Ocular Sequelae of Patients Hospitalized for Respiratory Failure During the COVID-19 Epidemic (SOCOVID)
Primary Purpose
COVID19, Ophthalmopathy
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Ophthalmologic exam
Sponsored by
About this trial
This is an interventional other trial for COVID19 focused on measuring COVID19
Eligibility Criteria
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
Sites / Locations
- Fondation A de Rothschild
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ophthalmologic exam
Arm Description
Outcomes
Primary Outcome Measures
Description of the ophthalmological problems observed
Multimodal ophthalmologic imaging
Secondary Outcome Measures
Full Information
NCT ID
NCT04387292
First Posted
May 12, 2020
Last Updated
August 2, 2021
Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
1. Study Identification
Unique Protocol Identification Number
NCT04387292
Brief Title
Ocular Sequelae of Patients Hospitalized for Respiratory Failure During the COVID-19 Epidemic
Acronym
SOCOVID
Official Title
Ocular Sequelae of Patients Hospitalized for Respiratory Failure During the COVID-19 Epidemic
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
September 7, 2020 (Actual)
Primary Completion Date
January 21, 2021 (Actual)
Study Completion Date
May 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID19, Ophthalmopathy
Keywords
COVID19
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ophthalmologic exam
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Ophthalmologic exam
Intervention Description
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)
Primary Outcome Measure Information:
Title
Description of the ophthalmological problems observed
Description
Multimodal ophthalmologic imaging
Time Frame
6 months after discharge of hospitalization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martine MAUGET FAYSSE, MD
Organizational Affiliation
Fondation A. de Rothschild
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fondation A de Rothschild
City
Paris
ZIP/Postal Code
75019
Country
France
12. IPD Sharing Statement
Learn more about this trial
Ocular Sequelae of Patients Hospitalized for Respiratory Failure During the COVID-19 Epidemic
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