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Chorioretinal Vascularization and Electrophysiological Changes After Carotid Revascularization (CAS-AOCT)

Primary Purpose

Carotid Stenosis

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Optical coherence tomography angiography and pattern electroretinogram
Sponsored by
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Carotid Stenosis

Eligibility Criteria

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

Inclusion Criteria: age >18 years old Carotid stenosis diagnosis with indication to perform carotid endarterectomy informed consent form signing Exclusion Criteria: age <18 years old recurrent intraocular inflammation retinal disease optic neuropathy, optic nerve drusen, opacity of the dioptric means in the pre- or post-operative period that prevents the acquisition of high-resolution images unstable fixation spheric refractive error > +/- 6 D spheric and/or +/- 3 D cylinder history of prior ocular surgery refusal of signing informed consent form

Sites / Locations

  • Policlinico Agostino Gemelli IRCCSRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study population

Arm Description

Outcomes

Primary Outcome Measures

Functional retinal changes
To evaluate rate of pattern electroretinography/pattern visual evoked potential improvement in both eyes before and after carotid endarterectomy

Secondary Outcome Measures

Retinal vascular density changes
To evaluate rate of chorioretinal vascular density improvement trough angiographic optical coherence tomography before and after carotid endarterectomy

Full Information

First Posted
April 19, 2023
Last Updated
July 3, 2023
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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1. Study Identification

Unique Protocol Identification Number
NCT05835869
Brief Title
Chorioretinal Vascularization and Electrophysiological Changes After Carotid Revascularization
Acronym
CAS-AOCT
Official Title
Electrophysiological and Morphofunctional Changes of Retina and Choroid Vascularization After Carotid Endarterectomy, a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 20, 2023 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The aim of the study is to evaluate changes in retinal function by means of electro-functional examinations of the retina and to associate them with any changes in chorioretinal vascular density occurring in the ipsilateral eye after carotid revascularization surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carotid Stenosis

7. Study Design

Primary Purpose
Diagnostic
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
Study population
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
Optical coherence tomography angiography and pattern electroretinogram
Intervention Description
Optical coherence tomography angiography is an infrared eye scan that analyzes retinal vascularization and anatomy
Primary Outcome Measure Information:
Title
Functional retinal changes
Description
To evaluate rate of pattern electroretinography/pattern visual evoked potential improvement in both eyes before and after carotid endarterectomy
Time Frame
1 week and 3 months
Secondary Outcome Measure Information:
Title
Retinal vascular density changes
Description
To evaluate rate of chorioretinal vascular density improvement trough angiographic optical coherence tomography before and after carotid endarterectomy
Time Frame
1 week and 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age >18 years old Carotid stenosis diagnosis with indication to perform carotid endarterectomy informed consent form signing Exclusion Criteria: age <18 years old recurrent intraocular inflammation retinal disease optic neuropathy, optic nerve drusen, opacity of the dioptric means in the pre- or post-operative period that prevents the acquisition of high-resolution images unstable fixation spheric refractive error > +/- 6 D spheric and/or +/- 3 D cylinder history of prior ocular surgery refusal of signing informed consent form
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antonio Baldascino, MD
Phone
+393388771472
Email
antonio.baldascino@policlinicogemelli.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Baldascino, MD
Organizational Affiliation
Policlinico Agostino Gemelli IRRCS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Policlinico Agostino Gemelli IRCCS
City
Roma
State/Province
RM
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio Baldascino, MD
Phone
+393388771472
Email
antonio.baldascino@policlinicogemelli.it

12. IPD Sharing Statement

Learn more about this trial

Chorioretinal Vascularization and Electrophysiological Changes After Carotid Revascularization

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