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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - IMCUSTOMEYE (IMaging-based CUSTOMised EYE diagnostics)

Teaser

Summary

The projectâ€™s main objective is to develop novel, non-invasive, label-free, imaging-based and in-depth diagnostic tool(s) meaning a change in the paradigm for diagnosis and treatment of vision-threatening conditions such as keratoconus, myopia, glaucoma, cataract and presbyopia. The prevalence of these conditions ranges between 0.05% (keratoconus) to 100% (presbyopia, in the >50 yr old population), and can often lead to loss of independence and productivity. Current standards for diagnosis and treatment rely on limited quantitative information, which limits the ability for treatment to be customised in line with individual patient needs. The novel imaging device delivers morphological, biomechanical and optical biomarkers for improved diagnosis, as well as inputs to customised numerical eye models for treatment guidance. This customised approach will lead to significant improvement in both the provision and cost of eye healthcare.

Work performed

\"Within the described period, the partners have developed two versions (at CSIC and IPC) of an air-puff OCT 3D corneal deformation imaging device based on nano-sensitive OCT technology and commercial or customized air-puff modules (see specific objective a). The systems were set-up at CSIC and IPC, and the results have presented in a proceeding (by Curatolo et al., 2018) at the Congress of the Optical Society of Spain, and in article format by Maczynska et al. (Journal of Biophotonics, 2019), and other manuscripts. The systems have been tested on silicone samples, biological samples and porcine eyes. A patient study is on its way, with approximate start in summer 2019. Therefore, ethical documentation has been sent out to the Ethics committees of the clinical partners, with reviews (from FIOV) expected within the upcoming month.
A part of specific objective a) is the evaluation of sound excitation and/or frequency air-puff excitation to analyse resonance frequencies of the cornea. Here fore, NUIG and CSIC (in collaboration with the Wellman Center, Cambridge, MA, USA) have developed methods to excite the cornea using frequency pressure-waves, either using sound or custom developed high-speed air-puff devices. NUIG and CSIC have developed acquisition protocols and processing algorithms, and performed tests ex vivo in phantom, porcine and bovine eyes.
A detailed description including all steps to fulfil the objective is provided in the following section. It includes design of various air-puff modules, integration and synchronization within the OCT systems, and validation of the completed system.
With these achievements, the partners have decided to lead way to different possible commercial products, which include a \"\"big box\"\" device with high specificity and sensitivity for eye care specialists, a \"\"small box\"\" device, possibly for primary practitioners and optometrists with a high sensitivity for corneal abnormalities.
For the specific objective b), ULIV has developed eye finite element models of the cornea and sclera, and integrated air-puff domain computational fluid-dynamics models. Simulations have been made to identify the optimal parameters for the instruments (corneal scanning protocol, air puff pressure) in the so-called \"\"big box\"\" approach. ULIV has also completed a study on the simulation of corneal deformation to air-puff in 9 specific location and acoustic/air puff frequency stimulation to study the potential for corneal resonance frequency as a biomarker for corneal abnormality, both potential routes to the small box device. ULIV has also developed routines to retrieve corneal mechanical properties from the imaging data. Details about the results are given in section 1.2.
The partners (CSIC, IPC, NUIG, 2EyesVision) have been working on translating the new imaging modalities, into a compact diagnostic tool in the clinic (specific objective c). With the current state of the art, it was concluded that different commercial set-ups are possible, as described above (\"\"small box\"\" and \"\"big box\"\" device), and development strategies included both approaches. A report with specific details on miniaturisation was prepared and discussed between partners.
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Final results

Progress beyond the state of the art:

The project will deliver innovative optical imaging-based technologies and quantitative analysis that will have an impact on substantially improving in-depth diagnosis and more effective treatment of age and life-style eye diseases.

(1) Screening of keratoconus will surpass current methods based only on corneal topography, through a biomarker probing mechanical properties.

(2) Improved Introacular Pressure measurement, taking into account mechanical properties, impacting glaucoma diagnostic and monintoring

(3) Patient-specific distribution of mechanical elastic, viscoelastic and anisotropic parameters which will allow to construct patient-specific methods of mechanical response and planning of surgery (refractive, intracorneal ring segment and incision in cataract surgery)

Expected results until the end of the project

Compact dynamic imaging device for corneal mechanical biomarker, Correction of Intraocular Pressure (IOP), corneal thickness and keratoconus screening
Multi-meridian corneal deformation imaging system coupled with inverse modeling techniques to estimate corneal mechanical properties
Patient-specific eye opto-mechanical models for surgical planning
Clinical demonstrations on keratoconus and glaucoma patients
Clinical demonstrations in refractive surgery, ICRS and cataract patients, and predicted optimized surgery in those patients

Potential impacts:

Diagnosis of keratoconus will surpass current screening methods based only on corneal topography, including patient-specific distribution of mechanical elastic, viscoelastic and anisotropic parameters affecting visual degradation.
Management of glaucoma will also improve by accurate measurements of intraocular pressure, corrected by the individual\'s corneal biomechanical response.
Candidates for refractive surgery will be screened not only using corneal thickness and topographical observations, but also on the predicted mechanical response to surgery.
Predictive eye models will allow prescribing and customising corneal implants, and placement for the treatment of keratoconus, myopia or presbyopia, based on the simulated biomechanical and optical response. Similarly, the custom models will guide the optimal location and dimensions for corneal incision in cataract surgery as well as the selection of the optimal intraocular lens.
The technology will be used as a benchmark for optimisation and customisation of treatment and serve to validate current treatment options, by comparing clinical outcomes with the predictions of the customised models.
The project will have an impact on securing and reinforcing industrial leadership in the biophotonics-related market for analysis and diagnostic imaging systems.
The project will leverage efforts of 6 European companies in the field of biophotonics and imaging diagnostics, with complementary skills and expertise, reinforcing industrial leadership of consolidated companies and securing synergetic competitiveness and growth backed up by academic and clinical leaders in the area.