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

• Conditions: Ischemic Stroke
• Interventions: Device: Optical Coherence Tomography Angiography

• Registration Number: NCT05243849
• Lead Sponsor: Peking University Third Hospital

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 Timeline

• Status Verified: 2021-12
• Study First Submitted: 2021-12-29
• Study Start: 2022-01-01
• Study First Submitted QC: 2022-02-07
• Last Update Submitted: 2022-02-07
• Study First Posted: 2022-02-17
• Last Update Posted: 2022-02-17
• Primary Completion: 2022-06
• Study Completion: 2022-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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).

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Exclusion Criteria

1. 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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control	Optical Coherence Tomography Angiography	Inclusion criteria for healthy controls were no history of ischemic stroke or other neurological and ocular diseases.
Ischemic Stroke	Optical Coherence Tomography Angiography	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).

Primary Outcome Measures

Name	Time	Method
Vascular Area Density(VAD)	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)	immediately after meeting the inclusion and exclusion criteria	The total numbers of pixels in the FAZ region
FAZ Axis Ratio(FAR)	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)	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)	immediately after meeting the inclusion and exclusion criteria	A well-known parameter which indicates the degree of geometric complexity of vasculature
FAZ Circularity(FC)	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)	immediately after meeting the inclusion and exclusion criteria	Similar to FC, but is less sensitive to irregular borders along the parameter of FAZ

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, China