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NCT04601012 Clinical Trial

OCTA Study: Retinal Vascular Changes in Patients With SARS-CoV-2 Infection

Covid19 Clinical Trial

Official title:
Optical Coherence Tomography Angiography in Patients Affected by SARS-CoV-2 Infection: a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04601012
Other study ID # 2020/03
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 20, 2020
Est. completion date October 22, 2020

Study information
Verified date October 2020
Source Federico II University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study evaluates the retinal vascular features using optical coherence tomography angiography in patients that have been affected by COVID-19.

Description:

To investigate the potential role of optical coherence tomography angiography in identifying the changes in retinal vessel density in patients that have been affected by COVID-19. The optical coherence tomography angiography represents a noninvasive diagnostic technique that allows a detailed analysis of retinal vascular features.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date October 22, 2020
Est. primary completion date October 20, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - age older than 18 years - diagnosis of previous COVID-19 - absence of previous ocular surgery, congenital eye disease, high myopia (>6 dioptres), actual or previous diagnosis of glaucoma, optic disc anomaly, macular or vitreoretinal diseases. - absence of significant lens opacities, low-quality OCT and OCT-A images. Exclusion Criteria: - age younger than 18 years - absence of previous diagnosis of COVID-19 - presence of previous ocular surgery, congenital eye disease, high myopia (>6 dioptres), actual or previous diagnosis of glaucoma, optic disc anomaly, macular or vitreoretinal diseases. - presence of significant lens opacities, low-quality OCT and OCT-A images.

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Optical coherence tomography angiography
Each subject underwent optical coherence tomography angiography to evaluate the retinal vessel density.

Locations
Country Name City State
Italy University of Naples "Federico II" Naples

Sponsors (1)
Lead Sponsor Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary The measurements of retinal features in patients with previous diagnosis of COVID19, using optical coherence tomography angiography. The parameter analyzed by optical coherence tomography angiography was: retinal vessel density one month
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