NCT04601012

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

September 20, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2020

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

October 22, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 22, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 23, 2020

Completed
Last Updated

January 19, 2021

Status Verified

October 1, 2020

Enrollment Period

1 month

First QC Date

October 22, 2020

Last Update Submit

January 14, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Patients with COVID19

The patients with previous diagnosis of COVID19

Diagnostic Test: Optical coherence tomography angiography

Control subjects

Healthy subjects without actual and previous ocular diseases

Diagnostic Test: Optical coherence tomography angiography

Interventions

Each subject underwent optical coherence tomography angiography to evaluate the retinal vessel density.

Control subjectsPatients with COVID19

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Naples "Federico II"

Naples, 80100, Italy

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Gilda Cennamo

    Federico II University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 22, 2020

First Posted

October 23, 2020

Study Start

September 20, 2020

Primary Completion

October 20, 2020

Study Completion

October 22, 2020

Last Updated

January 19, 2021

Record last verified: 2020-10

Locations