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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04385810
Other study ID # JDS_2020_13
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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