Examination of Myopia Progression and Consequences and Mechanism of Soft Multifocal Contact Lens Myopia Control - Data Coordinating Center
Examination of Myopia Progression and Consequences and Mechanism of Soft Multifocal Contact Lens Myopia Control - Data Coordinating Center
批准号:
10382370
负责人:
LISA A Jordan
金额:
$25.36万
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
项目状态:
已结题
起止时间:
2014-04-01 至 2024-03-31
关键词:
11 year oldAddressAffectBiological MarkersBiometryCaringChildChildhoodClinicalClinical Trials DesignCohort StudiesConduct Clinical TrialsContact LensesDataData CollectionData Coordinating CenterEnrollmentEnsureEnvironmentEnvironmental Risk FactorExposure toEyeGoalsGrowthHealth Care CostsLightLiteratureMeasurementMeasuresMediatingMethodologyMonitorMyopiaNational Eye InstituteOpticsOutcomeOutcome StudyParticipantPatientsPeripheralPersonsPhotosensitivityPositioning AttributeProceduresProtocols documentationPupilQuality of lifeRandomizedRandomized Clinical TrialsRefractive ErrorsReportingResearch DesignRetinal Ganglion CellsRiskRoleSafetySecureShapesSpecific qualifier valueStudy SubjectTestingThickTimeUnited StatesVisionVisitcohortdata managementdata qualitydesignefficacy evaluationelectronic data capture systemfollow-upimprovedlenslongitudinal datasetnegative affectprotocol developmentquality assuranceresponserisk minimizationside effectstandard of caretreatment effecttreatment group
中文摘要
这是BLINK2研究的数据协调中心的建议,该中心的主要目标是
用生物标记物(脉络膜)的非侵入性测量确定近视进展的相关性
厚度和固有的光敏性视网膜神经节细胞介导的瞳孔功能)和室外光线
暴露在儿童身上。如果多焦点隐形眼镜使近视的进展速度比
单视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,如多焦点隐形眼镜配戴是否改变
调节功能以及治疗效果是否短暂。具体地说,我们将调查
近视进展是否因配戴多焦点隐形眼镜而减慢或只是延缓,以及是否存在
停止多焦点接触后近视进展的“反弹”,进展率增加
隐形眼镜。
这项研究将通过确定哪些近视儿童将从近视控制中受益最大
谁最有可能进步,从而最大限度地增加受益的潜力,并将风险降至最低。BLINK2将
通过研究最重要的眼部和环境因素对进展的影响来实现这一目标
风险因素最近被认为是控制眼睛生长的因素。该项目将收集最广泛的
儿童近视脉络膜厚度的纵向数据集。这项研究将检验这个重要的问题
此外,户外活动时间和光照是否会影响近视发病后的进展
这些影响是由固有的感光性视网膜神经节细胞介导的。如果软性多焦点隐形眼镜
在眨眼研究中显示出临床上有意义的近视进展减缓,这项研究也将回答
许多重要的问题是我们的临床同事经常问的。我们就会知道
儿童佩戴多焦点隐形眼镜多年;我们将知道多焦点隐形眼镜是否减慢或
只需延缓近视进展,我们就会知道近视进展是否会随着
停止佩戴软性多焦点隐形眼镜。
这项提案所提出的问题的答案可能会改善6000万近视患者的护理
美国的儿童。虽然普通量近视的后果很少是看不见的-
所有近视患者的生活质量都受到了负面影响,治疗的医疗费用也受到了威胁
近视很严重(1990年约为46亿美元)。国家眼科研究所认识到有必要
“评估延缓近视发病或减缓近视进展的潜在治疗方法的有效性,
例如改变周边散焦的镜片。“眨眼2寻求最大化益处,同时降低
多焦点隐形眼镜配戴用于近视控制,同时回答有关
近视进展的后果和机制,这是一个影响很大一部分人的问题。
英文摘要
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.
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依托单位:
海外基金