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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04601012
Recruitment Status : Completed
First Posted : October 23, 2020
Last Update Posted : October 26, 2020
Sponsor:
Information provided by (Responsible Party):
Gilda Cennamo, Federico II University

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
Covid19 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.

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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 COVID-19: a Pilot Study
Actual Study Start Date : September 20, 2020
Actual Primary Completion Date : October 20, 2020
Actual Study Completion Date : October 22, 2020

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.




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04601012


Locations
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Italy
University of Naples "Federico II"
Naples, Italy, 80100
Sponsors and Collaborators
Federico II University
Investigators
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Principal Investigator: Gilda Cennamo Federico II University
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Responsible Party: Gilda Cennamo, Principal Investigator, Federico II University
ClinicalTrials.gov Identifier: NCT04601012    
Other Study ID Numbers: 2020/03
First Posted: October 23, 2020    Key Record Dates
Last Update Posted: October 26, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No