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

COVID19 Clinical Trial

— SOCOVID  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04387292
• Other study ID #: MMT_2020_12
• Status: Completed
• Phase: N/A
• Start date: September 7, 2020
• Est. completion date: May 15, 2021

Study information

• Verified date: August 2021
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: May 15, 2021
• Est. primary completion date: January 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID19
• Eye Diseases
• Ophthalmopathy
• Respiratory Insufficiency

Intervention

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)

Locations

Country	Name	City	State
France	Fondation A de Rothschild	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Description of the ophthalmological problems observed	Multimodal ophthalmologic imaging	6 months after discharge of hospitalization