RecruitingPhase 4NCT05344274

Retinal Blood Flow and Autoregulation

Direct Measures of Retinal Blood Flow and Autoregulation as Robust Biomarkers for Early Glaucoma


Sponsor

University of Maryland, Baltimore

Enrollment

90 participants

Start Date

May 23, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 88 Years

Plain Language Summary

Simplified for easier understanding

This study is measuring blood flow in the retina and examining the eye's ability to automatically regulate that blood flow in people with early glaucoma, pre-glaucoma (glaucomatous optic nerve damage without vision loss yet), or healthy eyes, to better understand how blood flow changes relate to vision loss. **You may be eligible if...** - You are 18 years or older - You have an open-angle structure in your eye (grade 3 or 4) - Your prescription is between -8.00 and +3.00 diopters - Your best-corrected vision is 20/25 or better - You fall into one of these categories: early glaucoma, pre-perimetric glaucoma (nerve damage without visual field loss), or healthy eyes **You may NOT be eligible if...** - You are on glaucoma medications and unwilling to pause them for 4 weeks - You have other significant eye conditions - You do not meet the vision or prescription criteria Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTIndocyanine Green Angiography

Erythrocyte Mediated Angiography with indocyanine green as well as conventional indocyanine green angiography will be conducted to determine retinal blood flow

BIOLOGICALIsocapnic Oxygen

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.

DIAGNOSTIC_TESTOcular Imaging with Optical Coherence Tomography (OCT) and Adaptive Optics (AO)

Investigators will image subjects with OCT as well as AO technology to determine retinal ganglion cell density, vessel density, and vessel flowrates


Locations(4)

University of Maryland Faculty Physicians, Inc

Baltimore, Maryland, United States

University of Maryland Medical Center

Baltimore, Maryland, United States

University of Maryland, Baltimore

Baltimore, Maryland, United States

Food and Drug Administration (FDA)

Silver Spring, Maryland, United States

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NCT05344274


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