Imaging retinal structure in premature babies to guide care
Official title: Analyzing Retinal Microanatomy in Retinopathy of Prematurity to Improve Care 3 (BabySTEPS3)
Run by Duke University · NCT07738874 · Data updated 2026-11-12
This study tests whether bedside ultra-widefield eye imaging can better guide treatment decisions for retinopathy of prematurity in preterm infants.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 0 Days to 9 Months |
| Sex | All |
| Enrollment | 175 (estimated) |
| Sponsor | Duke University Academic / other |
| Locations | 2 sites (Durham, North Carolina and 1 other locations) |
| Status | Recruiting |
| Started | December 1, 2026 |
| Main results expected | June 30, 2031 |
| Study ends | December 31, 2031 |
| Registry record updated | September 17, 2026 |
| Trial ID | NCT07738874 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Infants at risk for ROP who are within 35 weeks postmenstrual age at first visit and whose guardians consent to participate, treated or monitored by participating centers.
✕Probably not a fit
Infants whose imaging or disease course does not respond to imaging-guided assessment may not experience a clear benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional program seeks to use ultra-widefield OCT and wide-field imaging to characterize retina-wide disease in retinopathy of prematurity at key care points. It aims to provide objective, less stressful imaging that helps identify referral and treatment needs, monitor response, and detect reactivation. The study involves healthcare teams and is conducted across Duke University and the University of Pennsylvania with NEI support. Imaging will be performed in the nursery setting to minimize infant stress while collecting data on disease severity and progression. Findings could inform earlier, more precise interventions and improve long-term vision outcomes for preterm infants.
Why it matters
Potential benefit: If successful, infants could receive more timely and tailored care with reduced stress from monitoring, potentially preserving vision.
How similar studies have gone: Previous work in ROP has shown promise for imaging-based monitoring, but widespread clinical benefit from bedside UWF-OCT imaging remains to be demonstrated, making this approach somewhat novel.
Who can join: the full rules
Show full inclusion / exclusion 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)
Where it's running
-
Duke University Eye Center
Durham, North Carolina, United States Recruiting -
University of Pennsylvania, Center for Preventive Ophthalmology and Biostatistics
Philadelphia, Pennsylvania, United States Active not recruiting
Study contacts
- Principal investigator: Xi Chen, MD — Duke University
- Study coordinator: Xi Chen, MD
- Email: xi2.chen@duke.edu
- Phone: 919-684-8434
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Does early red blood cell transfusion affect complications and neurodevelopment in premature infants?
This study tests whether giving blood transfusions in the first month of life in premature babies is linked to early complications like ROP, NEC, BPD, IVH, and to later neurodevelopmental outcomes.
-
Testing FLQ-101 for retinopathy of prematurity in very premature newborns
This will test whether giving FLQ-101 to very premature babies (born at 26+0 to 27+6 weeks and weighing ≥650 g) is safe and produces the expected drug effects in their bodies.
-
Low-dose Conbercept treatment for Retinopathy of Prematurity
This study is testing if a low-dose eye treatment called Conbercept can help preterm infants with Retinopathy of Prematurity feel better and improve their vision.
-
Evaluating pain relief methods during eye exams for premature infants
This study is testing two different ways to hold premature infants during eye exams to see which one helps reduce their pain better.
-
New imaging technology for diagnosing retinopathy of prematurity in infants
This study is testing a new imaging technology to help doctors better see and understand eye problems in premature infants with retinopathy of prematurity.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.