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

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.

Study Overview

• Status: Recruiting
• Conditions: Covid19; Retina Injury

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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Camille JUNG, MD; Phone Number: +33 01 45 17 50 00; Email: camille.jung@chicreteil.fr
• Study Contact Backup: Name: Alexandra MIERE, MD; Phone Number: +33 01 45 17 50 00; Email: alexandra.miere@chicreteil.fr

Study Locations

• France
  • IDF
    • Créteil, IDF, France, 94000
      • Recruiting
      • Centre Hospitalier Intercommunal de Créteil
      • Contact: Alexandra MIERE, MD; Email: alexandra.miere@chicreteil.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Inpatients with COVID-19, patients who were hospitalised for COVID-19 and patients with COVID-19 who did not require hospitalisation

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Impact of retinal vascular density changes on visual acuity at inclusion	Severity and impact of retinal damage	Up to one week after inclusion
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Intercommunal Creteil

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2021
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: November 2, 2020
• First Submitted That Met QC Criteria: May 10, 2021
• First Posted (Actual): May 11, 2021

Study Record Updates

• Last Update Posted (Actual): June 7, 2023
• Last Update Submitted That Met QC Criteria: June 5, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: OCT; OCT-A
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: COVID-RET

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No