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

July 3, 2023 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Electrophysiological and Morphofunctional Changes of Retina and Choroid Vascularization After Carotid Endarterectomy, a Pilot Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

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: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study population
Diagnostic test: Optical coherence tomography angiography and pattern electroretinogram
Optical coherence tomography angiography is an infrared eye scan that analyzes retinal vascularization and anatomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional retinal changes
Time Frame: 1 week and 3 months
To evaluate rate of pattern electroretinography/pattern visual evoked potential improvement in both eyes before and after carotid endarterectomy
1 week and 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retinal vascular density changes
Time Frame: 1 week and 3 months
To evaluate rate of chorioretinal vascular density improvement trough angiographic optical coherence tomography before and after carotid endarterectomy
1 week and 3 months

Collaborators and Investigators

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

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

  • Principal Investigator: Antonio Baldascino, MD, Policlinico Agostino Gemelli IRRCS

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 (Actual)

April 20, 2023

Primary Completion (Estimated)

July 1, 2023

Study Completion (Estimated)

April 30, 2024

Study Registration Dates

First Submitted

April 19, 2023

First Submitted That Met QC Criteria

April 19, 2023

First Posted (Actual)

April 28, 2023

Study Record Updates

Last Update Posted (Actual)

July 6, 2023

Last Update Submitted That Met QC Criteria

July 3, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5532

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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