NCT02448355

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2016

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 28, 2014

Completed
6 months until next milestone

First Posted

Study publicly available on registry

May 19, 2015

Completed
10 months until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

November 25, 2015

Status Verified

November 1, 2015

Enrollment Period

1 year

First QC Date

November 28, 2014

Last Update Submit

November 24, 2015

Conditions

ChoroidCarotid StenosisCarotid Endarterectomy

Keywords

OCT

Outcome Measures

Primary Outcomes (1)

  • Change in choroidal thickness

    Change in choroidal thickness (microns) on OCT pictures

    one year

Secondary Outcomes (2)

  • Visual acuity

    One year

  • Retinal changes

    One year

Study Arms (1)

Patient undergoing carotid endarterectomy

EXPERIMENTAL

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

Interventions

OCT swept source DRI-Atlantis, TopconDEVICE

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.

Patient undergoing carotid endarterectomy

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Carotid stenosis requiring surgical management

You may not qualify if:

  • Ocular conditions: media opacities precluding fundus visualization, bilateral no-light perception
  • Ocular surgery within 6 months prior to endarterectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Carotid Stenosis

Condition Hierarchy (Ancestors)

Carotid Artery DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 28, 2014

First Posted

May 19, 2015

Study Start

March 1, 2016

Primary Completion

March 1, 2017

Study Completion

December 1, 2017

Last Updated

November 25, 2015

Record last verified: 2015-11