Covid19NCT04601012
OCTA Study: Retinal Vascular Changes in Patients With SARS-CoV-2 Infection
An observational study of Covid19, run by Federico II University at 1 site in Italy.
Trial summary
This study evaluates the retinal vascular features using optical coherence tomography angiography in patients that have been affected by COVID-19. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- Optical coherence tomography angiography
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 20 Sep 2020to 22 Oct 2020
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The participans were older than 18 years with previous diagnosis of COVID-19. They did not present other ophthalmological diseases.
Who may be able to join
- age older than 18 years
- diagnosis of previous COVID-19
- absence of previous ocular surgery, congenital eye disease, high myopia (>6 dioptres), actual or previous diagnosis of glaucoma, optic disc anomaly, macular or vitreoretinal diseases.
- absence of significant lens opacities, low-quality OCT and OCT-A images.
Who cannot join
- age younger than 18 years
- absence of previous diagnosis of COVID-19
- presence of previous ocular surgery, congenital eye disease, high myopia (>6 dioptres), actual or previous diagnosis of glaucoma, optic disc anomaly, macular or vitreoretinal diseases.
- presence of significant lens opacities, low-quality OCT and OCT-A images.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optical Coherence Tomography Angiography in Patients Affected by SARS-CoV-2 Infection: a Pilot Study
This study evaluates the retinal vascular features using optical coherence tomography angiography in patients that have been affected by COVID-19.
Read the detailed description
To investigate the potential role of optical coherence tomography angiography in identifying the changes in retinal vessel density in patients that have been affected by COVID-19.
The optical coherence tomography angiography represents a noninvasive diagnostic technique that allows a detailed analysis of retinal vascular features.
- Conditions
- Covid19
- Being tested
- Optical coherence tomography angiography
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical coherence tomography angiographyDiagnostic test
Each subject underwent optical coherence tomography angiography to evaluate the retinal vessel density.
| Study group | Role | What they receive |
|---|---|---|
| Patients with COVID19 | The patients with previous diagnosis of COVID19 Receives: Diagnostic Test: Optical coherence tomography angiography | |
| Control subjects | Healthy subjects without actual and previous ocular diseases Receives: Diagnostic Test: Optical coherence tomography angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
The measurements of retinal features in patients with previous diagnosis of COVID19, using optical coherence tomography angiography.
The parameter analyzed by optical coherence tomography angiography was: retinal vessel density
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2020
- Study start20 Sep 2020
- Primary completion20 Oct 2020
- Study completion22 Oct 2020
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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gilda Cennamo, Federico II University
- Investigators
- Gilda Cennamo, Principal investigator, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04601012
- Sponsor's protocol ID
- 2020/03
- Status last verified
- Oct 2020
- First submitted
- 22 Oct 2020
- Last updated
- 19 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Coherence Tomography Angiography in Patients Affected by SARS-CoV-2 Infection: a Pilot Study
- ClinicalTrials.gov ID
- NCT04601012
- Acronym / sponsor ID
- 2020/03
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 20 Sep 2020 (actual)
- Primary completion
- 20 Oct 2020 (actual)
- Study completion
- 22 Oct 2020 (actual)
- First posted
- 23 Oct 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.
This study evaluates the retinal vascular features using optical coherence tomography angiography in patients that have been affected by COVID-19.
Detailed description
To investigate the potential role of optical coherence tomography angiography in identifying the changes in retinal vessel density in patients that have been affected by COVID-19.
The optical coherence tomography angiography represents a noninvasive diagnostic technique that allows a detailed analysis of retinal vascular features.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with COVID19 | – | Diagnostic Test: Optical coherence tomography angiographyThe patients with previous diagnosis of COVID19 |
| Control subjects | – | Diagnostic Test: Optical coherence tomography angiographyHealthy subjects without actual and previous ocular diseases |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The participans were older than 18 years with previous diagnosis of COVID-19. They did not present other ophthalmological diseases.
Key inclusion criteria (4 listed)
- age older than 18 years
- diagnosis of previous COVID-19
- absence of previous ocular surgery, congenital eye disease, high myopia (>6 dioptres), actual or previous diagnosis of glaucoma, optic disc anomaly, macular or vitreoretinal diseases.
- absence of significant lens opacities, low-quality OCT and OCT-A images.
Key exclusion criteria (4 listed)
- age younger than 18 years
- absence of previous diagnosis of COVID-19
- presence of previous ocular surgery, congenital eye disease, high myopia (>6 dioptres), actual or previous diagnosis of glaucoma, optic disc anomaly, macular or vitreoretinal diseases.
- presence of significant lens opacities, low-quality OCT and OCT-A images.
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 |
|---|---|---|
| Optical coherence tomography angiographyEach subject underwent optical coherence tomography angiography to evaluate the retinal vessel density. | Diagnostic test | Control subjects, Patients with COVID19 |
Primary outcome
The measurements of retinal features in patients with previous diagnosis of COVID19, using optical coherence tomography angiography.
Time frame: one month
The parameter analyzed by optical coherence tomography angiography was: retinal vessel density
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 19 Jan 2021.
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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.
Gilda Cennamo principal investigator
Federico II University
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, run by Federico II University at 1 site in Italy.
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 4 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 19 Jan 2021. 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 Italy. 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?
The measurements of retinal features in patients with previous diagnosis of COVID19, using optical coherence tomography angiography. (time frame: one month). 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 19 Jan 2021.