COVID-19 Patient Cohort: Retinal Damage in Non-invasive Retinal Imaging (OCTA)

Covid19 Clinical Trial

Official title:

COVID-19 Patient Cohort: Retinal Damage in Non-invasive Retinal Imaging (OCTA)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04881253
• Other study ID #: COVID-RET
• Status: Recruiting
• Start date: November 5, 2021
• Est. completion date: December 2024

Study information

• Verified date: June 2023
• Source: Centre Hospitalier Intercommunal Creteil
• Contact: Camille JUNG, MD
• Phone: 01 45 17 50 00
• Email: camille.jung[@]chicreteil.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The objective of this research is to build a collection of non-invasive retinal imaging (OCT and OCTA) in order to investigate the incidence and impact of retinal damage in patients who have or have had COVID-19.

Description:

This monocentric study is aimed at 3 types of patients:

• Those who have been hospitalized for Covid-19 during the epidemic

• Newly infected and diagnosed patients Covid-19

• Those with paucisymptomatic Covid-19 who did not require hospitalisation

At the patient's inclusion, an ophthalmologic assessment will be performed including :

• visual acuity,

• SD-OCT + multicolor,

• OCT-A,

• color retinography,

Fundus examination, optical coherence tomography (OCT) and optical coherence tomography angiography (OCTA) in all COVID-19 patients may detect retinal lesions. In addition, if a correlation is demonstrated between clinical and paraclinical parameters and between disease severity and retinal vascular damage in non-invasive imaging (OCT and OCTA), this would allow a better understanding of the pathophysiology of the disease, as well as factors that may influence disease severity and the mechanisms potentially responsible for the observed disorders.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years old

• Diagnosis of COVID-19 proven on RT-PCR, antigenic test or chest CT scan

• Affiliation to the general social security system

• A consent signed by the patient

Exclusion Criteria:

• Refusal of patient participation

Related Conditions & MeSH terms

• COVID-19
• Covid19

Locations

Country	Name	City	State
France	Centre Hospitalier Intercommunal de Créteil	Créteil	IDF

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Intercommunal Creteil

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retinal damage at inclusion after Covid-19 infection	Comparison of retinal damage in patients with patients with severe forms of Covid-19 versus patients with mild forms of the disease	Up to one week after inclusion
Secondary	Change of retinal vascular density at inclusion after Covid-19 infection	Comparison of retinal damage in patients with severe forms of Covid-19 versus patients with mild forms of the disease	Up to one week after inclusion
Secondary	Impact of retinal vascular density changes on visual acuity at inclusion	Severity and impact of retinal damage	Up to one week after inclusion
Secondary	Presence of Retinal toxicity (atrophy) on multimodal retinal imagery	Correlation between the presence of changes in multimodal imaging (fundus autofluorescence, multicolor and OCTA) and the associated antiviral treatment for Covid-19.	Up to one week after inclusion