Not a traditional drug phase: Handheld Optical Coherence Tomography with OCT Angiography for Retinopathy of Prematurity
Retinopathy of prematurity is a leading cause of childhood blindness worldwide. The fovea, a critical location in the retina determining visual acuity and visual function, and the blood vessels around it, are abnormally developed in infants with retinopathy of prematurity.
Official registry: https://clinicaltrials.gov/study/NCT05558059 · Duke University · enrollment listed as 16
What this phase means
This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.
They plan to enroll about 16 people at 2 sites. Taking part typically means using or being fitted with a device plus check-ins.
Official title (unrewritten)
Elucidating Perifoveal Vasculature Development in Infants
Interventions: Handheld Optical Coherence Tomography with OCT Angiography
Primary outcome (registry wording): Change in vascular density of intermediate and deep vascular plexus at the fovea and perifovea
Who it is for (from inclusion criteria)
- Ages any to 2 Months
- 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 less than 34 6/7 weeks postmenstrual age at first visit
Who the registry excludes
- Infant 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)
Public study contact (from the registry)
Xi Chen, MD
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
2 listed- Duke University — Durham, North Carolina (recruiting)
- University of Pennsylvania — Philadelphi, Pennsylvania (not_yet_recruiting)
FAQ about this NCT record
Is NCT05558059 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT05558059?
Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT05558059?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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