Ocular Blood Flow Imaging for Glaucoma Assessment

ConditionGlaucoma

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-88

SponsorUniversity of Maryland, Baltimore

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

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.

Treatment groups

150 Participants

are divided into 3 treatment groups

Group A: ControlOther 1 intervention

Group B: GlaucomaOther 1 intervention

Group C: Pre-perimetric GlaucomaOther 1 intervention

Trial outcomes

Primary outcomes

Blood flow velocity measure

Dynamic video of ocular blood flow

Time frame

through study completion, an average of 1 year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Maryland, Baltimore

Lead sponsor

National Eye Institute (NEI)

Collaborator

Vasoptic Medical, Inc

Collaborator

Source ClinicalTrials.gov

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