Analyzing Retinal Microanatomy in ROP
Completed
Conditions studied: Retinopathy of Prematurity, Neurodevelopmental Disorders, Macular Edema
In brief
Retinopathy of prematurity (ROP) is a disorder of development of the neural retina and its vasculature that may impact vision in vulnerable preterm neonates for a lifetime. This study utilizes new technology to determine visual and neurological development of very preterm infants in the intensive care nursery, during a period of rapid growth of the retina, optic nerve and brain. The long-term goal of this study is to help improve preterm infant health care via objective bedside imaging and analysis that characterizes early critical indicators of poor vision, neurological development and ROP, which will rapidly translate to better early intervention and improved future vision care.
Key facts
- Study ID
- NCT02887157
- Run by
- Duke University
- People needed
- 191
- Starts
- 2016-07-22
- Expected to finish
- 2021-04-15
- Last updated by the study team
- 2023-02-10
Who can join
Age: 1 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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 with likelihood of follow up at standard of care visits at approximately 1-month, 4-months, 9-months and 2 years corrected age
- Infant/child undergoing clinically indicated examination under anesthesia (for the testing of the custom widefield OCT lens) that may or may not have eye pathology. (Only for Aim 1)
- Infant meets the American Association of Pediatrics eligibility of ROP screening (Infants with a birth weight of ≤1500 g or gestational age of 30 weeks), and is age ≤ 34 6/7 weeks postmenstrual age at first visit
- Adults (over the age of 18 years) that may or may not have eye pathology (Only for Aim *Participants in Aim 3 will not have a brain MRI, collection of scavenged blood for neuroinflammatory markers, or the neurodevelopmental 2-year visit.
You may not qualify if…
- Participant or Parent/Legal Guardian (of infant/child) 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 Peters anomaly or cataract)
- Infant has a health condition, other than prematurity, that has a profound impact on brain development (e.g. anencephaly). Note that infants with brain hemorrhages and sequelae would be eligible.
Where it is running
- University of Florida — Gainesville, Florida, United States
- Washington University — St Louis, Missouri, United States
- Duke University Eye Center — Durham, North Carolina, United States
- University of Pennsylvania — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.