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Ocular Blood Flow Imaging for Glaucoma Assessment

NCT05726058 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-03-28

No results posted yet for this study

Summary

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

Conditions

Interventions

DEVICE

XyCAM with oxygen

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.

Sponsors & Collaborators

  • National Eye Institute (NEI)

    collaborator NIH

  • Vasoptic Medical, Inc

    collaborator UNKNOWN

  • University of Maryland, Baltimore

    lead OTHER

Principal Investigators

  • Grace Forbes, MS · University of Maryland, Baltimore

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
88 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-30
Primary Completion
2026-12-31
Completion
2027-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05726058 on ClinicalTrials.gov