Chorioretinal Vascularization and Electrophysiological Changes After Carotid Revascularization

Not Applicable

Recruiting

• Conditions: Carotid Stenosis
• Interventions: Diagnostic Test: Optical coherence tomography angiography and pattern electroretinogram

• Registration Number: NCT05835869
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2023-04
• Study First Submitted: 2023-04-19
• Study First Submitted QC: 2023-04-19
• Study Start: 2023-04-20
• Study First Posted: 2023-04-28
• Primary Completion: 2023-07-01
• Last Update Submitted: 2023-07-03
• Last Update Posted: 2023-07-06
• Study Completion: 2024-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• age >18 years old
• Carotid stenosis diagnosis with indication to perform carotid endarterectomy
• informed consent form signing

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study population	Optical coherence tomography angiography and pattern electroretinogram	-

Primary Outcome Measures

Name	Time	Method
Functional retinal changes	1 week and 3 months	To evaluate rate of pattern electroretinography/pattern visual evoked potential improvement in both eyes before and after carotid endarterectomy

Secondary Outcome Measures

Name	Time	Method
Retinal vascular density changes	1 week and 3 months	To evaluate rate of chorioretinal vascular density improvement trough angiographic optical coherence tomography before and after carotid endarterectomy

Trial Locations

Locations (1)

Policlinico Agostino Gemelli IRCCS; 🇮🇹 Roma, RM, Italy