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:10606492
- 负责人:
- 金额:$ 27.91万
- 依托单位:
- 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:
- 关键词:11 year oldAdherenceAffectBindingBiological MarkersBiometryCertificationChildChildhoodClinicalContact LensesDataData CollectionData Coordinating CenterEnrollmentEnsureEnvironmentEnvironmental Risk FactorEquipmentExposure toEyeFocal AdhesionsGoalsGrantGrowthHuman ResourcesLightManualsMeasurementMeasuresMediatingMethodsMyopiaOhioOptometryOutcomeOutcome StudyParticipantPersonsPoliciesProceduresProtocols documentationPublicationsPupilQuality ControlRandomizedRefractive ErrorsRetinal Ganglion CellsRiskStudy SubjectTestingThickThinnessTimeTrainingUnited StatesUniversitiesVisionVisitclinical centerclinical practicecollegedesignexperiencefollow-uphuman subject protectionlenslongitudinal datasetpatient subsetsrandomized, clinical trialsrecruitresponserisk minimizationside effectstandard of caretreatment effecttreatment group
项目摘要
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将通过确定以下因素来识别最能从近视控制中受益的近视儿童:
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。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Donald O. Mutti其他文献
Predicting the onset of myopia in children: results from the CLEERE study
- DOI:
10.1186/s12886-021-02036-9 - 发表时间:
2021-07-14 - 期刊:
- 影响因子:1.700
- 作者:
Donald O. Mutti;Lisa A. Jordan;Karla Zadnik - 通讯作者:
Karla Zadnik
Ocular component growth in children with persistent hyperopia
- DOI:
10.1016/j.jaapos.2012.12.078 - 发表时间:
2013-02-01 - 期刊:
- 影响因子:
- 作者:
Simone L. Li;Vidhya Subramanian;Reed M. Jost;Donald O. Mutti;Eileen E. Birch - 通讯作者:
Eileen E. Birch
Donald O. Mutti的其他文献
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{{ truncateString('Donald O. Mutti', 18)}}的其他基金
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:
10240451 - 财政年份:2014
- 资助金额:
$ 27.91万 - 项目类别:
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 - 财政年份:2014
- 资助金额:
$ 27.91万 - 项目类别:
Soft Bifocal Contact Lens Myopia Control - Clincal Center
软双焦点隐形眼镜近视控制 - 临床中心
- 批准号:
8609228 - 财政年份:2014
- 资助金额:
$ 27.91万 - 项目类别:
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