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Ocular Blood Flow Imaging for Glaucoma Assessment

Primary Purpose

Glaucoma

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
XyCAM with oxygen
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Glaucoma focused on measuring glaucoma, xycam, blood flow, imaging, ophthalmology, retinal blood flow, eye disease

Eligibility Criteria

18 Years - 88 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Maryland Eye Associates at RedwoodRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Control

Glaucoma

Pre-perimetric Glaucoma

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Blood flow velocity measure
Dynamic video of ocular blood flow

Secondary Outcome Measures

Full Information

First Posted
December 12, 2022
Last Updated
May 31, 2023
Sponsor
University of Maryland, Baltimore
Collaborators
National Eye Institute (NEI), Vasoptic Medical, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT05726058
Brief Title
Ocular Blood Flow Imaging for Glaucoma Assessment
Official Title
Ocular Blood Flow Imaging for Glaucoma Assessment
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 30, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore
Collaborators
National Eye Institute (NEI), Vasoptic Medical, Inc

4. Oversight

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
Data Monitoring Committee
Yes

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
glaucoma, xycam, blood flow, imaging, ophthalmology, retinal blood flow, eye disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Other
Arm Description
All control participants will be first be imaged pre-intervention.
Arm Title
Glaucoma
Arm Type
Other
Arm Description
All participants with glaucoma will be first be imaged pre-intervention.
Arm Title
Pre-perimetric Glaucoma
Arm Type
Other
Arm Description
All participants with pre-perimetric glaucoma will be first be imaged pre-intervention.
Intervention Type
Device
Intervention Name(s)
XyCAM with oxygen
Intervention Description
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 Information:
Title
Blood flow velocity measure
Description
Dynamic video of ocular blood flow
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
88 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Osamah J Saeedi, MD, MS
Phone
(410) 328-5929
Email
osaeedi@som.umaryland.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grace Forbes, MS
Organizational Affiliation
University of Maryland, Baltimore
Official's Role
Study Director
Facility Information:
Facility Name
University of Maryland Eye Associates at Redwood
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Osamah Saeedi, MD, MS

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34673279
Citation
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.
Results Reference
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Ocular Blood Flow Imaging for Glaucoma Assessment

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