# Secondary Data Analysis for Neonates with Retinal OCT Imaging

> **NIH NIH R21** · DUKE UNIVERSITY · 2022 · $257,350

## Abstract

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...

## Key facts

- **NIH application ID:** 10508609
- **Project number:** 1R21EY034138-01
- **Recipient organization:** DUKE UNIVERSITY
- **Principal Investigator:** CYNTHIA ANN TOTH
- **Activity code:** R21 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $257,350
- **Award type:** 1
- **Project period:** 2022-09-30 → 2024-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10508609

## Citation

> US National Institutes of Health, RePORTER application 10508609, Secondary Data Analysis for Neonates with Retinal OCT Imaging (1R21EY034138-01). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10508609. Licensed CC0.

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