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Trial record 5 of 429 for:    shaare zedek

Ocular Effects of Carotid Endarterectomy

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ClinicalTrials.gov Identifier: NCT02448355
Recruitment Status : Unknown
Verified November 2015 by joel hanhart, Shaare Zedek Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : May 19, 2015
Last Update Posted : November 25, 2015
Sponsor:
Information provided by (Responsible Party):
joel hanhart, 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


Condition or disease Intervention/treatment Phase
Choroid Carotid Stenosis Carotid Endarterectomy Device: OCT swept source DRI-Atlantis, Topcon Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Ocular Effects of Carotid Endarterectomy A Cohort Longitudinal Study
Study Start Date : March 2016
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : December 2017

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.




Primary Outcome Measures :
  1. Change in choroidal thickness [ Time Frame: one year ]
    Change in choroidal thickness (microns) on OCT pictures


Secondary Outcome Measures :
  1. Visual acuity [ Time Frame: One year ]
    Visual acuity as assessed by Snellen chart

  2. Retinal changes [ Time Frame: One year ]
    Analysis of OCT pictures



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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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Responsible Party: joel hanhart, MD, Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT02448355     History of Changes
Other Study ID Numbers: hanhart1
First Posted: May 19, 2015    Key Record Dates
Last Update Posted: November 25, 2015
Last Verified: November 2015
Keywords provided by joel hanhart, Shaare Zedek Medical Center:
OCT
Additional relevant MeSH terms:
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Carotid Stenosis
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases