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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)
Who can join
All ages · All sexes · Healthy volunteers welcome
Full eligibility criteria
Inclusion Criteria: * Children previously enrolled in BabySTEPS1 (Pro00069721) that have already consented to being contacted for this school age follow on study, Cohort 1 only * Parent/Legal Guardian is able and willing to consent to study participation with follow up approximately between 4.5 and 5 years of age (consent available in Spanish\* and English) (SA 1 only) * Parent/Legal Guardian is able and willing to consent to study participation for the infant (SA 2 and 2c only) * Infant/child undergoing clinically-indicated examination under anesthesia that may or may not have eye pathology (SA 2 only) * Infant inborn or outborn at (SA 2 only): * Duke Hospital (Years 1, 2 and 3) with birth weight ≤1000 grams, and/or 20 0/7 to 28/ 6/7 (\<29 weeks) gestational age * Duke Hospital (Years 1, 2 and 3) at high risk to require treatment for ROP irrespective of birth weight and gestational age (e.g. pre-plus, severe ROP in zone 1, APROP, etc.) * Duke Regional Hospital (Years 4 and 5) that meets the American Association of Pediatrics eligibility of ROP screening (Infants with a birth weight of ≤1500 g or gestational age of 30 weeks) * Adults (over the age of 18 years) that may or may not have eye pathology (SA 2 only) 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) (SA2 only) * Infant has a health condition, other than prematurity, that has a profound impact on brain development (e.g. anencephaly) (SA2 only)
About the study
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.
What is being tested
- Investigational ultracompact OCT and OCTA system (device)
- retinal photographs (device)
Sponsor: Duke University · Participants: 236 · Started: Aug 16, 2021
Contact the study team
- Cynthia A Toth, MD · Phone: 919-684-5631
- Michelle N McCall, MCAPM, BA · Phone: 919-684-0544
Official record on ClinicalTrials.gov — NCT04995341
Locations in the U.S.
| North Carolina | Duke University Eye Center, Durham |
| Pennsylvania | University of Pennsylvania, Center for Preventive Ophthalmology and Biostatistics, Philadelphia (Not yet recruiting) |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.