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

Primary Purpose

Covid19, Sars-CoV2

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Ophthalmologic exam
Sponsored by
Fondation Ophtalmologique Adolphe de Rothschild
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Covid19 focused on measuring ophthalmological lesions

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fondation Adolphe de Rothschild

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ophthalmologic exam

Arm Description

Outcomes

Primary Outcome Measures

Describe ophthalmologic damage to the cornea with direct exam at day 0
Direct exam
Describe ophthalmologic damage to the cornea with direct exam at day 7
Direct exam
Describe ophthalmologic damage to the cornea with direct exam at day 14
Direct exam
Describe ophthalmologic damage to the cornea with direct exam at discharge of hospital
Direct exam
Describe ophthalmologic damage to the cornea with slit lamp exam at day 0
Slit lamp exam
Describe ophthalmologic damage to the cornea with slit lamp exam at day 7
Slit lamp exam
Describe ophthalmologic damage to the cornea with slit lamp exam at day 14
Slit lamp exam
Describe ophthalmologic damage to the cornea with slit lamp exam at discharge of hospital
Slit lamp exam
Describe tear film anomalies at day 0
Shirmer test
Describe tear film anomalies at day 7
Shirmer test
Describe tear film anomalies at day 14
Shirmer test
Describe tear film anomalies at discharge of hospital
Shirmer test
Describe ophthalmologic damage to the retina at day 0
Retinophotography
Describe ophthalmologic damage to the retina at day 7
Retinophotography
Describe ophthalmologic damage to the retina at day 14
Retinophotography
Describe ophthalmologic damage to the retina at discharge of hospital
Retinophotography
Describe ophthalmologic damage to the optic nerve at day 0
Retinophotography
Describe ophthalmologic damage to the optic nerve at day 7
Retinophotography
Describe ophthalmologic damage to the optic nerve at day 14
Retinophotography
Describe ophthalmologic damage to the optic nerve at discharge of hospital
Retinophotography

Secondary Outcome Measures

Full Information

First Posted
April 29, 2020
Last Updated
November 13, 2020
Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
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1. Study Identification

Unique Protocol Identification Number
NCT04385810
Brief Title
Description of Ophthalmologic Injuries in Intensive Care During the SARS-CoV2 Epidemic - COVID19
Acronym
DOCOV
Official Title
Description of Ophthalmologic Injuries in Intensive Care During the SARS-CoV2 Epidemic - COVID19
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
April 27, 2020 (Actual)
Primary Completion Date
July 29, 2020 (Actual)
Study Completion Date
July 29, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Ophtalmologique Adolphe de Rothschild

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Sars-CoV2
Keywords
ophthalmological lesions

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ophthalmologic exam
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Ophthalmologic exam
Intervention Description
Direct exam and Slit lamp exam Shirmer test Retinophotography At inclusion, day 7, day 14 and discharge from hospital
Primary Outcome Measure Information:
Title
Describe ophthalmologic damage to the cornea with direct exam at day 0
Description
Direct exam
Time Frame
Day 0
Title
Describe ophthalmologic damage to the cornea with direct exam at day 7
Description
Direct exam
Time Frame
Day 7
Title
Describe ophthalmologic damage to the cornea with direct exam at day 14
Description
Direct exam
Time Frame
Day 14
Title
Describe ophthalmologic damage to the cornea with direct exam at discharge of hospital
Description
Direct exam
Time Frame
Discharge of hospital, up to 3 months
Title
Describe ophthalmologic damage to the cornea with slit lamp exam at day 0
Description
Slit lamp exam
Time Frame
Day 0
Title
Describe ophthalmologic damage to the cornea with slit lamp exam at day 7
Description
Slit lamp exam
Time Frame
Day 7
Title
Describe ophthalmologic damage to the cornea with slit lamp exam at day 14
Description
Slit lamp exam
Time Frame
Day 14
Title
Describe ophthalmologic damage to the cornea with slit lamp exam at discharge of hospital
Description
Slit lamp exam
Time Frame
Discharge of hospital, up to 3 months
Title
Describe tear film anomalies at day 0
Description
Shirmer test
Time Frame
Day 0
Title
Describe tear film anomalies at day 7
Description
Shirmer test
Time Frame
Day 7
Title
Describe tear film anomalies at day 14
Description
Shirmer test
Time Frame
Day 14
Title
Describe tear film anomalies at discharge of hospital
Description
Shirmer test
Time Frame
Discharge of hospital, up to 3 months
Title
Describe ophthalmologic damage to the retina at day 0
Description
Retinophotography
Time Frame
Day 0
Title
Describe ophthalmologic damage to the retina at day 7
Description
Retinophotography
Time Frame
Day 7
Title
Describe ophthalmologic damage to the retina at day 14
Description
Retinophotography
Time Frame
Day 14
Title
Describe ophthalmologic damage to the retina at discharge of hospital
Description
Retinophotography
Time Frame
Discharge of hospital, up to 3 months
Title
Describe ophthalmologic damage to the optic nerve at day 0
Description
Retinophotography
Time Frame
Day 0
Title
Describe ophthalmologic damage to the optic nerve at day 7
Description
Retinophotography
Time Frame
Day 7
Title
Describe ophthalmologic damage to the optic nerve at day 14
Description
Retinophotography
Time Frame
Day 14
Title
Describe ophthalmologic damage to the optic nerve at discharge of hospital
Description
Retinophotography
Time Frame
Discharge of hospital, up to 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Michel DEVYS, MD
Organizational Affiliation
Fondation Adolphe de Rothschild
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fondation Adolphe de Rothschild
City
Paris
ZIP/Postal Code
75019
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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