NCT06797765

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 20, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 28, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2026

Completed
Last Updated

May 29, 2026

Status Verified

November 1, 2025

Enrollment Period

1.6 years

First QC Date

December 21, 2024

Last Update Submit

May 28, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Throughout study completion up to 28 days

Study Arms (2)

Control

Normal healthy human subjects

Device: OCTA

Patients

Patients with neurological disease

Device: OCTA

Interventions

OCTADEVICE

Optical Coherence Tomography Angiography

ControlPatients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Control and Patient population

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75235, United States

Location

Related Publications (1)

  • 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.

    PMID: 15817102BACKGROUND

MeSH Terms

Conditions

StrokeSubarachnoid HemorrhageCerebral Hemorrhage

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesIntracranial HemorrhagesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 21, 2024

First Posted

January 28, 2025

Study Start

October 20, 2024

Primary Completion

May 20, 2026

Study Completion

May 20, 2026

Last Updated

May 29, 2026

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Pilot study

Locations