Corioretinic Vascularization Changes After Carotid Revascularization

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05835869

Collaborator

(none)

Enrollment

Arm

12.4

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Carotid Stenosis	Diagnostic Test: Optical coherence tomography angiography and pattern electroretinogram	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Electrophysiological and Morphofunctional Corioretinic Vascularization Changes After Carotid Revascularization, a Pilot Study

Anticipated Study Start Date :

Apr 20, 2023

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Apr 30, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Functional retinal changes [1 week and 3 months]
To evaluate functional changes in the retinal layers through electrophysiological tests before and after carotid endarterectomy

Secondary Outcome Measures

Retinal vascular density changes [1 week and 3 months]
To evaluate corioretinic vascular density changes trough angiographic optical coherence tomography before and after carotid endarterectomy

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

ClinicalTrials.gov Identifier:

NCT05835869

Other Study ID Numbers:

5532

First Posted:

Apr 28, 2023

Last Update Posted:

Apr 28, 2023

Last Verified:

Apr 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Carotid Stenosis

Neovascularization, Pathologic

Study Results

No Results Posted as of Apr 28, 2023