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

January 14, 2021 updated by: Gilda Cennamo, Federico II University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Naples, Italy, 80100
        • University of Naples "Federico II"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The participans were older than 18 years with previous diagnosis of COVID-19. They did not present other ophthalmological diseases.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with COVID19
The patients with previous diagnosis of COVID19
Diagnostic test: Optical coherence tomography angiography
Each subject underwent optical coherence tomography angiography to evaluate the retinal vessel density.
Control subjects
Healthy subjects without actual and previous ocular diseases
Diagnostic test: Optical coherence tomography angiography
Each subject underwent optical coherence tomography angiography to evaluate the retinal vessel density.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federico II University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 20, 2020

Primary Completion (ACTUAL)

October 20, 2020

Study Completion (ACTUAL)

October 22, 2020

Study Registration Dates

First Submitted

October 22, 2020

First Submitted That Met QC Criteria

October 22, 2020

First Posted (ACTUAL)

October 23, 2020

Study Record Updates

Last Update Posted (ACTUAL)

January 19, 2021

Last Update Submitted That Met QC Criteria

January 14, 2021

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020/03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Covid19

Clinical Trials on Optical coherence tomography angiography

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saint Lucia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe