Imaging Retinal Vasculature in Infant Eyes

Study Overview
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Brief Summary
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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.

Official Title
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Elucidating Perifoveal Vasculature Development in Infants

Conditions
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Retinopathy of Prematurity

Intervention / Treatment
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* Device: Handheld Optical Coherence Tomography with OCT Angiography


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Maximum Age: 2 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br>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<br>* 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.<br>* Other names: Handheld OCT and OCTA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Retinopathy of Prematurity, Optical Coherence Tomography, Perifoveal vasculature, Vascular development, Macular edema, ROP, OCT, Prematurity, Optical Coherence Tomography Angiography, OCTA