NCT04385810

Brief Summary

The management of patients with SARS-CoV2 in respiratory distress can expose to corneal or retinal lesions induced by the stay in intensive care. Examination by ophthalmologists would make it possible to detect the most of the ophthalmologic problems known in intensive care and to provide an early, preventive or curative therapeutic response when possible, in order to avoid irreversible visual loss. The object of the research is to assess the presence and the importance of surface ophthalmologic lesions, the presence and the importance of retinal or optic nerve lesions, in order to improve the monitoring and primary prevention of this population

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for not_applicable covid19

Timeline
Completed

Started Apr 2020

Shorter than P25 for not_applicable covid19

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

Study Start

First participant enrolled

April 27, 2020

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

April 29, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 13, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 29, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 29, 2020

Completed
Last Updated

January 6, 2026

Status Verified

November 1, 2020

Enrollment Period

3 months

First QC Date

April 29, 2020

Last Update Submit

January 2, 2026

Conditions

Covid19Sars-CoV2

Keywords

ophthalmological lesions

Outcome Measures

Primary Outcomes (20)

  • Describe ophthalmologic damage to the cornea with direct exam at day 0

    Direct exam

    Day 0

  • Describe ophthalmologic damage to the cornea with direct exam at day 7

    Direct exam

    Day 7

  • Describe ophthalmologic damage to the cornea with direct exam at day 14

    Direct exam

    Day 14

  • Describe ophthalmologic damage to the cornea with direct exam at discharge of hospital

    Direct exam

    Discharge of hospital, up to 3 months

  • Describe ophthalmologic damage to the cornea with slit lamp exam at day 0

    Slit lamp exam

    Day 0

  • Describe ophthalmologic damage to the cornea with slit lamp exam at day 7

    Slit lamp exam

    Day 7

  • Describe ophthalmologic damage to the cornea with slit lamp exam at day 14

    Slit lamp exam

    Day 14

  • Describe ophthalmologic damage to the cornea with slit lamp exam at discharge of hospital

    Slit lamp exam

    Discharge of hospital, up to 3 months

  • Describe tear film anomalies at day 0

    Shirmer test

    Day 0

  • Describe tear film anomalies at day 7

    Shirmer test

    Day 7

  • Describe tear film anomalies at day 14

    Shirmer test

    Day 14

  • Describe tear film anomalies at discharge of hospital

    Shirmer test

    Discharge of hospital, up to 3 months

  • Describe ophthalmologic damage to the retina at day 0

    Retinophotography

    Day 0

  • Describe ophthalmologic damage to the retina at day 7

    Retinophotography

    Day 7

  • Describe ophthalmologic damage to the retina at day 14

    Retinophotography

    Day 14

  • Describe ophthalmologic damage to the retina at discharge of hospital

    Retinophotography

    Discharge of hospital, up to 3 months

  • Describe ophthalmologic damage to the optic nerve at day 0

    Retinophotography

    Day 0

  • Describe ophthalmologic damage to the optic nerve at day 7

    Retinophotography

    Day 7

  • Describe ophthalmologic damage to the optic nerve at day 14

    Retinophotography

    Day 14

  • Describe ophthalmologic damage to the optic nerve at discharge of hospital

    Retinophotography

    Discharge of hospital, up to 3 months

Study Arms (1)

Ophthalmologic exam

EXPERIMENTAL
Procedure: Ophthalmologic exam

Interventions

Ophthalmologic examPROCEDURE

Direct exam and Slit lamp exam Shirmer test Retinophotography At inclusion, day 7, day 14 and discharge from hospital

Ophthalmologic exam

Eligibility Criteria

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

You may qualify if:

  • patient SARS-CoV2 positive (RT-PCR or chest scanner)
  • hospitalized in intensive care

You may not qualify if:

  • traumatic lesion of the face or any other condition preventing any ophthalmological evaluation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondation Adolphe de Rothschild

Paris, 75019, France

Location

Related Publications (1)

  • Stephan S, Cohen F, Salviat F, Thevenin S, Devys JM, Cochereau I, Gabison E. Evaluation of the impact of intensive care support for COVID-19 on the ocular surface in a prospective cohort of 40 eyes. Ocul Surf. 2021 Oct;22:13-14. doi: 10.1016/j.jtos.2021.06.008. Epub 2021 Jun 23. No abstract available.

    PMID: 34174393RESULT

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

Study Officials

  • Jean Michel DEVYS, MD

    Fondation Adolphe de Rothschild

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 29, 2020

First Posted

May 13, 2020

Study Start

April 27, 2020

Primary Completion

July 29, 2020

Study Completion

July 29, 2020

Last Updated

January 6, 2026

Record last verified: 2020-11

Locations

FR(1)