Product/Device Description


The app is intended for use by competent/capable adults as a self-test at home to aid in the characterisation of the central vision and metamorphopsia (visual distortion) and as an aid in monitoring changes in central vision and metamorphopsia (e.g. due to disease deterioration or treatments) in patients with (or at risk of) maculopathies. For common medical indications refer to the clinical indications section.

The app gathers visual function data from on-screen puzzle games, with which the user interacts. By analysing the user's interactions, the app generates visual scores. Patients are advised to use the app in a well-lit environment with minimal distractions. If they typically wear glasses for reading, they should wear them during the evaluation. Patients are instructed to use the app at a distance within the range 30 - 40 cm from the screen, with this guidance provided during the app's interactive automatic onboarding process.


For the characterisation of central vision akin to visual acuity, the app uses vanishing optotypes within a gamified environment, allowing it to measure visual acuity without relying on traditional eye chart letters. The user is asked to tap all of the circles that are visible.


For the characterisation of metamorphopsia (distortion), the app uses a ring of dots requesting the user to click on the spot which is sitting outside the circle. The app analyses the response to the interactions made.


The OKKO Health App provides outputs both to the patient and to the prescribing eye care professional via the Clinician Dashboard (a medical device accessory). This dashboard enables clinicians to view and manage data for their registered patients and must be used according to the product’s Instructions for Use for eye care professionals.


The OKKO Health App is an adjunct to clinical care and the purpose of the product is two-fold:

  1. Collecting vision data: by capturing screen interactions with presented images, the OKKO Health App derives a score based upon the responses. The OKKO Health App presents this score data longitudinally in a graphical format. This is visualised within the mobile device OKKO Health App itself, but can also be shared and visualised with the eye care professional. 
  2. Providing educational material: Providing relevant educational material to promote the patient’s health literacy and empowerment about their eye condition. The app provides push notifications that the patient can click on in order to engage in relevant content.

2 Intended Purpose/ Intended Use

OKKO Health App is intended for the collection and visualisation of data related to visual function. Specifically, the characterisation of the central vision and metamorphopsia (visual distortion) and as an aid in monitoring changes in central vision and metamorphopsia (e.g. due to disease deterioration or treatments) in patients with (or at risk of) maculopathies. OKKO Health is intended to be used by patients on a mobile device with the capability to regularly perform a simple self-test at home and by their healthcare provider who has access to the test results.


OKKO Health App is NOT intended to detect, diagnose, prevent, treat, or mitigate any disease or medical condition; diagnosis and clinical decision-making remain the responsibility of the healthcare provider.


Limitations of Use, data provided by OKKO Health is not to be used as the basis to postpone or cancel regular appointments with healthcare providers.


Clinical Indications

The OKKO Health App is intended to be used by adults over 18 and with or at risk of maculopathy. Common medical indications include:

  • Disorder of the macula (SCTID 422338006), including for example:


Age-related macular degeneration (SCTID 267718000)


Macular retinal edema (disorder) SCTID: 37231002



Contraindications

Caution (and clinical judgement) should be used when prescribing OKKO in the case of:

  1. Very high risk of Retinal detachment (SCTID 42059000)
  2. Conditions where the visual acuity in both eyes is expected to be worse than 1.0 logMAR


The OKKO Health App data is NOT intended to replace any aspect of the clinical examination or appointments with eyecare professionals.

Intended Population / Intended Users

The OKKO Health App is intended to be used by adults over 18 and with or at risk of reduced central vision or metamorphopsia (distortion) due to maculopathy.

The intended patient/user population is regularly under the care of an eye care professional.

Patient/user state:

  1. Patient is a user: alert, mentally competent.
  2. Patients/users should be familiar with smartphone/tablets and are able to tap on the screen and interact with the mobile device application.
  3. The patient/user has competent dexterity to use a mobile device.
  4. Patient/user has normal or corrected hearing to normal audio level.
  5. Patient/user is capable of comprehending instructions in English language (or other languages as applicable

Intended Use Environment

The OKKO Health App can be used anywhere that it is safe to use your mobile device, a distraction free usage of the OKKO Health App is expected.


It is recommended that patients use the OKKO Health App in a distraction free well-lit environment. If a patient typically wears glasses to read, they are asked to wear these during the evaluation period. Patients are asked to play the OKKO Health App at a range 30 - 40 cm distance from the screen. This instruction takes place during interactive automatic onboarding within the app.

The OKKO Health App needs internet connectivity (data plan or wifi) for data transmission. The regular use of the product does not require the internet for operation.

The OKKO Health App is designed for use on smartphones or tablets that run on Android or iOS:

  1. The OKKO Health application supports most smartphones running Android 9 or later, and iOS 13 or later (this means that iPhone 6 and earlier models are not supported, as they run on IOS 12).
  2. Have screen pixel density of at least 250 pixels per inch and physical width of at least 5.5cm.
  3. Have a physical screen brightness within a usable and comfortable range within typical environments (as permitted within the phone).
  4. Do not have additional artificial screen magnification or increased screen contrast/screen colour modifications enabled while using the app.
  5. OKKO Health App is not permitted on foldable devices.

Warnings

  1. Do not use for diagnosis of new or existing eye problems.
  2. Do not use if your screen/screen protector is damaged as this may affect results.
  3. Make sure screen modes on your device that affect the screen brightness and/or colours are switched off, as they may affect results - find instructions on how to turn off these screen modes here.
  4. Do not use screen magnification or increased screen contrast or have screen colour modifications enabled while using the app, as this may affect results.
  5. Do not use your account on more than one device (choose one device you'd like to use for the OKKO Health app).
  6. Do not allow others to use your account as this will affect your health results.
  7. Do not use the app if you do not meet the criteria stated in the Indications for Use section above.
  8. Do not use the app to replace appointments with your eye care professional.
  9. Do not let advice in the app override advice provided by your eye care professional.

Precautions

  1. Consult your eye care professional if you feel your vision has deteriorated, regardless of the app results.
  2. This device is non-interventional and non-decision making.
  3. This device does not act as a replacement for appointments with eye care professionals.
  4. This device app requires a compatible, functioning mobile device with a compatible iOS or Android operating system (see list of compatible devices and operating systems here.
  5. Ensure you have read and understood these Instructions for Use and follow all in-app instructions on how to play correctly.

Benefits of the OKKO Health App

  1. The OKKO Health App enables users/patients to perform a simple self-assessment of their visual function from the comfort of their home using a portable mobile device.
  2. The app facilitates access to visual function data, supporting eye care professionals and healthcare providers in monitoring and managing patient eye health.

Recommendations

The OKKO Health App can be used anywhere that it is safe to use your mobile phone, at any time when you have enough free time to use the application without getting distracted.

It is recommended that users use the OKKO Health App in a well-lit environment with minimal distractions. A well-lit environment means a room with daylight, or neutral overhead lighting. You should avoid bright reflections on the device screen (for example, with the sun entering a window behind you), coloured lighting, very dark rooms, or using the app outside on a bright day. Make sure that your environment is calm - for example, do not play near dangerous areas, while supervising children or animals, or while operating machinery.

If a user typically wears glasses to read, they are asked to wear these during the evaluation period. Users are asked to play the OKKO Health App at 30-40cm distance from the screen.

If there is no internet connection, a measurement can still be performed, but the measurement analysis will only be available after the connection has been restored as the information must be sent to the cloud for proper analysis. If offline data is stored in the app, the next time the user visits the Home Screen they are prompted to send unsubmitted data to the server. If the user’s device is connected to the internet, the data will be sent successfully. If it is not connected to the internet, users will continue being prompted to send unsubmitted data until there is no offline data stored.

Compatibility

The OKKO Health mobile app is designed for use on smartphones or tablets that:

  1. Have screen pixel density of at least 250 pixels per inch, but below 600 pixels per inch, and a screen resolution width of at least 750 pixels and physical width of at least 5.5cm
  2. Have a physical screen brightness within a usable and comfortable range within typical environments.
  3. Do not have screen magnification or increased screen contrast/screen colour modifications enabled while using the app.