Ocular Effects of Carotid Endarterectomy

Not Applicable

• Conditions: Carotid Stenosis; Carotid Endarterectomy; Choroid
• Interventions: Device: OCT swept source DRI-Atlantis, Topcon

• Registration Number: NCT02448355
• Lead Sponsor: Shaare Zedek Medical Center

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-11-28
• Study First Submitted QC: 2015-05-14
• Study First Posted: 2015-05-19
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-24
• Last Update Posted: 2015-11-25
• Study Start: 2016-03
• Primary Completion: 2017-03
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patient undergoing carotid endarterectomy	OCT swept source DRI-Atlantis, Topcon	All patients undergoing carotid endarterectomy in Shaare Zedek Medical Center Visual acuity measurement (Snellen) SS-OCT (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. * On pre-op visit (Monday) * Day 1 post-surgery * Discharge day * Week 1 post-surgery * Month 1 post-surgery

Primary Outcome Measures

Name	Time	Method
Change in choroidal thickness	one year	Change in choroidal thickness (microns) on OCT pictures

Secondary Outcome Measures

Name	Time	Method
Retinal changes	One year	Analysis of OCT pictures
Visual acuity	One year	Visual acuity as assessed by Snellen chart