Ocular Sequelae of Patients Hospitalized for Respiratory Failure During the COVID-19 Epidemic (SOCOVID)

August 2, 2021 updated by: Fondation Ophtalmologique Adolphe de Rothschild

Ophthalmologic damages secondary to COVID-19 coronavirus infection are little described. The ocular involvement is probably multiple, ranging from pathologies of the anterior segment such as conjunctivitis and anterior uveitis to disorders that threaten vision such as retinitis or optic neuropathy. On the other hand, in addition to this impairment, when patients are hospitalized for acute respiratory failure, complications related to possible resuscitation, medication prescriptions, positioning and oxygenation.

COVID-19 itself, has several components:

  • An apoptotic action of the viral attack which will generate cellular destruction, whether pulmonary, cardiac or renal or maybe ocular
  • A secondary autoimmune action with the development of major vascular inflammation, possibly reaching the retinal, choroidal, and optic nerve vessels. A secondary "hyper" inflammatory syndrome with flashing hypercytokinemia and multi-organ decompensation is described in 3,7% to 4 ,3% of severe cases.
  • A thromboembolic action

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Upon discharge from hospital for COVID-19 infection (or during a telephone call for patients already discharged at the start of the study), patients will be informed of the study. An ophthalmology appointment will be given to them between 4 and 6 months after their discharge.

During the ophthalmology appointment, the patient's clinical data will be collected during an interview (medical and treatment history, blood group). The patient will benefit from a full ophthalmological examination.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

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

  • France
      • Paris, France, 75019
        • Fondation A De Rothschild

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients having been hospitalized for a confirmed COVID-19 infection (CT-scanner or PCR- Polymerase chain reaction)

Exclusion Criteria:

  • Pregnant or breastfeeding woman

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

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ophthalmologic exam
Procedure: Ophthalmologic exam
  • Visual acuity (ETDRS exam)
  • Slit lamp examination : fluorescein test, Oxford score, break up time, Schirmer II test
  • Lipiview
  • Eye pressure measurement (air tonometer)
  • Wide field retinophotography
  • Multicolor and auto-fluorescence retinophotography
  • Indocyanine green retinal angiography
  • Optical coherence tomography (OCT) B posterior pole scan
  • OCT Angiography (OCT-A) of the optic nerve and posterior pole
  • Adaptive optics
  • Visual field (Humphrey)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Description of the ophthalmological problems observed
Time Frame: 6 months after discharge of hospitalization
Multimodal ophthalmologic imaging
6 months after discharge of hospitalization

Collaborators and Investigators

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

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Investigators

  • Principal Investigator: Martine MAUGET FAYSSE, MD, Fondation A. de Rothschild

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 7, 2020

Primary Completion (Actual)

January 21, 2021

Study Completion (Actual)

May 15, 2021

Study Registration Dates

First Submitted

May 12, 2020

First Submitted That Met QC Criteria

May 12, 2020

First Posted (Actual)

May 13, 2020

Study Record Updates

Last Update Posted (Actual)

August 3, 2021

Last Update Submitted That Met QC Criteria

August 2, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MMT_2020_12

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.

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