Dynamic Alterations in Blood Flow in Glaucoma Measured with Laser Speckle Contrast Imaging.
Alfred Vinnett, Jayanth Kandukuri, Christopher Le...
https://pubmed.ncbi.nlm.nih.gov/34673279Actively Recruiting
Phase Not Applicable
Age: 18Years - 88Years
All Genders
Healthy Volunteers
ID05726058
Ocular Blood Flow Imaging for Glaucoma Assessment
Led by University of Maryland, Baltimore · Updated on 2025-03-28
150
Participants Needed
1
Research Sites
17 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 XyCAM RI and XyCAM FC devices for retinal blood flow imaging in managing glaucoma. The main goals are to determine if blood flow measurements can distinguish early-stage glaucoma eyes from matched controls and to validate that the XyCAM FC can simultaneously capture stereo fundus photos and blood flow monitoring. Participants will receive pupil dilation with eye drops before undergoing imaging tests using the XyCAM RI or XyCAM FC devices and standard clinical tools including color fundus photography, optical coherence tomography, and standard automated perimetry. Some tests involve inhaling 100% oxygen while being imaged with the XyCAM devices. The total testing time includes about 80 minutes for the XyCAM sessions plus 60 minutes for the standard imaging. Throughout the study, participants will have measurements of blood pressure, heart rate, height, and weight taken. The main outcome measured is blood flow velocity, tracked for about one year. Participants include healthy controls and those with glaucoma or pre-perimetric glaucoma. The study is non-randomized and includes ongoing monitoring of imaging results and physiological data during visits.
CONDITIONS
Brief Title
Ocular Blood Flow Imaging for Glaucoma Assessment
Who Can Participate
Age: 18Years - 88Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Age 18 and older with binocular vision
- Able to provide informed consent
- Healthy control or recommended for glaucoma assessment
- Diagnosed with moderate to severe glaucoma in at least one eye as determined by Hodapp Anderson Criteria
You will not qualify if you...
- Significant media opacity such as a visually significant cataract or corneal scar
- Previous ocular surgery other than 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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Less than 3 hours on the imaging day
Participants undergo imaging of the retina using the XyCAM RI or XyCAM FC device and routine clinical instruments after pupil dilation with Tropicamide to assess ocular blood flow and glaucoma status.
1 imaging visit (in-person)
Long-term Monitoring
Duration - Up to 1 year
Participants are monitored for blood flow velocity measures for up to one year following the imaging assessments.
Follow-up visits as scheduled for up to 1 year
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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