About Vedea
▎ Research Version — for clinical research purposes only ▎
This product is an investigational medical device and does not yet have a CE mark. Use is only permitted within the approved clinical trial.
Manufacturer / Sponsor Vedea B.V. Europalaan 400 3526 KS Utrecht The Netherlands Chamber of Commerce (KvK): 76188345 Phone: +31 85 250 2515 Email: info@vedea.com Web: http://www.vedea.com
This Research Version Vedea Amblyopia Therapy (VAT) is a digital therapy for children with amblyopia (lazy eye). The therapy is delivered via a smartphone in a VR headset (Google Cardboard compatible), 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 help documents.
Clinical Research:
Research Protocol: NL-010980 • PI-01.01/ OZR-2024-13
Latest Amendment: -
METC: Medical Research Ethics Committee Erasmus MC
METC Reference: tba
WMO Registration: WMO NL-010980
Research Site: The Rotterdam Eye Hospital (ROI)
Sponsor: Vedea 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 / 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 http://www.igj.nl.
Help & Contact: Research Helpdesk (questions regarding the use of the app or VR headset):
Email: support@vedea.com
Phone: +31 85 250 2515
Online: support.vedea.com
Opening hours: weekdays 09:00–17:00
Response time: we aim to respond immediately (via live chat) or within 2 business days for non-urgent queries.
Privacy and 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
Read our full Privacy Policy for Research Participants.
Participant Rights: As a participant (or 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 — version = build date
Last Update: 2026-04-01
Therapy App (VR): 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 iOS 16+
Hardware: Smartphone in Google Cardboard compatible VR headset. The current compatibility list can be found at support.vedea.com.
Open Source & Licenses: This app uses open-source components. The full list of licenses and attributions can be found here: 3rd-party-licenses
Documents:
Participant Information Sheet (PIS)
Informed Consent Form (ICF)
Instructions for Use (IFU)
Privacy Policy for Research Participants
