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Dominik Pražák

inTENSE Project: DEVELOPING RESEARCH CAPABILITIES FOR TRACEABLE INTRAOCULAR PRESSURE MEASUREMENT S. Dominik Pražák. Need. Glaucoma is the world's leading cause of irreversible blindness Only treatable risk factor is the ocular hypertension

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Dominik Pražák

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  1. inTENSE Project:DEVELOPING RESEARCH CAPABILITIES FOR TRACEABLE INTRAOCULAR PRESSURE MEASUREMENTS Dominik Pražák

  2. Need • Glaucomaistheworld's leading cause of irreversible blindness • Only treatable risk factoristheocular hypertension • Non-invasive intra-ocular pressure (IOP) measurement isinevitable for glaucoma prevention Present situation of IOP metrology in Central Europe: • Traceability of IOP-measurement weakly established in Eastern Europe • Specific requirements for medical device metrology not recognized (IOP-metrology appendix of pressure metrology) • No research capacity to provide traceability for new tonometer types • No research capacity for new ophthalmologicmeasurands (e.g. cornea thickness) • Many NMIs lack capacity or resources to build owninfrastructure for IOP metrology

  3. Consortium • NMIs involved: BEV, CMI,GUM, PTB, SMU, UME-TÜBITAK. • University partners: STU, PU.

  4. Objective 1 "Research capabilities" Develop IOP measurement and research capabilities at CMI for existing IOP measurement principles and devices • Advancedtrainingof CMI personnel • Enable CMI to provide IOP traceability for other countries • Establishment of a training centre • Inter-laboratory comparisons

  5. Theentryleveltrainingforthenewpersonnelperformed by CMI. The advancedtrainingsperformed by PTB: Impression tonometer Applanation tonometer Non-contact tonom. + flapper Non-cont.tonom. + rubbereyes Contour tonometer Re-boundtonometer

  6. Objective 2 "New measurands" • Development of research capabilities enabling to cope with future developments in ophthalmology • identify new measurands, devices or measurement conditions(SMU, SlovakTechnical University, Palacký University) • evaluate new developments from the point-of-view of metrological checks

  7. Researchoffactorsinfluencing IOP measurements(corneal rigidity, central corneal thickness, corneal curvature, astigmatism, eyesurgery, corneal degenerations, physical activities, hypoxia, head position, hydratation of body, coffee and energy drinks, pupil dilation, accommodation, diurnal rhythm).

  8. Comparisonsofresultsobatined by Goldmann, rebound and non-contact tonometers. • FEM model ofcornea. Strains at max. pressure – after applanation

  9. Cooperation with Slovak Academy of Science on 3D printing of eye membranes

  10. Objective 3 "Smart specialisation" • Create and implement a smart specialisation concept for IOP traceability at CMI • Establish network of NMIs, academic, regulators, manufacturers • Perpetuate CMI research capabilities • CMI  provider of IOP traceability for Central Europe • Embedding of future customers  coordinated, sustainable approach

  11. Objective 4 "The extended concept" Extend the smart specialisation concept • geographically beyond Central Europe • thematically to other medical devices • Establish cooperation with OIML, ... • Prepare for Medical Device Regulation • Strategic plan towards European Centre on Medical Metrology • European Metrology Network?

  12. Impactactivities • Publications • Stakeholder workshops • Stakeholdercommittee • Working group on eye tonometry • PhD-students • Hands-on training workshop at CMI • Final project symposium • Regular updates for OIML TC18 "Medical measuring instruments". With the prospect for a new OIML recommendation on non-contact tonometry. Also EURAMET TG-Health, BIPM. • Good-practice guides • White paper on Smart Specialisation Concept

  13. A final workshop beorganized in May 2020. More infolaterat: intense.cmi.cz

  14. Thankyouvery much foryourattentioninTENSE team

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