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

Recruiting

• Conditions: Retina Injury; Covid19

• Registration Number: NCT04881253
• Lead Sponsor: Centre Hospitalier Intercommunal Creteil

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2020-11-02
• Study First Submitted QC: 2021-05-10
• Study First Posted: 2021-05-11
• Study Start: 2021-11-05
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-05
• Last Update Posted: 2023-06-07
• Primary Completion: 2023-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Retinal damage at inclusion after Covid-19 infection	Up to one week after inclusion	Comparison of retinal damage in patients with patients with severe forms of Covid-19 versus patients with mild forms of the disease

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Centre Hospitalier Intercommunal de Créteil; 🇫🇷 Créteil, IDF, France