Covid19NCT04881253
COVID-19 Patient Cohort: Retinal Damage in Non-invasive Retinal Imaging (OCTA)
An observational study of Covid19 and Retina Injury, run by Centre Hospitalier Intercommunal Creteil at 1 site in France.
Trial summary
The objective of this research is to build a collection of non-invasive retinal imaging (OCT and OCTA) in order to investigate the incidence and impact of retinal damage in patients who have or have had COVID-19. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Retina Injury
- How many people
- 23 participants
- Where
- 1 siteFrance
- Study dates
- 5 Nov 2021to 17 Jan 2023
- Phase
- Observational
- 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
Study population: Inpatients with COVID-19, patients who were hospitalised for COVID-19 and patients with COVID-19 who did not require hospitalisation
Who may be able to join
- Age ≥ 18 years old
- Diagnosis of COVID-19 proven on RT-PCR, antigenic test or chest CT scan
- Affiliation to the general social security system
- A consent signed by the patient
Who cannot join
- Refusal of patient participation
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this research is to build a collection of non-invasive retinal imaging (OCT and OCTA) in order to investigate the incidence and impact of retinal damage in patients who have or have had COVID-19.
Read the detailed description
This monocentric study is aimed at 3 types of patients:
- Those who have been hospitalized for Covid-19 during the epidemic
- Newly infected and diagnosed patients Covid-19
- Those with paucisymptomatic Covid-19 who did not require hospitalisation
At the patient's inclusion, an ophthalmologic assessment will be performed including :
- visual acuity,
- SD-OCT + multicolor,
- OCT-A,
- color retinography,
Fundus examination, optical coherence tomography (OCT) and optical coherence tomography angiography (OCTA) in all COVID-19 patients may detect retinal lesions. In addition, if a correlation is demonstrated between clinical and paraclinical parameters and between disease severity and retinal vascular damage in non-invasive imaging (OCT and OCTA), this would allow a better understanding of the pathophysiology of the disease, as well as factors that may influence disease severity and the mechanisms potentially responsible for the observed disorders.
- Conditions
- Covid19, Retina Injury
- Keywords
- OCT-A, OCT
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal damage at inclusion after Covid-19 infection
Comparison of retinal damage in patients with patients with severe forms of Covid-19 versus patients with mild forms of the disease
Measured: Up to one week after inclusion
Secondary outcomes (3)
Change of retinal vascular density at inclusion after Covid-19 infection
Comparison of retinal damage in patients with severe forms of Covid-19 versus patients with mild forms of the disease
Measured: Up to one week after inclusion
Impact of retinal vascular density changes on visual acuity at inclusion
Severity and impact of retinal damage
Measured: Up to one week after inclusion
Presence of Retinal toxicity (atrophy) on multimodal retinal imagery
Correlation between the presence of changes in multimodal imaging (fundus autofluorescence, multicolor and OCTA) and the associated antiviral treatment for Covid-19.
Measured: Up to one week after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2021
- Study start5 Nov 2021
- Primary completion17 Jan 2023
- Study completion17 Jan 2023
Why it stopped: End of covid crisis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04881253
- Sponsor's protocol ID
- COVID-RET
- Status last verified
- Aug 2025
- First submitted
- 2 Nov 2020
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 Patient Cohort: Retinal Damage in Non-invasive Retinal Imaging (OCTA)
- ClinicalTrials.gov ID
- NCT04881253
- Acronym / sponsor ID
- COVID-RET
- Conditions
- Covid19, Retina Injury
- Keywords
- OCT-A, OCT
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: End of covid crisis
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- Study start
- 5 Nov 2021 (actual)
- Primary completion
- 17 Jan 2023 (actual)
- Study completion
- 17 Jan 2023 (actual)
- First posted
- 11 May 2021 (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 objective of this research is to build a collection of non-invasive retinal imaging (OCT and OCTA) in order to investigate the incidence and impact of retinal damage in patients who have or have had COVID-19.
Detailed description
This monocentric study is aimed at 3 types of patients:
- Those who have been hospitalized for Covid-19 during the epidemic
- Newly infected and diagnosed patients Covid-19
- Those with paucisymptomatic Covid-19 who did not require hospitalisation
At the patient's inclusion, an ophthalmologic assessment will be performed including :
- visual acuity,
- SD-OCT + multicolor,
- OCT-A,
- color retinography,
Fundus examination, optical coherence tomography (OCT) and optical coherence tomography angiography (OCTA) in all COVID-19 patients may detect retinal lesions. In addition, if a correlation is demonstrated between clinical and paraclinical parameters and between disease severity and retinal vascular damage in non-invasive imaging (OCT and OCTA), this would allow a better understanding of the pathophysiology of the disease, as well as factors that may influence disease severity and the mechanisms potentially responsible for the observed disorders.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inpatients with COVID-19, patients who were hospitalised for COVID-19 and patients with COVID-19 who did not require hospitalisation
Key inclusion criteria (4 listed)
- Age ≥ 18 years old
- Diagnosis of COVID-19 proven on RT-PCR, antigenic test or chest CT scan
- Affiliation to the general social security system
- A consent signed by the patient
Key exclusion criteria (1 listed)
- Refusal of patient participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Retinal damage at inclusion after Covid-19 infection
Time frame: Up to one week after inclusion
Comparison of retinal damage in patients with patients with severe forms of Covid-19 versus patients with mild forms of the disease
3 secondary outcomes
Change of retinal vascular density at inclusion after Covid-19 infection
Time frame: Up to one week after inclusion
Impact of retinal vascular density changes on visual acuity at inclusion
Time frame: Up to one week after inclusion
Presence of Retinal toxicity (atrophy) on multimodal retinal imagery
Time frame: Up to one week after inclusion
Results and safety
The study was stopped early (reason given: End of covid crisis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Retina Injury, run by Centre Hospitalier Intercommunal Creteil 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 4 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: stopped early, as of the sponsor's last update on 2 Sep 2025. 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 was stopped early (reason given: End of covid crisis). Results are not available in the source record.
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?
Retinal damage at inclusion after Covid-19 infection (time frame: Up to one week after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Sep 2025.