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

Sponsor
Centre Hospitalier Intercommunal Creteil (Other)
Overall Status
Recruiting
CT.gov ID
NCT04881253
Collaborator
(none)
100
Enrollment
1
Location
30.9
Anticipated Duration (Months)
3.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This monocentric study is aimed at 2 types of patients:

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

    • Newly infected and diagnosed patients Covid-19

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

    • visual acuity,

    • SD-OCT + multicolor,

    • OCT-A,

    • color retinography,

    Depending on the data of the ophthalmological examination (normal or abnormal), a follow-up will be proposed within the framework of the research, with possibly at most 2 additional visits for the follow-up of the evolution of the lesions which will be found on the images.

    Fundus examination, optical coherence tomography (OCTA) 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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    COVID-19 Patient Cohort: Retinal Damage in Non-invasive Retinal Imaging (OCTA)
    Actual Study Start Date :
    Nov 5, 2021
    Anticipated Primary Completion Date :
    Jun 1, 2023
    Anticipated Study Completion Date :
    Jun 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Change of retinal vascular density from baseline to month 6 after Covid-19 infection [6 months after covid-19 infection]

      Correlation between the presence of changes in vascular density and the severity of the disease (symptomatic, asymptomatic, hospitalized, admitted to intensive care)

    Secondary Outcome Measures

    1. Impact of retinal retinal vascular density changes on visual acuity at month 1 [1 months after covid-19 infection]

      Severity and impact of retinal damage

    2. Impact of retinal retinal vascular density changes on visual acuity at month 3 [3 months after covid-19 infection]

      Severity and impact of retinal damage

    3. Impact of retinal retinal vascular density changes on visual acuity at month 6 [6 months after covid-19 infection]

      Severity and impact of retinal damage

    4. Remission of retinal vascular density changes after infection at month 1 on OCTA (vascular density, %) [1 month after covid-19 infection]

      Evolution of retinal lesions

    5. Remission of retinal vascular density changes after infection at month 3 on OCTA (vascular density, %) [3 months after covid-19 infection]

      Evolution of retinal lesions

    6. Remission of retinal vascular density changes after infection at month 6 on OCTA (vascular density, %) [6 months after covid-19 infection]

      Evolution of retinal lesions

    7. Presence of Retinal toxicity (atrophy) on multimodal retinal imagery [1 months after covid-19 infection]

      Correlation between the presence of changes in multimodal imaging (fundus autofluorescence, multicolor and OCTA) and the associated antiviral treatment for Covid-19).

    8. Presence of Retinal toxicity (atrophy) on multimodal retinal imagery [3 months after covid-19 infection]

      Correlation between the presence of changes in multimodal imaging (fundus autofluorescence, multicolor and OCTA) and the associated antiviral treatment for Covid-19).

    9. Presence of Retinal toxicity (atrophy) on multimodal retinal imagery [6 months after covid-19 infection]

      Correlation between the presence of changes in multimodal imaging (fundus autofluorescence, multicolor and OCTA) and the associated antiviral treatment for Covid-19).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Age ≥ 18 years old

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

    • Affiliation to the general social security system

    • A consent signed by the patient

    Exclusion Criteria:
    • Refusal of patient participation

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Centre Hospitalier Intercommunal de Créteil Créteil IDF France 94000

    Sponsors and Collaborators

    • Centre Hospitalier Intercommunal Creteil

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Hospitalier Intercommunal Creteil
    ClinicalTrials.gov Identifier:
    NCT04881253
    Other Study ID Numbers:
    • COVID-RET
    First Posted:
    May 11, 2021
    Last Update Posted:
    Apr 29, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Centre Hospitalier Intercommunal Creteil
    OCT-A
    OCT
    Additional relevant MeSH terms:
    COVID-19

    Study Results

    No Results Posted as of Apr 29, 2022