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Clinical Trials/NCT05243849
NCT05243849UnknownNot Applicable

Characterization of Retinal Microvascular and FAZ Changes in Ischemic Stroke and Its Different Types

Peking University Third Hospital1 site in 1 country100 target enrollmentStarted: January 1, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
100
Locations
1
Primary Endpoint
Vascular Area Density(VAD)

Study Overview

Brief Summary

The study aimed to access the microvascular changes in the superficial capillary plexus (SCP) and deep capillary plexus (DCP) in patients with ischemic stroke and its different types using optical coherence tomography angiography.

Detailed Description

Investigators used OCTA to quantitatively access the retinal microvasculature of SCP and DCP, aiming to detect the geometry changes of retinal microvasculature and FAZ in ischemic stroke patients and its different types.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
40 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Patients who were diagnosed with ischemic stroke by MRI were scheduled for an OCTA examination. The diagnosis of ischemic stroke was obtained from previous diagnostic reports or electronic medical records, according to the diagnostic criteria from the Trial of Org 10172 in Acute Stroke Treatment (TOAST).

Exclusion Criteria

  • Retinal diseases or diseases affecting vessel structure in fundus photography, including age-related maculopathy; diabetic retinopathy, central serous chorioretinopathy, retinal pigment epithelial detachment and glaucoma); poor cooperation in ophthalmic examinations; high refractive error (>+6.00 D or <-6.00 D Spherical Equivalent); low-quality OCTA images (signal strength index < 6/10). Inclusion criteria for healthy controls were no history of ischemic stroke or other neurological and ocular diseases.

Outcomes

Primary Outcomes

Vascular Area Density(VAD)

Time Frame: immediately after meeting the inclusion and exclusion criteria

The total length in millimeters of perfused retinal microvasculature per unit area in square millimeters in the annular region of analyzed area

FAZ Area(FA)

Time Frame: immediately after meeting the inclusion and exclusion criteria

The total numbers of pixels in the FAZ region

FAZ Axis Ratio(FAR)

Time Frame: immediately after meeting the inclusion and exclusion criteria

The ratio between the major and minor axes of the fitted ellipse from the FAZ boundary. The axis ratio of a perfect circular FAZ is equal to 1

Vascular Orientation Distribution(VOD)

Time Frame: immediately after meeting the inclusion and exclusion criteria

The direction of each vascular pixel to indicate the trend of the blood flow

Vascular Fractal Dimension(VFD)

Time Frame: immediately after meeting the inclusion and exclusion criteria

A well-known parameter which indicates the degree of geometric complexity of vasculature

FAZ Circularity(FC)

Time Frame: After meeting the inclusion and exclusion criteria

The ratio of the perimeter of the FAZ to the parameter of a circle with equal area, reflecting the degree of roundness of the FAZ

FAZ Roundness(FR)

Time Frame: immediately after meeting the inclusion and exclusion criteria

Similar to FC, but is less sensitive to irregular borders along the parameter of FAZ

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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