Actively Recruiting

Phase Not Applicable
Age: 18Years - 88Years
All Genders
Healthy Volunteers
ID05726058

Ocular Blood Flow Imaging Study Using XyCAM for Glaucoma Assessment and Management

Led by University of Maryland, Baltimore · Updated on 2025-03-28

150

Participants Needed

1

Research Sites

213 weeks

Total Duration

On this page

Sponsors

U

University of Maryland, Baltimore

Lead Sponsor

N

National Eye Institute (NEI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to evaluate the use of the FDA-cleared retinal blood flow imaging instruments XyCAM RI and XyCAM FC in managing glaucoma. The study focuses on whether blood flow measurements can distinguish between eyes with early-stage glaucoma and matched controls, and whether the XyCAM FC can simultaneously capture stereo fundus photography and monitor ocular blood flow. Participants include healthy controls, those recommended for glaucoma assessment, and patients diagnosed with moderate to severe glaucoma. Participants will undergo multiple imaging tests including those with the XyCAM RI or XyCAM FC devices to capture retinal images and blood flow data. Standard clinical imaging such as color fundus photography, optical coherence tomography, and standard automated perimetry will also be performed. Eye drops (Tropicamide) will be used to dilate pupils before imaging sessions. After standard imaging, participants will inhale 100% oxygen through a mask and be re-imaged using the XyCAM devices to assess changes. During the study, participants will have measurements taken for blood pressure, heart rate, height, and weight. Various imaging sessions will be conducted, lasting about 80 minutes for test data and an additional 60 minutes for standard clinical data. The main outcome measured is the blood flow velocity in the retina over approximately one year. This detailed monitoring aims to provide insights into glaucoma assessment and management.

CONDITIONS

Official Title

Ocular Blood Flow Imaging for Glaucoma Assessment

Who Can Participate

Age: 18Years - 88Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 and older with binocular vision
  • Able to provide informed consent
  • Participant is a healthy control OR recommended for glaucoma assessment OR diagnosed with moderate to severe glaucoma in at least one eye as determined by Hodapp Anderson Criteria
Not Eligible

You will not qualify if you...

  • Significant media opacity such as a visually significant cataract or corneal scar
  • Previous ocular surgery except uncomplicated cataract extraction, laser trabeculoplasty (ALT or SLT), or YAG capsulotomy
  • Prior ocular disease other than glaucoma
  • Anatomically narrow angles or prior adverse reaction to Tropicamide or fluorescein dye
  • More than 15 diopters of refractive error
  • Female who is pregnant or nursing
  • Diabetes mellitus

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Maryland Eye Associates at Redwood

Baltimore, Maryland, United States, 21201

Actively Recruiting

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Research Team

O

Osamah J Saeedi, MD, MS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

3

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Published Research Related To This Trial