Imaging Retinal Vasculature in Infant Eyes

Retinopathy of Prematurity Clinical Trial

Official title:

Elucidating Perifoveal Vasculature Development in Infants

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05558059
• Other study ID #: Pro00111105
• Secondary ID: 1R01EY03413401
• Status: Not yet recruiting
• Start date: August 2024
• Est. completion date: August 31, 2027

Study information

• Verified date: May 2024
• Source: Duke University
• Contact: Xi Chen, MD
• Phone: (919) 684-8434
• Email: xi2.chen[@]duke.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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. However, how these blood vessels form during development of the human fovea remains unclear. This research will advance our understanding of the fundamental knowledge of how the blood vessels around the fovea form in infants, and how they change in diseased states such as preterm birth or retinopathy of prematurity.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 16
• Est. completion date: August 31, 2027
• Est. primary completion date: August 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 2 Months

Eligibility

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 less than 34 6/7 weeks postmenstrual age at first visit

Exclusion Criteria:

• Participant or Parent/Legal Guardian unwilling or unable to provide consent

• 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)

Related Conditions & MeSH terms

• Premature Birth
• Retinal Diseases
• Retinopathy of Prematurity

Intervention

Device:
• Handheld Optical Coherence Tomography with OCT Angiography
OCT systems are in vivo optical imaging technology that allows non-contact imaging of early-stage ocular pathology. They create real-time, non-invasive images of ocular microstructure and have become standard-of-care instruments in ophthalmic imaging in clinics and operating rooms. In contrast to the visible light used in clinical eye examinations, because infrared light is not visible, the participant is not disturbed by the light. OCT imaging allows the capture of hundreds of B-scan (cross-sectional) images in seconds. These B-scans are analyzed for depth-resolved information and can also be stacked to create a volume and the stack may be summed up to create a retinal image. OCT angiography (OCTA) is an extension of the OCT systems, by taking images at the same location over time to extract retinal vascular flow information. It has been utilized to assess the ocular blood flow in many adult and pediatric patients.

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Duke University	National Institutes of Health (NIH), University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in vascular density of intermediate and deep vascular plexus at the fovea and perifovea	Measured by retinal OCTA imaging.	During hospitalization (at approximately 32-44 weeks post menstrual age, PMA)
Secondary	Change in vascular density of superficial vascular plexus at the fovea and perifovea	Measured by retinal OCTA imaging.	During hospitalization (at approximately 32-44 weeks post menstrual age, PMA)
Secondary	Change in avascular zone size of superficial, intermediate and deep vascular plexus	Measured by retinal OCTA imaging.	During hospitalization (at approximately 32-44 weeks post menstrual age, PMA)
Secondary	Change in network length of intermediate and deep vascular plexus	Vascular density of superficial vascular plexus at the fovea and perifovea; Avascular zone size of superficial, intermediate and deep vascular plexus; Network morphology of intermediate and deep vascular plexus; Network length of intermediate and deep vascular plexus.	During hospitalization (at approximately 32-44 weeks post menstrual age, PMA)