NCT05260229

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 12, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 14, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 2, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
Last Updated

March 2, 2022

Status Verified

October 1, 2021

Enrollment Period

5 months

First QC Date

February 14, 2022

Last Update Submit

February 24, 2022

Conditions

Internal Carotid Artery Stenosis

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • 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

  • 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

  • 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

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who have been diagnosed with carotid artery stenosis and need surgery.

You may qualify if:

  • 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.

You may not qualify if:

  • Patients with severe systemic disease;
  • Patients with poor dioptric stroma;
  • Patients with nystagmus;
  • Patients with incomplete profile.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of ophthalmology and neurology at Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

RECRUITING

MeSH Terms

Conditions

Carotid Stenosis

Condition Hierarchy (Ancestors)

Carotid Artery DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Yan Cui, doctor

CONTACT

（+86）18560088136cyeleanor@163.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2022

First Posted

March 2, 2022

Study Start

December 12, 2021

Primary Completion

April 30, 2022

Study Completion

May 31, 2022

Last Updated

March 2, 2022

Record last verified: 2021-10

Locations

CN(1)