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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)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07738874
Acronym
(BabySTEPS3)
Enrollment
175
Registered
2026-07-31
Start date
2026-12-01
Completion date
2031-12-31
Last updated
2026-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retinopathy of Prematurity (ROP)

Keywords

Optical Coherence Tomography (OCT), Retinopathy of Prematurity, Ultra-widefield Optical Coherence Tomography (UWF-OCT), Referral warranted ROP (RW-ROP), Treatment requiring ROP (TR-ROP), Premature birth, Eye Diseases, Retinal Diseases, Obstetric Labor, Premature, Obstetric Labor Complications, Pregnancy Complications, Infant, Premature, Diseases, Infant, Newborn, Diseases

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.

Detailed description

Retinopathy of prematurity (ROP) remains the leading cause of childhood blindness in the US and other developed countries, blinding 150,000-200,000 children worldwide annually and leaving many more visually impaired. This vision loss is lifelong and impacts neurodevelopment. While current treatments including the addition of anti-VEGF therapies decrease the likelihood of severe vision loss from ROP, these benefits have come with a burden of monitoring for recurrence, added to the widespread task of monitoring for onset of treatment requiring ROP. This is a global issue, as the improved survival of younger preterm infants increases the burden of care in a world where there is a worsening shortage of experts for bedside ROP exams. A major barrier to improving ROP management and outcomes is the lack of easy access to incisive, objective measures of ROP disease severity, especially at critical junctures for referral or treatment, response to treatment and reactivation without causing infant stress in the nursery. ROP monitoring by standard care exam and handheld widefield photographs (e.g., RetCam by Natus) use white light, are stressful to the infant, and are repeated more often in more premature infants and with more severe ROP; their induced stress can contribute to poorer neurodevelopment. Drawing/scores of an exam are subjective, and Retcam photos are limited by loss of view from areas of shadow, worse in eyes with dark pigmentation or vitreous haze, and from avoidance response in infants, especially after term age when ROP retreatment decisions must be made. These may contribute to expert disagreement on ROP disease severity based on such photos. AI-generated models are often based on curated sets of good quality images which do not reflect real-world, lower-quality photos. With the newest generation of handheld OCTs, a field-of-view wider than ROP photographs is possible, as the researchers have established for the proposed renewal. In the current grant period, they have established that with high speed swept-source OCT imaging of a smaller field-of-view, they can obtain: OCT images of good contrast that are agnostic to fundus pigmentation, less infant stress due to lack of visible light, vascular views further into the margin of the imaging field due to coherence gating inherent to OCT, and reproducible depth-resolved retinal measures of risk (e.g. choroid) for treatment requiring disease and of neovascularization, regression and traction at the vascular-avascular junction. Multiple research groups have studied OCT imaging in preterm infants, but rigorous studies to classify ROP on OCT relative to standard care classification are rare. Without such translation, there is a risk that with the use of OCT images physicians will overtreat features, rather than treating ROP at severity levels based on clinical trial evidence. The proposed study will provide clinician-scientists with more objective and precise OCT-based measures of level of severity within (and relative to) current ROP classification. Having completed the necessary groundwork, the investigators are prepared to test our hypotheses and validate OCT-based measures for referral warranted (RW) and treatment requiring (TR)-ROP. The researchers will demonstrate through measures of infant stress, scalable grading and AI tools, the basis for OCT imaging use to improve ROP care.

Interventions

DEVICEUltra-widefield Optical Coherence Tomography (UWF-OCT)

Handheld retinal OCT imaging at the bedside or in clinic with an ultra-widefield handheld optical coherence tomography

DEVICEWide-field ophthalmic imaging system

Handheld wide-field ophthalmic fundus imaging at the bedside or in clinic

Sponsors

Duke University
Lead SponsorOTHER
University of Pennsylvania
CollaboratorOTHER
National Eye Institute (NEI)
CollaboratorNIH

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

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.

Eligibility

Sex/Gender
ALL
Age
0 Days to 9 Months
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Sensitivity and specificity of ultra-widefield OCT vs bionocular indirect ophthalmoscopy or fundus photograph to identify referral-warranted retinopathy of prematurityUp to 60 weeks post-menstrual ageOCT markers that determine the presence or absence of referral-warranted retinopathy of prematurity.
Measurement of infant stressUp to 60 weeks post-menstrual ageAssessment 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)

Secondary

MeasureTime frameDescription
Retinal thickness at the fovea and surrounding optic nerve as measured by OCT readingUp to 9 months corrected ageRetinal thickness (microns) at the fovea and surrounding optic nerve.
Artificial Intelligence algorithms to classify ROPUp to 60 weeks post-menstrual ageDevelopment of clinician-in-the-loop AI-based ROP classification algorithm for OCT imaging
ROP vascular severity scoreUp to 9 months corrected ageScale of 1-9 based on retinal vessel dilation and tortuosity
ROP severity as determined by clinical examUp to 9 months corrected ageClinical determination of the presence and/or severity of retinal vessel tortuosity, aggressive ROP, extra retinal neovascularization, shunt vessels, vitreous opacities, vitreous haze, retinoschisis and retinal detachment
ROP severity as determined by retinal photo readingUp to 9 months corrected agePresence and/or severity of retinal vessel tortuosity, aggressive ROP, extra retinal neovascularization, shunt vessels, vitreous opacities, vitreous haze, retinoschisis and retinal detachment as determined by fundus photograph grading
ROP severity as determined by OCT readingUp to 9 months corrected agePresence and/or severity of: retinal vessel tortuosity, vascular abnormality score by OCT (VASO), aggressive ROP, extra retinal neovascularization, vitreous abnormalities, shunt vessels,retinoschisis and retinal detachment as determined by OCT grading.

Countries

United States

Contacts

CONTACTXi Chen, MD
xi2.chen@duke.edu919-684-8434
CONTACTMichelle N McCall, MCAPM, BA
michelle.mccall@duke.edu919-684-0544
PRINCIPAL_INVESTIGATORXi Chen, MD

Duke University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 18, 2026