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Analyzing Retinal Microanatomy in Retinopathy of Prematurity to Improve Care

RecruitingNAAges 0 Days - 9 MonthsAllDuke University
NCT07738874 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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)
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What it tests

  • Ultra-widefield Optical Coherence Tomography (UWF-OCT)
  • Wide-field ophthalmic imaging system
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Where

2 sites
Duke University Eye Center
Durham, United States
University of Pennsylvania, Center for Preventive Ophthalmology and Biostatistics
Philadelphia, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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