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

Covid19 Clinical Trial

— DOCOV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04385810
• Other study ID #: JDS_2020_13
• Status: Completed
• Phase: N/A
• Start date: April 27, 2020
• Est. completion date: July 29, 2020

Study information

• Verified date: November 2020
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: July 29, 2020
• Est. primary completion date: July 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Covid19
• Sars-CoV2

Intervention

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

Locations

Country	Name	City	State
France	Fondation Adolphe de Rothschild	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

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