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Ocular Effects of Carotid Endarterectomy

Primary Purpose

Choroid, Carotid Stenosis, Carotid Endarterectomy

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
OCT swept source DRI-Atlantis, Topcon
Sponsored by
Shaare Zedek Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Choroid focused on measuring OCT

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Patient undergoing carotid endarterectomy

    Arm Description

    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

    Outcomes

    Primary Outcome Measures

    Change in choroidal thickness
    Change in choroidal thickness (microns) on OCT pictures

    Secondary Outcome Measures

    Visual acuity
    Visual acuity as assessed by Snellen chart
    Retinal changes
    Analysis of OCT pictures

    Full Information

    First Posted
    November 28, 2014
    Last Updated
    November 24, 2015
    Sponsor
    Shaare Zedek Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02448355
    Brief Title
    Ocular Effects of Carotid Endarterectomy
    Official Title
    Ocular Effects of Carotid Endarterectomy A Cohort Longitudinal Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 2016 (undefined)
    Primary Completion Date
    March 2017 (Anticipated)
    Study Completion Date
    December 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Shaare Zedek Medical Center

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Choroid, Carotid Stenosis, Carotid Endarterectomy
    Keywords
    OCT

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Patient undergoing carotid endarterectomy
    Arm Type
    Experimental
    Arm Description
    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
    Intervention Type
    Device
    Intervention Name(s)
    OCT swept source DRI-Atlantis, Topcon
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Change in choroidal thickness
    Description
    Change in choroidal thickness (microns) on OCT pictures
    Time Frame
    one year
    Secondary Outcome Measure Information:
    Title
    Visual acuity
    Description
    Visual acuity as assessed by Snellen chart
    Time Frame
    One year
    Title
    Retinal changes
    Description
    Analysis of OCT pictures
    Time Frame
    One year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    120 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Learn more about this trial

    Ocular Effects of Carotid Endarterectomy

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