Ocular Effects of Carotid Endarterectomy

November 24, 2015 updated by: joel hanhart, Shaare Zedek Medical Center

Ocular Effects of Carotid Endarterectomy A Cohort Longitudinal Study

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

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

18 years to 120 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in choroidal thickness
Time Frame: one year
Change in choroidal thickness (microns) on OCT pictures
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual acuity
Time Frame: One year
Visual acuity as assessed by Snellen chart
One year
Retinal changes
Time Frame: One year
Analysis of OCT pictures
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shaare Zedek Medical Center

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

March 1, 2016

Primary Completion (Anticipated)

March 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

November 28, 2014

First Submitted That Met QC Criteria

May 14, 2015

First Posted (Estimate)

May 19, 2015

Study Record Updates

Last Update Posted (Estimate)

November 25, 2015

Last Update Submitted That Met QC Criteria

November 24, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • hanhart1

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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