Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R01EY03413401 | Other Grant/Funding Number | National Eye Institute |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Pennsylvania | OTHER |
| National Institutes of Health (NIH) | NIH |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Handheld Optical Coherence Tomography with OCT Angiography | Device | 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. |
| 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) |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Preterm infants undergoing screening for retinopathy of prematurity
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xi Chen, MD | Contact | (919) 684-8434 | xi2.chen@duke.edu | |
| Michelle N McCall | Contact | (919) 684-0544 | michelle.mccall@duke.edu |
| Name | Affiliation | Role |
|---|---|---|
| Xi Chen, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University | Recruiting | Durham | North Carolina | 27710 | United States |
The Elucidating Perifoveal Vascular Development in Infants study data cannot be analyzed for publication until they are released by the study Principal Investigator upon final review and approval by the Data Safety and Monitoring Committee.
Data will be made available as follows:
Approved recipients will need to enter into a data sharing agreement. Costs for compilation and access to the datasets will be the responsibility of the recipients.
Data will be made available after the completion of the study.
Data requests must be submitted to the PI or the Statistical Analysis Center. Approved recipients will need to enter into a data sharing agreement.
Costs for compilation and access to the datasets will be the responsibility of the recipients.
Not provided
Not provided
| ID | Term |
|---|---|
| D012178 | Retinopathy of Prematurity |
| D008269 | Macular Edema |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D007235 | Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
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) |
| University of Pennsylvania | Not yet recruiting | Philadelphia | Pennsylvania | 19104 | United States |
|
| D009358 |
| Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |