Analyzing Retinal Microanatomy in Retinopathy of Prematurity to Improve Care

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-9
SponsorDuke University

About this trial

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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

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 design

Treatments tested in this trial

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

Treatment groups

175 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Duke University

Lead sponsor

University of Pennsylvania

Collaborator

National Eye Institute (NEI)

Collaborator