The Talkingeyes & More project, carried out by Talkingeyes & More GmbH in Erlangen, focused on creating augmented‑ and virtual‑reality (AR/VR) solutions for optometric diagnostics and telemedicine. The core technical outcome was a VR system that quantitatively assesses binocular fusion across multiple gaze directions. This system was patented in the United States (patent No. 11,653,864) and received CE‑certification as a Class 1 medical device under the EU Medical Device Regulation (MDR). The certification process required extending the company’s existing quality management system to meet MDR specifications, and the device was subsequently integrated into the MedStage® web‑based patient‑record platform, enabling automatic storage of results and remote evaluation by ophthalmologists within the Talkingeyes® Collaboration Network.
Parallel to the fusion system, a smartphone‑based perimetry application was developed and validated against the gold‑standard Octopus G1 perimetry. In a study involving 19 healthy controls, 17 patients with ocular hypertension, 11 pre‑perimetric glaucoma, and 46 perimetric glaucoma subjects, the smartphone perimetry examined a 30° visual field with 59 test positions matching the Octopus G1 pattern. The mean sensitivity (MS) values showed a strong correlation (r = 0.815, p < 0.05) with the Octopus results. Test‑retest reliability was good (r = 0.591, p < 0.05) and intra‑individual correlation reached r = 0.693. These findings demonstrate that the VR‑based and smartphone‑based tools can reliably reproduce standard visual‑field measurements, supporting their use as home‑care diagnostics that can be remotely reviewed by clinicians.
Additional diagnostic modules were created, including a virtual‑reality Amsler grid and a binocular fusion test that can be administered via head‑mounted displays or smartphones. Usability studies with control participants and patients informed iterative refinements, and the results were documented as requirements for future medical‑device releases. A paper on “Improved diagnostics through virtual techniques” was published in the German ophthalmology journal Augenspiegel (March 2022), and the VR fusion system was presented at the DOG eye congress in Berlin in 2023. The project also produced several peer‑reviewed articles on VR applications for visual‑field assessment, mild traumatic brain injury detection, and stereopsis evaluation in post‑COVID patients.
Collaboration was central to the project’s success. The research was conducted in partnership with the Friedrich‑Alexander University Erlangen, Ludwig‑Maximilians‑University Munich (LMU), the Max‑Planck‑Institute (MPI), and the University of Tübingen. Each partner contributed expertise in regulatory science, software engineering, clinical validation, and data management. The project ran from early 2021 through September 2023, with key milestones such as the initiation of the internship on 1 April 2021, the completion of the regulatory requirements analysis, and the final integration of the diagnostic tools into the MedStage® platform. Funding was provided through a German research programme aimed at fostering digital health innovations, enabling the development of these AR/VR‑based optometric solutions and their transition toward marketable medical devices.
