An interventional study of Ultra-widefield Optical Coherence Tomography (UWF-OCT) and Wide-field ophthalmic imaging system in Retinopathy of Prematurity (ROP), sponsored by Duke University. Recruiting at 2 sites in United States. Open to participants aged 0 Days to 9 Months. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by Duke University · Not applicable, Interventional, and Other
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.
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.
169 studies on the registry are indexed under Retinopathy of Prematurity; 27 are open to participants now.
This study's planned enrollment of 175 is above the median of 82 across 102 interventional studies indexed under Retinopathy of Prematurity.
Browse Retinopathy of Prematurity studies →Duke University is the lead sponsor of 2,063 studies on the registry; 273 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 167 (82%) have results posted.
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Exclusion Criteria:
175 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.
Device: Ultra-widefield Optical Coherence Tomography (UWF-OCT)
455 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.
Device: Ultra-widefield Optical Coherence Tomography (UWF-OCT) · Device: Wide-field ophthalmic imaging system
45 infants treated for ROP: Compare OCT measures to clinical findings of ROP regression and identify early signs of ROP reactivation.
Device: Ultra-widefield Optical Coherence Tomography (UWF-OCT)
Handheld retinal OCT imaging at the bedside or in clinic with an ultra-widefield handheld optical coherence tomography
Also known as: optical coherence tomography
Handheld wide-field ophthalmic fundus imaging at the bedside or in clinic
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.
Time frame: 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)
Time frame: Up to 60 weeks post-menstrual age
Retinal thickness at the fovea and surrounding optic nerve as measured by OCT reading
Retinal thickness (microns) at the fovea and surrounding optic nerve.
Time frame: Up to 9 months corrected age
Artificial Intelligence algorithms to classify ROP
Development of clinician-in-the-loop AI-based ROP classification algorithm for OCT imaging
Time frame: Up to 60 weeks post-menstrual age
ROP vascular severity score
Scale of 1-9 based on retinal vessel dilation and tortuosity
Time frame: Up to 9 months corrected age
ROP severity as determined by clinical exam
Clinical 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
Time frame: Up to 9 months corrected age
ROP severity as determined by retinal photo reading
Presence 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
Time frame: Up to 9 months corrected age
ROP severity as determined by OCT reading
Presence 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.
Time frame: Up to 9 months corrected age
Not enrolling at this site.
Plan to share: Yes — 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.
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.
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Jun 2031, 54 months later.
Of 28 non-industry interventional studies with no phase under Retinopathy of Prematurity, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 31. This study's planned 54 months is above that.
Counting every sponsor, half of 30 studies reached it within 14 months; a quarter within 11 and three quarters within 31.
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