Analyzing Retinal Microanatomy in ROP

CompletedOBSERVATIONAL
Enrollment

191

Participants

Timeline

Start Date

July 22, 2016

Primary Completion Date

December 31, 2020

Study Completion Date

April 15, 2021

Conditions
Retinopathy of PrematurityNeurodevelopmental DisordersMacular 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.

Trial Locations (4)

19104

University of Pennsylvania, Philadelphia

27705

Duke University Eye Center, Durham

32611

University of Florida, Gainesville

63130

Washington University, St Louis

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

National Eye Institute (NEI)

NIH

collaborator

University of Pennsylvania

OTHER

collaborator

Washington University School of Medicine

OTHER

collaborator

University of Florida

OTHER

lead

Duke University

OTHER