Chorioretinal Vascularization and Electrophysiological Changes After Carotid Revascularization

NCT ID: NCT05835869

Last Updated: 2023-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-20

Study Completion Date

2024-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Carotid Stenosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Study population

Group Type EXPERIMENTAL

Optical coherence tomography angiography and pattern electroretinogram

Intervention Type DIAGNOSTIC_TEST

Optical coherence tomography angiography is an infrared eye scan that analyzes retinal vascularization and anatomy

Interventions

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Optical coherence tomography angiography and pattern electroretinogram

Optical coherence tomography angiography is an infrared eye scan that analyzes retinal vascularization and anatomy

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Antonio Baldascino, MD

Role: PRINCIPAL_INVESTIGATOR

Policlinico Agostino Gemelli IRRCS

Locations

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Policlinico Agostino Gemelli IRCCS

Roma, RM, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Antonio Baldascino, MD

Role: CONTACT

+393388771472

Facility Contacts

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Antonio Baldascino, MD

Role: primary

+393388771472

Other Identifiers

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5532

Identifier Type: -

Identifier Source: org_study_id

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