- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05260229
The Observation About the Effects of Internal Carotid Artery Stenosis on Fundus Vessels and the Changes of Fundus Vessels After Interventional Therapy
February 24, 2022 updated by: Qilu Hospital of Shandong University
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.
Study Overview
Status
Recruiting
Conditions
Study Type
Observational
Enrollment (Anticipated)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yan Cui, doctor
- Phone Number: (+86)18560088136
- Email: cyeleanor@163.com
Study Locations
-
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Shandong
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Jinan, Shandong, China, 250012
- Recruiting
- Department of ophthalmology and neurology at Qilu Hospital of Shandong University
-
Contact:
- Xuepeng Yang, undergrad
- Phone Number: (+86)15628762662
- Email: 2420930410@qq.com
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients who have been diagnosed with carotid artery stenosis and need surgery.
Description
Inclusion Criteria:
- Patients who have been diagnosed with carotid artery stenosis and need surgery;
- Patients whose vision won't get worse soon;
- Patients have not had any eye surgeries;
- Patients with complete profile.
Exclusion Criteria:
- Patients with severe systemic disease;
- Patients with poor dioptric stroma;
- Patients with nystagmus;
- Patients with incomplete profile.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The differences of perfusion density in the Forum of the optical coherence tomography angiography(OCTA )of Zeiss Company
Time Frame: 2022-01-31
|
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
|
|
The differences of perfusion density in the Forum of the optical coherence tomography angiography(OCTA )of Zeiss Company
Time Frame: 2022-02-14
|
The perfusion density differences between the fundus vessels on the carotid artery stenosis side and the same side after interventional surgery.
|
2022-02-14
|
|
The differences of vessel density in the Forum of the optical coherence tomography angiography(OCTA )of Zeiss Company
Time Frame: 2022-01-31
|
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
|
|
The differences of vessel density in the Forum of the optical coherence tomography angiography(OCTA )of Zeiss Company
Time Frame: 2022-02-14
|
The vessel density differences between the fundus vessels on the carotid artery stenosis side and the same side after interventional surgery.
|
2022-02-14
|
|
The perimeter and area of the fovea avascular zone(FAZ)in the Forum of the optical coherence tomography angiography(OCTA )of Zeiss Company
Time Frame: 2022-02-14
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
December 12, 2021
Primary Completion (ANTICIPATED)
April 30, 2022
Study Completion (ANTICIPATED)
May 31, 2022
Study Registration Dates
First Submitted
February 14, 2022
First Submitted That Met QC Criteria
February 24, 2022
First Posted (ACTUAL)
March 2, 2022
Study Record Updates
Last Update Posted (ACTUAL)
March 2, 2022
Last Update Submitted That Met QC Criteria
February 24, 2022
Last Verified
October 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- cuiyanqiluteam
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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