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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04387292
Other study ID # MMT_2020_12
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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