Clinical Development of an Ultrasensitive OCT Device to Improve the Management of Eye Disease

Imaging technology has revolutionised how eye disease is detected, diagnosed and managed. Known as "optical biopsy", optical coherence tomography (OCT) has transformed retinal imaging. Corneal imaging, however, has been relatively neglected in current clinical systems. Supported by an ongoing i4i product development grant (II-LA-0813-20005), our multidisciplinary research team has, with strong support from patient and public groups, developed a novel ultra-sensitive OCT (US-OCT) prototype with fast and accurate automated analysis tools. We have demonstrated this bench-top "single-shot" device s unique capability to obtain high-resolution images free of motion artefacts with ex-vivo human donor corneas. It enables clinicians to visualise and monitor structural changes in cellular and non-cellular corneal layers and the tear film. The unprecedented detailed information acquired by our device will improve understanding and management of common debilitating eye diseases in primary and secondary care, bringing patient benefit and cost improvements to the NHS. Significant improvements will be brought to the detection and management of eye diseases such as keratoconus and Fuchs dystrophy as well as to surgical planning and management of lamellar corneal and refractive surgery. In the longer term, it will have wider applications to the anterior segment and retina. In this project, we aim to develop our bench-top prototype into a regulatory compliant, clinically-useful and commercially-viable device focused on imaging the cornea, enabling earlier disease detection, more accurate monitoring, stratified and personalised management with future applications to other ocular tissues. This will be achieved via three inter-dependent workpackages (WPs) that will focus on product development via a compliant route, clinical studies to support applicability and effectiveness, and the development of a clinically and commercially relevant route-to-market strategy to underpin the project s future. WP1: Product development (month 1-36). We will develop our prototype bench-top unit to a clinic-ready device that meets all EU requirements for CE marking. We will extend our current concept design and documentation, work up our commercial analysis, engage with our new medical device development and regulatory compliance partner, and develop and manufacture our clinical prototype by the end of month 18 for clinical evaluation. Further development and optimisation work will be continued for further imaging functionalities and for improved usability, portability, robustness and maintenance. WP2: Human volunteer studies (month 1-36). We will first investigate device usability with 10 healthy volunteers by the end of month 15, to support and inform the product design and development. Clinical evaluation will be conducted to demonstrate safety and confirm the step-change improvement in clinical efficacy of our US-OCT device between months 18 and 33. There will be three groups of participants: 40 patients with keratoconus, 30 with FECD and/or corneal lamellar surgery, and 20 healthy volunteers. There will be 3 visits (baseline, month 3 and 9) for each participant, following a study specific protocol. Efficacy measures will comprise sensitivity, specificity, and reproducibility while cost-effectiveness will be established by a heath economics exercise. Approvals as appropriate will be obtained before the studies. WP3: IP management, commercialisation and PPI (month 1-36). We will cover the intellectual property and develop a robust commercialisation strategy to market. PPI will be embedded throughout. The WPs reflect the inter-dependent nature of best-practice product and commercial development. WP deliverables will, for much of the project timescale, rely on regular review by the dedicated project steering committee to enable inter-connectivity and a progressive development process. Our project end-point will be: Device ready for CE marking. Com