Retinopathy of Prematurity (ROP)(BabySTEPS3)NCT07738874
Analyzing Retinal Microanatomy in Retinopathy of Prematurity to Improve Care
A study testing Ultra-widefield Optical Coherence Tomography (UWF-OCT) and Wide-field ophthalmic imaging system in people with Retinopathy of Prematurity (ROP), run by Duke University at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 0 days to 9 months
- Conditions the study is for
- Retinopathy of Prematurity (ROP)
- What is being tested?
- Ultra-widefield Optical Coherence Tomography (UWF-OCT) and Wide-field ophthalmic imaging system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Dec 2026to 31 Dec 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 days to 9 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 1 recruiting
- Recruiting
Duke University Eye Center
Durham, North Carolina, 27705
Xi Chen, MD, PhD, 919-684-8434, xi2.chen@duke.edu
Michelle N McCall, MCAPM, BA, 919-684-0544, michelle.mccall@duke.edu
- Active, not recruiting
University of Pennsylvania, Center for Preventive Ophthalmology and Biostatistics
Philadelphia, Pennsylvania, 19104
About this study
Official title: Analyzing Retinal Microanatomy in Retinopathy of Prematurity to Improve Care 3 (BabySTEPS3)
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.
Read the 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.
- Conditions
- Retinopathy of Prematurity (ROP)
- Being tested
- Ultra-widefield Optical Coherence Tomography (UWF-OCT), Wide-field ophthalmic imaging system
- 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
- Medical subject headings
- Retinopathy of Prematurity, Premature Birth, Eye Diseases, Retinal Diseases, Obstetric Labor, Premature, Obstetric Labor Complications, Pregnancy Complications, Infant, Premature, Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultra-widefield Optical Coherence Tomography (UWF-OCT)Device
Also called optical coherence tomography
Handheld retinal OCT imaging at the bedside or in clinic with an ultra-widefield handheld optical coherence tomography
Wide-field ophthalmic imaging systemDevice
Handheld wide-field ophthalmic fundus imaging at the bedside or in clinic
| Study group | Role | What they receive |
|---|---|---|
| Test bedside UWF-OCT versus bionocular indirect ophthalmoscopic exam to identify RW-ROP and TR-ROP | Experimental | 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. Receives: Device: Ultra-widefield Optical Coherence Tomography (UWF-OCT) |
| Test bedside UWF-OCT versus fundus photos to identify RW-ROP and TR-ROP | Experimental | 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. Receives: Device: Ultra-widefield Optical Coherence Tomography (UWF-OCT); Device: Wide-field ophthalmic imaging system |
| Test UWF-OCT versus binocular indirect ophthalmoscopic exam to characterize ROP regression | Experimental | 45 infants treated for ROP: Compare OCT measures to clinical findings of ROP regression and identify early signs of ROP reactivation. Receives: Device: Ultra-widefield Optical Coherence Tomography (UWF-OCT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: Up to 60 weeks post-menstrual age
Secondary outcomes (6)
Retinal thickness at the fovea and surrounding optic nerve as measured by OCT reading
Retinal thickness (microns) at the fovea and surrounding optic nerve.
Measured: 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
Measured: Up to 60 weeks post-menstrual age
ROP vascular severity score
Scale of 1-9 based on retinal vessel dilation and tortuosity
Measured: 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
Measured: 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
Measured: 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.
Measured: Up to 9 months corrected age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start1 Dec 2026 (estimated)
- Primary completion30 Jun 2031 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinopathy of Prematurity (ROP)Studies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 175 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pennsylvania, National Eye Institute (NEI)
- Responsible party
- Sponsor
- Investigators
- Xi Chen, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07738874
- Sponsor's protocol ID
- Pro00120254
- Other IDs
- R01EY025009
- Acronym
- (BabySTEPS3)
- Status last verified
- Sep 2026
- First submitted
- 27 Jul 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analyzing Retinal Microanatomy in Retinopathy of Prematurity to Improve Care 3 (BabySTEPS3)
- ClinicalTrials.gov ID
- NCT07738874
- Acronym / sponsor ID
- (BabySTEPS3) / Pro00120254
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 175 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- University of Pennsylvania, National Eye Institute (NEI)
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 30 Jun 2031 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 31 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test bedside UWF-OCT versus bionocular indirect ophthalmoscopic exam to identify RW-ROP and TR-ROP | Experimental | Device: Ultra-widefield Optical Coherence Tomography (UWF-OCT)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. |
| Test bedside UWF-OCT versus fundus photos to identify RW-ROP and TR-ROP | Experimental | Device: Ultra-widefield Optical Coherence Tomography (UWF-OCT), Device: Wide-field ophthalmic imaging system455 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 | Experimental | Device: Ultra-widefield Optical Coherence Tomography (UWF-OCT)45 infants treated for ROP: Compare OCT measures to clinical findings of ROP regression and identify early signs of ROP reactivation. |
Who may qualify
- Ages
- 0 days to 9 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultra-widefield Optical Coherence Tomography (UWF-OCT)Also: optical coherence tomographyHandheld retinal OCT imaging at the bedside or in clinic with an ultra-widefield handheld optical coherence tomography | Device | Test UWF-OCT versus binocular indirect ophthalmoscopic exam to characterize ROP regression, Test bedside UWF-OCT versus bionocular indirect ophthalmoscopic exam to identify RW-ROP and TR-ROP, Test bedside UWF-OCT versus fundus photos to identify RW-ROP and TR-ROP |
| Wide-field ophthalmic imaging systemHandheld wide-field ophthalmic fundus imaging at the bedside or in clinic | Device | Test bedside UWF-OCT versus fundus photos to identify RW-ROP and TR-ROP |
Primary outcome
Sensitivity and specificity of ultra-widefield OCT vs bionocular indirect ophthalmoscopy or fundus photograph to identify referral-warranted retinopathy of prematurity
Time frame: Up to 60 weeks post-menstrual age
OCT markers that determine the presence or absence of referral-warranted retinopathy of prematurity.
Measurement of infant stress
Time frame: Up to 60 weeks post-menstrual age
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)
6 secondary outcomes
Retinal thickness at the fovea and surrounding optic nerve as measured by OCT reading
Time frame: Up to 9 months corrected age
Artificial Intelligence algorithms to classify ROP
Time frame: Up to 60 weeks post-menstrual age
ROP vascular severity score
Time frame: Up to 9 months corrected age
ROP severity as determined by clinical exam
Time frame: Up to 9 months corrected age
ROP severity as determined by retinal photo reading
Time frame: Up to 9 months corrected age
ROP severity as determined by OCT reading
Time frame: Up to 9 months corrected age
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: 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.
Related trials for Retinopathy of Prematurity (ROP)
RecruitingObservational study
An Observational Study to Collect Data on How Aflibercept (Eylea) Given Using a Paediatric Dosing Device is Used in Preterm Babies With Retinopathy of Prematurity in the United Kingdom (UK)
Retinopathy of Prematurity, Preterm Infants
RecruitingObservational study
The Correlation Between Red Cell Transfusion and Complications of Prematurity
Retinopathy of Prematurity (ROP), Bronchopulmonary Dysplasia (BPD)
RecruitingObservational study
Imaging Retinal Vasculature in Infant Eyes
Retinopathy of Prematurity
RecruitingPhase 1
Safety, PK and PD of FLQ-101 in Premature Neonates
Retinopathy of Prematurity (ROP)
RecruitingObservational study
Point-of-Care Ophthalmic Diagnostic Imaging of Retinopathy of Prematurity
Retinopathy of Prematurity (ROP), ROP Examination
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xi Chen, MD principal investigator
Duke University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultra-widefield Optical Coherence Tomography (UWF-OCT) and Wide-field ophthalmic imaging system in people with Retinopathy of Prematurity (ROP), run by Duke University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xi Chen, MD (919-684-8434, xi2.chen@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of ultra-widefield OCT vs bionocular indirect ophthalmoscopy or fundus photograph to identify referral-warranted retinopathy of prematurity (time frame: Up to 60 weeks post-menstrual age). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.