Analyzing Retinal Microanatomy in ROP

Summary

Retinopathy of prematurity (ROP) is a disorder of development of the neural retina and its vasculature that may impact vision in vulnerable preterm neonates for a lifetime. This study utilizes new technology to determine visual and neurological development of very preterm infants in the intensive care nursery, during a period of rapid growth of the retina, optic nerve and brain. The long-term goal of this study is to help improve preterm infant health care via objective bedside imaging and analysis that characterizes early critical indicators of poor vision, neurological development and ROP, which will rapidly translate to better early intervention and improved future vision care.

Conditions

• Retinopathy of Prematurity
• Neurodevelopmental Disorders
• Macular Edema

Interventions

DEVICE

Swept Source OCT

The swept source optical coherence tomography device was developed at Duke University as the result of collaboration between the Departments of Ophthalmology and Biomedical Engineering. The SSOCT system has a 100kHz repetition rate, 1050nm-centered swept-source light source (Axsun Technologies). This swept-source system allows near real-time OCT imaging during movement while imaging and it provides better OCT imaging of the choroid. The SSOCT system is a non-contact device and therefore does not touch the eye.

OTHER

Magnetic Resonance Imaging

Non-sedated research brain MRI: Magnetic resonance imaging (MRI) is a minimal risk procedure that uses a magnet and radio waves to make diagnostic medical images of the body. There have been no ill effects reported from exposure to the magnetism or radio waves used in this test. However, it is possible that harmful effects could be recognized in the future. A known risk is that the magnet could attract certain kinds of metal. Therefore, we will carefully ask about metal within the body. If there is any question about potentially hazardous metal within the body, MRI imaging will not be performed. We will also keep the examining room locked so that no one carrying metal objects can enter while the child is in the scanner.

OTHER

Scavenged blood collection

Serum/plasma (residual in the laboratory) collected as part of clinically indicated care will be shipped to the University of Florida for neuroinflammatory biomarker testing to identify central nervous system cellular injury.

Sponsors & Collaborators

• National Eye Institute (NEI)

  collaborator NIH

• University of Pennsylvania

  collaborator OTHER

• Washington University School of Medicine

  collaborator OTHER

• University of Florida

  collaborator OTHER

• Duke University

  lead OTHER

Principal Investigators

• Cynthia A Toth, MD · Duke Health

Eligibility

Min Age

30 Weeks

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-07-22

Primary Completion

2020-12-31

Completion

2021-04-15

Countries

• United States

Study Locations