Millions of people worldwide suffer from wet age-related macula degeneration (wAMD), imparing the central part of vision and potentially leading to blindness. The state-of-the-art treatment consists of injecting anti-vascular endothelial growth factor (anti-VEGF) into the eyeball every 1-6 months. Although the timing of those injections is crucial for best possible treatment outcome, there is currently no reliable means for the treating physician to define upfront when a next injection is requried.
Helbling has supported Kubota Vision in developing a low-cost device to monitor the disease progression and enable ideal timing of anti-VEGF injections. The retinal monitor system consists of a handheld device operated by the patient, a tablet with an application, and cloud software. The small form factor, the lightweight design and an auto-capture functionality enable patients to operate the retinal monitor on their own.
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Key Figures
- From ideation to clinical devices
- Handheld device, tablet and cloud software
- ISO 13485 compliant development
- Deep neural network for retinal thickness extraction and fluid detection
Our Contribution
- Responsible for all engineering disciplines, incl. system engineering
- Development of novel swept-source optical coherence tomography technology based on VCSEL
- Product development of the retinal monitor, the tablet app and the cloud implementation
- From proof-of-concept to product equivalent devices within 16 months
- Built and verification of 13 product equivalent devices for clinical evaluation
- Usability and clinical evaluation at multiple sites, incl. data analysis
- Collaboration in and coordination of an international partner network, incl. clinicians, regulatory experts, medical doctors, marketing and reimbursement specialists
Outcome
- Requirements met for ease of use, cost of goods and minimum clinically relevant performance
- Retinal thickness change of ±25 µm is detected with 95% sensitivity and 95% specificity
- Presence of fluid detected with a true positive rate of 97% and a true negative rate of 92%
- Feedback from clinicians shows that the tradeoff between ease-of-use, cost and performance is interesting and closes a gap in patient care
- Patented technology
Contact
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Internationales Unternehmen der Papierindustrie – Analyse des Dampfsystems
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6-Streifenausbau Aarau Ost – Verzweigung Birrfeld – Bauherrenunterstützung
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