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An innovative double technologies medical device for corneal diseases.

Periodic Reporting for period 2 - MD-SD-OCT (An innovative double technologies medical device for corneal diseases.)

Reporting period: 2016-06-01 to 2017-05-31

The main objective of CSO business project is to introduce into the market the innovative MD-SD-OCT, a new ophthalmology instrument, which is able to detect, with a single tool, a range of optical pathologies wider than the state of the art technologies are capable to support, with higher performances and significant reduction of manufacturing cost.
This target has been reached through the integration of traditional topography approach (Placido's disk) and innovative patented Spectral Domain Optical Coherence Tomography (ref. WO 2014/155286 A1), into a single, compact and flexible diagnosis device, real breakthrough for the market at the state of art. As a results of the technology innovation proposed and due to the usage of a less expensive technology invented by CSO (new SD-OCT management system, covered by international patent), the overall cost of the device is significantly lower than the existing applicable technology (about 40% less). CSO - with higher performance, significantly lower cost and new double technology MD-SD-OCT - will be able to improve its competitiveness in the market of ophthalmology diagnosis devices.
“MS-39” is a device that can capture high-definition images of the ocular anterior segment and accurately measure various clinically interesting ocular structures - anterior and posterior corneal surface, anterior chamber, irido-cornea angles, pupil diameter... The device integrates in one machine one of the most advanced current technologies in ophthalmology, the optical coherence tomography in the spectral domain (SD-OCT, Spectral Domain – Optical Coherence Tomography) with two proven technologies, which are Placido disc and infrared pupillography. Placido disc technology is based on optical laws of reflection and allows accurate and reliable measurements of the sole anterior corneal surface. The SD-OCT system is based on interferometry in the spectral domain and instead allows for the acquisition of high-definition tomographic images of sections of the anterior segment and, through subsequent processing, the measurement of the anterior and posterior corneal surfaces, the anterior chamber, the irido-corneal angles [and thickness (pachymetry)]. The pupillometer is a lighting and capturing system in the infrared spectrum and allows measurement of the size of the pupil and decentralization in various light conditions (scotopic vision, mesopic, photopic) and the dynamic measurement in the transition from a bright photopic to scotopic condition.
A device with these characteristics has several applications in ophthalmology for:
- Diagnosis of diseases of the eye anterior segment
- Screening of Keratoconus, a corneal disease (progressive non-inflammatory corneal dystrophy) which usually affects both eyes (96% of cases)
- Refractive Surgery and Cataract Surgery
- Screening glaucoma angle-closure
- Follow-up for corneal transplants and Follow-up to trauma
- Design and monitoring of specialized contact lenses.
During the project’s life time the device has evolved from TRL 6 to TRL 9.
• All the technical issues related to the existing rough prototype have been solved.
• Main ophthalmologists have validated a number of pre-series models.
• MS-39 received CE Certification.
• The European patent related to the device has been awarded.
• Prototypes of MS-39 have been presented in the main Ophthalmologist congresses and fairs.

Thanks to this H2020 SME2 project CSO is now ready to launch in the market the innovative anterior segment OCT named MS-39.
MS-39 is a cornea dedicated OCT.
It is an all in one device (no remote light source device) that include high performance on anterior surface of the cornea thanks to the Placido topography, MS-39 merges data by the Arc-Step (Placido disk) reconstruction to the data obtained by AS-OCT images.
The integration of the two technologies allows to obtain the accurate measurement in elevations, thickness, curvature and power terms for the whole cornea
• AS-OCT images give accurate corneal elevation and thickness data for the whole anterior segment (front and rear)
• AS-OCT Section:
 1 image (1600 A-Scan) over 16 mm
 averaged
• AS-OCT topography:
 25 sections over 16 mm (1024 A-scans each)
 not averaged
 Anterior chamber 3D reconstruction
 Maps (Ø 10 mm)

Thanks to this technology many information can be displayed:
• Sagittal (or Axial) curvature anterior and posterior
• Tangential curvature anterior and posterior
• Corneal thickness
• Anterior and posterior elevation
• Anterior chamber depth
• Anterior, posterior and equivalent refractive map
• Anterior, posterior and total corneal aberrometry
• Epithelial

Now that the device is ready for the market, next meeting in Lisbon for ESCRS and New Orleans for AAO will be the once where CSO will could offer the device for sell at a very competitive price
The most important feature of MD-SD-OCT will probably be its final cost for the end user.
The price will be about 40% less of best performing OCT currently on the market, with better performances. This will enable a wider diffusion of such an important equipment, needed for diagnosis of several serious diseases of the eye and for post-surgery analysis.

The final cost is not the only benefit deriving from the investment for the end user.

The factors that may be beneficial in terms of cost effectiveness, if compared with the state of the art technology, can be summarized as follow:
• TECHNOLOGY IMPROVEMENT: represent a benefit in terms of competitiveness for the end user. The technology at the state of the art, is not able to provide the integration of two different diagnosis systems.
• PRICE: significantly lower price. The customer will pay less, for an higher performance device.
• PERFORMANCE IMPROVEMENT, in terms of image resolution, measurability of all the are covered by the diagnostic device and in terms of accuracy of the output, thanks to the new patented SD-OCT technology
• RELIABILITY of the medical result: it will allow detecting pathologies in an early state and, at the same time, avoiding false detection.

All of these elements will potentially determine a positive socio-economic impact in early diagnosis of corneal pathologies.

The high resolution of the images of the sections of the anterior segment allows evaluating with reliability the presence and extent of corneal pathologies of the anterior segment likeCataract anf Glaucoma

Corneal transplant is an operation aimed at all diseases of the cornea that reduce visual acuity or opacity of the tissue (post-infectious or post-traumatic scars, corneal dystrophies or degeneration) or its distortion (keratoconus, trauma). The operation involves replacing the damaged tissue with a donor cornea. The new corneal flap, which restores the transparency of the cornea, allows the patient to recover vision. The high resolution of the images of the anterior segment sections allows to assess with a certain facility the outcome of a corneal transplant and to carry out measures for the evaluation of the optical quality after surgery.

The ability to measure very accurately the anterior corneal surface makes it an important instrument for planning refractive surgery, to correct defects of myopia, hyperopia and astigmatism.
Th e new disruptive MS-39