NCT05726058

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
11mo left

Started Mar 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Mar 2023Apr 2027

First Submitted

Initial submission to the registry

December 12, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 13, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

March 30, 2023

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2027

Last Updated

March 28, 2025

Status Verified

March 1, 2025

Enrollment Period

3.8 years

First QC Date

December 12, 2022

Last Update Submit

March 24, 2025

Conditions

Glaucoma

Keywords

glaucomaxycamblood flowimagingophthalmologyretinal blood floweye disease

Outcome Measures

Primary Outcomes (1)

  • Blood flow velocity measure

    Dynamic video of ocular blood flow

    through study completion, an average of 1 year

Study Arms (3)

Control

OTHER

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

Device: XyCAM with oxygen

Glaucoma

OTHER

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

Device: XyCAM with oxygen

Pre-perimetric Glaucoma

OTHER

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

Device: XyCAM with oxygen

Interventions

XyCAM with oxygenDEVICE

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.

ControlGlaucomaPre-perimetric Glaucoma

Eligibility Criteria

Age18 Years - 88 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Maryland Eye Associates at Redwood

Baltimore, Maryland, 21201, United States

RECRUITING

Related Publications (1)

  • 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.

    PMID: 34673279BACKGROUND

MeSH Terms

Conditions

GlaucomaEye Diseases

Interventions

Oxygen Inhalation Therapy

Condition Hierarchy (Ancestors)

Ocular Hypertension

Intervention Hierarchy (Ancestors)

Respiratory TherapyTherapeutics

Study Officials

  • Grace Forbes, MS

    University of Maryland, Baltimore

    STUDY DIRECTOR

Central Study Contacts

Osamah J Saeedi, MD, MS

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 12, 2022

First Posted

February 13, 2023

Study Start

March 30, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

April 30, 2027

Last Updated

March 28, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)