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Ocular Effects of Carotid Endarterectomy

NCT ID: NCT02448355

Last Updated: 2015-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2017-12-31

Brief Summary

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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

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Conditions

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Choroid Carotid Stenosis Carotid Endarterectomy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Patient undergoing carotid endarterectomy

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

Group Type EXPERIMENTAL

OCT swept source DRI-Atlantis, Topcon

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shaare Zedek Medical Center

OTHER

Sponsor Role lead

Responsible Party

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joel hanhart

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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hanhart1

Identifier Type: -

Identifier Source: org_study_id