GlaucomaNCT05726058
Ocular Blood Flow Imaging for Glaucoma Assessment
A study testing XyCAM with oxygen in people with Glaucoma, run by University of Maryland, Baltimore at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 88 yearsHealthy volunteers can take part
- Conditions the study is for
- Glaucoma
- What is being tested?
- XyCAM with oxygen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2023to 30 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 88 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Maryland Eye Associates at Redwood
Baltimore, Maryland, 21201
Osamah Saeedi, MD, MS
About this study
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:
Read more
- 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
Read the 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
- Being tested
- XyCAM with oxygen
- Keywords
- glaucoma, xycam, blood flow, imaging, ophthalmology, retinal blood flow, eye disease
- Medical subject headings
- Glaucoma, Eye Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | All control participants will be first be imaged pre-intervention. Receives: Device: XyCAM with oxygen |
| Glaucoma | Other | All participants with glaucoma will be first be imaged pre-intervention. Receives: Device: XyCAM with oxygen |
| Pre-perimetric Glaucoma | Other | All participants with pre-perimetric glaucoma will be first be imaged pre-intervention. Receives: Device: XyCAM with oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood flow velocity measure
Dynamic video of ocular blood flow
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start30 Mar 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI), Vasoptic Medical, Inc
- Responsible party
- Principal investigator, Osamah Saeedi, University of Maryland, Baltimore
- Investigators
- Grace Forbes, MS, Study director, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05726058
- Sponsor's protocol ID
- HP-00102645
- Other IDs
- 1R44EY034064-01
- Status last verified
- Jun 2026
- First submitted
- 12 Dec 2022
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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.
PubMed 34673279
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ocular Blood Flow Imaging for Glaucoma Assessment
- ClinicalTrials.gov ID
- NCT05726058
- Acronym / sponsor ID
- HP-00102645
- Conditions
- Glaucoma
- Keywords
- glaucoma, xycam, blood flow, imaging, ophthalmology, retinal blood flow, eye disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI), Vasoptic Medical, Inc
- Study start
- 30 Mar 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 13 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Device: XyCAM with oxygenAll control participants will be first be imaged pre-intervention. |
| Glaucoma | Other | Device: XyCAM with oxygenAll participants with glaucoma will be first be imaged pre-intervention. |
| Pre-perimetric Glaucoma | Other | Device: XyCAM with oxygenAll participants with pre-perimetric glaucoma will be first be imaged pre-intervention. |
Who may qualify
- Ages
- 18 to 88 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XyCAM with oxygenAfter 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. | Device | Control, Glaucoma, Pre-perimetric Glaucoma |
Primary outcome
Blood flow velocity measure
Time frame: through study completion, an average of 1 year
Dynamic video of ocular blood flow
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Background: PubMed 34673279Vinnett 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Grace Forbes, MS study director
University of Maryland, Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing XyCAM with oxygen in people with Glaucoma, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Osamah J Saeedi, MD, MS ((410) 328-5929, osaeedi@som.umaryland.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood flow velocity measure (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05726058, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.