Ocular Blood Flow Imaging for Glaucoma Assessment

• Sponsor: University of Maryland, Baltimore (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05726058
• Collaborator: National Eye Institute (NEI) (NIH), Vasoptic Medical, Inc (Other)
• Enrollment: 150
• Arms: 3
• Anticipated Duration (Months): 34.1

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Glaucoma	Other: Oxygen	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 150 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Ocular Blood Flow Imaging for Glaucoma Assessment
• Anticipated Study Start Date: Mar 1, 2023
• Anticipated Primary Completion Date: Jan 1, 2025
• Anticipated Study Completion Date: Jan 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Other: Control All control participants will be first be imaged pre-intervention.	Other: 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.
Other: Glaucoma All participants with glaucoma will be first be imaged pre-intervention.	Other: 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.
Other: Pre-perimetric Glaucoma All participants with pre-perimetric glaucoma will be first be imaged pre-intervention.	Other: 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.

Outcome Measures

Primary Outcome Measures

1. Blood flow velocity measure [through study completion, an average of 1 year]

   Dynamic video of ocular blood flow

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 88 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Maryland, Baltimore
• National Eye Institute (NEI)
• Vasoptic Medical, Inc

Investigators

• Study Director: Grace Forbes, MS, University of Maryland School of Medicine

Study Documents (Full-Text)

None provided.

More Information

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.

• Responsible Party: Osamah Saeedi, Professor, University of Maryland, Baltimore
• ClinicalTrials.gov Identifier: NCT05726058
• Other Study ID Numbers: HP-00102645; 1R44EY034064-01
• First Posted: Feb 13, 2023
• Last Update Posted: Feb 13, 2023
• Last Verified: Feb 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Osamah Saeedi, Professor, University of Maryland, Baltimore: glaucoma; xycam; blood flow; imaging; ophthalmology; retinal blood flow; eye disease
• Additional relevant MeSH terms: Glaucoma

Study Results

No Results Posted as of Feb 13, 2023