- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04385810
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
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Paris, France, 75019
- Fondation Adolphe de Rothschild
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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
Investigators
- Principal Investigator: Jean Michel DEVYS, MD, Fondation Adolphe de Rothschild
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- JDS_2020_13
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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