Secondary Data Analysis for Neonates with Retinal OCT Imaging

新生儿视网膜 OCT 成像二次数据分析

• 批准号: 10508609
• 负责人: CYNTHIA ANN TOTH
• 金额: $ 25.74万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-30 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10508609
• 关键词: Adult; Age; Anatomy; Biological; Birth; Blindness; Blood Vessels; Caring; Characteristics; Classification; Clinical; Clinical Data; Clinical Research; Clinical Trials; Clinical and Translational Science Awards; Color; Comparison arm; Cystoid Macular Edema; Data; Data Analyses; Data Set; Diagnosis; Disease; Disease Marker; Early identification; Enrollment; Evaluation; Eye; Foundations; Funding; Fundus; Future; Ganglion Cell Layer; Glean; Goals; Health; Image; Imaging Device; Infant; Investigation; Light; Lighting; Location; Longitudinal Studies; Measurable; Measures; Methodology; Methods; Microanatomy; Morphology; National Center for Research Resources; Nose; Observational Study; Ophthalmoscopes; Optic Nerve; Optical Coherence Tomography; Optical Methods; Optics; Outcome; Participant; Pattern; Peripheral; Pigmentation physiologic function; Premature Infant; Protocols documentation; Race; Reproducibility; Research; Retina; Retinopathy of Prematurity; Risk; Risk Marker; Severities; Severity of illness; Stress; System; Telemedicine; Testing; Therapeutic Intervention; Therapy trial; Thick; Time; United States National Institutes of Health; Vascular Diseases; Visit; Work; base; diagnostic tool; fundus imaging; health data; imaging modality; improved; infant monitoring; inflammatory marker; insight; macula; neonatal hypoxic-ischemic brain injury; neonate; neovascularization; pre-clinical; prevent; prospective; retinal imaging; retinal nerve fiber layer; screening; secondary analysis; success

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.

项目摘要 视网膜OCT成像新生儿的次要数据分析包括来自330名婴儿参与者的数据 之前入组过前瞻性观察性研究，其中包括使用研究性OCT设备 在床边成像。这些数据被分为两组：早产儿视网膜病变（ROP） 组和健康足月儿组。ROP组由239名早产儿的数据组成， 从以下研究中获得ROP：Hartwell基金会资助的光谱域光学相干 婴幼儿眼部断层扫描成像：一种实用的诊断工具和方法， 炎症标志物与极早产儿囊样黄斑水肿的盲源性相关性 试点国家研究资源中心-临床和转化科学奖，床边光学 婴儿缺氧缺血性脑病的评估和NIH资助的视网膜分析 早产儿视网膜病变改善护理（称为BabySTEPS）研究的显微解剖学。健康术语 婴儿组包括前两个月作为对照组的91名健康足月婴儿的数据 上述或NIH资助的低眼压缺血性脑病床边光学视网膜评估研究 在婴儿研究中。本建议的具体目标与上述任何一项建议的目标都不重叠。 问题研究将对这些独特数据进行拟定的次要分析研究，以实现以下目标： (1)确定鼻黄斑中的神经节细胞层厚度是否与以下因素高度相关且变化较小： 视诊比视诊乳头状斑束神经纤维层厚度;（2）显影更客观， 通过结合横截面，对与血管疾病严重程度相关的OCT数据进行有效和严格的分析， （a）在临床预加时， 加上疾病，和（B）之前发生的更大的血管疾病的严重程度;（3）评价非常早期的效用 视网膜和脉络膜OCT测量提供早期预测临床ROP严重程度的方法;（4）评估眼底 色素沉着作为一个生物学变量，与早产儿中的中央凹凹形态更密切相关， 与种族分类的对比;以及（5）定义OCT在等效术语上的测量和特征差异 考虑生物学变量，早产儿与最小ROP、早产儿与ROP和足月儿之间的年龄。一 本提案的目标是对现有的唯一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ROP的临床试验和未来的远程医疗用途。额外 目的是识别晚期ROP或进展风险的早期标志物，以改进图像分级方法， 优化准确性和效率，并确定这些OCT测量与 在足月出生的婴儿。这项工作对早产儿的临床研究和眼部护理有很大的帮助 全世界的婴儿