OdySight®

Intended use

OdySight® is a medical software intended for self-evaluation of the following visual parameters: near visual acuity and symptoms such as metamorphopsia and scotoma. The test results are transmitted to physician.

OdySight® doesn’t interpret the test results and it is not intended to diagnose but rather to help patients determine if they need to consult a physician for diagnosis and treatment.
Indications: OdySight® is indicated for adult patients aged 18 and over.

Product presentation

OdySight is a remote based medical monitoring system, which can be used by the patient remotely and can report results into a web dashboard at the clinical center, allowing the healthcare professional to identify those patients who need to come in for a visit and examination.

The app is prescribed to the patient by a healthcare professional.

It is intended for patients with eye disease that, from the point of view of the healthcare professional, would benefit from remote monitoring of visual parameters: near visual acuity or presence or progression of metamorphopsia and scotoma. It is to assist with the planning of follow up care between scheduled clinic visits.

OdySight is recommended for patients affected by eye disease requiring regular, close monitoring of vision, such as wet or dry forms of AMD at risk of neovascularization, diabetic retinopathy with or without macular edema, high myopia with risk of neovascularization and other similar, treatable causes of blindness.

OdySight doesn't interpret the test results and is not intended to diagnose. The diagnosis and patient treatment remain the responsibility of the physician.

OdySight does not replace regularly scheduled clinic visits to monitor eye diseases.

OdySight shall be prescribed to adult users who have:

1. Binocular vision equal to or better than 3/10 (0,5 logMAR; (20/63))
2. Access to a compatible smartphone and/or tablet
3. A valid email address and phone number to create an account
4. The competence to use the app and complete the test modules remotely, without the guidance of a healthcare professional

Contre-indications

OdySight app is contra-indicated for:

• epileptic users
• users with a binocular visual acuity of less than 3/10 (0.5 logMAR; 20/63)
• users with both eyes with monocular visual acuity lower than 1/10

Product description

OdySight is a digital technology system composed of two different components: the OdySight app for users and OdySight dashboard for healthcare professional.

The OdySight app is divided into the following modules:

• the Near Visual Acuity (NVA) module allows the user to test their visual acuity; based on the ETDRS (Early Treatment for Diabetic Retinopathy Study);
• the Amsler Grid (AG) module evaluates metamorphosis and scotomas; based on the paper Amsler grid;
• the authentication module allows users to securely connect to the OdySight application;
• the menu module allows for navigation within the OdySight app;
• the game and DLC modules: related to the puzzles which are designed for the retention of the user.

The OdySight online dashboard

Intended for the healthcare professional who prescribes the OdySight app to users. The healthcare professional can then view the results from the vision tests performed by users.

NB: The game module is not considered as a part of OdySight as medical device.

OdySight app

The application consists two parts: vision tests (visual acuity, Amsler grid), and a game (puzzles). The vision tests are intended to collect test results similar to those usually obtained in a medical center using standard methods.

The visual acuity test assesses near vision, while the Amsler grid test assesses the evolution of scotomas (black spots) and / or metamorphosis (deformation).

Near visual acuity and Amsler Grid tests in the OdySight app

OdySight Dashboard

The dashboard, intended for use by healthcare professionals, is a secure website for viewing the results of vision tests taken by their patients.

Product performance

OdySight allows the remote monitoring of visual parameters.

OdySight is a tool intended to complement your standard medical monitoring.

It does not replace visits and examinations prescribed by your physician, which you should continue to attend.

If the results of your tests seem to indicate the need, OdySight will advise you to contact your referring healthcare professional. Their contact details are recorded and can be accessed from the application.

This clinical investigational plan was designed to evaluate visual acuity, an important component of any eye examination and used to establish and monitor a patient's ocular status. Visual acuity is the most used visual parameter to characterize and follow up chronic optical diseases.

The vision tests have been compared and evaluated during a clinical study to standard tests performed in medical centers. The clinical study demonstrated that the visual acuity tests and the Amsler grid of OdySight have a significant accordance to the tests carried out in medical centers (gold standards used - the EDTRS Sloan near visual and distance ETDRS charts and paper Amsler Grid).

NB: Visual acuity alerts will be validated as part of clinical trials.

The color of paint splatters appearing in vision tests (visual acuity) is of purely artistic interest and does not indicate a right or wrong answer.

Every day, OdySight tells you which test has to be done and on which eye. On average, a test takes 5 minutes to complete.

This test allows you to unlock the fun part of the application. These game sessions are designed to be relatively short and not tire your eyes.

Visual acuity test

Visual acuity is the ability to discern the thinnest possible character with maximum contrast. In the monitoring and diagnosis of ocular diseases, we carry out this measure eye by eye using optimal optical correction (corrective lenses).

The international standard for vision tests is the ETDRS. The test used in OdySight is directly inspired by this reference.

For reasons of international compatibility, OdySight^® uses the version of the ETDRS with the "Tumbling E", which is already used in certain sight tests:

Near visual acuity, as calculated in OdySight, is tested at a set distance of 40 cm, one eye at a time, with glasses for near vision.

IMPORTANT: If the results of your tests seem to require it, OdySight will advise you to contact your physician. Please follow this advice.

Amsler grid test

The Amsler grid was created by Marc Amsler, a Swiss ophthalmologist, in 1945. It is a self-monitoring tool for maculopathies such as AMD and macula edema.

By staring at the center of the grid with one eye open at a set distance (around 40 cm), a person may see metamorphopsia (wavy lines) or scotoma (white, colored, or black patches) appear, which are symptoms of a change to an optical condition. In this case, monitoring by an ophthalmologist is required.

If, when taking the Amsler grid test on OdySight, you notice the appearance or deterioration of one of these anomalies, contact your physician immediately.

Security

Personal health data are made available to the physician on a dashboard. Such data including the results of the vision tests are hosted by a certified health data server in the European Union. The transmission of data by the server to the dashboard is secured and encrypted.