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

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild (Other)

Overall Status

Completed

CT.gov ID

NCT04387292

Collaborator

(none)

Enrollment

Location

Arm

8.2

Actual Duration (Months)

4.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
COVID19 Ophthalmopathy	Procedure: Ophthalmologic exam	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

34 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Sep 7, 2020

Actual Primary Completion Date :

Jan 21, 2021

Actual Study Completion Date :

May 15, 2021

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

Description of the ophthalmological problems observed [6 months after discharge of hospitalization]
Multimodal ophthalmologic imaging

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fondation A de Rothschild	Paris		France	75019

Sponsors and Collaborators

Fondation Ophtalmologique Adolphe de Rothschild

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fondation Ophtalmologique Adolphe de Rothschild

ClinicalTrials.gov Identifier:

NCT04387292

Other Study ID Numbers:

MMT_2020_12

First Posted:

May 13, 2020

Last Update Posted:

Aug 3, 2021

Last Verified:

Aug 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Fondation Ophtalmologique Adolphe de Rothschild

COVID19

Additional relevant MeSH terms:

COVID-19

Respiratory Insufficiency

Eye Diseases

Study Results

No Results Posted as of Aug 3, 2021