NCT05835869

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 19, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

April 20, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 28, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
Last Updated

July 6, 2023

Status Verified

April 1, 2023

Enrollment Period

2 months

First QC Date

April 19, 2023

Last Update Submit

July 3, 2023

Conditions

Carotid Stenosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Retinal vascular density changes

    1 week and 3 months

Study Arms (1)

Study population

EXPERIMENTAL
Diagnostic Test: Optical coherence tomography angiography and pattern electroretinogram

Interventions

Optical coherence tomography angiography and pattern electroretinogramDIAGNOSTIC_TEST

Optical coherence tomography angiography is an infrared eye scan that analyzes retinal vascularization and anatomy

Study population

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age \>18 years old
  • Carotid stenosis diagnosis with indication to perform carotid endarterectomy
  • informed consent form signing

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Policlinico Agostino Gemelli IRCCS

Roma, RM, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Carotid Stenosis

Condition Hierarchy (Ancestors)

Carotid Artery DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Antonio Baldascino, MD

    Policlinico Agostino Gemelli IRRCS

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonio Baldascino, MD

CONTACT

+393388771472antonio.baldascino@policlinicogemelli.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 19, 2023

First Posted

April 28, 2023

Study Start

April 20, 2023

Primary Completion

July 1, 2023

Study Completion

April 30, 2024

Last Updated

July 6, 2023

Record last verified: 2023-04

Locations

IT(1)