CompletedNCT04385810DOCOVUpdated Jan 6, 2026

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

An interventional study of Ophthalmologic exam in Covid19 and Sars-CoV2, sponsored by Fondation Ophtalmologique Adolphe de Rothschild. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-06.

Sponsored by Fondation Ophtalmologique Adolphe de Rothschild · Not applicable, Interventional, and Prevention

Phase: Not applicable
Study type: Interventional
Enrollment: 23
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study 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

Conditions studied

Covid19
Sars-CoV2

Browse trials for

COVID-19 7,640

Keywords

ophthalmological lesions

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 23 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.

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Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild is the lead sponsor of 311 studies on the registry; 77 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

patient SARS-CoV2 positive (RT-PCR or chest scanner)
hospitalized in intensive care

Exclusion criteria

Exclusion Criteria:

traumatic lesion of the face or any other condition preventing any ophthalmological evaluation

Study design

Phase: Not applicable
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 23 participants (actual)

Study arms

Experimental
Ophthalmologic exam
Procedure: Ophthalmologic exam

Interventions

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

What researchers measure

Primary outcomes

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

Study locations

1 site

Fondation Adolphe de Rothschild
Paris, 75019, France

References and documents

Publications

Stephan S, Cohen F, Salviat F, Thevenin S, Devys JM, Cochereau I, Gabison E. Evaluation of the impact of intensive care support for COVID-19 on the ocular surface in a prospective cohort of 40 eyes. Ocul Surf. 2021 Oct;22:13-14. doi: 10.1016/j.jtos.2021.06.008. Epub 2021 Jun 23. No abstract available. PubMed 34174393 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04385810
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Responsible party: Sponsor
First posted: May 13, 2020
Start date: Apr 27, 2020
Primary completion: Jul 29, 2020
Completion: Jul 29, 2020
Last update: Jan 6, 2026

Study contacts

Jean Michel DEVYS, MD

principal investigator · Fondation Adolphe de Rothschild

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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