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

Sponsor
Fondation Ophtalmologique Adolphe de Rothschild (Other)
Overall Status
Completed
CT.gov ID
NCT04385810
Collaborator
(none)
23
1
1
3.1
7.5

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Ophthalmologic exam
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
23 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Description of Ophthalmologic Injuries in Intensive Care During the SARS-CoV2 Epidemic - COVID19
Actual Study Start Date :
Apr 27, 2020
Actual Primary Completion Date :
Jul 29, 2020
Actual Study Completion Date :
Jul 29, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ophthalmologic exam

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

Outcome Measures

Primary Outcome Measures

  1. Describe ophthalmologic damage to the cornea with direct exam at day 0 [Day 0]

    Direct exam

  2. Describe ophthalmologic damage to the cornea with direct exam at day 7 [Day 7]

    Direct exam

  3. Describe ophthalmologic damage to the cornea with direct exam at day 14 [Day 14]

    Direct exam

  4. Describe ophthalmologic damage to the cornea with direct exam at discharge of hospital [Discharge of hospital, up to 3 months]

    Direct exam

  5. Describe ophthalmologic damage to the cornea with slit lamp exam at day 0 [Day 0]

    Slit lamp exam

  6. Describe ophthalmologic damage to the cornea with slit lamp exam at day 7 [Day 7]

    Slit lamp exam

  7. Describe ophthalmologic damage to the cornea with slit lamp exam at day 14 [Day 14]

    Slit lamp exam

  8. Describe ophthalmologic damage to the cornea with slit lamp exam at discharge of hospital [Discharge of hospital, up to 3 months]

    Slit lamp exam

  9. Describe tear film anomalies at day 0 [Day 0]

    Shirmer test

  10. Describe tear film anomalies at day 7 [Day 7]

    Shirmer test

  11. Describe tear film anomalies at day 14 [Day 14]

    Shirmer test

  12. Describe tear film anomalies at discharge of hospital [Discharge of hospital, up to 3 months]

    Shirmer test

  13. Describe ophthalmologic damage to the retina at day 0 [Day 0]

    Retinophotography

  14. Describe ophthalmologic damage to the retina at day 7 [Day 7]

    Retinophotography

  15. Describe ophthalmologic damage to the retina at day 14 [Day 14]

    Retinophotography

  16. Describe ophthalmologic damage to the retina at discharge of hospital [Discharge of hospital, up to 3 months]

    Retinophotography

  17. Describe ophthalmologic damage to the optic nerve at day 0 [Day 0]

    Retinophotography

  18. Describe ophthalmologic damage to the optic nerve at day 7 [Day 7]

    Retinophotography

  19. Describe ophthalmologic damage to the optic nerve at day 14 [Day 14]

    Retinophotography

  20. Describe ophthalmologic damage to the optic nerve at discharge of hospital [Discharge of hospital, up to 3 months]

    Retinophotography

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fondation Adolphe de Rothschild Paris France 75019

Sponsors and Collaborators

  • Fondation Ophtalmologique Adolphe de Rothschild

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier:
NCT04385810
Other Study ID Numbers:
  • JDS_2020_13
First Posted:
May 13, 2020
Last Update Posted:
Nov 16, 2020
Last Verified:
Nov 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Fondation Ophtalmologique Adolphe de Rothschild
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 16, 2020