Description of Ophthalmologic Injuries in Intensive Care During the SARS-CoV2 Epidemic - COVID19 (DOCOV)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Paris, France, 75019
        • Fondation Adolphe de Rothschild

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ophthalmologic exam
Direct exam and Slit lamp exam Shirmer test Retinophotography At inclusion, day 7, day 14 and discharge from hospital

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Describe ophthalmologic damage to the cornea with direct exam at day 0
Time Frame: Day 0
Direct exam
Day 0
Describe ophthalmologic damage to the cornea with direct exam at day 7
Time Frame: Day 7
Direct exam
Day 7
Describe ophthalmologic damage to the cornea with direct exam at day 14
Time Frame: Day 14
Direct exam
Day 14
Describe ophthalmologic damage to the cornea with direct exam at discharge of hospital
Time Frame: Discharge of hospital, up to 3 months
Direct exam
Discharge of hospital, up to 3 months
Describe ophthalmologic damage to the cornea with slit lamp exam at day 0
Time Frame: Day 0
Slit lamp exam
Day 0
Describe ophthalmologic damage to the cornea with slit lamp exam at day 7
Time Frame: Day 7
Slit lamp exam
Day 7
Describe ophthalmologic damage to the cornea with slit lamp exam at day 14
Time Frame: Day 14
Slit lamp exam
Day 14
Describe ophthalmologic damage to the cornea with slit lamp exam at discharge of hospital
Time Frame: Discharge of hospital, up to 3 months
Slit lamp exam
Discharge of hospital, up to 3 months
Describe tear film anomalies at day 0
Time Frame: Day 0
Shirmer test
Day 0
Describe tear film anomalies at day 7
Time Frame: Day 7
Shirmer test
Day 7
Describe tear film anomalies at day 14
Time Frame: Day 14
Shirmer test
Day 14
Describe tear film anomalies at discharge of hospital
Time Frame: Discharge of hospital, up to 3 months
Shirmer test
Discharge of hospital, up to 3 months
Describe ophthalmologic damage to the retina at day 0
Time Frame: Day 0
Retinophotography
Day 0
Describe ophthalmologic damage to the retina at day 7
Time Frame: Day 7
Retinophotography
Day 7
Describe ophthalmologic damage to the retina at day 14
Time Frame: Day 14
Retinophotography
Day 14
Describe ophthalmologic damage to the retina at discharge of hospital
Time Frame: Discharge of hospital, up to 3 months
Retinophotography
Discharge of hospital, up to 3 months
Describe ophthalmologic damage to the optic nerve at day 0
Time Frame: Day 0
Retinophotography
Day 0
Describe ophthalmologic damage to the optic nerve at day 7
Time Frame: Day 7
Retinophotography
Day 7
Describe ophthalmologic damage to the optic nerve at day 14
Time Frame: Day 14
Retinophotography
Day 14
Describe ophthalmologic damage to the optic nerve at discharge of hospital
Time Frame: Discharge of hospital, up to 3 months
Retinophotography
Discharge of hospital, up to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jean Michel DEVYS, MD, Fondation Adolphe de Rothschild

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 27, 2020

Primary Completion (Actual)

July 29, 2020

Study Completion (Actual)

July 29, 2020

Study Registration Dates

First Submitted

April 29, 2020

First Submitted That Met QC Criteria

May 12, 2020

First Posted (Actual)

May 13, 2020

Study Record Updates

Last Update Posted (Estimated)

January 6, 2026

Last Update Submitted That Met QC Criteria

January 2, 2026

Last Verified

November 1, 2020

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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