ClinicalTrials.gg
RecruitingNCT05726058Updated Jul 2, 2026

Ocular Blood Flow Imaging for Glaucoma Assessment

An interventional study of XyCAM with oxygen in Glaucoma, sponsored by University of Maryland, Baltimore. Recruiting at 1 site in United States. Open to participants aged 18 Years to 88 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-02.

Sponsored by University of Maryland, Baltimore · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Started Mar 2023; still recruiting 3 years 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Non-randomized
Ages
18 Years to 88 Years
Sex
All
01

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
Read the 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 automated perimetry (SAP) - the "standard clinical data". The investigators will perform five tests. The first two tests will be conducted using the XyCAM RI or XyCAM FC to obtain "test data". The final two tests will be conducted using routine clinical instruments to obtain "standard clinical data". The investigators will administer eye drops (Tropicamide) to dilate the participant's pupils prior to the first test. Tropicamide is a chemical that causes pupil dilation and is commonly used by doctors to examine the participant's eyes. The entire set of test data sessions should last less than eighty (80) minutes with an additional 60 minutes for carrying out the necessary procedures and imaging using the standard clinical data.

02

Conditions studied

  • Glaucoma

Keywords

  • glaucoma
  • xycam
  • blood flow
  • imaging
  • ophthalmology
  • retinal blood flow
  • eye disease
03

In context

Glaucoma

1,419 studies on the registry are indexed under Glaucoma; 223 are open to participants now.

This study's planned enrollment of 150 is above the median of 61 across 964 interventional studies indexed under Glaucoma.

Browse Glaucoma studies →

Lead sponsor

University of Maryland, Baltimore is the lead sponsor of 700 studies on the registry; 132 are open to participants now.

Of its 92 completed or terminated interventional studies of FDA-regulated products, 66 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 88 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 18 and older with binocular vision
  • Able to provide
  • 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 criteria

Exclusion Criteria:

  • 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 ( 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
150 participants (estimated)

Study arms

  • Other
    Control

    All control participants will be first be imaged pre-intervention.

    Device: XyCAM with oxygen

  • Other
    Glaucoma

    All participants with glaucoma will be first be imaged pre-intervention.

    Device: XyCAM with oxygen

  • Other
    Pre-perimetric Glaucoma

    All participants with pre-perimetric glaucoma will be first be imaged pre-intervention.

    Device: XyCAM with oxygen

Interventions

  • DeviceXyCAM 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.

06

What researchers measure

Primary outcomes

  1. Blood flow velocity measure

    Dynamic video of ocular blood flow

    Time frame: through study completion, an average of 1 year

07

Study locations

1 of 1 sites recruiting
  • University of Maryland Eye Associates at Redwood
    Baltimore, Maryland 21201, United States
    Recruiting
    • Osamah Saeedi, MD, MS · Contact
08

References and documents

Publications

  • Vinnett A, Kandukuri J, Le C, Cho KA, Sinha A, Asanad S, Thompson G, Chen V, Rege A, Saeedi OJ. Dynamic Alterations in Blood Flow in Glaucoma Measured with Laser Speckle Contrast Imaging. Ophthalmol Glaucoma. 2022 May-Jun;5(3):250-261. doi: 10.1016/j.ogla.2021.10.005. Epub 2021 Oct 18. PubMed 34673279 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05726058
Collaborators
National Eye Institute (NEI), Vasoptic Medical, Inc
Responsible party
Osamah Saeedi (Professor, University of Maryland, Baltimore) — Principal investigator
First posted
Feb 13, 2023
Start date
Mar 30, 2023
Primary completion
Dec 31, 2027 (estimated)
Completion
Apr 30, 2028 (estimated)
Last update
Jul 2, 2026

Study contacts

Osamah J Saeedi, MD, MS
Contact
osaeedi@som.umaryland.edu
(410) 328-5929
Grace Forbes, MS
study director · University of Maryland, Baltimore

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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