Ocular Blood Flow Imaging for Glaucoma Assessment

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
University of Maryland, Baltimore
Study ID
NCT05726058
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 88 Years
Healthy Volunteers
Accepted

Interventions

  • XyCAM with oxygen — DEVICE
    After the standard imaging protocols, participants will be asked to inhale 100% oxygen through a mask and will be re-imaged using the XyCAM RI or XyCAM FC.

Study Details

The goal of this clinical trial is to investigate the use of an FDA-cleared retinal blood flow imaging instrument called the XyCAM RI and XyCAM FC (Vasoptic Medical, Inc., Columbia, MD) in glaucoma management. The main question it aims to answer are: * Can the investigators use blood flow to discriminate between eyes with early-stage glaucoma and variable-matched controls? * Can the investigators validate that the XyCAM FC simultaneously captures both stereo fundus photography and ocular blood flow monitoring? Participants will be * measured for their blood pressure, heart rate, height, and weight * dilated with tropicamide * imaged using the XyCAM RI, fundus photography, optical coherence tomography, and standard automated perimetry * imaged using the XyCAM RI while inhaling 100% oxygen through a mask

Key Dates

Start date
Mar 30, 2023
Status verified
Mar 2025
Primary completion
Dec 31, 2026
Completion
Apr 30, 2027

Study Design

Enrollment
150 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Other: Control
    All control participants will be first be imaged pre-intervention.
  • Other: Glaucoma
    All participants with glaucoma will be first be imaged pre-intervention.
  • Other: Pre-perimetric Glaucoma
    All participants with pre-perimetric glaucoma will be first be imaged pre-intervention.

Primary Outcome Measure

Blood flow velocity measure [ Time Frame: through study completion, an average of 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Maryland Eye Associates at RedwoodBaltimoreMaryland21201
Osamah Saeedi, MD, MS

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