Recruiting

Ocular Blood Flow

Sponsor:

University of Maryland, Baltimore

Code:

NCT05726058

Conditions

Glaucoma

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

XyCAM with oxygen

Study Details

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 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

Conditions

Glaucoma

Study ID

NCT05726058

Start date

Mar 30, 2023

Status verified date

Jun, 2026

Completion date

Apr 30, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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 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 (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

Study Design

Enrollment

150 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

other: Control

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

other: Glaucoma

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

other: Pre-perimetric Glaucoma

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

Interventions

XyCAM 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.

Primary outcome measure

  • Blood flow velocity measure [ Time Frame: through study completion, an average of 1 year ]

Central Contacts and Locations

Central contacts

Osamah J Saeedi, MD, MS

(410) 328-5929osaeedi@som.umaryland.edu

Locations

University of Maryland Eye Associates at Redwood

Recruiting

Baltimore, Maryland, United States, 21201

More Information

Sponsor

University of Maryland, Baltimore

Last update posted

Jul 2, 2026

Last verified

Jun, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by University of Maryland, Baltimore on 2026-07-02. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.