# Development of Flow Based Biomarkers for Retinopathy of Prematurity - Supplemental Aim

> **NIH NIH R43** · VASOPTIC MEDICAL, INC. · 2020 · $96,145

## Abstract

ABSTRACT
This application is a request for an administrative supplement to our funded grant ID 1R43EY030798-01.
Retinopathy of Prematurity (ROP) is a potentially blinding disease that occurs in the earliest weeks of life. The
disease is currently one of the top three causes of childhood blindness in the world and is the number one
cause of blindness in countries of a medium level of economic development. One in nine children born in
the US, or half a million babies per year, are born prematurely; worldwide, the number is estimated at 15
million. Current American Academy of Pediatrics guidelines mandate an ophthalmology screening exam
for 2-5% of these infants to assess the risk of developing ROP. Ophthalmologists diagnose and make
decisions about the initial treatment of ROP based on the appearance of the retinal blood vessels. The
current standard of care for diagnosis of ROP is a subjective evaluation of vessel dilatation and tortuosity
based on a static fundus photograph. The only instruments marketed for imaging the infant retina that may
assist in ROP diagnostics are bulky and expensive making them unsuitable for widespread use. Hence, there
is a critical need for a standardized, more accurate method of screening infants for ROP using a convenient,
affordable, and portable instrument. Semi-automated methods are available to quantify the vascular
morphologic changes seen in ROP; however, these technologies lack the ability to objectively and
automatically quantify and detect the condition.
This Phase I effort proposes to design and develop the XyCAM NEO™—a handheld, noninvasive imager
capable of measuring retinal blood flow with high spatial resolution, for diagnosis and management of ROP
and test the crucial hypothesis that XyCAM NEO derived flow-based metrics can be utilized for monitoring
of status of ROP and Plus Disease. The XyCAM NEO will use laser speckle contrast imaging (LSCI) to capture
blood flow information over a wide field of view of the infant retina without the need for exogenous dyes.
This additional information is complementary to that available using fundus photography, and the addition
of novel flow-based biomarkers to conventional biomarkers such as vessel tortuosities, diameters, lengths,
and densities is expected to improve diagnostics. Specifically, we propose to adapt our retinal imaging
technology that has been validated in adult human subjects for use in premature infants in the neonatal
intensive care unit (NICU) environment; and demonstrate through an early feasibility clinical study that
blood flow in premature infants with severe ROP is different than in those with low-grade ROP. In doing so,
we also expect to demonstrate the ability and potential of the XyCAM NEO derived flow-based biomarkers
to discriminate between a severe and mild disease state. The present request for an administrative
supplement seeks funds for re-engineering the optical assembly and the computational hardware of the
proposed XyCAM NEO sys...

## Key facts

- **NIH application ID:** 10098795
- **Project number:** 3R43EY030798-01S1
- **Recipient organization:** VASOPTIC MEDICAL, INC.
- **Principal Investigator:** Abhishek Rege
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $96,145
- **Award type:** 3
- **Project period:** 2019-09-01 → 2020-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10098795

## Citation

> US National Institutes of Health, RePORTER application 10098795, Development of Flow Based Biomarkers for Retinopathy of Prematurity - Supplemental Aim (3R43EY030798-01S1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10098795. Licensed CC0.

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