RecruitingNot ApplicableNCT04995341

Retinal Microanatomy in Retinopathy of Prematurity (BabySTEPS2)

Analyzing Retinal Microanatomy in Retinopathy of Prematurity to Improve Care 2 and School Age Follow on Study (BabySTEPS2)


Sponsor

Duke University

Enrollment

236 participants

Start Date

Aug 16, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

Retinopathy of prematurity (ROP) is a disorder of development of the neural retina and its vasculature that can impact vision in vulnerable preterm neonates for a lifetime. This study tests high-speed optical coherence tomography (OCT) technology compared to conventional color photographs at the bedside of very preterm infants in the intensive care nursery, to characterize previously unseen abnormalities that can predict a need for referral for ROP treatment, or poor visual or neurological development later in life, up to pre-school age. Our long-term goal is to help improve preterm infant health and vision via objective bedside imaging and analysis that characterizes early critical indicators of ROP, and poor visual function and neurological development, which will rapidly translate to better early intervention and improved future care.


Eligibility

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Investigational ultracompact OCT and OCTA system and a medical device called retinal photographs for people with retinopathy of prematurity. The study is currently recruiting participants at 2 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEInvestigational ultracompact OCT and OCTA system

Handheld bedside retinal OCT and OCT angiography imaging with an investigational portable system with ultracompact handpiece

DEVICEretinal photographs

retinal photographs with a commercial portable bedside widefield fundus camera system


Locations(2)

Duke University Eye Center

Durham, North Carolina, United States

University of Pennsylvania, Center for Preventive Ophthalmology and Biostatistics

Philadelphia, Pennsylvania, United States

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NCT04995341


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