Condition category
Infections and Infestations
Date applied
06/08/2020
Date assigned
07/08/2020
Last edited
07/08/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
The coronavirus disease of 2019 (COVID-19) is caused by the severe acute respiratory syndrome coronavirus 2 (SARS-COV-2). Since first reported in December 2019, COVID-19 has led to a global pandemic, spreading throughout the world. It is a new disease and the global medical community are still trying to understand how and why the virus makes people sick. Improving this understanding is crucial if effective treatments for this disease are to be developed.
Researchers know that, in COVID-19, the blood vessels of many organs become ‘sticky’, causing clots to form. These clots interfere with the function of the body and can cause serious complications such as pulmonary emboli (PE), stroke and heart attacks. The vessels may also become fragile and leaky causing bleeding.
It is often difficult to do tests specifically to look at the blood vessels in patients who are unwell. However, you can get a direct look at the vessels using a camera to take photographs of the back of the eye. This is known as fundal photography and many people have had this done at their optician or in clinics such as the Diabetic Eye Clinic. We would like to examine how COVID-19 affects the vessels at the back of the eye to help us understand the disease and how it might be more effectively treated.

Who can participate?
Members of the public can enter the study if they are:
• Aged ≥18 years, there is no upper age limit
• Seen in hospital for symptoms related to COVID-19
• Able to understand verbal and written English

What does the study involve?
The researchers will ask participants to do the following:
• Complete a consent form
• Have a bedside photograph taken of the back of each eye
• Permit clinical researchers to record some information about the severity of your illness
The bedside photographs take just a few seconds although there is a flash. Participants will not require dilating eye drops for the photographs. The photograph will remain in their clinical record, but clinical researchers will also analyse them.
If they are well enough, participants will be asked have to a more detailed eye scan known as optical coherence tomography (OCT). This involves going to a specialised department and is optional. The OCT scan involves looking into a different type of camera and doesn’t involve any radiation. It takes a few minutes to perform.
The researchers will also ask if they can access the records of fundal photographs participants have had in the past e.g. at their optician or at the Eye Hospital so that they can compare and analyse these.
They will ask to repeat the photographs (and OCT) in 4 weeks’ time with completion of a questionnaire about how participants found the examination. This is optional.

What are the possible benefits and risks of participating?
The photographs of the back of the eye may alert the doctors to problems with the blood vessels that may require treatment. The earlier this is detected, the better. In the longer term, information obtained from this research may lead to routine screening of fundal photographs for those who are unwell with COVID-19 and improvement in the understanding and treatment of COVID-19.
it may be somewhat annoying to have a photograph taken of the eyes when feeling unwell No harm is expected from the photograph. Similarly, there are no particular risks associated with OCT, but it can be wearisome to have an additional test when feeling unwell.

Where is the study run from?
Southmead Hospital (UK)

When is the study starting and how long is it expected to run for?
We will aim to start the study on 16th August 2020 pending regulatory approval. We expect the study to run for 4 months but this will depend on the prevalence of SARS-CoV-2 in the community.

Who is funding the study?
Study funds have been awarded from the Wellcome Trust via the Elizabeth Blackwell Institute Rapid Response Call (COVID-19), University of Bristol and the Department of Neurology Charitable Funds, Southmead Hospital, Bristol.

Who is the main contact?
Dr Claire Rice, C.M.Rice@bristol.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Dr Claire Rice

ORCID ID

https://orcid.org/0000-0002-9851-4426

Contact details

Clinical Neurosciences
Bristol Medical School
University of Bristol
Level 1 Learning and Research Building
Southmead Hospital
Bristol
BS10 5NB
United Kingdom
+44 (0)1174146695
c.m.rice@bristol.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

IRAS 286315

Study information

Scientific title

Visualising vasculopathy in COVID-19 using portable fundoscopy

Acronym

VisVasc COVID-19

Study hypothesis

Bedside, hand-held fundoscopy can be used to assess quantitatively the effects of COVID-19 on retinal vasculature.

Ethics approval

Not provided at time of registration

Study design

Single site observational feasibility study

Primary study design

Observational

Secondary study design

Feasibility study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

COVID-19 (SARS-CoV-2 infection)

Intervention

1. Perform bedside fundal photography with or without optical coherence tomography on patients with COVID-19 at baseline and 4 week follow up
2. Assess tolerability of bedside fundal photography by recording adverse events and using patient and clinician self-report intervention acceptability questionnaires
3. Quantify retinal vascular abnormalities and compare them with historical patient records and/ or age-matched controls
4. Analyse data to inform outcome measures to determine whether retinal vasculopathy predicts COVID-19 severity risk

Intervention type

Other

Phase

Drug names

Primary outcome measure

1. Safety of performing the study measured using adverse events reported throughout the study
2. Tolerability of the study measured using a modified version of participant and clinician self-report intervention acceptability questionnaire at a single time

Secondary outcome measures

1. Retinal vascular abnormalities will be quantified using proxy-Early Treatment Diabetic Retinopathy Study (ETDRS)/International Clinical Grading system grading of retinopathy and maculopathy and artificial intelligence software (e.g. EyeArt™) using fundal photography at baseline and 4 weeks
2. Macular and peripapillary retinal thickness and the thickness of the retinal layers will be analysed according to standard retinopathy parameters using optical coherence tomography data at baseline and 4 weeks (where available)

Overall trial start date

06/08/2020

Overall trial end date

05/08/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Emergency Department or hospital admission for symptoms related to COVID-19
2. Aged ≥18 years
3. Fluency in English

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30

Participant exclusion criteria

1. COVID-19 patients receiving palliative care
2. Eye disease precluding fundoscopy
3. Significant agitation precluding safe practice of fundoscopy

Recruitment start date

17/08/2020

Recruitment end date

16/12/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Southmead Hospital
Department of Neurology
Bristol
BS10 5NB
United Kingdom

Sponsor information

Organisation

North Bristol NHS Trust

Sponsor details

Level 2 Learning and Research Building
Southmead Hospital
Bristol
BS10 5NB
United Kingdom
+44 (0)1174149330
lindsey.lacey@nbt.nhs.uk

Sponsor type

Hospital/treatment centre

Website

https://www.nbt.nhs.uk/research-innovation

Funders

Funder type

Research organisation

Funder name

Wellcome Trust via Elizabeth Blackwell Institute, University of Bristol

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

International organizations

Location

United Kingdom

Funder name

Southmead Hospital

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date.

Intention to publish date

05/08/2022

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

07/08/2020: Trial’s existence confirmed by University of Bristol.