EFCLIN will publish the slide shows of those speakers, who have given free their presentations.
Manufacturers’ Forum, Thursday, 28th April 2022
Guided by Erik Smidt
Opening Session, Friday, 29th April 2022
Welcoming Address of the president – Armin Duddek
Keynote 1; Multifocal Scleral Lenses – Dr. Diego López Alcon – Scleral lenses are, without a doubt, the contact lenses that have grown the most in recent years. As their name suggests, they are lenses that rest solely and exclusively on the sclera. Therefore, every effort must be made to ensure that the lens does not touch the cornea or the limbus. Scleral lenses have become for many specialists the first choice of optical treatment for irregular corneas and ocular surface diseases. They are also able to compensate for myopia, hyperopia, astigmatism and presbyopia in healthy corneas. The combination of scleral lenses and multifocality is a challenge for manufacturers and scleral lens specialists. In this presentation we will discuss the limitations of contact lenses in general. We will also discuss the differences in fitting multifocal hydrophilic lenses and multifocal scleral lenses. And finally, we will discuss what areas of knowledge and research need to be addressed in order to understand the real effect of multifocal scleral lenses on vision.
Find the presentation here.
Keynote 2; Smart Contact Lenses – the Past, the Present and the Future – Prof. Dr. Andrés Vasquez Quintero, University of Gent, Belgium – with a short introduction of Peter Vermeulen –
Recent advances in wearable electronics are not only focusing on devices integrated on textiles and accessories, but also on conformal devices in close contact with the human body. The potential applications include smart contact lenses. These lenses are foreseen to be applied in different fields ranging from biomedical diagnosis and entertainment to vision correction, among others. However, challenges lie ahead mostly regarding to their integration into fully autonomous systems. This talk will explore different applications for smart lenses, visiting current technology and challenges for the future.
Find the presentation here.
Keynote 3; Accommodating IOLs and the Holy Grail – Dr. David Spalton –
Cataract surgery now centres on providing spectacle independence for distance, intermediate and near vision. All multifocal designs compromise light distribution causing loss of contrast and dysphotopsia from glare and halos. These problems would be solved by an accommodating lens. There have been numerous designs all of which have so far failed. Interest now has moved to IOL designs which change their radius of curvature under accommodative stimulation. This presentation reviews the present state of development of IOLs which eventually transform cataract surgery.
Find the presentation here.
CL Lectures, Friday, 29th April 2022
New Technology in Blocking System – Dr Marco Iovino, Medlac srl. Italy – Contact lenses produced by Lathe cut had a big improvement in cutting precision with new technology developed by lathes manufacturers. Blocking system remains a critical element to the manufacturing process and it involve into the final quality of the lenses more than we can know. The potential of the new MED-BLOCK system was developed and studied with a scientific approach to evaluate the actual benefits by comparing it to the cost of the technology itself.
Find the presentation here.
Evolving Ortho-K Lens Construction to Optimize Myopia Control – Randy Kojima, Pacific University Oregon –
Orthokeratology lenses are being employed as the principle optical intervention for myopia control in children. However, how has lens construction evolved to meet this application? This course will review new approaches and the corresponding science and research to create improved outcomes for children.
Software Validation in the CL Industry – Filippo Selden, Advanced Medical srl, Italy – The International Framework is consolidating the path towards globalization of Medical Devices’ regulatory requirements, see “International Medical Device Regulators Forum (IMDRF)”. The new environment is pushing all actors in the CL Industry into focusing on new areas of betterment. The Covid emergency has contributed to accelerate this phenomenon.
This talk will describe the concept of Software Validation, the Regulatory Context, its role in a Lab’s own Quality Management System and how Advance Medical has approached the subject with its own Software Validation Protocol. Since the Medical Device Manufacturer is the “responsible for validation”, the Protocol has been structured to assist the Manufacturer’s QMS management as referenced in the quality standards of ISO 13485:2016 and GMPs specific for the production of medical devices, based on a risk analysis (ISO 14971:2016) that takes into account the Software’s impact on Quality Management System processes.
The Protocol has already been implemented in TS Lac, a leading company in the Italian market. The overall project was coordinated by Effetre, a regulatory and quality consultancy company with 30 years of experience in the field of contactology.
Find the presentation here.
IOL Session, Friday, 29th April 2022
Multifocal intraocular lenses after more than 10 years. Proper use. – Dr. Gonzalo José Bernabeu Arias, Madrid Hospitals, Madrid, Spain – In recent years, the use of multifocal intraocular lenses has become a common tool in cataract surgery. However, in my presentation, I will try to convey to the audience the importance of the proper use of these lenses, when to use them, who not to use them, why there are cases of dissatisfied patients, and how to make a good selection of the ideal patient for this implant.
My experience with these lenses could not be better, but it requires a constant study of the different types of lenses, how each of them works, having good technology in the ophthalmology office and being a good surgeon.
Commercial presentations 11 – 13: Larsen Equipment Design, Schneider GmbH, DAC International
Update and New Challenges in Toric Intraocular Lenses – Dr. Ana Hervás Ontiveros, Hospital La Fe Valencia, Valencia, Spain – New and updated toric lenses, calculators and regression formulas offer the opportunity for more accurate lens selection for our patients.
Concurrently, improvements in topographic evaluation of corneal keratometry have allowed for a decrease in unplanned residual corneal astigmatism. Measuring posterior corneal astigmatism is especially valuable in eyes with corneal pathologies when planning to implant toric intraocular lens and now allows access to this patient population.
Commercial presentations 14 – 16:
Optical Effects of IOL Complications – Dr Timur Yildirim – Nowadays, there is a wide range of different intraocular lens models on the market, especially in terms of variations of optic designs. In addition to normal monofocal lenses or so-called monofocal+ lenses, there are EDOF lenses with enhanced depth of focus and diffractive trifocal lenses. In general, there is a trend towards developing optics that have as few side effects as possible. By side effects we mean above all optical phenomena such as halo, glare and scattered light. It has to be said that trifocal lenses generally have these kinds of complications. The advantage, however, is that the trifocal lenses produce relatively assured good vision in one area, especially at close range. New lenses on the market, such as special EDOF lenses, show a low side effect profile. However, these lenses do not have a 100% guarantee of covering the entire visual range and it is very often necessary for these patients to wear reading glasses.
The lecture will go into detail about the individual lens models and the effects on optical side effects and provide relevant examples.
MDR Lectures/ Workshops, Saturday, 30th April 2022
EUROMCONTACT – the Voice of the CL and CLP to the EU: main Challenges and Priorities for the Industry in a Challenging Political Environment – Pascale Rouhier
Contact Lens Materials – Update on PFAS Questions – Pascale Rouhier – The aim of this session is to ensure that the wider industry is aware of the significant, and potentially existential challenge that our industry is facing in light of the potential ban, or heavily restrictive regulation, of substances that are considered as PFAS: used in fluoro-silicone acrylate RGP materials, some hydrogel materials and some components used in lens care products.
This session will briefly cover the timeline of this challenge from the initial question raised by the five EU Member States (that are moving to have PFAS regulated under the REACH regulations), through to the public consultation that will be held by ECHA (European Chemicals Agency), and to what efforts the PFAS working group of EUROMCONTACT have thus far taken. This will cover the ongoing work on developing industry white papers to support the concept of essentiality of use, both in terms of the clinical application of lenses that depend upon high oxygen permeability RGP materials, as well as the technical requirements of why PFAS substances are included in the various polymers.
Commercial Presentations 17 – 18: Boston Materials, Contamac Ltd.
Contact lens materials – testing per the requirements of ISO 10993 part 18 – Chemical characterization and ISO 18369 part 4 = Physicochemical properties. – Nicky Soubry – This is being presented from the perspective of the manufacturers (owners, manufacturing leads, engineers and the quality teams), and not from a professional micro-biologist/toxicologist perspective. This topic needs wider understanding within a business in order to successfully work through some of the material-specific challenges of the MDR.
Find the presentation here.
MDR Preparation – Tips & Tricks, PMS & Vigilance – Yolanthe Gwaba – Tips to be MDR ready: A short overview of MDR compliance expectations – enhanced requirements for MDR technical files, what has changed? Reviewing Technical Files and NB requirements. Vigilance post the date of application: understanding Chapter VII – post market surveillance, vigilance and market surveillance and application to legacy/MDD devices. Updating the Post Market Surveillance Plan: What is a Periodic safety update report? Integrating the PSUR into documentation.
Find the presentation here.
State of Play on UDI for Contact Lenses and EUDAMED – Nicky Soubry – The UDI attribution for contact lenses is a complex matter that has been a topic of discussion since the publication of the MDR. This year the discussion has taken a new turn, and the goal is to come to a final solution. During this presentation you will receive an update on the state of play on UDI attribution for contact lenses and the registration of devices in EUDAMED.
Find the presentation here.
Dr. Gonzalo José Bernabeu Arias – Ophthalmologist from 2004.
Ophtalmology Medical Director in HM Montepríncipe and HM Vallés. Madrid. Director of Cataract and Refractive Surgery in HM Hospitals group. More than 1000 surgeries per year.
Very important experience in multifocal intraocular lenses, with more than 5000 implanted. Opinion Leader for Zeiss and Bausch&Lomb.
Live surgery in the best congress in Spain.Professor at the Faculty of Medicine Ceu San Pablo.
Jolanthe Gwaba is the EU Authorised Representative and a senior Regulatory Specialist for Bausch & Lomb’s Vision Care business. She received her bachelor’s degree in Toxicology, has an MSc in Medical Devices Regulatory Affairs, and a postgraduate diploma in Biopharmaceutical Regulatory affairs. She has experience in the medical devices’ distributor/ importer sector across a wide range of devices and is an active representative of Bausch & Lomb with the IrishMedTech Association and Euromcontact Working Groups.
Dr. Ana Hervás Ontiveros – Bachelor of Medicine and Surgery from the University of Valencia. (05-13-2010. Valencia, Spain (Bachelor degree)). Specialization in Ophthalmology. Universitari and Polytechnic Hospital La Fe (Date 05-13-2015, Valencia, Spain). Specialization in refractive surgery and anterior segment. Master of University of Valladolid. Valladolid, Spain (Master’s degree).
Ophthalmologist in hospital LA FE VALENCIA, Spain since Feb. 2019 up to the actuality in a fixed contract in a full time. Ophthalmologist at a private clinic EON VALENCIA since March 2020 uo to the actuality, CEO.
Specialization in Ophthalmology at NEW UNIVERSITY AND POLYTECHNIC HOSPITAL LA FE. VALENCIA, Spain, May 2015.
Marco Iovino – 2001: Optometrist and Optician Degree at Vinci IRSOO of Florence; 2005: Degree in Orthoptic and Oftalmology assistence Secon University of Napoli; 2006: Low vision Master; 2008: Contact lenses and corneal topography Master; Contact lens fitter and designer at Medlac Srl Italy; Responsable of research and developement department of Medlac Srl; Speaker at major congresses of Optometry and Ophtalmology in Italy.
Randy Kojima is the Clinical Research and Development Director for Precision Technology based in Vancouver, Canada. He also serves as Research Scientist and Clinical Instructor at the Pacific University College of Optometry in Forest Grove, Oregon. Additionally, he is a clinical advisor to Medmont Instruments in Melbourne, Australia. Randy has published numerous articles and submitted posters on various Contact lens related topics as well as been a contributing author in a number of text book chapters. He lectures globally and enjoys sharing insights, methods and research with eye care colleagues from around the world. Randy is a Fellow of the American Academy of Optometry, the British Contact Lens Association, the Scleral Lens Education Society and the International Academy of Orthokeratology.
Dr. Diego López Alcón is graduate from University of Murcia in 1996 where he also obtained his Inter-University Master’s Degree in Research in Vision Sciences (2012). He is associated professor of optometry and contact lenses since 2005 at University of Murcia. He also combines his teaching activity with the direction of the specialty contact lens fitting section at the CUVI University Eye Clinic.
He is a member of the CIVIUM research group, which is specialized in accommodation and its loss with age, myopia control, optical aberration and its compensation or induction with contact lenses and new devices.
He is actually finishing his Phd about multifocal scleral lenses and his relationship with high order aberrations.
Filippo Selden is the Managing Director of Advance Medical, the company that has developed FocalPoints, the preferred software solution in the contact lens industry. Filippo has contributed to the growth of the Advance since 2009 and he has taken the role of Managing Director in 2019. Filippo has a solid marketing and managerial background developed in over twenty years of experience in the most diverse industries. He started in the late 90s in Digital Marketing as a precursor of the Italian market. He developed his managerial skills in the role of Head of Strategic Marketing in both Universal and EMI. He then completed his experience working closely with Renato Liffredo, the founder of both Biotech and Advance Medical. Since 2015 he is the Coordinator of the Master in Brand Management of IED Milano, where he also gives lesson on Strategic Marketing.
Erik Smidt started his career in optics more than thirty years ago as an ECP for different companies, small as well as a chain in retail. After that period he was a Professional service Manager for Friederichs, a Dutch wholesaler for several years. With the change of distribution of the lenses of Ciba Vision Erik fulfilled Key account management in combination with a Professional Service role in the Benelux for this company. In 1997 ERCON Contactlenzen en Consultancy was founded by him, a Distributor of contact lenses and a consultant for Fitting contact lenses and Marketing solutions for the ECP and practices.
From 2005 till 2013 Erik was a member of the board of EFCLIN , from 2011 to 2013 as president of the organization.
Nicky Soubry has a Master in Economic Sciences and is graduated as Optician-Optometrist. He is the co-owner of Belgian Optical Supply bvba and PureCon bvba.
Belgian Optical Supply (BOS) is a Belgian based manufacturer and distributor of contact lenses, contact lens solutions & instruments, while PureCon is a consultancy company in Medical Devices.
He’s has an extensive knowledge of the manufacturing process, the fitting of contact lenses and the regulatory requirements. He has been the RA/QA manager of BOS for the past 12 years, and is an active member of the Regulatory Affairs Focus Group of both Efclin and Euromcontact.
For Euromcontact, he serves as an industry expert for the UDI Working Group of the European Commission
Dr. David Spalton trained at Moorfields Eye Hospital and St Thomas’ Hospital and holds Fellowships at the Royal College of Surgeons, the Royal College of Physicians and the Royal College of Ophthalmologists. He did fellowships in uveitis, medical and neuro-ophthalmology at St Thomas’ Hospital and the Hospital for Neurology and Neurosurgery, Queen Square, London. At St Thomas’ Hospital he established a special interest in cataract surgery, complex cataract surgery and intraocular lens design and in 2010 was appointed Professor of Ophthalmology at King’s College, London in recognition of his research work.
He is a past President of the United Kingdom and Ireland Society of Cataract and Refractive Surgeons (UKISCRS) and was President of the European Society of Cataract and Refractive Surgeons (ESCRS) 2016/17. He has given many named lectures including the Ridley Medal Lecture at the ESCRS in 2010, the highest award of the Society, in recognition of his research on intraocular lens design. He has published over 180 scientific papers and his book, An Atlas of Clinical Ophthalmology, won the prize for the Best Medical Textbook of the Year in 1984 for the 1st edition and 2005 for the 3rd edition, a unique feat in medical publishing.
He is a Trustee for the Fight for Sight and a consultant to a number of ophthalmic device and ophthalmic biotech companies.
Prof. Andrés Vásquez Quintero received his Bachelor degrees in Electronics and Mechanics Engineering from ECI (Colombia) and ENIM (France) in 2008. He obtained his MSc. in Microelectronics Engineering from TUDelft (The Netherlands) in 2010; and his Ph.D. from EPFL (Switzerland), on flexible electronics. He is a former postdoc fellow of the SNSF and the Marie Skłodowska Curie grants. His current work involves novel smart packaging solutions for medical devices (implantable and/or wearable). From 2018, he was appointed as part time Assistant Professor at Ghent University, and from 2021 he is the Chief Technology Officer and co-founder of Azalea Vision in Belgium.
Dr Timur M. Yildirim – Since 03/2017 Department of Ophthalmology, Heidelberg University Hospital (Head of Department: Prof. Gerd U. Auffarth, MD, PhD, FEBO)
09/2010- 12/2016 Medical studies, University of Heidelberg, Heidelberg, Germany
03/2012- 07/2016 Internships in Cologne, Denpasar, Davos, Canterbury and Ankara