Ocular Effects of Carotid Endarterectomy

Carotid Stenosis Clinical Trial

Official title:

Ocular Effects of Carotid Endarterectomy A Cohort Longitudinal Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02448355
• Other study ID #: hanhart1
• Status: Not yet recruiting
• Phase: N/A
• First received: November 28, 2014
• Last updated: November 24, 2015
• Start date: March 2016
• Est. completion date: December 2017

Study information

• Verified date: November 2015
• Source: Shaare Zedek Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

All patients undergoing carotid endarterectomy in Shaare Zedek Medical Hospital, during about 1 year, will be offered to participate.

Retinal and choroidal structural changes will be assessed using swept-source OCT technology

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 120 Years

Eligibility

Inclusion Criteria:

• Carotid stenosis requiring surgical management

Exclusion Criteria:

• Ocular conditions: media opacities precluding fundus visualization, bilateral no-light perception

• Ocular surgery within 6 months prior to endarterectomy

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Carotid Endarterectomy
• Carotid Stenosis
• Choroid

Intervention

Device:
• OCT swept source DRI-Atlantis, Topcon
3-dimensional scanning protocol with 3 µm axial resolution and a speed of 100,000 A-scans per second. 256 B-scans to be taken on an area of 12 × 9 µm.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shaare Zedek Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in choroidal thickness	Change in choroidal thickness (microns) on OCT pictures	one year	No
Secondary	Visual acuity	Visual acuity as assessed by Snellen chart	One year	No
Secondary	Retinal changes	Analysis of OCT pictures	One year	No