About Vedea Parent App

EXCLUSIVELY FOR CLINICAL INVESTIGATION — not CE-marked

This product is an investigational medical device and does not yet have a CE mark. Use is only permitted within the approved clinical trial. Follow the instructions of your investigating clinician.

Device & Manufacturer Identification

Device trade name: Vedea Amblyopia Therapy (VAT)
UDI-DI (VAT Therapy App): 8720938514005

Investigational Version (Therapy / Game App): 2.0
Parent App release (PWA): Last Update 2026-06-06
Clinical investigation reference: Trial 2 · NL-010980 / OZR-2024-13

Manufacturer: Vedea Healthware B.V.
Address:Europalaan 400, 3526 KS Utrecht, The Netherlands

Chamber of Commerce (KvK): 76188345

Phone: +31 85 250 2515
Email: info@vedea.com
Web: www.vedea.com
Instructions for Use: www.vedea.com/ifu
User support: support.vedea.com

About the Device

This Vedea Amblyopia Therapy (VAT) Research Version is a digital therapy for children with amblyopia (lazy eye). The therapy is delivered via a smartphone in a Google Cardboard compatible VR headset, in combination with this companion app for parents.

In this research phase, VAT is used to further substantiate effectiveness and safety. The therapy is always prescribed and supervised by an ophthalmologist or orthoptist.

What This App Does

View progress, contact the support team, access patient information (playtime monitoring), and access help documents.

Clinical Research

• Research Protocol: NL-010980 · PI-01.01 / OZR-2024-13

• METC: Medical Research Ethics Committee Erasmus MC

• WMO Registration: WMO NL-010980

• Research Site: The Rotterdam Eye Hospital (ROI)

• Sponsor: Vedea Healthware B.V., Utrecht

The study is conducted in accordance with ICH-GCP, ISO 14155, and MDR 2017/745 Article 62.

For full participant information and the signed Informed Consent Form (ICF): see Documents in the menu of this app.

Reporting Serious Adverse Events

If anything occurs during or after a therapy session that concerns you, such as persistent headache, nausea, double vision, or any other unexpected event, please contact:

• Email: support@vedea.com

• Phone: +31 85 250 2515

• Or via the treating ophthalmologist or orthoptist at The Rotterdam Eye Hospital

For questions or concerns outside of the research team, you may contact the independent physician listed in your Participant Information Sheet (PIS). You may also report incidents directly to the Dutch Health and Youth Care Inspectorate (IGJ) via www.igj.nl.

Help & Contact

Research Helpdesk for questions on use of the app or VR headset:

• Email: support@vedea.com

• Phone: +31 85 250 2515

• Online: support.vedea.com

Opening hours: weekdays 09:00 to 17:00. We aim to respond immediately via live chat, or within 2 business days for non-urgent queries.

Privacy & Your Data

Vedea processes your child's personal data exclusively within the approved research protocol, in accordance with the General Data Protection Regulation (GDPR) and ICH-GCP. Data is stored on servers within the European Union.

Privacy inquiries: info@vedea.com. See our full Privacy Policy for Research Participants.

Participant Rights

As a participant, or as the legal representative of a participant, you have the right to:

• Withdraw your consent at any time, without providing a reason

• Access the data collected about your child

• Request correction or deletion of data, insofar as research methodology permits

• Ask questions to an independent physician not involved in the study

To exercise these rights, email info@vedea.com or contact the research team.

Technical Information

• Parent Application: Progressive Web App. Release identifier: deployment timestamp (Last Update above) plus git commit SHA recorded under SOP-201

• Therapy App (Game App): Android application, distributed via Google Play Store

• UDI-DI Therapy App: 8720938514005

• Supported OS (Therapy App): Android 13 or higher

• Supported OS (Parent App): Android 13 or higher, or iOS 16 or higher

• Hardware: Smartphone in a Google Cardboard compatible VR headset. Current compatibility list at support.vedea.com

Open Source & Licenses

This app uses open-source components. The full list of licenses and attributions: 3rd-party-licenses.

Documents

• Participant Information Sheet (PIS)

• Informed Consent Form (ICF)

• Instructions for Use (IFU)

• Privacy Policy for Research Participants

This product does not have a CE mark and is not commercially available. Use exclusively within the approved clinical trial.