Retinal Imaging for Retinopathy of Prematurity
((BabySTEPS3) Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
Retinopathy of prematurity (ROP) is a disorder of development of the retina and its vasculature that can impact vision in vulnerable preterm neonates for a lifetime. A major barrier to improving ROP outcomes is the lack of easy access and low stress means to obtain objective measures of ROP disease severity across the retina in these infants. The long-term goal of this program is to provide information which will improve preterm infant health and vision via objective bedside imaging and analysis that characterizes retina-wide ROP level of disease, its response to treatment and development, and to rapidly translate this for better early intervention and improved future vision care.
Who Is on the Research Team?
Xi Chen, MD
Principal Investigator
Duke University
Are You a Good Fit for This Trial?
This trial is for premature infants at risk of or diagnosed with retinopathy of prematurity (ROP), a condition affecting the eyes. It focuses on preterm babies who may develop vision problems due to early birth.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Infants undergo bedside ultra-widefield OCT retinal imaging and standard-of-care exams to assess ROP severity
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of retinal thickness and ROP severity
Extension
Optional long-term follow-up to assess ongoing retinal health and development
What Are the Treatments Tested in This Trial?
Trial Overview
Researchers are testing advanced eye imaging tools—ultra-widefield OCT and wide-field ophthalmic imaging—to safely and easily scan the entire retina in preterm infants, aiming to better detect and monitor ROP.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
455 infants at risk for retinopathy of prematurity: 175 infants will be enrolled and have beside ultra-widefield OCT retinal imaging, fundus imaging, and binocular indirect ophthalmoscopic exam. Data from newly enrolled infants will be combined with 280 infants who had similar imaging in BabySTEPS1, BabySTEPS2, and the Duke Investigational Pediatric OCT study to perform artificial intelligence (AI) based RW-ROP and TR-ROP severity assessment and to add OCT risk measures to AI-based prediction of RW-ROP and TR-ROP.
175 infants at risk for retinopathy of prematurity will be enrolled and have beside ultra-widefield OCT retinal imaging and standard-of-care binocular indirect ophthalmoscopic (BIO) exam.
45 infants treated for ROP: Compare OCT measures to clinical findings of ROP regression and identify early signs of ROP reactivation.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Duke University
Lead Sponsor
University of Pennsylvania
Collaborator
National Eye Institute (NEI)
Collaborator
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