NCT04387292

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at below P25 for not_applicable covid19

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 13, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

September 7, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 21, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2021

Completed
Last Updated

January 6, 2026

Status Verified

August 1, 2021

Enrollment Period

5 months

First QC Date

May 12, 2020

Last Update Submit

January 2, 2026

Conditions

Keywords

COVID19

Outcome Measures

Primary Outcomes (1)

  • Description of the ophthalmological problems observed

    Multimodal ophthalmologic imaging

    6 months after discharge of hospitalization

Study Arms (1)

Ophthalmologic exam

EXPERIMENTAL
Procedure: Ophthalmologic exam

Interventions

* 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)

Ophthalmologic exam

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients having been hospitalized for a confirmed COVID-19 infection (CT-scanner or PCR- Polymerase chain reaction)

You may not qualify if:

  • Pregnant or breastfeeding woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondation A de Rothschild

Paris, France, 75019, France

Location

Related Publications (1)

  • Abdelmassih Y, Azar G, Bonnin S, Scemama Timsit C, Vasseur V, Spaide RF, Behar-Cohen F, Mauget-Faysse M. COVID-19 Associated Choroidopathy. J Clin Med. 2021 Oct 13;10(20):4686. doi: 10.3390/jcm10204686.

MeSH Terms

Conditions

COVID-19Eye Diseases

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Martine MAUGET FAYSSE, MD

    Fondation A. de Rothschild

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2020

First Posted

May 13, 2020

Study Start

September 7, 2020

Primary Completion

January 21, 2021

Study Completion

May 15, 2021

Last Updated

January 6, 2026

Record last verified: 2021-08

Locations