Periodic Reporting for period 1 - ODYSSEUS (Ophtalmic Device for eYe StructureS Examination with Ultrahigh reSolution)
Période du rapport: 2020-08-01 au 2022-07-31
Existing ocular screening instruments lack the high resolution necessary for accurate diagnosis of the complicated diseases. As a result, many major conditions stay widely underdiagnosed and not well understood including dry eye (340 million people affected), glaucoma (80 million affected), age-related macular degeneration (200 million), etc. Few attempts to create an accurate high-resolution device have not been successful so far due to the technical limitations (e.g. confocal microscopy required undesired direct physical contact with a patient's eye) as well as the excessive costs. Project ODYSSEUS aimed at bringing to clinics and at commercializing a new promising high-resolution technology called Full field optical coherence tomography (FFOCT). Fundamental physical principles behind FFOCT, in particular the interference of the incoherent light waves, allow for building a non-contact high-resolution eye imager at a fraction of the cost of the alternative technologies. Following along the tasks of the project we have created the first FFOCT prototype suitable for use in clinics. Clinical adoption of the prototype was facilitated by the fact that it was implemented on top of the conventional Spectral-domain OCT technology that is well-known to doctors. Thanks to the extensive optical design as well as to the adoption of the latest camera technology, the integrated prototype produced similar image quality as the independent sub-devices. The total cost of the prototype measured 40,000€ - a fraction of the price of the closest competitive techniques. The prototype became compact, 30 cm x 30 cm x 70 cm, fitting on the conventional clinical table. Following the analysis of the light power and the general safety, the device received authorization to be installed at the Quinze-Vingts National Ophthalmology Hospital, Paris. The instrument was convenient to be used not only by the researchers/engineers but also by the trained orthoptists for screening of the healthy subjects and clinical patients. The first data collected from the patients highlighted the far-reaching benefits of the cell-resolution. In particular, FFOCT could detect the micron-size changes caused by the several ocular conditions including keratoconus, Fuch’s endothelial dystrophy, age-related conditions, dry eye and age-related macular degeneration. Comparison with the conventional OCT devices showed that FFOCT could detect the diseases at the earlier stages. Earlier diagnosed diseases can also be treated earlier, potentially leading to the better outcome for the patients. The latter will be validated following the clinical trials on the larger patient cohorts following the end of ODYSSEUS project. Beyond the corneal and retinal imaging, FFOCT demonstrated the cell-resolution images of the trabecular meshwork pores that play the key role in glaucoma. To our knowledge this is first time that these structures could be clearly resolved with high-detail in human subjects. Future glaucoma-focused clinical trials will be quantitatively evaluating the disease severity, the effects of the medications as well as the after-surgery recovery progress potentially leading to improvements in the diagnosis and treatment of millions of patients. During the ODYSSEUS project we have found many collaborators in France and abroad that will be testing our device and expanding the search for the new cell-resolution clinical biomarkers. Of the particular interest are the biomarkers that reflect both the ocular conditions and the general health issues (e.g. diabetes, cardiovascular, Alzheimer). In order to provide the FFOCT technology to the interested hospitals, we have established a start-up (SharpEye) and received the first major awards recognizing our innovation.