的近视控制受益的近视儿童 最有可能进步的人，从而最大程度地提高了利益的潜力和最大程度地降低风险。 Blink2会 通过研究对最重要的眼和环境的进展的影响来实现这一目标 危险因素最近假设控制眼睛的生长。该项目将收集最广泛的 关于儿童近视的脉络膜厚度的纵向数据集。该研究将测试重要问题 除了是否是否会影响户外和轻曝光是否会影响发病后近视的进展 这些影响是由本质上光敏的视网膜神经节细胞介导的。如果柔软的多灶性隐形眼镜 在眨眼研究期间显示近视进展的临床意义有意义，该研究还将回答 我们的临床同事经常提出许多重要的问题。我们将知道 儿童多年的多灶性隐形眼镜磨损；我们会知道多灶性隐形眼镜是缓慢还是 只需延迟近视发展；我们会知道近视进步是否会增加 柔软多灶性隐形眼镜磨损的停用。 该提案解决的问题的答案可以改善对6000万近视的护理 美国的孩子。虽然普通数量的近视的后果很少见到 威胁性，所有近视患者的生活质量受到负面影响，医疗保健费用 近视很高（1990年约46亿美元）。国家眼科研究所认识到需要 ”评估潜在治疗的效率，以延迟发作或减缓近视的进展， 眨眼2旨在最大化利益，同时降低了风险 多灶性隐形眼镜磨损用于近视控制，同时回答有关重要的科学和临床问题 近视进展的后果和机制，这一问题影响了很大一部分人。