Analyzing Retinal Microanatomy in Retinopathy of Prematurity to Improve Care
(BabySTEPS3)
2 other identifiers
interventional
175
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2026
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2026
CompletedFirst Submitted
Initial submission to the registry
July 27, 2026
CompletedFirst Posted
Study publicly available on registry
July 31, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2031
July 31, 2026
July 1, 2026
5 years
July 27, 2026
July 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Sensitivity and specificity of ultra-widefield OCT vs bionocular indirect ophthalmoscopy or fundus photograph to identify referral-warranted retinopathy of prematurity
OCT markers that determine the presence or absence of referral-warranted retinopathy of prematurity.
Up to 60 weeks post-menstrual age
Measurement of infant stress
Assessment of stress and discomfort using modified CRIES score (crying 0-4; facial expression 0-2; heart rate beats per minute; change in respiratory support) during each eye imaging and compared to baseline pre-imaging score adverse events recorded during imaging (bradycardia, tachycardia, desaturation, emesis, and ocular adverse events e.g. conjunctival hemorrhage)
Up to 60 weeks post-menstrual age
Secondary Outcomes (6)
Retinal thickness at the fovea and surrounding optic nerve as measured by OCT reading
Up to 9 months corrected age
Artificial Intelligence algorithms to classify ROP
Up to 60 weeks post-menstrual age
ROP vascular severity score
Up to 9 months corrected age
ROP severity as determined by clinical exam
Up to 9 months corrected age
ROP severity as determined by retinal photo reading
Up to 9 months corrected age
- +1 more secondary outcomes
Study Arms (3)
Test bedside UWF-OCT versus bionocular indirect ophthalmoscopic exam to identify RW-ROP and TR-ROP
EXPERIMENTAL175 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.
Test bedside UWF-OCT versus fundus photos to identify RW-ROP and TR-ROP
EXPERIMENTAL455 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.
Test UWF-OCT versus binocular indirect ophthalmoscopic exam to characterize ROP regression
EXPERIMENTAL45 infants treated for ROP: Compare OCT measures to clinical findings of ROP regression and identify early signs of ROP reactivation.
Interventions
Handheld retinal OCT imaging at the bedside or in clinic with an ultra-widefield handheld optical coherence tomography
Handheld wide-field ophthalmic fundus imaging at the bedside or in clinic
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
- University of Pennsylvaniacollaborator
- National Eye Institute (NEI)collaborator
Study Sites (2)
Duke University Eye Center
Durham, North Carolina, 27705, United States
University of Pennsylvania, Center for Preventive Ophthalmology and Biostatistics
Philadelphia, Pennsylvania, 19104, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xi Chen, MD
Duke University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- While all participants have the investigational imaging, throughout image grading, the principal investigator and image analysts are masked to all health data (including retinopathy of prematurity examination findings) except age at time of imaging.
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 27, 2026
First Posted
July 31, 2026
Study Start
July 1, 2026
Primary Completion (Estimated)
June 30, 2031
Study Completion (Estimated)
December 31, 2031
Last Updated
July 31, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Shared data generated from this project will be made available as soon as possible, and no later than the time of publication or one year after the end of the funding period, whichever comes first. The duration of preservation and sharing of the data will be a minimum of 6 years after the end of the funding period.
- Access Criteria
- All de-identified datasets of downstream analyses that can be shared will be deposited in the Duke Research Data Repository and/or Open Science Framework. There are no anticipated factors or limitations that will affect the access, distribution, or reuse of the de-identified and shareable scientific data generated in downstream analysis by the proposal. Controlled access will not be used for downstream analysis; those data permitted to be shared, will be shared by unrestricted download. Some datasets (e.g. identifiable retinal images) may require a Data Use Agreement (DUA). Requests for access will be reviewed by the study team and the institutional data access committee to ensure ethical use.
This project will produce imaging data generated and obtained from the research ultra-widefield (UWF-) OCT system and associated clinical imaging systems (RetCam fundus imaging). The following data files will be used or produced over the course of the project: OCT volumes consisting of 3D data (.broct and .tiff), Natus RetCam images (.mlx) but in DICOM format and exportable as (.tiff). RetCam data may include accompanying metadata such as date/time of image capture. Downstream analysis of the primary OCT data such as segmentations of targeted ocular layers will be stored in matrices in .mat or .numpy formats. To protect research participant identities, individual data at the segmentation level and summarized data will be made available for sharing. We will share de-identified downstream individual-participant level data where possible. De-identification will occur by removing currently accepted forms of PHI from the datasets.