CClinicalTrials.gg
CompletedNCT04601012Updated Jan 19, 2021

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

An observational study in Covid19, sponsored by Federico II University. Completed at 1 site in Italy. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-19.

Sponsored by Federico II University · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
40
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Covid19

Browse trials for

03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 40 is below the median of 260 across 3,135 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Federico II University is the lead sponsor of 356 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

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

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.
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
40 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • Diagnostic testOptical coherence tomography angiography

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

06

What researchers measure

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

    Time frame: one month

07

Study locations

1 site
  • University of Naples "Federico II"
    Naples, 80100, Italy
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 19, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04601012
Lead sponsor
Federico II University
Responsible party
Gilda Cennamo (Principal Investigator, Federico II University) — Principal investigator
First posted
Oct 23, 2020
Start date
Sep 20, 2020
Primary completion
Oct 20, 2020
Completion
Oct 22, 2020
Last update
Jan 19, 2021

Study contacts

Gilda Cennamo
principal investigator · Federico II University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion