Retinal Microanatomy in Retinopathy of Prematurity (BabySTEPS2) - Trial NCT04995341

Timeline & Enrollment

Primary Outcome

Optotype Visual acuity scores (Cohort 1 only),Visual function scores (Cohort 1 only),Neurodevelopmental scores at 2-year study visit (Cohort 1 only),Retinal thickness at the fovea and surrounding optic nerve as measured by OCT reading (Cohort 1-3),Microanatomy as measured by OCT reading,Microanatomy as measured by retinal photo reading (Cohort 3 only),Microanatomy as measured by clinical exam (Cohort 1-3),Measurement of stress of imaging (Cohort 3 only),Assessment of ease of imaging (Cohort 3 only),ROP vascular severity score (Cohort 3 only)

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.

ICD-10 Classifications