Retinal Microanatomy in Retinopathy of Prematurity (BabySTEPS2) (NCT04995341)
Analyzing Retinal Microanatomy in Retinopathy of Prematurity to Improve Care 2 and School Age Follow on Study (BabySTEPS2)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Duke University Eye Center — Durham, North Carolina
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (2 Sites)
- Duke University Eye Center — Durham, North Carolina
- University of Pennsylvania, Center for Preventive Ophthalmology and Biostatistics — Philadelphia, Pennsylvania
📞 Contact the Study Coordinator
Phone: (919) 684-5631
Email: cynthia.toth@duke.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Retinopathy of Prematurity
- Bevacizumab Treatment For Type 1 ROP — Little Rock, Arkansas
- Validation of i-ROP DL to Detect More Than Mild ROP — Portland, Oregon
- Extension Study to Evaluate the Long-Term Outcomes of Pediatric Patients Who Received Treatment for Retinopathy of Prematurity in the VGFTe-ROP-1920 Study (Acronym: Butterfleye Next) — La Jolla, California
- Clinical and Genetic Analysis of ROP — Palo Alto, California
- Imaging Retinal Vasculature in Infant Eyes — Durham, North Carolina
Explore by condition: All Retinopathy of Prematurity clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.