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Clinical Trial Details — Status: Recruiting

Administrative data

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

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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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