Retinal Blood Flow and Autoregulation
Part of paid clinical trials in Baltimore, Maryland.
- Sponsor
- University of Maryland, Baltimore
- Study ID
- NCT05344274
- Phase
- PHASE4
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 88 Years
- Healthy Volunteers
- Accepted
Interventions
- Indocyanine Green Angiography — DIAGNOSTIC_TESTErythrocyte Mediated Angiography with indocyanine green as well as conventional indocyanine green angiography will be conducted to determine retinal blood flow
- Isocapnic Oxygen — BIOLOGICALInvestigators will evaluate retinal blood flow (RBF) in response to oxygen supplementation at a constant level of carbon dioxide (isocapnic hyperoxia) to isolate the vascular autoregulatory response to oxygen.
- Ocular Imaging with Optical Coherence Tomography (OCT) and Adaptive Optics (AO) — DIAGNOSTIC_TESTInvestigators will image subjects with OCT as well as AO technology to determine retinal ganglion cell density, vessel density, and vessel flowrates
Study Details
The purpose of this study is to establish autoregulation of retinal blood flow in arterioles and capillaries as a biomarker for early primary open angle glaucoma.
Key Dates
- Start date
- May 23, 2022
- Status verified
- Nov 2025
- Primary completion
- Sep 30, 2027
- Completion
- Sep 30, 2027
Study Design
- Enrollment
- 90 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- DIAGNOSTIC
Arms
- Experimental: Isocapnic OxygenInvestigators will evaluate retinal blood flow in response to oxygen supplementation.
Primary Outcome Measure
Autoregulation of retinal blood flow [ Time Frame: 3 years ]
Central Contacts
- Osamah Saeedi, MD, MS(410) 328-5929
Locations (4)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Maryland Faculty Physicians, Inc | Baltimore | Maryland | 21201 | - |
| University of Maryland Medical Center | Baltimore | Maryland | 21201 | - |
| University of Maryland, Baltimore | Baltimore | Maryland | 21201 | - |
| Food and Drug Administration (FDA) | Silver Spring | Maryland | 20903 | - |
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