Carotid Stenosis Clinical Trial
— CAS-AOCTOfficial title:
Electrophysiological and Morphofunctional Changes of Retina and Choroid Vascularization After Carotid Endarterectomy, a Pilot Study
NCT number | NCT05835869 |
Other study ID # | 5532 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | April 20, 2023 |
Est. completion date | April 30, 2024 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Italy | Policlinico Agostino Gemelli IRCCS | Roma | RM |
Lead Sponsor | Collaborator |
---|---|
Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
Italy,
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 |
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