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Clinical Trials/NCT05835869
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

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.

Registry
clinicaltrials.gov
Start Date
April 20, 2023
End Date
April 30, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

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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