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Analyzing Retinal Microanatomy in Retinopathy of Prematurity to Improve Care
Analyzing Retinal Microanatomy in Retinopathy of Prematurity to Improve Care 3 (BabySTEPS3)
Who can join
0 Days – 9 Months · All sexes
Full eligibility criteria
Inclusion Criteria: * Health care provider, knowledgeable of protocol, agrees that study personnel could contact the Parent/Legal guardian * Parent/Legal Guardian is able and willing to consent to study participation for the infant * Infant meets the American Association of Pediatrics eligibility of ROP screening, and is age \< 35 weeks postmenstrual age at first visit * Infants transferred to nursery for ROP treatment (some participants) Exclusion Criteria: * Participant or Parent/Legal Guardian unwilling or unable to provide consent * Adult participant or infant/child has a health or eye condition that preclude eye examination or retinal imaging (e.g. corneal opacity such as with Peter's anomaly or cataract) * Infant has a health condition, other than prematurity, that has a profound impact on brain development (e.g. anencephaly)
About the study
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.
What is being tested
- Ultra-widefield Optical Coherence Tomography (UWF-OCT) (device)
- Wide-field ophthalmic imaging system (device)
Sponsor: Duke University · Participants: 175 · Started: Dec 1, 2026
Contact the study team
- Xi Chen, MD · Phone: 919-684-8434
- Michelle N McCall, MCAPM, BA · Phone: 919-684-0544
Official record on ClinicalTrials.gov — NCT07738874
Locations in the U.S.
| North Carolina | Duke University Eye Center, Durham |
Conditions
- Retinopathy of Prematurity
- Premature Birth
- Eye Care
- Retinal Disorders
- Preterm Labor
- Childbirth Problems
- Tumors and Pregnancy
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.