OctaNCT06797765
Optical Coherence Tomography Angiography in Neurological Disease
An observational study of Octa and Stroke, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
Optical Coherence Tomography Angiography (OCTA) is a non-invasive tool that images the neurovascular structures of the eye by using near-infrared light. Previous literature has demonstrated the potential of OCTA as a screening tool in stroke, but its utility in other neurological illness such as intracranial… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Octa, Stroke, Subarachnoid Hemorrhage
- What is being tested?
- OCTA
- Type of treatment
- Medical device
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2024to 20 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Control and Patient population
Who may be able to join
- Age 18 years or older
- Patient admitted to the neuroscience intensive care unit with a diagnosis of: subarachnoid hemorrhage, intracerebral hemorrhage, intracranial aneurysm (ruptured or unruptured), intracranial vascular malformation, ischemic stroke, seizure disorder, intracranial infection, intracranial tumor(s), inflammatory demyelinating disease, traumatic brain injury and/or neuromuscular respiratory failure OR subjects from the community without major neurologic, cardiovascular, pulmonary or metabolic disease
Who cannot join
- Pregnancy
- Non-English speaking
- GCS motor score less than 6 (i.e. must be able to follow commands)
- Temporary or permanent physical limitation that renders the patient unable to sit up and look inside OCTA device
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optical Coherence Tomography Angiography in Neurological Disease: A Pilot Study
Optical Coherence Tomography Angiography (OCTA) is a non-invasive tool that images the neurovascular structures of the eye by using near-infrared light. Previous literature has demonstrated the potential of OCTA as a screening tool in stroke, but its utility in other neurological illness such as intracranial hemorrhage is unclear. Hence, this pilot study will gather preliminary data to support future grant applications to investigate this area more fully by recruiting patients with neurological illness and healthy controls and comparing their OCTA imaging parameters.
- Conditions
- Octa, Stroke, Subarachnoid Hemorrhage, Intracerebral Hemorrhage
- Being tested
- OCTA
- Medical subject headings
- Stroke, Subarachnoid Hemorrhage, Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCTADevice
Optical Coherence Tomography Angiography
| Study group | Role | What they receive |
|---|---|---|
| Control | Normal healthy human subjects Receives: Device: OCTA | |
| Patients | Patients with neurological disease Receives: Device: OCTA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascular and Perfusion Density in healthy controls
Quantitative measure of retinal microperfusion. No definite time points are defined since different neurological diseases have different patterns of evolution and patient/provider availability may change.
Measured: Once (approx. 10 mins)
Vascular and Perfusion Density in Patients with neurological disease
Quantitative measure of retinal microperfusion. No definite time points are defined since different neurological diseases have different patterns of evolution and patient/provider availability may change.
Measured: Throughout study completion up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start20 Oct 2024
- Primary completion20 May 2026
- Study completion20 May 2026
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 OctaStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noah Jouett, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06797765
- Sponsor's protocol ID
- STU-2024-0876
- Status last verified
- Nov 2025
- First submitted
- 21 Dec 2024
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Pilot study
Publications
Patton N, Aslam T, Macgillivray T, Pattie A, Deary IJ, Dhillon B. Retinal vascular image analysis as a potential screening tool for cerebrovascular disease: a rationale based on homology between cerebral and retinal microvasculatures. J Anat. 2005 Apr;206(4):319-48. doi: 10.1111/j.1469-7580.2005.00395.x.
PubMed 15817102
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Coherence Tomography Angiography in Neurological Disease: A Pilot Study
- ClinicalTrials.gov ID
- NCT06797765
- Acronym / sponsor ID
- STU-2024-0876
- Conditions
- Octa, Stroke, Subarachnoid Hemorrhage, Intracerebral Hemorrhage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 20 Oct 2024 (actual)
- Primary completion
- 20 May 2026 (actual)
- Study completion
- 20 May 2026 (actual)
- First posted
- 28 Jan 2025 (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.
Optical Coherence Tomography Angiography (OCTA) is a non-invasive tool that images the neurovascular structures of the eye by using near-infrared light. Previous literature has demonstrated the potential of OCTA as a screening tool in stroke, but its utility in other neurological illness such as intracranial hemorrhage is unclear. Hence, this pilot study will gather preliminary data to support future grant applications to investigate this area more fully by recruiting patients with neurological illness and healthy controls and comparing their OCTA imaging parameters.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | Device: OCTANormal healthy human subjects |
| Patients | – | Device: OCTAPatients with neurological disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Control and Patient population
Key inclusion criteria (2 listed)
- Age 18 years or older
- Patient admitted to the neuroscience intensive care unit with a diagnosis of: subarachnoid hemorrhage, intracerebral hemorrhage, intracranial aneurysm (ruptured or unruptured), intracranial vascular malformation, ischemic stroke, seizure disorder, intracranial infection, intracranial tumor(s), inflammatory demyelinating disease, traumatic brain injury and/or neuromuscular respiratory failure OR subjects from the community without major neurologic, cardiovascular, pulmonary or metabolic disease
Key exclusion criteria (4 listed)
- Pregnancy
- Non-English speaking
- GCS motor score less than 6 (i.e. must be able to follow commands)
- Temporary or permanent physical limitation that renders the patient unable to sit up and look inside OCTA device
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 |
|---|---|---|
| OCTAOptical Coherence Tomography Angiography | Device | Control, Patients |
Primary outcome
Vascular and Perfusion Density in healthy controls
Time frame: Once (approx. 10 mins)
Quantitative measure of retinal microperfusion. No definite time points are defined since different neurological diseases have different patterns of evolution and patient/provider availability may change.
Vascular and Perfusion Density in Patients with neurological disease
Time frame: Throughout study completion up to 28 days
Quantitative measure of retinal microperfusion. No definite time points are defined since different neurological diseases have different patterns of evolution and patient/provider availability may change.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Background: PubMed 15817102Patton N, Aslam T, Macgillivray T, Pattie A, Deary IJ, Dhillon B. Retinal vascular image analysis as a potential screening tool for cerebrovascular disease: a rationale based on homology between cerebral and retinal microvasculatures. J Anat. 2005 Apr;206(4):319-48. doi: 10.1111/j.1469-7580.2005.00395.x.
- Individual participant dataSharing planned: No. Pilot study
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Octa and Stroke, run by University of Texas Southwestern Medical Center 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 2 inclusion and 4 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: finished, as of the sponsor's last update on 29 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vascular and Perfusion Density in healthy controls (time frame: Once (approx. 10 mins)). The study lists 2 primary outcomes in all. 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 NCT06797765, 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 29 May 2026.