Covid19DOCOVNCT04385810
Description of Ophthalmologic Injuries in Intensive Care During the SARS-CoV2 Epidemic - COVID19
A study testing Ophthalmologic exam in people with Covid19 and Sars-CoV2, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Ophthalmologic exam
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteFrance
- Study dates
- 27 Apr 2020to 29 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient SARS-CoV2 positive (RT-PCR or chest scanner)
- hospitalized in intensive care
Who cannot join
- traumatic lesion of the face or any other condition preventing any ophthalmological evaluation
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Ophthalmologic exam
- Keywords
- ophthalmological lesions
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ophthalmologic examProcedure or surgery
Direct exam and Slit lamp exam Shirmer test Retinophotography At inclusion, day 7, day 14 and discharge from hospital
| Study group | Role | What they receive |
|---|---|---|
| Ophthalmologic exam | Experimental | Not described Receives: Procedure: Ophthalmologic exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Describe ophthalmologic damage to the cornea with direct exam at day 0
Direct exam
Measured: Day 0
Describe ophthalmologic damage to the cornea with direct exam at day 7
Direct exam
Measured: Day 7
Describe ophthalmologic damage to the cornea with direct exam at day 14
Direct exam
Measured: Day 14
Describe ophthalmologic damage to the cornea with direct exam at discharge of hospital
Direct exam
Measured: Discharge of hospital, up to 3 months
Describe ophthalmologic damage to the cornea with slit lamp exam at day 0
Slit lamp exam
Measured: Day 0
Describe ophthalmologic damage to the cornea with slit lamp exam at day 7
Slit lamp exam
Measured: Day 7
Describe ophthalmologic damage to the cornea with slit lamp exam at day 14
Slit lamp exam
Measured: Day 14
Describe ophthalmologic damage to the cornea with slit lamp exam at discharge of hospital
Slit lamp exam
Measured: Discharge of hospital, up to 3 months
Describe tear film anomalies at day 0
Shirmer test
Measured: Day 0
Describe tear film anomalies at day 7
Shirmer test
Measured: Day 7
Describe tear film anomalies at day 14
Shirmer test
Measured: Day 14
Describe tear film anomalies at discharge of hospital
Shirmer test
Measured: Discharge of hospital, up to 3 months
Describe ophthalmologic damage to the retina at day 0
Retinophotography
Measured: Day 0
Describe ophthalmologic damage to the retina at day 7
Retinophotography
Measured: Day 7
Describe ophthalmologic damage to the retina at day 14
Retinophotography
Measured: Day 14
Describe ophthalmologic damage to the retina at discharge of hospital
Retinophotography
Measured: Discharge of hospital, up to 3 months
Describe ophthalmologic damage to the optic nerve at day 0
Retinophotography
Measured: Day 0
Describe ophthalmologic damage to the optic nerve at day 7
Retinophotography
Measured: Day 7
Describe ophthalmologic damage to the optic nerve at day 14
Retinophotography
Measured: Day 14
Describe ophthalmologic damage to the optic nerve at discharge of hospital
Retinophotography
Measured: Discharge of hospital, up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study start27 Apr 2020
- Primary completion29 Jul 2020
- Study completion29 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Jean Michel DEVYS, MD, Principal investigator, Fondation Adolphe de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04385810
- Sponsor's protocol ID
- JDS_2020_13
- Acronym
- DOCOV
- Status last verified
- Nov 2020
- First submitted
- 29 Apr 2020
- Last updated
- 6 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Description of Ophthalmologic Injuries in Intensive Care During the SARS-CoV2 Epidemic - COVID19
- ClinicalTrials.gov ID
- NCT04385810
- Acronym / sponsor ID
- DOCOV / JDS_2020_13
- Keywords
- ophthalmological lesions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 27 Apr 2020 (actual)
- Primary completion
- 29 Jul 2020 (actual)
- Study completion
- 29 Jul 2020 (actual)
- First posted
- 13 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ophthalmologic exam | Experimental | Procedure: Ophthalmologic exam |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patient SARS-CoV2 positive (RT-PCR or chest scanner)
- hospitalized in intensive care
Key exclusion criteria (1 listed)
- traumatic lesion of the face or any other condition preventing any ophthalmological evaluation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ophthalmologic examDirect exam and Slit lamp exam Shirmer test Retinophotography At inclusion, day 7, day 14 and discharge from hospital | Procedure or surgery | Ophthalmologic exam |
Primary outcome
Describe ophthalmologic damage to the cornea with direct exam at day 0
Time frame: Day 0
Direct exam
Describe ophthalmologic damage to the cornea with direct exam at day 7
Time frame: Day 7
Direct exam
Describe ophthalmologic damage to the cornea with direct exam at day 14
Time frame: Day 14
Direct exam
Describe ophthalmologic damage to the cornea with direct exam at discharge of hospital
Time frame: Discharge of hospital, up to 3 months
Direct exam
Describe ophthalmologic damage to the cornea with slit lamp exam at day 0
Time frame: Day 0
Slit lamp exam
Describe ophthalmologic damage to the cornea with slit lamp exam at day 7
Time frame: Day 7
Slit lamp exam
Describe ophthalmologic damage to the cornea with slit lamp exam at day 14
Time frame: Day 14
Slit lamp exam
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
Describe tear film anomalies at day 0
Time frame: Day 0
Shirmer test
Describe tear film anomalies at day 7
Time frame: Day 7
Shirmer test
Describe tear film anomalies at day 14
Time frame: Day 14
Shirmer test
Describe tear film anomalies at discharge of hospital
Time frame: Discharge of hospital, up to 3 months
Shirmer test
Describe ophthalmologic damage to the retina at day 0
Time frame: Day 0
Retinophotography
Describe ophthalmologic damage to the retina at day 7
Time frame: Day 7
Retinophotography
Describe ophthalmologic damage to the retina at day 14
Time frame: Day 14
Retinophotography
Describe ophthalmologic damage to the retina at discharge of hospital
Time frame: Discharge of hospital, up to 3 months
Retinophotography
Describe ophthalmologic damage to the optic nerve at day 0
Time frame: Day 0
Retinophotography
Describe ophthalmologic damage to the optic nerve at day 7
Time frame: Day 7
Retinophotography
Describe ophthalmologic damage to the optic nerve at day 14
Time frame: Day 14
Retinophotography
Describe ophthalmologic damage to the optic nerve at discharge of hospital
Time frame: Discharge of hospital, up to 3 months
Retinophotography
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Results publication: PubMed 34174393Stephan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean Michel DEVYS, MD principal investigator
Fondation Adolphe de Rothschild
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ophthalmologic exam in people with Covid19 and Sars-CoV2, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Describe ophthalmologic damage to the cornea with direct exam at day 0 (time frame: Day 0). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04385810, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.