Ocular Blood Flow Imaging for Glaucoma Assessment

NCT ID: NCT05726058

Last Updated: 2025-03-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-30
• Study Completion Date: 2027-04-30

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

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.

Conditions

Glaucoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Control

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

Group Type: OTHER

XyCAM with oxygen

Intervention Type: 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.

Glaucoma

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

Group Type: OTHER

XyCAM with oxygen

Intervention Type: 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.

Pre-perimetric Glaucoma

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

Group Type: OTHER

XyCAM with oxygen

Intervention Type: 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.

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 88 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Eye Institute (NEI)

NIH

Sponsor Role: collaborator

Vasoptic Medical, Inc

UNKNOWN

Sponsor Role: collaborator

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

Osamah Saeedi

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Grace Forbes, MS

Role: STUDY_DIRECTOR

University of Maryland, Baltimore

Locations

University of Maryland Eye Associates at Redwood

Baltimore, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Osamah J Saeedi, MD, MS

Role: CONTACT

osaeedi@som.umaryland.edu

(410) 328-5929

Facility Contacts

Osamah Saeedi, MD, MS

Role: primary

References

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.

Reference Type: BACKGROUND

PMID: 34673279 (View on PubMed)

Other Identifiers

1R44EY034064-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HP-00102645

Identifier Type: -

Identifier Source: org_study_id