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Clinical Trials/NCT06797765
NCT06797765CompletedNot Applicable

Optical Coherence Tomography Angiography in Neurological Disease: A Pilot Study

University of Texas Southwestern Medical Center2 sites in 1 country7 target enrollmentStarted: October 20, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
7
Locations
2
Primary Endpoint
Vascular and Perfusion Density in healthy controls

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •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

Exclusion Criteria

  • •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

Arms & Interventions

Control

Normal healthy human subjects

Intervention: OCTA (Device)

Patients

Patients with neurological disease

Intervention: OCTA (Device)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Noah Jouett

Assistant Professor

University of Texas Southwestern Medical Center

Study Sites (2)

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