NCT05835869
Recruiting
Not Applicable
Electrophysiological and Morphofunctional Changes of Retina and Choroid Vascularization After Carotid Endarterectomy, a Pilot Study
Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 site in 1 country30 target enrollmentApril 20, 2023
ConditionsCarotid Stenosis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Carotid Stenosis
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Functional retinal changes
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Retinal vascular density changes(1 week and 3 months)
Study Sites (1)
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