Chorioretinal Vascularization and Electrophysiological Changes After Carotid Revascularization

Carotid Stenosis Clinical Trial

— CAS-AOCT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05835869
• Other study ID #: 5532
• Status: Recruiting
• Phase: N/A
• Start date: April 20, 2023
• Est. completion date: April 30, 2024

Study information

• Verified date: April 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: Antonio Baldascino, MD
• Phone: +393388771472
• Email: antonio.baldascino[@]policlinicogemelli.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 30, 2024
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carotid Stenosis
• Neovascularization, Pathologic

Intervention

Diagnostic Test:
• Optical coherence tomography angiography and pattern electroretinogram
Optical coherence tomography angiography is an infrared eye scan that analyzes retinal vascularization and anatomy

Locations

Country	Name	City	State
Italy	Policlinico Agostino Gemelli IRCCS	Roma	RM

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional retinal changes	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	Retinal vascular density changes	To evaluate rate of chorioretinal vascular density improvement trough angiographic optical coherence tomography before and after carotid endarterectomy	1 week and 3 months