RECRUITING Not applicable ClinicalTrials.gov

Analyzing Retinal Microanatomy in Retinopathy of Prematurity to Improve Care

Sponsor: Duke University • ClinicalTrials.gov ID: NCT07738874

Registry updated: 2026-09-17

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Description

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.

Interventions

Ultra-widefield Optical Coherence Tomography (UWF-OCT) (Device)
Handheld retinal OCT imaging at the bedside or in clinic with an ultra-widefield handheld optical coherence tomography
Wide-field ophthalmic imaging system (Device)
Handheld wide-field ophthalmic fundus imaging at the bedside or in clinic

Eligibility criteria

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)

Conditions

Retinopathy of Prematurity (ROP)

Locations

Duke University Eye Center — Durham, North Carolina, United States
University of Pennsylvania, Center for Preventive Ophthalmology and Biostatistics — Philadelphia, Pennsylvania, United States

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record

Accelerate Your Clinical Trial Recruitment