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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05260229
Other study ID # cuiyanqiluteam
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 12, 2021
Est. completion date May 31, 2022

Study information

Verified date October 2021
Source Qilu Hospital of Shandong University
Contact Yan Cui, doctor
Phone (+86)18560088136
Email cyeleanor@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The investigators plan to collect 30 participants with internal carotid artery stenosis to observed the relationship between the degree of internal carotid artery stenosis and fundus vessels (and blood flow)density before operation, and compared with participants without internal carotid artery stenosis.The fundus blood flow density will be observed after intervention operation in order to see whether the operation is effective to improve the density of fundus vessels and blood flow or not.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date May 31, 2022
Est. primary completion date April 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 45 Years to 80 Years
Eligibility Inclusion Criteria: 1. Patients who have been diagnosed with carotid artery stenosis and need surgery; 2. Patients whose vision won't get worse soon; 3. Patients have not had any eye surgeries; 4. Patients with complete profile. Exclusion Criteria: 1. Patients with severe systemic disease; 2. Patients with poor dioptric stroma; 3. Patients with nystagmus; 4. Patients with incomplete profile.

Study Design


Locations

Country Name City State
China Department of ophthalmology and neurology at Qilu Hospital of Shandong University Jinan Shandong

Sponsors (1)

Lead Sponsor Collaborator
Qilu Hospital of Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary The differences of perfusion density in the Forum of the optical coherence tomography angiography(OCTA )of Zeiss Company The perfusion density differences between the fundus vessels(both the macula area and the optic disc area) on the carotid artery stenosis side and the not-significant narrowing side,or the perfusion density differences between the fundus vessels(both the macula area and the optic disc area) on the carotid artery stenosis side and the side with carotid artery stenosis of different degrees. 2022-01-31
Primary The differences of perfusion density in the Forum of the optical coherence tomography angiography(OCTA )of Zeiss Company The perfusion density differences between the fundus vessels on the carotid artery stenosis side and the same side after interventional surgery. 2022-02-14
Primary The differences of vessel density in the Forum of the optical coherence tomography angiography(OCTA )of Zeiss Company The vessel density differences between the fundus vessels(both the macula area and the optic disc area) on the carotid artery stenosis side and the not-significant narrowing side,or the vessel density differences between the fundus vessels(both the macula area and the optic disc area) on the carotid artery stenosis side and the side with carotid artery stenosis of different degrees. 2022-01-31
Primary The differences of vessel density in the Forum of the optical coherence tomography angiography(OCTA )of Zeiss Company The vessel density differences between the fundus vessels on the carotid artery stenosis side and the same side after interventional surgery. 2022-02-14
Primary The perimeter and area of the fovea avascular zone(FAZ)in the Forum of the optical coherence tomography angiography(OCTA )of Zeiss Company The differences between the perimeter and area of the fovea avascular zone(FAZ) of the carotid artery stenosis side before and after interventional surgery. 2022-02-14
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