NCT03640494

Bedside Optical Retinal Assessment of Hypoxic Ischemic Encephalopathy in Infants

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 57 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 20 Days
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to develop a novel noninvasive bedside optical coherence tomography (OCT) imaging technique in newborn infants with HIE that improves our ability to assess the range of retinal effects from HIE and to diagnose and monitor treatments of HIE.

Conditions

• Hypoxic-Ischemic Encephalopathy

Interventions

Type	Name	Description
DEVICE	Optical Coherence Tomography	This is an observational study in which subjects will be imaged with optical coherence tomography (OCT). OCT systems are optical imaging technology that allow non-contact imaging of the microanatomy of the retina, optic nerve head and retinal blood vessels. The OCT devices are held above (and do not touch) the eye. Unlike visible light from many examination devices, the infrared OCT beam is barely visible to the human eye as it sweeps across the retina. Thus the infant is not disturbed by the light.

Timeline

• Start date: 2018-08-28
• Primary completion: 2021-02-28
• Completion: 2021-02-28
• First posted: 2018-08-21
• Last updated: 2021-04-08

Locations

2 sites across 1 country: United States