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

Sponsor
Federico II University (Other)
Overall Status
Completed
CT.gov ID
NCT04601012
Collaborator
(none)
40
Enrollment
1
Location
1.1
Actual Duration (Months)
38
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Optical coherence tomography angiography

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 Design

Study Type:
Observational
Actual Enrollment :
40 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Optical Coherence Tomography Angiography in Patients Affected by SARS-CoV-2 Infection: a Pilot Study
Actual Study Start Date :
Sep 20, 2020
Actual Primary Completion Date :
Oct 20, 2020
Actual Study Completion Date :
Oct 22, 2020

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. The measurements of retinal features in patients with previous diagnosis of COVID19, using optical coherence tomography angiography. [one month]

    The parameter analyzed by optical coherence tomography angiography was: retinal vessel density

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Naples "Federico II" Naples Italy 80100

Sponsors and Collaborators

  • Federico II University

Investigators

  • Principal Investigator: Gilda Cennamo, Federico II University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gilda Cennamo, Principal Investigator, Federico II University
ClinicalTrials.gov Identifier:
NCT04601012
Other Study ID Numbers:
  • 2020/03
First Posted:
Oct 23, 2020
Last Update Posted:
Jan 19, 2021
Last Verified:
Oct 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
COVID-19

Study Results

No Results Posted as of Jan 19, 2021