Secondary Data Analysis for Neonates with Retinal OCT Imaging

项目摘要 新生儿视网膜OCT成像二次数据分析包括330名婴儿参与者的数据 之前参加了前瞻性观察研究，其中包括使用调查性OCT设备 在床边进行影像检查。这些数据被分为两组：早产儿视网膜病变(ROP) 健康足月组和健康足月组。ROP组由239名早产儿的数据组成 来自以下研究的ROP：哈特威尔基金会资助的光谱域光学相干 婴幼儿眼部断层成像：一种实用的诊断工具和方法及预防研究 失明资助的炎症标志物与极早产儿黄斑囊样水肿的相关性 国家研究资源试点中心-临床和翻译科学奖，床边光学 新生儿缺氧缺血性脑病的评估和美国国立卫生研究院资助的视网膜分析 早产儿视网膜病变改善护理(称为婴儿步)的显微解剖研究健康术语 婴儿组由前两组中91名健康足月婴儿的数据组成 以上或在NIH资助的缺氧缺血性脑病的床边视网膜光学评估中的研究 在婴儿研究中。本提案的具体目标与上述任何一项的目标不重叠 学习。将对这些独特数据进行拟议的二次分析研究，以实现以下目标： (1)确定鼻斑神经节细胞层厚度是否与神经节细胞层厚度高度相关，而与 访视比视网膜神经纤维层厚度在视网膜乳头状瘤束中；(2)发展更客观， 通过结合横断面数据对与血管疾病严重程度相关的OCT数据进行高效、严格的分析 (厚度)和面部OCT测量以评分ROP中的血管疾病：(A)在临床预加和 再加上疾病，以及(B)在更严重的血管疾病发作之前；(3)评估非常早的 视网膜和脉络膜OCT测量提供临床ROP严重程度的早期预测；(4)评估眼底 色素沉着作为一个生物学变量与早产儿中心凹形态更密切相关 对比种族分类；以及(5)定义OCT在等值术语上的测量和特征的差异 考虑生物学变量，ROP最小的早产儿、ROP早产儿和足月儿之间的年龄。一个 本方案的目标是对现有唯一的OCT数据进行二次分析，以优化分析 早产儿OCT数据，以便更有效地用于临床试验和未来在ROP中的远程医疗使用。其他内容 目标是识别晚期ROP或进展的早期风险标记，完善图像分级方法 以优化准确性和效率，并确定这些OCT措施与那些措施之间的差异 在足月出生的婴儿中。这项工作对早产儿的临床研究和眼部护理具有很大的潜力。 世界各地的婴儿。

Project Summary The Secondary Data Analysis for Neonates with Retinal OCT Imaging includes data from 330 infant participants previously enrolled into prospective observational studies which included use of investigational OCT devices for imaging at the bedside. These data have been divided into two groups: the Retinopathy of Prematurity (ROP) Group and the Healthy Term Infant Group. The ROP Group consists of data from 239 preterm infants evaluated for ROP from the following studies: The Hartwell Foundation funded Spectral Domain Optical Coherence Tomography Imaging of Infant Eyes: A Practical Diagnostic Tool and Methodology, the Research to Prevent Blindness funded Association of Inflammatory Markers and Cystoid Macular Edema in Very Preterm Infants, a pilot National Center for Research Resources - Clinical and Translational Science Award, Bedside Optical Assessment of Hypoxic Ischemic Encephalopathy in Infants, and the NIH funded Analyzing Retinal Microanatomy in Retinopathy of Prematurity to Improve Care (called BabySTEPS) study. The Healthy Term Infant Group consists of data from 91 infants enrolled as healthy term infants in a comparison arm in the first two studies above or in the NIH funded Bedside Optical Retinal Assessment of Hypoxic Ischemic Encephalopathy in Infants study. The specific aims of this proposal do not overlap with the aims of any of the aforementioned studies. The proposed secondary analyses study of these unique data will be performed to achieve the following: (1) Determine if ganglion cell layer thickness in the nasal macula is highly correlated with and less variable from visit to visit than retinal nerve fiber layer thickness in the papillomacular bundle; (2) Develop more objective, efficient, and rigorous analysis of OCT data related to vascular disease severity by incorporating cross-sectional (thickness) and en face OCT measures to score vascular disease in ROP: (a) at time of clinical pre-plus and plus disease, and (b) preceding onset of greater vascular disease severity; (3) Evaluate the utility of very early retinal and choroidal OCT measures to provide early prediction of clinical ROP severity; (4) Evaluate fundus pigmentation as a biological variable more closely correlated to foveal pit morphology in preterm infants in contrast to racial classification; and (5) Define the difference in measures and features on OCT at term equivalent age between preterm with minimal ROP, preterm with ROP and term infants, considering biological variables. A goal of this proposal is to perform the secondary analysis on unique existing OCT data to optimize the analysis of preterm infant OCT data for more efficient use for clinical trials and future telemedicine uses in ROP. Additional goals are to identify early markers of risk of advanced ROP or progression, to refine methods for image grading to optimize accuracy and efficiency, and to establish the differences between these OCT measures and those in term-born infants. This work has great potential to be of benefit for clinical research and eye care of premature infants worldwide.