Imaging Retinal Vasculature in Infant Eyes

Sponsor

Duke University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05558059

Collaborator

University of Pennsylvania (Other), National Institutes of Health (NIH) (NIH)

Enrollment

Locations

Anticipated Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Retinopathy of Prematurity	Device: Handheld Optical Coherence Tomography with OCT Angiography

Study Design

Study Type:

Observational

Anticipated Enrollment :

16 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Elucidating Perifoveal Vasculature Development in Infants

Anticipated Study Start Date :

Dec 31, 2022

Anticipated Primary Completion Date :

Aug 31, 2027

Anticipated Study Completion Date :

Aug 31, 2027

Arms and Interventions

Arm	Intervention/Treatment
Cohort 1 16 preterm infants undergoing ROP screening to optimize methods to acquire and process beside infant perifoveal vascular imaging and assess rigor and reproducibility. The visits in the ICN (Intensive Care Nursery) will occur between 32 and 43 weeks post menstrual age at the time of ROP screening exams. Study visits will include, but are not limited to: Ocular examination OCT imaging of retinal microanatomy OCTA imaging of retinal microvasculature Medical and ocular history Adverse event documentation	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. Other Names: Handheld OCT and OCTA

Arm

Intervention/Treatment

Cohort 1

16 preterm infants undergoing ROP screening to optimize methods to acquire and process beside infant perifoveal vascular imaging and assess rigor and reproducibility. The visits in the ICN (Intensive Care Nursery) will occur between 32 and 43 weeks post menstrual age at the time of ROP screening exams. Study visits will include, but are not limited to: Ocular examination OCT imaging of retinal microanatomy OCTA imaging of retinal microvasculature Medical and ocular history Adverse event documentation

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.

Other Names:

Handheld OCT and OCTA

Outcome Measures

Primary Outcome Measures

Change in vascular density of intermediate and deep vascular plexus at the fovea and perifovea [During hospitalization (at approximately 32-44 weeks post menstrual age, PMA)]
Measured by retinal OCTA imaging.

Secondary Outcome Measures

Change in vascular density of superficial vascular plexus at the fovea and perifovea [During hospitalization (at approximately 32-44 weeks post menstrual age, PMA)]
Measured by retinal OCTA imaging.
Change in avascular zone size of superficial, intermediate and deep vascular plexus [During hospitalization (at approximately 32-44 weeks post menstrual age, PMA)]
Measured by retinal OCTA imaging.
Change in network length of intermediate and deep vascular plexus [During hospitalization (at approximately 32-44 weeks post menstrual age, PMA)]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 2 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)