Status:
RECRUITING
Ocular Blood Flow Imaging for Glaucoma Assessment
Lead Sponsor:
University of Maryland, Baltimore
Collaborating Sponsors:
National Eye Institute (NEI)
Vasoptic Medical, Inc
Conditions:
Glaucoma
Eligibility:
All Genders
18-88 years
Phase:
NA
Brief 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 ma...
Detailed Description
The investigators will capture images of the participant's retina using the XyCAM RI or XyCAM FC ("test data") and by color fundus photography, optical coherence tomography (OCT), and standard automat...
Eligibility Criteria
Inclusion
- Age 18 and older with binocular vision
- Able to provide informed consent
- Patient is a healthy control OR is recommended for glaucoma assessment OR diagnosed with moderate to severe glaucoma in at least one eye as determined by Hodapp Anderson Criteria
Exclusion
- The subject has significant media opacity (e.g., a visually significant cataract or significant corneal scar)
- The subject has previous ocular surgery other than uncomplicated cataract extraction, laser trabeculoplasty (ALT or SLT), or YAG capsulotomy
- The subject has prior ocular disease other than glaucoma
- The subject has anatomically narrow angles or a prior adverse reaction to administration of Tropicamide or fluorescein dye
- The subject has more than 15 diopters of refractive error
- The subject is a female who is pregnant or nursing
- The subject has diabetes mellitus
Key Trial Info
Start Date :
March 30 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2027
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT05726058
Start Date
March 30 2023
End Date
April 30 2027
Last Update
March 28 2025
Active Locations (1)
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1
University of Maryland Eye Associates at Redwood
Baltimore, Maryland, United States, 21201