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_TEST
    Erythrocyte Mediated Angiography with indocyanine green as well as conventional indocyanine green angiography will be conducted to determine retinal blood flow
  • Isocapnic Oxygen — BIOLOGICAL
    Investigators 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_TEST
    Investigators 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 Oxygen
    Investigators will evaluate retinal blood flow in response to oxygen supplementation.

Primary Outcome Measure

Autoregulation of retinal blood flow [ Time Frame: 3 years ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
University of Maryland Faculty Physicians, IncBaltimoreMaryland21201-
University of Maryland Medical CenterBaltimoreMaryland21201-
University of Maryland, BaltimoreBaltimoreMaryland21201-
Food and Drug Administration (FDA)Silver SpringMaryland20903-

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