v1.0.1

RetinaLyze DR is an algorithm, which enables safe, efficient and fast investigation of potential pathological changes like minor black lesions on the retina, which could indicate early signs of eye disease like Diabetic Retinopathy (DR) in both clinical and retail settings. The purpose of the RetinaLyze DR algorithm is to make it accessible to perform and receive screenings for signs of Diabetic Retinopathy.

The algorithm analyzes fundus images and gives instant and easily understandable results. The entire process involves only the image from fundus cameras.

Before you continue reading about the RetinaLyze DR algorithm, it would be a great idea to familiarize yourself with the eye disease, Diabetic Retinopathy. Read more below.

What is RetinaLyze DR?

RetinaLyze DR is an algorithm in RetinaLyze that analyses a photograph of the retina, taken with a fundus camera, and find signs of changes (or lack of changes). If the system finds changes, the patient is referred to an eye specialist for further examination and treatment. Retinalyze DR is made to investigate the fundus image for the typical lesions of diabetic retinopathy like micro-aneurysms and minor hemorrhages.

How to use RetinaLyze DR

Who to investigate

Diabetes patients are the primary group of people, who at risk of getting Diabetic Retinopathy. Since diabetes is a slowly developing disease, up to 60% of the diabetes patients are not aware of their condition. Therefore, it may be a good idea to screen all patients/customers for DR, specifically from an age of 16 and upwards as is standard of care. There is a risk of false negatives and false positives when investigating younger patients. This can be avoided by using the ESB or attending an ophthalmologist.

Read about risk factors in the article about diabetic retinopathy here.

Initiating the analysis in the RetinaLyze WebApp

Please read the general Get Started guide before continuing, if you are new to the RetinaLyze Webapp.

Upload the fundus photo as usual (manually or automatically)
Initiate the analysis by clicking on "Run DR analysis"

Understanding the results

The result of the automated analysis is displayed in two parts.
One is a colour-representation of the severity of the changes found (Red, Yellow or Green), the other is an overlay showing the changes found (if any).

Colour summary of result

Green result

Green indicates that no pathological changes like minor black lesions on the retina have been found.

Yellow result

Yellow indicates minor black lesions have been found i.e. a few haemorrhages and/or micro-aneurysms which could indicate early signs of DR. The yellow result should be treated as a red result, if one or more of the following statements are true. The patient/client:

Shows a repeated yellow result over a period of 2-3 months.
Reports symptoms of Diabetic Retinopathy (dark spots in vision field, fluctuating or semi-permanent blurred vision)
Is diagnosed with Diabetes

Temporary haemorrhages (caused by feverish disease or heavy lifting) as well as image artefacts (causes of false positives), can also lead to a yellow result. Read this article to learn how ensure good image quality and avoid false positives. In general, keep in mind that the same quality is needed for manual and automated assessments.
If you are unsure, whether you're dealing with a false positive or a true positive, try recapturing the image or have the patient/client come in for a screening in 2-3 months.

If none of the above are true, treat the yellow result as a green result.

Red result

Red indicates that there are indications of lesions i.e. several haemorrhages and/or micro-aneurysms which could indicate early signs of DR.

DR overlay

The DR overlay marks changes, found by the algorithm, on the retina. The DR overlay is available through the 'Toggle DR-overlay'-button above the fundus images.

Above you see the same fundus image without markings (left) and with markings on the DR-related changes (right).

Communicating the results & Taking action

In general

The RetinaLyze DR algorithm and the result should be considered a tool for a screening or diagnostic process, and not a diagnosis in itself. A diagnosis for Diabetic Retinopathy, should always be carried out by an ophthalmologist during the subsequent full assessment of patients vision and general eye health in clinical settings.

The screening and information provided by the RetinaLyze DR algorithm does not replace a consultation with an ophthalmologist, who will be able to give the patient/client a more complete assessment of their vision and general eye health.

Green result

It's important to convey the following:

An investigation, not diagnosis, has been performed for indications of minor black lesions which could indicate early signs of DR.
No indication of minor black lesions which could indicate early signs of DR have been found and the client doesn't need to be referred to an ophthalmologist for further examination for DR.
If the client is already attending regular checkups with an ophthalmologist, has a scheduled appointment with an ophthalmologist, has been diagnosed with or treated for retinal eye-diseases or shows signs/has symptoms of eye diseases, they should keep attending their appointment(s) and/or seek medical attention, since green results may be false negatives.

An example of a formal communication of a Green result to the customer could be the following:

"RetinaLyze has performed an investigation for indications of minor black lesions which could indicate early signs of DR on a photo of your retina.

RetinaLyze DR looks for indications of lesions i.e. haemorrhages and/or micro-aneurysms which could indicate early signs of DR.

No immediate pathological changes were found which could indicate early signs of DR.

On the basis of this analysis, there has not been found any reason to contact an ophthalmologist earlier than already scheduled."

Yellow result

It's important to convey the following:

An investigation, not diagnosis, has been performed for indications of minor black lesions which could indicate early signs of DR.
A few pathological changes were found which could indicate early signs of DR.
If the patient is a diagnosed diabetic, they should contact their diabetes care provider, if they are not aware of the DR progression. If the patient is not a diagnosed diabetic, they should be invited to a new screening within 2-3 months.
If the client is already attending regular checkups with an ophthalmologist, has a scheduled appointment with an ophthalmologist, has been diagnosed with or treated for retinal eye-diseases or shows signs/has symptoms of eye diseases, they should keep attending their appointment(s) and/or seek medical attention, since green results may be false negatives.

An example of a formal communication of a Yellow result to the customer could be the following:

"RetinaLyze has performed an investigation for indications of minor black lesions which could indicate early signs of DR on a photo of your retina.

RetinaLyze DR looks for indications of lesions i.e. haemorrhages and/or micro-aneurysms which could indicate early signs of DR.

A few pathological changes were found which could indicate early signs of DR.

On the basis of this analysis, it is recommended to contact an ophthalmologist within months for further examination, if you are a diagnosed diabetic. If you do not have diabetes, you do not need to bring forward your visit to the ophthalmologist, but it is recommended to get the screening again in 2-3 months or discuss this with your ophthalmologist at your next routine visit."

Red result

It's important to convey the following:

An investigation, not diagnosis, has been performed for indications of minor black lesions which could indicate early signs of DR.
Pathological changes were found which could indicate early signs of DR.
The patient should schedule an appointment with an ophthalmologist within 6 months.
If the client notices symptoms of DR, they should seek medical attention earlier.
If the client is already attending regular checkups with an ophthalmologist, has a scheduled appointment with an ophthalmologist, has been diagnosed with or treated for retinal eye-diseases or shows signs/has symptoms of eye diseases, they should keep attending their appointment(s) and/or seek medical attention, since green results may be false negatives.

An example of a formal communication of a Red result to the customer could be the following:

"RetinaLyze has performed an investigation for indications of minor black lesions which could indicate early signs of DR on a photo of your retina.

RetinaLyze DR looks for indications of lesions i.e. haemorrhages and/or micro-aneurysms which could indicate early signs of DR.

A few pathological changes were found which could indicate early signs of DR.

On the basis of this analysis, it is recommended to contact an ophthalmologist within 6 months for further examination. If you notice symptoms of DR, please seek medical attention earlier.”