Recruiting

Observational StudyAnalyzing Retinal Microanatomy in Retinopathy of Prematurity to Improve Care

Sponsor:

Duke University

Code:

NCT07738874

Conditions

Retinopathy of Prematurity (ROP)

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Ultra-widefield Optical Coherence Tomography (UWF-OCT)

Wide-field ophthalmic imaging system

Study Details

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.

Conditions

Retinopathy of Prematurity (ROP)

Study ID

NCT07738874

Start date

Dec 1, 2026

Status verified date

Sep, 2026

Completion date

Dec 31, 2031

Anticipated

Primary completion date

Jun 30, 2031

Anticipated

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

175 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Test bedside UWF-OCT versus bionocular indirect ophthalmoscopic exam to identify RW-ROP and TR-ROP

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.

experimental: Test bedside UWF-OCT versus fundus photos to identify RW-ROP and TR-ROP

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.

experimental: Test UWF-OCT versus binocular indirect ophthalmoscopic exam to characterize ROP regression

45 infants treated for ROP: Compare OCT measures to clinical findings of ROP regression and identify early signs of ROP reactivation.

Interventions

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

Wide-field ophthalmic imaging system

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

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 ]
Measurement of infant stress [ Time Frame: Up to 60 weeks post-menstrual age ]

Central Contacts and Locations

Central contacts

Xi Chen, MD

919-684-8434 xi2.chen@duke.edu

Michelle N McCall, MCAPM, BA

919-684-0544 michelle.mccall@duke.edu

Locations

Duke University Eye Center

Recruiting

Durham, North Carolina, United States, 27705

Contacts

Xi Chen, MD, PhD

919-684-8434 xi2.chen@duke.edu

Michelle N McCall, MCAPM, BA

919-684-0544 michelle.mccall@duke.edu

Principal Investigator:

Xi Chen, MD, PhD

More Information

Sponsor

Duke University

Last update posted

Sep 17, 2026

Last verified

Sep, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-18. This information was provided to ClinicalTrials.gov by Duke University on 2026-09-17.