GlobalCONTACT - 01/2022

From lens materials to industry support, we see the importance of working together to deliver products and expertise that truly transform patients’ lives.

90th Edition of GlobalCONTACT

Today we celebrate our 30 th anniversary of GlobalCONTACT and you have the 90 th issue in front of you. We take this as an opportunity to look back and review the beginnings and development of GlobalCONTACT.

The magazine has had three publishers and has been a close witness to all the ups and downs in the contact lens industry. In 1992, 'Contact' (as it was aptly named at the time) was published as the journal of the European association EFCLIN. However, it only appeared nine times under this flag before being handed over to EPS and Wim Aalbers who published it from 1995 to 2008. Chance and the firm resolve of Wim Aalbers and Jörg Spangemacher who wanted this magazine to continue to exist and genuinely foster Contact within the industry, led to GlobalCONTACT passing into our hands in Germany in the autumn of 2008. May we introduce ourselves?

As our reader, you are of course familiar with this trade magazine for the contact lens industry and the unique media mix with the digital edition in the GlobalCONTACT app. The Eyepress Publishing House, which gives GlobalCONTACT its home, publishes a wide range of trade journals for experts from various disciplines in optometry, optics and ophthalmology. The portfolio includes five German and English language journals as well as six indices. They are published as print products as well as online and in their own app. There are editorially designed websites for all magazines.

So, in 2008 another publication was added to the existing ones. But it is much more than that: The contact lens business is a remarkable and committed industry built on longtime friendships and a tightly woven network. I count myself as fortunate to have been involved from day one, even though as an optometrist initially I found it challenging. For me it was important to find out how this industry ticks, who does what, and which topics could be of particular interest to the readers.

Now, almost 14 years later, I still come to work on GlobalCONTACT every day with the same enthusiasm as I did on my very first day.

For page 32+33, I went through the archive of my photos of GlobalCONTACT from over the past 14 years. During that time, I have accompanied the magazine, the industry and the people involved. Many of them have become friends; some have unfortunately already left us over the years.

We would like to thank you very much for this trusting cooperation and your loyalty! So let’s look forward with optimism to the next 30 years! Whenever you have an idea, something to share or even some criticism, please go ahead and let us know. It is very much appreciated.

However, let us not forget one thing during this time: The war in Ukraine is an immense tragedy for all people who live or have lived in Ukraine and are now on the run. The whole world, and Europe in particular, is watching anxiously for any further developments – and so are we at GlobalCONTACT. In the next issue, we would like to address the consequences for our industry as they may occur: The shortage of raw materials but also how business relations with Russia and the people and employees in the respective countries are affected. We would therefore like to hear your opinion. Please write to me directly: silke@global-cl.com ■

SILKE SAGE Editor-In-Chief silke@global-cl.com

A WORLD OF OPPORTUNITIES 2022

Spanish culture combined with ancient and modern science has found Sitges/Barcelona to be the perfect location for business and leisure time as well.

The 48th EFCLIN Congress & Exhibition takes place there from 28th – 30th April 2022. For an engaging lecture program, manufacturer’s forum and the best trade exhibition in the business, it can’t be beaten. It’s where the Contact Lens & IOL Industry from Europe, the Far East, North America and beyond come together… will you be there?

THE

Edition of GlobalCONTACT

TRANSFORMING LIVES

INDEX TO ADVERTISERS

Title: Contamac, www.contamac.com

Inside front cover: Bausch + Lomb Inc., www.bausch.com

Page 4: Efclin, www.efclin.com

Page 7, 31: OPTOCRAFT GmbH, www.optocraft.com

Page 9: Misupco, Inc., www.misupco.com

Page 11: AMETEK Precitech, Inc., www.precitech.com

Page 15: Schneider GmbH & Co. KG, www.schneider-om.com

Page 17: Rotlex, www.rotlex.com

Page 28, 55: K & Y Diamond Ltd, www.kydiamond.ca

Page 29: DIATEC Diamanttechnik GmbH, www.diatec-pforzheim.de

Page 30, 49: Larsen Equipment Design Inc., www.larsenequipment.com

Page 31, 41: Optimec Systems Ltd., www.optimecsystems.com

Page 47: LAMBDA-X S.A., www.lambda-x.com

Inside back cover: Acuity Polymers, Inc, www.acuitypolymers.com

Outside back cover: DAC International, Inc., www.dac-intl.com

NAMES TO NOTE

Aalbers, Wim 24

Frumkin, Valeri 3 4 Hein, Jessica 4 8 Hoy, Lachlan 4 4 L arsen, Erik 37 Meegan, Millie 4 4 Müller, Leonie 4 8 Urschinger, Timm 52 van der Worp, Eef 38

TECHNOLOGY

Freeform lenses made by liquid polymers I nterview with Valeri Frumkin by Hanna Diewald

MANUFACTURING

FITTING BACKGROUND

Safety in sclerals E ef van der Worp

U ltra-Dk contact lenses L achlan Hoy & Millie Meegan

I maging techniques – case study Jessica Hein, Leonie Müller

BUSINESS + MARKETING

Self-determined salaries I nterview with Timm Urschinger

REPORT 18 Global Specialty Lens Symposium (GSLS) Silke Sage

E xpert talk on MDR

Euromcontact market data report 2021

All about you

Samsara Vision awarded NUB status 1 reimbursement designation for SING IMT

Samsara Vision announced that the German Institute for Hospital Remuneration (InEK) has granted NUB (Neue Untersuchungsund Behandlungsmethoden) Status 1 reimbursement designation for the SING IMT (smaller-incision new-generation implantable miniature telescope). The SING IMT is approved for people living with late-stage, age-related macular degeneration (AMD) who are 55 years of age or older in CE referenced countries since May 2020.

The NUB process allows negotiations between participating hospitals and health insurance providers regarding supplemental reimbursement of new medical treatments with the potential to improve the standard of care for patients in Germany.

Nearly invisible inside the eye, the tiny SING IMT is a Galilean telescope implant designed to improve visual acuity and quality of life for patients with late-stage, age-related macular degeneration. Comprised of ultra-precision micro-optics, the SING IMT is implanted during typical, out-patient cataract surgery. After recovering from surgery, the patients work closely with a low vision specialist and occupational therapists to learn how to use their new vision.

Because AMD is a progressive disease, over time, patients have adapted with the loss of vision in the central field of vision. Before receiving the SING IMT, patients must understand the

possible and realistic outcomes post-op and commit to working with their ophthalmological team to use visual techniques and exercises to maximize the effectiveness of SING IMT. Patients must also meet age, vision, cornea health, and other requirements noted in the patient information booklet to determine if they are a candidate for the SING IMT.

The telescopic implant is not a cure for late-stage age-related macular degeneration (AMD). It will not return vision to the level a patient had before AMD, nor will it completely make up for vision loss. The most common risks of the SING IMT surgery include inflammatory deposits or precipitates on the device and increased intraocular pressure. Significant adverse events include corneal edema, vision-impairing corneal edema, corneal transplant, and decrease in visual acuity. There is a risk that having the telescope implantation surgery could worsen vision rather than improve it. Individual results may vary.

addition to Dr. Stefan Krey and Joern Luethje, who have already been appointed as the CTO and CFO respectively, the new Trioptics management board was completed by Kristin Holzhey (CEO) and Simon Zilian (CSO) on January 1, 2022. Eugen Dumitrescu, who founded the company in 1991, will remain with the company until March 31, 2022, as an active managing director and then as a member of the advisory board. Since September 2019, Trioptics has been a member of the Jenoptik Group, which is based in Jena.

Change at the top of Trioptics

On April 1, 2022, Eugen Dumitrescu will be stepping down from his executive position after 30 years at the helm of the Wedel-based German company as he hands over the responsibility to a new and extended management team. In

Kristin Holzhey has been the managing director of Otto Vision Technology GmbH since 2019 and has been directing the integration of the Trioptics Group into the Jenoptik Group since 2020. Since January 1, 2022, Kristin Holzhey is the vice president in charge of the “Optical Test & Measurement” strategic business unit at Jenoptik and has taken on her new role as the CEO of Trioptics. The other new addition to the management team is Simon Zilian, who has been with Trioptics since 2005 and has played a key role in driving the company’s growth over the past 16 years. Since January 1, 2022, he is the CSO responsible for sales, marketing, service and customer care within the Trioptics Group.

SING IMT, a Galileo telescopic implant designed to improve visual acuity and quality of life for patients with late-stage age-related macular degeneration. Source: Samsara Vision

Dr. Stefan Krey, Simon Zilian, Kristin Holzhey, Jörn Lüthje (f.l.t.r.) Source: Trioptics

Johnson & Johnson Vision Care receives FDA approval for Acuvue Theravision with Ketotifen

Johnson & Johnson Vision Care, Inc. recently announced that the U.S. Food and Drug Administration (FDA) has approved Acuvue Theravision with Ketotifen (etafilcon A drug-eluting contact lens with ketotifen). Each lens contains 19 mcg ketotifen. Ketotifen is a well-established antihistamine. Acuvue Theravision with Ketotifen are daily disposable contact lenses indicated for the prevention of ocular itch due to allergic conjunctivitis and provide vision correction in patients who do not have red eyes, who are suitable for contact lens wear and who do not have more than 1.00D of astigmatism.

Within the U.S., approximately 40 percent of contact lens wearers suffer from itchy eyes due to ocular allergies, and nearly eight out of ten contact lenses wearers with eye allergies agree that they are frustrated when allergies interfere with their normal contact lens wear. While allergy eye drops are a very common treatment, one in two contact lens wearers say that the drops are inconvenient to use.

The announcement follows positive phase 3 clinical studies published in the journal Cornea and regulatory approval by the Japanese Ministry of Health, Labor and Welfare, and Health

Canada, where patients already have access to the new lenses. According to the phase 3 clinical studies, Acuvue Theravision with Ketotifen showed a clinically and statistically meaningful reduction in itchy allergy eyes as quickly as three minutes after lens insertion and lasting up to twelve hours; however, the lens may be worn for longer than twelve hours for vision correction.   “Ocular allergic itch in contact lens wearers may soon be an issue of the past thanks to the decision of the FDA in approving Acuvue Theravision with Ketotifen,” said Brian Pall, OD, MS, FAAO, Director, Clinical Science, Johnson & Johnson Vision Care. “These new lenses may help keep more people in contact lenses, since they relieve allergic eye itch for up to twelve hours, without the need for allergy drops, and provide vision correction.”

“At Johnson & Johnson Vision, we are committed to bringing forward new technologies and innovations that can improve vision and overall eye health,” said Thomas Swinnen, President, North America, Johnson & Johnson Vision Care, Inc. “This approval marks another significant milestone in Johnson & Johnson Vision’s legacy of rethinking what’s possible with contact lenses to meet the visual and eye health needs of people around the world.”

Come and see our news at the EFCLIN congress, 28.04. - 30.04.2022 in Barcelona. Know your quality! Metrology for contact lenses and intra ocular lenses.

Tel. +49 9131 69 15 00 email

CooperVision plastic neutral contact lens program posts first-year results

One year after CooperVision established the first plastic neutral contact lens through a partnership with Plastic Bank the program has made a significant environmental and social impact worldwide:

• The equivalent of nearly 28 million plastic bottles have been prevented from polluting the oceans.

• 171 coastal communities have directly benefited from exchanging ocean-bound plastic for necessities such as clean water, groceries, cooking oil, school tuition, and even health insurance.

According to CooperVision, their partnership with Plastic Bank, a social enterprise that builds ethical recycling ecosystems in coastal communities and reprocesses the materials for reintroduction into the global supply chain, is the largest plastic neutrality initiative in the contact lens industry.

30 years Trioptics

On December 1st , 2021, the optical metrology specialist Trioptics celebrated its 30th anniversary in business. The company, headquartered in Wedel near Hamburg, Germany, is one of the world’s leading companies in the field of optical measurement and manufacturing technology with subsidiaries and sales partners around the world. With their products and systems they aim to accompany and improve the development, production, and quality control of optical components, lenses, camera modules, and sensor systems worldwide.

Currently, 18 CooperVision subsidiaries in Europe and North America are participating with nine more in Asia, South America, and Europe slated to join this year. With this expanded scale, the program is expected to prevent the equivalent of nearly 90 million plastic bottles from reaching oceans in 2022 – more than three times the amount collected in 2021.

“We are constantly striving to identify novel solutions that not only address key sustainability challenges but also create new opportunities,” said Dan McBride, Executive Vice President (EVP), Chief Operating Officer of CooperCompanies. “By reexamining our relationship with plastic, we can help protect the world’s oceans and transform waste into a resource.”

“There is no single approach that achieves sustainability, so we need to manage plastic use on many fronts,” McBride continued. “There is no finish line either, so we invite contact lens wearers and the rest of the eye care industry to join us.”

Driven by the idea to significantly develop and lead the field of computer controlled optical metrology, Eugen Dumitrescu founded Trioptics on December 1st, 1991, in Wedel with two partners. The company states that their primary focus has always been the customer-oriented development of optical measurement systems, later expanding to include manufacturing instruments. Early on, they opened subsidiaries in Asia and the USA to quickly provide on-site support to their customers. Over the years, Trioptics has consistently expanded its product portfolio, continuously improved established measurement methods, and placed a significant focus on the automation of its systems. Large international and interdisciplinary customer projects are seen as just as important as the continuous development of the standard portfolio of products. The company serves the entire optical production value chain as one of the leading suppliers of optical measurement and manufacturing systems. In 2018, they moved to the new headquarters in Wedel, just a few hundred meters from the founding address. Today, roughly 500 employees worldwide work towards the success of the company. In 2020 Trioptics was integrated into the Jenoptik photonics group.

Euclid Systems Corporation, a global leader in advanced orthokeratology and proactive myopia management, announced two additions to its leadership team as well as the expansion of its manufacturing facility in Sterling, Virginia, USA.

Space at the Euclid facility in Sterling, Virginia, has now been expanded over 40%. Additions include larger manufacturing space, quality assurance labs, offices, and engineering/R&D space.

“With the launch of our game-changing Euclid Max Ortho-K lens this year, we have entered a very exciting time at Euclid. But our steadfast commitment to innovation is not taking a break. We’ve just expanded our manufacturing space and employee resources for the second time in three years and continue to grow our leadership team for future expansion,” said Euclid Systems CEO, Joseph

Boorady. “We’re pleased to welcome Greg Endicott and Mark Mercier, who bring decades of experience, innovation, and results in fast-paced healthcare environments. Their knowledge and leadership, as well as the brick-and-mortar expansion of our facilities, help fortify Euclid’s growth as a cutting-edge world leader in myopia management technologies.”

As Chief Information Officer (CIO), Greg Endicott will lead Euclid’s strategic technology program and drive business initiatives in collaboration with global business leaders, including exploration of emerging technologies and new strategies. Previously, Mr. Endicott had a leadership role at Baxter Bioscience and was inaugural CIO of two scientific research companies. New Senior Director of Operations is Mark Mercier, a transformation specialist with decades of experience in contact lens manufacturing at Bausch+Lomb. Mr. Mercier will drive efficient methodologies throughout Euclid’s manufacturing and fulfillment.

Euclid Systems names key leadership hires and announces major facility expansion

Source: Trioptics

New free form lens design feature

BostonSight announced their new free form lens design feature, Smart360, for the BostonSight Scleral product. Using Smart360, practitioners can design a free form lens from 16 mm to 19 mm, giving them ultimate flexibility. The organization was one of the first to introduce empirical fitting. In 2019, they introduced Scleral-IG, an image-guided fitting system for the BostonSight Scleral lens using Eaglet ESP. This year, the organization collaborated with a team of beta testers from the BostonSight Scleral network to evolve the technology, resulting in Smart360. Practitioners send a 360-degree scan of the eye directly to the organizations’ manufacturing lab via the practitioner’s FitConnect account. Smart360 currently integrates with the Oculus Pentacam CSP and CSP Pro and the Eaglet Eye ESP.

“Our ongoing commitment to research and achieving optimal patient outcomes drives our innovations in scleral lens design,” said Sara Yost, BostonSight’s President and CEO. “Data analysis from over 20,000 patient eyes, combined with our research, is used to improve our products and features, providing

practitioners with more fitting options for their patients, and ultimately better patient satisfaction.”

“Smart360 is simply another way to create a customized lens using the same great data-driven design technology that BostonSight is known for,” said Karen Carrasquillo, OD, PhD, FAAO, FSLS, FBCLA, Vice President of Clinical and Professional Affairs. What makes Smart360 unique in the empirical fitting market is that practitioners can continue to tailor the lens with BostonSight Scleral’s suite of smart features, including SmartChannel technology to vault anatomical obstacles and minimize suction and SmartSight technology to reduce higher order aberrations.”

All about markets

Contact lenses revenue

Ukraine and Russia

According to the Contact Lenses Report 2020, Statista Consumer Market Outlook, revenue in the contact lenses segment of the eyewear market was expected to amount to USD 15m in the Ukraine and to USD 485m

in Russia in 2022. In global comparison, most revenue was expected to be generated in the United States (USD 5,326m in 2022).

www.statista.com/outlook/cmo/eyewear/contact-lenses/ukraine, www.statista.com/outlook/cmo/eyewear/contact-lenses/russia

Laser vision correction procedure volume for Q4 2021

The Refractive Surgery Council (RSC) reported laser vision correction procedure volume for Q4 2021 at 190,509, marking a year-to-date increase of 32%

over 2020. The total procedure volume for 2021 topped 833,000 for the first time since RSC began tracking LASIK, SMILE, and PRK procedures in 2015, demonstrating a significant consumer shift toward refractive surgery options to glasses and contacts.

Contact lens wear in European countries

Euromcontact’s 2021 market data report states that of the 21.7 million wearers in the 34 countries covered, 56%

use daily disposable, 43.9% weekly/bi-weekly and monthly replacement lenses, and 0.07% conventional soft lenses.

China is Russia’s most important trading partner, accounting for 13% of the country’s exports in 2019. The world’s largest exporter is even more important as a supplier of goods for Russia, accounting for 22% of the country’s goods imports in the same year.

Source: www.statista.com/ chart/26973/russias-most-important-import-partners

EFCLIN 2022 www.efclin.com

ARVO 2022 www.arvo.org

EAOO & ECOO General Assembly www.visiondublin2022.com

BCLA Focus www.bcla.org.uk

NCC 2022 www.contactlenscongress.com/?lang=en

ICSC 2022 www.icscmeeting.com

ECLSO Congress 2022 www.eclso.eu

Vision By Design www.orthokmeeting.com

AAO 2022 www.aao.org

IOFT 2022 International Optical Fair Tokyo www.ioft.jp/en-gb.html

Apr 28-30 Barcelona/ Sitges (Spain)

May 1-4 Denver, CO (USA)

May 12-15 Dublin (Ireland)

June 11-12

Hybrid: online, Birmingham (UK)

June 26-27 Veldhoven (NL)

July 29-30 Fort Lauderdale, FL (USA)

Sep 2-3 Paris (France)

Sep 28 - Oct 2 Bellevue, WA (USA)

Sep 30 - Oct 3 Chicago, IL (USA)

Oct 18-20 Tokyo (JPN)

(due to the corona crisis, please check via the websites whether the event takes place) Advertisement

All about research

Bionic eye, handheld autorefractor measurements acceptance, mechanism for AMD, contact lenses with gold nanoparticles

After studying a bionic eye using a sheep model, researchers are confident it is safe for human trials. A paper found that eyeglasses made from QuickSee handheld autorefractor measurements were accepted equally to those made from subjective refraction measurements. A team from the University of Maryland School of Medicine has identified a new potential mechanism for age-related macular degeneration. Researchers reported infusing contact lenses with gold nanoparticles to create a safer way to see colors.

Study identifies new mechanism that may cause blindness in older adults

Using laboratory-grown roundworms, as well as human and mouse eye tissue, University of Maryland School of Medicine (UMSOM) researchers have identified a new potential mechanism for age-related macular degeneration – the leading cause of blindness among older adults. The UMSOM researchers say that the findings suggest a new and distinct cause that is different from the previous model of a problematic immune system, showing that the structural organization of the eye’s light-detecting cells may be affected by the disease. The discovery offers the potential to identify new molecular

targets to treat the disease. It was published in the Proceedings of the National Academy of Sciences (PNAS). Several years ago, researchers had identified genetic mutations in the protein complement factor H as a contributor in a large number of macular degeneration cases. Complement factor H marks cells in the body as self and protects them from attack by the immune system, whose job it is to eliminate invading pathogens and cells that do not belong. As a result, due to complement factor H’s role in this process, it was thought that macular degeneration was likely due to the immune system attacking its own body’s cells that were not marked properly as “self.”

According to Dr. Vogel, since identifying effective new therapies for the disease has been slow, he wanted to see if his team could find new insights from studying the disease components in his laboratory model of the roundworm, C. elegans.

Dr. Vogel’s team found a worm version of complement factor H protein located in the sensory neurons that help the worms detect chemicals, food, touch, and temperature. The protein appeared specifically in the middle region of the sensory neuron’s little antennas, known as cilia (that do the work of sensing the environment), just next to another known important antenna protein called inversin. However, in worms bred to lack complement factor H, they found the inversin spread throughout the antennas rather than remaining in the middle of the antennas. Next, the researchers confirmed their results in the lightdetecting cells in tissue from human retinas. Complement factor H and inversin had the same positioning next to each other in the antenna of light-detecting cells from healthy

samples. Yet in people with complement factor H mutations (i.e. people genetically predisposed to macular degeneration), they found the inversin spread around, no longer restricted to its neat banding pattern on the antenna.

“Our findings suggest that complement factor H plays a role in maintaining the organization of photoreceptor cilia, and this process may be defective in age-related macular degeneration,” says Vogel. “We plan to continue this work to determine how this structural disruption affects vision and to determine whether we can reverse the disruption and restore photoreceptor function.”

Sources: UMSOM [1]

Glowing sensory cells in the worm that make complement factor H protein. Photo: PNAS

Bionic eye study paves the way towards human trials

A bionic eye being developed by a team of biomedical researchers at the University of Sydney and UNSW has shown to be safe and stable for long-term implantation in a threemonth study, paving the way towards human trials.

The Phoenix99 Bionic Eye is an implantable system, designed to restore a form of vision to patients living with severe vision impairment and blindness caused by degenerative diseases, such

as retinitis pigmentosa. The device has two main components which need to be implanted: a stimulator attached to the eye and a communication module positioned under the skin behind the ear. Published in Biomaterials, the researchers used a sheep model to observe how the body responds and heals when implanted with the device, with the results allowing for further refinement of the surgical procedure. The biomedical research team is now confident the device could be trialled in human patients.  The team will now apply for ethics approval to perform clinical trials in human patients, as they continue to develop and test advanced stimulation techniques.

The Phoenix99 Bionic Eye works by stimulating the retina – a thin stack of neurones lining the back of the eye. In healthy eyes, the cells in one of the layers turn incoming light into electrical messages which are sent to the brain. In some retinal diseases, the cells responsible for this crucial conversion degenerate, causing vision impairment. The system bypasses these malfunctioning cells by stimulating the remaining cells directly, effectively tricking the brain into believing that light was sensed.

“Importantly, we found the device has a very low impact on the neurons required to ‘trick’ the brain. There were no unexpected reactions from the tissue around the device and we expect it could safely remain in place for many years,” said Mr Samuel Eggenberger, a biomedical engineer who is completing his doctorate with Head of School of Biomedical Engineering, Professor Gregg Suaning.

Sources: University of Sydney [2]

Color blindness-correcting contact lenses

Researchers reported infusing contact lenses with gold nanoparticles to create a safer way to see colors in ACS Nano. Some daily activities, such as determining if a banana is ripe, selecting matching clothes or stopping at a red light, can be difficult for those with color blindness. Most people with this genetic disorder have trouble discriminating red and green shades, and red-tinted glasses can make those colors more prominent and easier to see. However, these lenses are bulky and the lens material cannot be made to fix vision problems. Thus, researchers have shifted to the development of special tinted contact lenses. Although the prototype hot-pink dyed lenses improved red-green color perception in clinical trials, they leached dye, which led to concerns about their safety. Gold nanocomposites are nontoxic and have been used for centuries to produce "cranberry glass" because of the way they scatter light. So, Ahmed Salih, Haider Butt and colleagues wanted to see whether incorporating gold nanoparticles into contact lens material instead of dye could improve red-green contrast safely and effectively.

To make the contact lenses, the researchers evenly mixed gold nanoparticles into a hydrogel polymer, producing rose-tinted gels that filtered light within 520-580 nm, the wavelengths where red and green overlap. The most effective contact lenses were those with 40 nm-wide gold nanoparticles, because in tests, these particles did not clump or filter more color than necessary. In addition, these lenses had water-retention properties similar to those of commercial ones and were not toxic to cells growing in petri dishes in the lab. Finally, the researchers directly compared their new material to two commercially available pairs of tinted glasses, and their previously developed hot-pink dyed contact lens. The gold nanocomposite lenses were more selective in the wavelengths they blocked than the glasses. The new lenses matched the wavelength range of the dyed contact lenses, suggesting the gold nanocomposite ones would be suitable for people with red-green color issues without the potential safety concerns. The researchers say that the next step is to conduct clinical trials with human patients to assess comfort. The paper is freely available as an ACS AuthorChoice article.

Sources: American Chemical Society

The ocular and subcutaneous implant components of the Phoenix99. Photo: University of Sydney

Autorefractor measurements accepted by patients

A paper published by researchers at the Aravind Eye Institute in India, Johns Hopkins University, and the Massachusetts Eye and Ear Institute found that eyeglasses made from QuickSee handheld autorefractor measurements were accepted equally to those made from subjective refraction measurements. The study authors suggest that QuickSee, due to its accuracy and portability, could be used to radically expand access to eyeglasses in remote and low resource settings which lack professionals and clinical equipment to provide accurate prescriptions.

The paper in Ophthalmology, "Investigation of the accuracy of a low-cost, portable, autorefractor to provide well-tolerated eyeglass prescriptions: a randomized crossover trial," concluded that patients accepted eyeglasses made from QuickSee measurements equally to those made from subjective refraction. PlenOptika, the maker of the device, assisted in study design but its execution, analysis, and reporting was independent of the company.

Shivang Dave, PhD, CEO of PlenOptika and one of QuickSee's inventors, and his colleagues Daryl Lim, PhD, Eduardo Lage, PhD, and Nicholas Durr, PhD, invented the technology while

researchers at the Massachusetts Institute of Technology, in collaboration with the Regional Government of Madrid. The development was supported in part by grants from the National Eye Institute of the National Institutes of Health.

In wealthy nations where patients have access to licensed health care providers, the technology has also helped eye doctors provide on-site care, such as in nursing homes, correctional facilities, and community health centers. Even large eye health centers are using the device to manage large patient volumes efficiently. To date, QuickSee has been used to measure over three million people in 45 countries, and was found in prior peer-reviewed studies to produce measurements that strongly agree with subjective refraction.

Sources: PlenOptika

Referenzen: [1] www.medschool.umaryland.edu [2] www.sydney.edu.au

UPC 100 Vision // UPC nano

Where the highest surface accuracy and quality meets unrivaled productivity.

The compact and fully featured UPC 100 Vision is optimized for highly dynamic diamond turning of specialty contact lenses, IOL’s and mold inserts.

Complex freeform Silicone Hydrogel and GP surfaces for OrthoK, Scleral and Keratoconus designs with control for myopia, astigmatism and presbyopia, can be easily produced ‘polish-free’.

The UPC nano is the most economic and compact machine, with on-board freeform capabilities and an optional laser engraver, for manufacturing high-quality specialty contact lenses ready for polishing with minimal lens production costs. Both machines can be easily automated with the SCHNEIDER automation options.

QuickSee handheld autorefractor in use in India.

Photo: PlenOptika

All about products

Transforming Lives Together

When we work together as an industry, we can deliver products and expertise that truly transform patients’ lives.

Full Range of Materials

Led by industry insights, Contamac offers a complete range of contact lens materials to suit all indications. From our signature Optimum family of gas permeable materials, to Definitive silicone hydrogel materials and Contaflex hydrophilic soft lens materials, each with their own unique properties to benefit machinability, comfort and corneal health.

Educational Initiatives

We also believe that by investing in the professionals of our future, we can ensure they are fully equipped to transform the lives of patients. Whether it is through publications, videos or industry events, Contamac is proud to support an exchange of knowledge with the industry. Find out more: www.contamac.com, sales@contamac.co.uk

QualiLENS®100 for Automation

The new QualiLENS®100 for automation is a global and option-based solution, for R&D and production inspection machines, with a built-in fanless computer and PLC for Cleanrooms.

At V-OPTICS, we believe that handling lenses is tricky, risky, and burdensome. That’s why we have reflected on an all-in-one machine, able to embed any line of production, to be duplicated at will, for any type of inspection machines (contact lenses, IOL, ICL or semi-finished).

In 2021, we launched add-ons of new increasingly optic controls such as 2D dimensions, engraving reading and QC, automated cosmetic inspection, and advanced optical power. Machine-side, high resolution cameras and illumination are used to complement our patented technology: the “Phase shift Deflectometry and computations”. Software-side, we developed software package according to manufacturers and current equipment’s requirements. More is to come.

V-OPTICS, your partner “outside of the box”. info@v-optics. fr, www.v-optics.fr/en/automatic-lens-defect-control/

Optimizations for IOL production testing

OptiSpheric® IOL PRO 2 is TRIOPTICS’ fully automated optical IOL test stand. Developed for use in production, it provides a throughput of up to 100 lenses per batch. The ISO-compliant measurement of hydrophobic and hydrophilic lenses in air or in-situ can be performed with an accuracy of 0.3 % (power) for all types of intraocular lenses (incl. EDOF, multifocal and trifocal).

With the latest software module, the system can be connected to your database in accordance to FDA 21 CFR PART 11. This allows you to retrieve sample-specific data and measurement scripts from the server as well as to archive your measurement results in conformity with the standards. www.trioptics.com, info@trioptics.com

The Non-Paraxial Model Eye opens the doors of EDoF IOL metrology

As the complexity of IOL designs increases, metrology tools must become more powerful and effective to overcome new challenges, especially with the rise of Extended Depth of Focus (EDoF) IOL. Until recently, the Model Eye historically available in NIMO (mathematical model base on the summing of the wavefront of the IOL and the wavefront of a synthetic cornea) was perfectly appropriate. However, this method faces limitations for larger apertures and when the IOL and synthetic cornea show aberrations. LambdaX’s new Non-Paraxial Model Eye overcomes these issues by accounting for the focusing effect of the model eye and therefore the incident light entering the IOL not being collimated. The patent pending Non-Paraxial Model Eye implemented in IOL-MENTOR® opens way to more efficient measurements of complex refractive optics with wavefront sensors in IOL metrology for both R&D studies and production quality check. Since the model has been fully validated for measurements of lenses in-air and in-situ, the operation is simpler, more consistent, beneficial to IOL manufacturers and ultimately contributes to a better vision for the patient.

www.lambda-x.com , sales-ophthalmics@lambda-x.com

Metro cell

Complete Metrology Solutions for contact lenses and IOL's

Global Specialty Lens Symposium (GSLS)

A look back

Despite difficult circumstances due to the Corona pandemic, the Global Specialty Lens Symposium (GSLS) took place in Las Vegas from January 19 to 22 in presence. For those who could not attend the event, however, the organisers have a special ace up their sleeve. In the summer, the symposium will get an additional online-only extension. Special speakers and an interesting lecture programme will be included.

By Silke Sage

But first, a look back to Las Vegas. In total, the GSLS featured around 30 educational workshops, general lectures and sessions on all specialty lens topics with a focus on myopia management, scleral lenses, irregular cornea management, dry eye, multifocal contact lenses and specialty lens practice management. There were also more than 120 scientific posters, several free lectures presenting the latest research findings, and nearly 40 sponsored presentations where attendees could learn about new specialty lens designs.

In conversation with GlobalCONTACT, the organisers were quite satisfied with the conference and exhibition, although with just over 600 participants, only about half the usual number of visitors showed up in presence. "Considering the circumstances

we all have to live with at the moment, we consider it a very successful event," says co-organiser Professor Dr. Edward Bennett of the Missouri-St. Louis College of Optometry, adding: "There were also some last-minute cancellations among the exhibitors, but most of them came. I was able to make sure through personal conversations that they were very pleased, both with their decision to participate and with the attendance."

HIGHLIGHTS 2022

Edward Bennett complimented the high standard of the lectures offered. He reports: "I always give our lectures chair, Jason Nichols, my summary of positive and constructive thoughts about the meeting, and it was difficult to find any negatives.

GSLS Free Paper Session: (from left). Drs. Mari Fujimoto, Erin Tomiyama, Juan Gonzalo Carracedo RodrÌguez, and Jaume Paune. Standing: Dr. Ed Bennett (moderator). Photo courtesy of Dr. Jaume Paune

A highlight in my opinion was the presentation ‘Myopia control: treatment showdown 2.0’, moderated by Jeff Walline with an excellent panel consisting of Pauline Cho, Kate Gifford, Sally Dillehay and Ashley Wallace-Tucker. A series of seven practice cases were presented and each panel member spoke in favour of a different treatment option: 1) orthokeratology, 2) soft multifocal lenses, 3) myopia control with spectacle lenses and 4) low dose atropine. The audience was then asked which modality they thought was indicated in this particular case."

VIRTUAL GSLS

From June 9 to 11, the classic symposium will be expanded for the first time with an additional purely virtual version of the GSLS-V. Jason Nichols, who is the programme chair, told us

more about this: "We have planned four lecture series coorganised by international special lens organisations from Asia-Pacific, Europe and Latin America. We believe this will be the most international GSLS we've ever had!"

The preliminary programme is something to be excited about. You can follow the link directly in our GlobalCONTACT app or find it here: www.clspectrum.com/gsls-virtual/agenda n

Mark your calendars:

The next classic GSLS will take place again from January 18 to 21 in Las Vegas, Horseshoe (at the old Bally's Hotel & Casino).

GSLS Education Committee: Karen DeLoss OD, Patrick Caroline FCLSA, Jason Nichols OD, PhD (Chair), Lynette Johns OD, and Ed Bennett OD, MSEd. Photo: GSLS

Dr. Edward S. Bennett (right), Thomas E. Anastor GPLI Distinguished Service Award 2022 and Jan Svochak

Kenneth W. Leonhard (left). Winner of the Honorary Recognition Award 2022 and Chris Pantle

Naomi “Jo” Svochak GP Practitioner of the Year Award 2022: Dr. Stephanie L. Woo (right) and Dr. Bennett

30 years in the contact lens industry

Memories, impressions and opinions

Three decades are a long time – for a magazine, for an industry and also for the people who fill it with life. On the occasion of GlobalCONTACT's 30th birthday, we asked seven well-known personalities in our industry to take a look back and continue some strands of thought for us: on their first encounter with the contact lens industry, significant innovations of the past, challenges of the present and visions for the future. Read their memories, impressions and opinions here.

Edward Bennet

O.D., M.S.Ed., F.A.A.O., F.S.L.S., Executive Director and President, GP Lens Institute, Professor Emeritus University of Missouri-St. Louis College of Optometry

30 years ago I was ... developing video programs for the GP Lens Institute at a time when this was new and innovative. I was also beginning a 22 year labor of love with the Academy of Optometry Cornea, Contact Lenses & Refractive Technologies Section leadership.

I had my first encounter with the contact lens industry... in 1978. I was a beginning 4th year optometry student and had developed a tremendous interest in contact lenses. My optometry program (Indiana University School of Optometry) had just started a contact lens research clinic under the direction of Drs. Irvin Borish and Sarita Soni. I literally talked my way into this rotation which changed my life as I was able to perform clinical investigations on the first soft extended wear, gas permeable, and soft toric lenses. The first study was the D3X4 soft toric which – although it resulted in discomfort, edema, and inconsistent vision – impacted my life significantly in three ways: 1) the funding I received from Wesley-Jessen funded my tuition for the year; 2) I reported to Alan Tomlinson who then became a good friend and my research mentor until he became ill; and 3) one of the subjects was a second year student who I ultimately married.

The most significant innovations during this period were in my opinion... without a doubt the introduction of scleral lenses. They allowed for excellent vision and good initial comfort, allowing a significant percentage of irregular cornea patients to avoid surgery while also enhancing the quality of life of those with pathological dry eye. Secondly, we experienced a tremendous increase in our understanding of the importance of myopia management and developed innovative GP and soft lenses to help slow the progression of this condition.

The greatest challenge at the moment is... effective communication to the consumer that contact lenses are health care devices.

In 10 years, the industry will... continue to play an important role in refractive correction. Myopia management will become standard of care, and lenses for drug delivery, as well as smart auto-focus lenses for presbyopia will be available.

If I could wish for one innovation it would be... a way to make corneal lenses more initially comfortable, so that astigmats, presbyopes, children, and those with corneal disease have a truly exceptional initial experience.

Erik Larsen President Larsen Equipment Design

30 years ago I was... in our tenth year of the founding of Larsen Equipment Design and was just entering the international market.

I had my first encounter with the contact lens industry... in 1973 in a small shop owned by an ophthalmologist which did general machining and made machines to make CL.

The most significant innovations during this period were in my opinion...

CNC CL lathes.

Eef van der Worp

Optometrist

PhD, Eye-Contact-Lens Research & Education

30 years ago I was ... a student! But I was actually not at the optometry school in Utrecht in the Netherlands, but in Manchester (UK), doing an externship at Eurolens Research, Department of Optometry and Vision Science UMIST under supervision of Professor Nathan Efron. Magical times! Phil Morgan was there too, doing his PhD. I am pretty sure my enthusiasm for research and education sparked right there and then.

I had my first encounter with the contact lens industry... My first encounter with contact lenses as a wearer of rigid lenses, in the late 1980s: with the contact lens industry as such – about 30 years ago actually. I remember doing another externship for my education at NKL (back then) in Emmen in the Netherlands. And the Director Henk van Bruggen invited me personally for a dinner at a fancy restaurant (at least for a poor student!). We talked about the contact lens industry all night and ate fresh asparagus from the region. I will never forget.

The most significant innovations during this period were in my opinion... Corneal topography really has been quite instrumental. But in the end, it must be the resurgence of scleral lenses: that really had a significant impact on the industry. (See my article in this edition of GlobalCONTACT.) What a great journey, and how beautiful to be part of that ride. I can only feel gratitude being included in that and making so many great friends on the way.

It would never have been possible without... support and collaboration from our customers.

The greatest challenge at the moment is... global unrest.

In 10 years, the industry will... be dependent on global stability.

If I could wish for one innovation it would be.... peace.

It would never have been possible without... enthusiasm. The scleral lens arena is such a fun one, with so many people together working on this. I think, because it has been so much pioneering since the very first days of scleral lens fitting, that it feels like we are in this together: industry, researchers, educators, practitioners, etc. Love that.

The greatest challenge at the moment is... to make the next move. We know so much about the optics side of the eye and aberommetry – now it is time to implement that in practice. This is true for specialty soft lenses too, and myopia management applications: there are so many opportunities, it almost drives me nuts. But practitioners need to embrace it and exploit it.

In 10 years, the industry will... be a much better place as we will be starting to apply big data to our patients’ eyes. Trial sets will be obsolete (in any type of lens probably) by then. Like what we see with corneal rigid lenses in parts of the world and orthokeratology increasingly: you take the topography and create the best possible lens for that individual eye from that. Whether it be a corneal lens, corneal remodeling, scleral or soft specialty lens: that’s the way forward!

If I could wish for one innovation it would be... soft specialty lenses to mature, and to individually design better soft lenses if desired because of shape or optics. I think there is so much to gain here in terms of myopia control, improved comfort, better visual performance and reduction of dropout.

Marion Beeler

Dipl. Ing. (FH) Augenoptik SBAO, Association Manager VMI, EFCLIN Executive

Director

30 years ago I was... a contact lens specialist in a renowned contact lens practice in Lucerne, Switzerland.

I had my first encounter with the contact lens industry... in 1980 when I met the specialists from Wöhlk-Contactlinsen and Titmus Eurocon (now Alcon) for the first time.

The most significant innovations during this period were in my opinion... the silicone hydrogels, the more gas-permeable RGP materials, the quadrant-specified RGPs and the restart of Ortho-K. A lot also happened in terms of measurement technology 30 years ago, the first autorefractometers came on the market, measurement of the corneal periphery became a huge topic, fundus photography and other things came up. Socially, the spread of the worldwide-web and mobile phones changed our lives.

It would never have been possible without... all the fantastic innovative women and men in science and research and in the many small contact lens practices and optometry shops where practitioners have tried to develop new devices or techniques for their needs. The dialogue between research, practice and industry has taken the contact lens so far. Here in Europe we have had so many bright minds that I cannot list all the names. We also always looked to the USA and Australia. I still think of a formative meeting with Irving Fatt, the pioneer

of gas permeability measurements of contact lens materials, in 1993, when he said "vision is an island in the sea of blindness, and our job is to prevent that island from sinking."

The greatest challenge at the moment is... besides world peace, which seems threatened to me at the moment, climate change and environmental protection. In our industry it is to continue to encourage and support the innovative minds. We still need RGP lenses to provide good care for people with special vision problems. This must not be sacrificed on the altar of making a quick buck with disposable lenses, which of course have their justification and clientele. The market needs both.

Another challenge is the heavy regulation of the medical devices market, which includes IOLs, contact lenses and care products as well as spectacle lenses and frames. In addition, under the EU's "Green Deal", certain substances are to be banned from contact lens materials and care products. These demands are challenging the contact lens industry, as it takes 10-15 years to develop and test new materials until they are ready for the market.

In 10 years, the industry... of this sector will continue to stand together and, in healthy competition with each other, bring further top products to the market for the benefit of better vision.

If I could wish for one innovation it would be... the accommodative IOL or contact lens or the breathable lens material.

Robert McGregor Managing Director Contamac

30 years ago I was… still dreaming of becoming a professional footballer with Manchester United, I remain baffled how Utd’s scouting system missed me!

I had my first encounter with the contact lens industry... when supplying a glass of Whisky to my father in the Garden Shed. (See GlobalCONTACT 2020-3 and 2016-1)

The most significant innovations during this period were in my opinion... the invention and launch of silicone hydrogels, a significant chemistry milestone.

It would never have been possible without... exceptional chemists and corporations who understood the benefits this technology can provide to patient health.

The greatest challenge at the moment is... the external environment.

In 10 years, the industry will... remain buoyant whilst embracing many new technologies and innovations to ensure all companies continue to thrive, delivering products that enhance or change people’s lives.

If I could wish for one innovation it would be... environmentally friendly and sustainable unleaded fuel.

Ken Payne President DAC International

30 years ago I was... building DAC International’s European business, establishing sales and service for contact and intraocular lens manufacturers throughout West and East Europe and the Middle East.

I had my first encounter with the contact lens industry... in 1984 as an engineer at Hydron (later, Allergan Hydron) based in Farnborough, UK.

The most significant innovations during this period were in my opinion... the introduction of CNC machinery and manufacturing technologies such as ‘fast-tool-servo’ systems for complex (non-axisymmetric) lens geometries and the automation of manufacture of individual/prescription contact lenses. Ortho-K modality advancement and multi- and tri-focal IOL’s.

It would never have been possible without... innovators, technological advancement and incredible peers that saw far beyond their time

The greatest challenge at the moment is... pandemic and conflicts aside, the medical device regulation and continued downward lens price pressures.

In 10 years, the industry will... still be here! Will be subject to increased regulation. More widely automated vision solutions (closed-loop) from practice via manufacturing and back to patient. The awakening of disruptive technologies in vision correction techniques.

If I could wish for one innovation it would be... How to make an inflatable high precision fully automated lens manufacturing process  No, but really – A lab-in-a-box!

Wim Aalbers

30 years ago I was ... 45 years old, executive director of EFCLIN and had just started as publisher of this magazine. Exciting time, in which we revitalized EFCLIN with a great team of enthusiastic board members and developed a magazine that still exists and still is very successful.

I had my first encounter with the contact lens industry...

In 1972 I became Benelux area manager for Bausch & Lomb. We introduced the first soft contact lenses in Europe. In 1975 I started my contact lens practices. In the 90’s I started with Procornea in marketing and sales.

The most significant innovations during this period were in my opinion...

In Europe that was no doubt the introduction of the CE marking. A lot of struggling and resistance in the beginning, but we ended up with a better industry.

It would never have been possible without... The rules came from Europe. But the efforts of the industry and organizations like EFCLIN and Euromcontact made

it workable and improved the quality of the industry. Also monitoring new rules was very helpful.

The greatest challenge at the moment is... to maintain the professionalism of the contact lens practitioners at a high level. In several countries (soft) lenses are sold in drugstores and on the internet without any guidance. Lenses with only an indication of the power on the packaging. No diameter, thickness, curvature, material, geometry. That is dangerous and we see the results around.

In 10 years, the industry will... be partly based on disposables and prices. But we also see a very specialized professionalism. Think of myopia management, scleral lenses etc. Also, lenses as part of medical treatment will get more important, as production techniques will increase even more.

If I could wish for one innovation it would be... 3D printing of lenses and better quality of online communication.

Something else in retrospect

Looking back at the beginnings of GlobalCONTACT

When I was asked to write an article for this magazine about the magazine, I did not realize how much fun, and at the same time how much work, it would involve. All together it was great to do. This is how I approached it. By Wim Aalbers

In my office I have six books in which the first 50 magazines are neatly bound, weighing 12 kg (26.5 lb). For this assignment: great material to do some research. Flicking through all those past issues, many memories came back to me. It took me and my wife, Kitty, three full days to go through all the pages. But before I share some of this past information, let me first explain why this magazine was founded in the first place.

In 1991 EFCLIN was in a bad situation. There were only a few members left and there had not been any congress or meeting for a few years. The initial launch (by George Nissel) in 1972 was followed by fifteen successful years. But by 1991, it looked as if EFCLIN was doomed to end their activities.

A board meeting held in Spain, just before I was asked to join the board, had just two items on the agenda: 1. End EFCLIN or 2. Continue and how. We chose the second option and set out an ambitious plan to revitalize the organization.

RELAUNCH IN 1992

One of the tools we chose was to start a comprehensive newsletter in the form of a magazine. And that’s exactly what we did, and I was the one assigned by the board to start such magazine. The name we chose was ‘Contact’, that was the basis of the great magazine you are now holding! In 1992 the first issue (500 copies) was distributed to all members and potential members in Europe.

In this first issue there was, of course, an introduction by the president of EFCLIN, Toni Koller, since EFCLIN was responsible for the magazine. I had the honor of writing the first version of ‘From the editor’. And thus we started our journey into history.

A few facts that place the first issue in the context of 1992: Because we wanted to be as European as possible, all prices and rates were given in ECU, the currency that preceded the euro. It is also striking that there was a fax form included in the magazine. Looking back now, it makes you realize the internet and e-mail did not yet exist.

The column ‘Something Else’ was already in issue 1, a column I wrote for many years and with much pleasure. Looking at that picture of myself, it is evident that my weight at the time was 140 kg (300 lb). Kitty didn’t fail to notice…

THIS SPOOKY CE THING AND OTHER CHALLENGES

In that first issue there were several articles about the CE marking. In October 1992 we organized the first seminar for contact-lens manufacturers on this topic. And many were to follow all over Europe. There was a lot of incomprehension by most manufacturers who felt threatened, even though they knew it would take another six years before the regulation on medical devices would come into force. Still, the magazine published as much news as possible on the topic.

By the end of 1992 I was invited to join the Board of Euromcontact. In the run-up to this spooky CE thing, Euromcontact was able to influence the upcoming regulations. That was necessary because some rules were not reasonable for our industry. Medical devices were classified in four classes. Class one was for ‘high risk’ products like heart valves, etc. Such products could and can only be prescribed and dispatched by qualified specialists. At that time there was the enormous problem of mad cow disease. The result was that a definition of medical devices in class one was that, if any product contained any part of animal tissue or if animal tissue was used in the production, by definition they were class one products. At the time in the production of contact lenses bee wax and silk were used for polishing. So they were Class one!

Without Euromcontact (led by Micky Tillotson) contact lenses would completely have lost their existing distribution channels. There are many such examples, and that is why the magazine consistently reported extensively on the CE and Euromcontact.

THE EARLY YEARS

The first three issues had so called ‘narrow pages’. Between every two pages, there was a ‘flap’ with a short introduction about the content. It looked good, but it was rather expensive, so in the end we had to scrap it. However, the narrow page remained on the cover till 1996, issue 13.

In 1993 we reported on a special congress in October in Prague, held to celebrate the birthday of Otto Wichterle, the founder of the soft contact lens. David Walker started an interesting series of articles about quality management. Also in that year, we reported on an extraordinary experiment carried out by Paragon. They sent equipment into space with a space shuttle and investigated the way polymerization worked in such a situation.

Looking through the back numbers, Kitty and I were amazed how many advertisements there were in those issues, and indeed still are in the present issues. This confirms the viability of the concept over many years.

In 1993 we also introduced ‘searchers’. Small ads, free of charge, offering assistance, courses, second-hand goods, etc. It all worked out very well.

In issue no. 8, 1994, there was an ad that we just have to mention: for Larsen Equipment. Erik Larsen was not only present with an ad in that issue, but still is today. Sometime along the way, he also started to contribute interesting articles to each issue, and I know these articles have been greatly appreciated by many readers over the years.

TRANSFER OF RESPONSIBILITY

Since 1995, the magazine has no longer been published under the responsibility of EFCLIN but directly by EPS. The reason was that the magazine with a relatively low circulation was very costly. EPS (my company) had the ambition to expand the readership by offering the magazine to manufacturers all over the world. The result was that the circulation went up from the original 500 to almost 2.500 copies in over 50 countries.

During that period, we published the first reports from the UK on myopia control, while continuing to warn manufacturers to be prepared for the upcoming CE marking. The final Medical Device Directive (93/42/EEC) was published on January 1st, 1995, still a few years before the legislation finally came into force.

At the request of several readers, we started to publish a list of addresses of suppliers and organizations, with their fax numbers but still no internet or e-mail addresses.

At the end of 1995 we reported on the few companies who had received their CE approval and corresponding certificates. Many advertisements show pictures of people but one of them deserves special mention. The ad from EPT shows a young man

– a boy actually – working at a lathe. This was Edwin Fierkens. I have known Edwin since the early 1990s and we used to meet regularly at congresses. But his picture in this ad shows him at a very young age. There was no mirror available during my research, so I could not make a comparison to myself.

NEW NAME, NEW LAYOUT

In 1996 (issue no. 13) the design and the name of the magazine was changed. From then on, the name became GlobalCONTACT. And the design changed too. The narrow page on the cover disappeared and a new layout was adopted.

An alarming article under the title “Contact lenses will soon become obsolete”, written by David Burns, an optometrist from the UK, raised eyebrows. Had this prediction come true, the title GlobalCONTACT might have changed again to GlobalLASIK. YES! The first website we published. In 1996 the CLMA proudly announced their new website: http://www.contact.inter.net. Odd but true. (Today: https://www.clma.net/)

Just one issue of GlobalCONTACT later we started publishing more websites and e-mail addresses. In many advertisements from then on, this data was included as standard. In 1997 we even started publishing a separate list with new websites in our industry. The first article on corneal topography was published in 1996. From then on, as we all know, the development of this technique proceeded rapidly, until nowadays it is a method used in almost

all advanced practices. Not only that but manufacturers, too, increasingly became involved in the new measurement methods. In this picture from 1997 I weighed 103 kg (207 lb), 37 kg less than in 1992, which just goes to show how hard it is to work for this magazine.

In 1998 more and more enthusiastic reports came in on monovision. In issue no. 18 we reported on using this approach for golfers. Reports of contact lenses being fitted to babies also became more frequent.

In that year we introduced the GlobalCONTACT award. For many years this award was presented during the EFCLIN congress. The award was presented to the person who had published the most interesting or innovative article of the past year, and a jury panel was set up to judge it. What happened to this award? Why not reintroduce it? In 1998 the euro became an official currency.

APPROACH OF THE NEW MILLENNIUM

After the stressful previous few years, in the run up to the introduction of the new CE regulations, we now had to start worrying about the millennium bug. Horror stories about how computers would no longer work after January 1st , 2000, abounded everywhere. Although we took it serious, we tried to avoid real panic and concentrated on publishing reasonable information only – although we were worried too.

On August 18th, 1998, Otto Wichterle died. Brien Holden, who had known Otto very well, wrote a warm and moving appreciation. And so the new millennium 2000 finally arrived and, to everyone’s relief, planes did not fall out of the sky, no important data was lost, and no atomic bomb was launched automatically by mistake. The first GlobalCONTACT in 2000 was issue no. 24. Eight hectic years concerning the contact lens industry had been covered in 24 issues (weighing a total of 12 kg!). Next to the serious stuff, we always tried to bring a smile to our readers’ faces as well, not least through the cartoons by Mike Flanagan, but also by some nonsense articles like these:

THE SHOW GOES ON

We (Kitty, Paula and Renée) continued enthusiastically making “our” GlobalCONTACT, and 27 issues followed until issue no. 50 was the end. The end for us, but a new beginning for the team at Mediawelt led by Jörg Spangemacher. After Jörg retired, a new young team took it over and continues the good work under the

name Eyepress Fachmedien GmbH. Silke Sage, who has been involved with the magazine since issue no. 28, is the leading lady now, and as editorin-chief she is doing a great job. And our team? Well, Kitty is still my wife, Paula Bouwens, Renée Ong and their spouses are still good friends and we still get to meet regularly. This is probably the best article I have ever written for

I do not know where to start thanking people that made the first 16 years of GlobalCONTACT such a great experience for us. Advertisers, writers, organizations and all those who helped produce the magazine. Our sincere thanks to everyone for these exciting 16 years. But also to everyone who made it possible to continue and complete a total of 30 years. The magazine has changed a great deal, but who and what has not changed in 30 years?

GlobalCONTACT remains a magazine that is fit for its time, and still fulfills an important role in global communication for the contact lens industry.

I wish the publishers every success in the coming years, and I hope they will have as much fun in making the magazine as we had over the course of 50 issues.

And I hope, and expect, that in 2042 Silke Sage will sit down and write an article in GlobalCONTACT issue no. 150, looking back on 50 successful years of GlobalCONTACT! n

Wim Aalbers was Executive Director of EFCLIN until 2011. He wrote the columns "Something Else" since 1992. Active in the industry since 1972. He writes for GlobalCONTACT since it was founded in 1992.

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State of the art Polishers and Polishing Processes for Industrial Lens Manufacturing

Larsen Equipment Design was established in 1981 by a mechanical engineer with experience in optics manufacturing. The mission was to provide reliable optical fabrication machinery using readily available components, metric bearings, and redundant features to ensure reliability, accuracy and repeatability.

Starting with the development of polishing machinery for single point diamond turned optics, the goal was to offer easy to set up machines that yielded predictable results. These were primarily used on steep optics. In the mid 80’s when precision optics manufacturers started using our polishers, it was confirmed that our design actually produced figures of lambda/10 right out of the crate. That capability prompted a long standing relationship with several companies who make mini and micro optics (1-20 mm). “Compact, predictable, and easy to set up and maintain” is an ongoing refrain from our customers . Lens manufacturers look to us for tooling assistance and appreciate our “can do” approach as well. We have continued to support the small optics niche with these bench-top machines. Interestingly, our 1, 2, and 6 spindle polishers find applications in all processes. Some companies use multiple one spindle machines while others use our six spindle units. Of course, we adapt the easily modified spindles to customer requirements, or advise them as to the best approach.

With the advent of CNC lens generating, the polishing task has become easier. The predictable results from our polishers (they polish the generated figure) makes them easy to set up and capable of a high level of precision with a minimum amount of adjustment. Our success with small optics polishers led to the development of 20-80 mm capacity machines. Two dual spindle polishers are now available. These share the same design features (stainless

steel construction, clear machines settings) as in our proven smaller machines. The RP-232 is a “bridge” type radial arm machine using the upper spindle to follow the rotation of the lower drive spindle. The RP-231 is a “T” type radial arm machines using the top driven counter-rotating hex spindles to drive the lens/lap. This is an aggressive machine offering reduced cycle times.

Larsen Equipment Design was founded on the development of product and processes exclusively associated with lens manufacturing. Over the years our processes and equipment, as well as our distilled knowledge of the Industry have made us a valuable resource for lens manufacturers worldwide.

ADVANTAGES OF LARSEN EQUIPMENT DESIGN

• Focus on polishing technologies

• Access to problem solvers

• Fast from R&D to Production

• Leadership in Product/Process

• Development

RANGE OF PRODUCTS

• Polishers

• Beveling machines

• Tooling

• Custom Equipment

• Process Development

• Automated Blocking systems

Tel. +49 9131 69 15 00 Email sales@optocraft.de

OPTIMEC SYSTEMS

Optimec Systems Limited

In June 2020, after 43 years serving the industry, Optimec Ltd transformed into two brand new, progressive metrology companies. Optimec Systems Ltd (OSL) was founded to further develop its unique OCT technology, the is830 product range.

OCT provides unique features for contact and Intra-ocular lens measurement and testing, offering exceptional detail for all key aspects of acceptance and compliance. Since then, OSL has gone from strength to strength, enhancing the capabilities of the is830 product line and achieving ISO9001 accreditation, demonstrating OSL’s commitment to the highest quality products and services.

With brand new premises, OSL is now well placed to grow further, accommodating new automation capabilities and new team members joining in early 2022.

As proud member of EFCLIN, OSL is excited to have the opportunity to display new products at the EFCLIN exhibition in April 2022. Come and meet the team on stand 24 or follow us to see all the developments as they happen.

www.optimecsystems.com

30 years of GlobalCONTACT! Without you as readers, authors, advertisers, this would not have been be possible.

Thank you for your trust and loyalty!

Freeform lenses made by liquid polymers

An Interview with Dr. Valeri Frumkin

Researchers at Technion (Israel Institute of Technology) have developed an innovative method for producing high-quality optics using liquid polymers. The technology has several conceivable applications. It can potentially be used to produce spectacle lenses – from single vision to progressives –but also telescopes in future. The process was developed by Prof. Moran Bercovici and Dr. Valeri Frumkin. MAFO spoke with the latter about the potential of the new process. By Hanna Diewald

You were the person who first developed the method to produce freeform optical lenses with liquids. Can the technology actually be used to produce freeform lenses in future?

Yes, we hope so. We are an academic lab and obviously still in the development process, all the demonstrations that have been presented in the papers are done manually.

How does your invention work exactly?

Instead of using mechanical processing, the standard way of fabricating lenses today, we do not process anything. We define geometrical boundary constraints for something we call a “bounding frame” and then inject a liquid polymer into an immersion liquid. This liquid cancels gravity and gravitational effects, wherefore the polymer itself neither sinks nor flows to the surface – it just stays there. The shape of the

polymer is determined by the shape of the bounding frame and the volume injected.

The good thing is, the optical surfaces never get in contact with any mold or frame. There is no issue with removing them from walls or designing molds. We just get this perfectly smooth surface – with a surface roughness consistently of sub nanometer – without any effort.

What are the advantages of your technology?

One advantage of this method – even if we just look at the simplest spherical and cylindrical surfaces – is the fact, that we can process it in seconds. Another advantage is that there is almost no infrastructure necessary – no heavy, expensive machinery, no pollution and nothing is going to waste. The only issue that we are currently working on is reproducibility. For example, if I want to create a specific type of lens and want to be able to make, let us say 50,000 of these lenses, this obviously requires automation.

Source: Technion – Israel Institute of Technology

Are there any limitations on the product side. For example, will you be able to produce progressive lenses?

We showed in our paper that we can make freeform optics. We can produce a very smooth and infinite range of optical surfaces that can be quite complex but there is one important thing: we cannot create any optical surface! We can design and fabricate our own progressive lenses precisely, based on the functions given by the physics of liquid interfaces. In our opinion, the smartest way to progress is not to try to approximate designs of other optical engineers, but rather design our own lenses based on the needed functionality.

Are transparency and image quality comparable to those of conventional lenses?

There are some aspects to this question. The optical quality in principle is comparable, in some cases even better. You will not be able to see a difference, as our eyes are very good at correcting various defects. If you measure the optical quality, you will see a difference. This difference comes down to the fact that this is an industry that already exists for hundreds of years, it is very developed, and we are just in our infancy. It will take a while to catch up. Furthermore, the quality depends on the material used. We can use anything that is liquid and can be solidified. It does not even have to be a polymer. If we use UV curable polymers or thermosetting polymers, each of them has their own challenges. UV curable polymers are extremely easy to polymerize as they polymerize very fast, but if the polymerization is not uniform, you can induce variations in refractive indexes or variations in the shapes. Another aspect is the shrinkage of polymers. Major shrinkage can cause deformations, which also affect the properties, but as we can work with a very wide range of polymers, we are searching for the best candidates. And you can use thermosetting polymers also, just mix them with a crosslinker. The polymerization will be perfect in the sense that it is always uniform. It really comes down to materials when speaking about optical quality.

Is the process also suitable for mass production in the future?

In principle, there is no limitation but currently everything is done manually. However, a precise fabrication requires repeatability. The injection process must be automated and the specific frames need to be identical to one another. There are lots of small technical engineering issues. Those are small issues when you are a company but they are not so small when you are an academic lab, because everything requires a lot of work and there is a limited bandwidth in terms of time and people. It takes time to get to the point that we can consistently produce lenses, on the level that is required by the industry.

How long will it take to optimize your process for industrial production? It depends. There are some advantages of being in the academia and other advantages of starting a company and doing it on

an industrial scale. The advantage of the latter is that you do not have anything else to do. You can hire engineers, developers, chemists, put everyone on the desk and that will be the fastest way to solve the problem, obviously. The good thing of being in academia is that we are just scientists. Everybody is very willing to collaborate and show us what they are doing. This is great because we are learning a lot and it allows us to improve the method significantly. If we were a company, nobody would let us walk through their factory.

Deployment of a liquid lens. Source: Technion – Israel Institute of Technology

Polymerization process. Source: Technion – Israel Institute of Technology

Mor Elgarisi presenting a huge lens. Source: Technion – Israel Institute of Technology

So at least for now, we are trying to leave it in the academia, until we feel that the method is mature enough and we understand all the technical difficulties. We are sure that there are many challenges we are not even aware of now.

Is this technology also applicable to the contact lens or IOL industry?

In principle, yes – at least as far as we can tell. We can make very very large lenses for telescopes, for example, or very small ones – the physics is the same. However, the current technology used to make contact lenses seems to me to be very efficient. The question that arises here is: Does our technology have an advantage over the existing technology?

Do you already have a major target audience in mind?

We do not know yet… The lowest hanging fruit is to create simple spherical-cylindrical corrections and you still save this entire array of machines. That would already be a major improvement for the industry and it is relatively easy to get to that stage. From there, we can build on that. We can start thinking about injecting directly into eyewear frames, so you do not need to cut the lens and you can think about doing progressive lenses.

Very interesting for us are also freeform optics and rapid prototyping as many people in the industry told us that even if we do not produce a perfect lens but one that shows the functionality and allows them to test the design within minutes, it would be a very interesting direction. You can imagine having a device – equivalent to a 3D printer – and you enter a CAD file and design some plugins that connect our method

to a bounding frame. The device creates the bounding frame, injects the polymer and you have the testing component. However, what actually started the idea of trying to create optics was a conversation with other scientists about a huge problem. There exists a major challenge in the developing world of having access to affordable eyewear. We found this report from the World Economic Forum that 2.5 billion people do not have access to eyewear. This is a huge problem for the economy and the people. You can send cheap glasses in a container to a country but this is not really a long-term solution. Instead, you need to provide the capabilities to produce on-site in good quality.

Our method might be perfectly suited for that because you do not need a factory. This is something we are very interested in, in terms of doing something good.

Thank you for the interview. n

Liquid optics in space

The researchers also collaborate with NASA as the method relies on the fact that it eliminates gravity. In space, microgravity conditions can be achieved without using an immersion liquid and polymerization is unnecessary. This allows producing huge liquid mirrors using the same physics. The method will be much cheaper than whatever is done today, as it allows creating the optics in space instead of sending it there .

F.l.t.r.: Omer Luria (lab engineer and leader of the NASA collaboration), Mor Elgarisi (PhD student currently leading this project at the lab), Prof. Moran Bercovici (head of the Fluidic Technologies laboratory at Technion). Source: Technion – Israel Institute of Technology

Lab consultation

Working together

We are assisting a start-up lab with developing their process to make contact lenses, both corneal and scleral. The owner does not have a manufacturing background and has a local optometrist who is advising her on the blocking and finishing aspects of contact lens manufacturing. The optometrist has a one-person lab in his office and has fitted lenses for over five decades.

By Erik Larsen

On a recent call, the optometrist and the new lab owner were placing an order for a lens modification (beveling) machine, diamond coated tooling, and brass tooling. We discussed the various radii of the tools and the relative merits of the options of the blocking tooling and related process. Personally, I was thinking that the use of diamond coated tools on the CNC turned geometry was a bad idea. Why? First off, how do you know what the modified geometry is in case you need to do a re-fit? Second, why wasn’t the original design “correct”? Third, diamond grinding the PC requires significant post polishing. Fourth, the procedure requires a highly skilled technician for a successful outcome. We have been building beveling and modification machines since we started in business 40 years ago. In the last decade, the sales of the models of multi-spindle units (used in-lab) have fallen by about 90%. Sales of clinic one-spindle units have stayed fairly steady. Sales of diamond modification tools have fallen off along with the in-lab machines. Sales of sponge tools for cleaning, power changing, and edging have remained steady.

TOOLING OPTIONS

We also discussed the blocking tooling (arbors) they wanted for scleral lens production. After a few minutes, I realized that they planned on using corneal (12.7 mm diameter) radiused arbors to block the scleral base curves up to 19 mm. That meant that the part of the lens bigger than 12.7 mm diameter would be unsupported by the arbor; the PC would be sitting on a large volume of blocking compound. I ended up sending a few samples of corneal and large diameter scleral arbors for them to try out. In recent years, we have offered a variety of colored arbors that can serve as a color code for a narrow range of lens posterior geometries in order to maintain an approximate uniform wax thickness. The various arbors are to be turned to roughly match the back geometry.

In early 2015 I submitted an article called “The Legacy Lab”. It discussed the difference between two start-up labs: One set up by an “old school” manager and the other by a manager who understood and embraced the full capabilities of state-ofthe-art machines and processes. (This article can be viewed on our website or in the GlobalCONTACT-App.) Although, I did not specifically discuss lens modifications, I think that it was implied that modern methods and instrumentation resulted in lenses that did not require modifications. The reduction of sales of modification tooling and machines supports this notion. So, what is the solution for the lab owner we are working with? The key part is “we are working with”. We will continue to provide the products and services requested and make suggestions along the way to make their endeavor successful. n

Erik Larsen graduated from the University of Washington with a Mechanical Engineering degree in 1981 and started Larsen Equipment Design later that year. Erik Larsen has industry awards from CLMA and EFCLIN.

Going backstage with scleral lenses –a star is born

A trilogy on specialty contact lens safety – part 1

Looking back 30 years, it is no secret that probably one of the biggest surprises in our industry has been the re-emergence and development of modern scleral lenses. The surge of scleral lens publications demonstrates their incredible increase in the recent peer-reviewed literature. Truly, ‘A Star Is Born’, like in the 2018 American romantic drama with and by Bradly Cooper and featuring Lady Gaga. Interestingly, though, this is the fourth filmed version of that story after the original 1937 and 1954 American musical (starring Judy Garland) and another 1976 musical. By Eef van der Worp

The comparison with scleral lenses is striking: after small successes in the 1960s and 1970s, modern scleral lenses have now made their great comeback too – with bells on and to never go away again, it seems. What has caused this surge, and how safe is scleral lens wear?

TIP OF THE EYESBERG

The success of the modality in large part has to do with a better understanding of ocular surface shape. Optical coherence tomography (OCT) turned out to be an extremely helpful tool, as it soon was discovered that the transition zone from cornea

to sclera was ‘not all that curved at all’ but rather tangential in shape (a straight transition in many parts of the globe at least). Traditional textbooks had to be rewritten. In addition, although known through clinical wisdom by some, it was found that the ocular surface beyond the corneal borders was quite irregular (and increases in irregularity toward the periphery). And the term ‘height’ has since been used increasingly in the contact lens industry to replace ‘curvature,’ which is a game changer. Today, we can classify the sclera into different categories based on shape [1]. It can quite easily be assessed now when to start using back-toric-haptic scleral lens designs and more complex backsurface designs. Clinicians around the world agree that if you align the scleral lens better with the ocular surface, fewer problems arise and the chance of scleral lens success increases.

So, while the surface of the eye is quite well understood now – and this part of the puzzle is practically ‘solved’ – this was, literally, just the tip of the "eyesberg" regarding scleral lens wear. What is next is: What is happening behind the scleral lens during wear? Let’s go backstage on the set of ‘A Star Is Born,’ the scleral lenses edition. Everybody who has been backstage at a concert or anything

like that knows that it can be somewhat messy and chaotic there. Let’s see how messy it is with sclerals and where we stand.

OXYGEN DEBATE

Since the introduction of scleral lenses, there always has been a debate about suboptimal physiological conditions beneath the lens and the potential for inflammation and infection with the modality, as first, the oxygen delivery to the cornea is hampered by the fact that the scleral lens is much thicker than a rigid corneal lens (by a factor of about three), and second, the fluid layer behind the lens works as an extra filter (with an estimated Dk of 80). In essence, therefore, scleral lens wear can be likened to a piggyback system with two barriers [2] Furthermore, there seems to be hardly any tear film exchange possible behind a scleral lens, which obviously is different from tear exchange with a rigid corneal lens. Only recently, with the surge in scientific publications, has this topic been well documented. Work by Damien Fisher BAppSc, PhD, presented in the scleral lens supersession at the Global Specialty Lens Symposium (GSLS) and in the

Photo: Silke Sage

International Forum for Scleral Lens Research (IFSLR) 2022 in Las Vegas, showed that, contrary to previous beliefs, if the Dk of a scleral lens exceeds 100 units, then the oxygen delivery to the eye needed for normal functioning in daily wear is met in most cases. Lens thickness and lens reservoir variations help in providing more oxygen, but only if those variations are significant. [3] Lens fenestration, although potentially helpful in other ways, does not add much in terms of oxygen delivery to the cornea. Only in cases of compromised corneas (such as post-corneal transplant, post-radial keratectomy, etc.) can oxygen issues arise, but typically not in normal corneas.

WHAT (ABOUT) THE FOG?

A nuisance at best for sure is a phenomenon that is unique to scleral lens wear: midday fogging (MDF) [4]. It deserves a place in this overview; however, it does not seem to pose any risk with regard to safety. It is a risk, however, for scleral lens failure in terms of dropout. Maria Walker in her PhD work – also presented at both the GSLS and the IFSLR – showed a couple of things: there seems to be hardly any difference between the observance of MDF at day one in subjects versus at day four. In other words and to simplify things, ‘you have it or you don’t’, in a manner of speaking. She also looked at subjective versus objective MDF scores and found the two to be highly correlated. What this means is that if patients complain of MDF, we can also see it behind the lens. The ‘seeing’ is best documented using OCT if available, as this instrument can show the particle density behind the lens  [5]. The correlation between objective and subjective scores was highest, though, for the low grades of MDF; for the higher grades of 4 and 5 (out of 5), that correlation was much weaker.

The British Contact Lens Association (BCLA) CLEAR paper (Contact Lens Evidence-Based Academic Report) on sclerals advises to manage MDF as follows: decrease corneal clearance, improve landing zone alignment, treat underlying ocular

surface disease including allergies and dry eye disease and use a more viscous application fluid. And if all of this fails, then lens removal and reapplication once or sometimes twice daily is recommended. A nuisance for sure, but it does not pose any additional risk. It does show that tear replenishment behind the lens is minimal, though.

As a little side-step: conjunctival prolapse is another adverse event that is new and unique to scleral lens wear. The conjunctiva is ‘sucked under’ a portion of the haptic portion of the lens. Recent studies from Queensland University of Technology in Brisbane (AU) found that ten participants showed conjunctival prolapse 22 times (37%) [6]. All participants were asymptomatic, with no signs of ocular redness/irritation. Nasal prolapse was more prominent than temporal, and the prolapse had a mean elevation of ~71 μm. While, again, this is not the biggest concern in our practice, it surely is a nuisance as well, and the flap can adhere to the cornea in some cases (in which case it does become a serious adverse event). As with fogging, one of the proposed mechanisms to prevent this from happening is to improve landing zone alignment.

INFLAMMATION

What if there is tear stagnation behind a scleral lens? Is that worrisome? Investigators from Spain and Portugal conducted two important studies to investigate this. Gonzalo Carracedo et al [7] measured the ocular surface temperature on the eye during scleral lens wear in keratoconus patients. With inflammation, an increase in temperature can or should be observed. But no such thing was found: the patients wore the scleral lenses for six to nine hours, and scleral lens wear did not seem to modify the ocular surface temperature despite the presence of the tear film stagnation. Rute Macedo-de-Araújo et al [8] looked at the differences between inferior and superior bulbar conjunctiva goblet cells in scleral lens wear. Scleral lenses rest on the scleroconjunctival region, which could result in a mechanical impact on the bulbar conjunctiva that can hypothetically modify some properties of conjunctival cells. But they didn’t: there were no differences in goblet cell count or in goblet cell density, and it seems that scleral lens wear does not affect the density and secretion of goblet cells.

MICROBIAL KERATITIS

What about the most important potential adverse event in contact lens practice: microbial keratitis (MK)? The topic of safety in specialty lens practice was part of a large session at GSLS, with coverage of that in the April edition of Contact Lens Spectrum [9] In essence, a keratitis is an inflammation of the eye, but in this case some type of micro-organism is the cause. Only 15% of the eyes developing an MK in contact lens wear (any type of lens) will experience permanent vision loss, but depending on the condition and the type of micro-organism, an MK can have quite a devastating outcome for the cornea and patient.

Fig. 1: history of peer-reviewed scleral lens publications: courtesy of Rute Juliana Ferreira Macedo de Araújo.

Scleral lenses do not seem to pose an exceptionally large risk of corneal infections, Melissa Barnett OD, FAAO, FSLS, FBCLA, reported at the GSLS, quoting from the CLEAR paper on scleral lenses. [10] It is not easy to put a hard number on the incidence rate of MK in scleral lens wear, no matter how much we would like to communicate that to patients in practice. Despite the success of scleral lenses, the vast sample sizes needed to provide any serious numbers on incidence rates – which involve hundreds of thousands of lens wear years – are simply not available. And a complicating factor with this category is that underlying pathology is often present. Even in standard keratoconus, the epithelium is thinned and the cornea is more vulnerable than in the normal eye, but this vulnerability increases with different diseases, dystrophies and certainly with ocular surface disease conditions— and the risk of MK may also be increased. One 2014 paper by Shorter et al  [11] found the risk of MK with scleral lens wear in ocular surface disease to be 33 per 10,000 patient years, but with a large 95% confidence interval between 5.8 to 182. However, the balance of risks versus benefits in scleral lens wear almost always turns out in favor of the modality—as patients simply have inferior vision without scleral lens wear. As stated in the April 2022 Contact Lens Spectrum article on lens care in specialty lens practice, while special attention to lens care seems to be warranted for any lens modality, special lens care for scleral lenses must be advised. In other words, hygiene with lens handling is crucial to improve scleral lens safety, perhaps even more so than material Dk considerations. Barnett at GSLS also reported that difficulty with lens handling is greater with scleral lens wear (63%) compared to with rigid corneal lens wear (40%) and that handling issues are the primary reason why scleral lens wearers drop out. [12, 13, 14]

IOP

Finally, there is the concern about a potential increase in intraocular pressure (IOP) with scleral lens wear. Again, this concern has been raised since the first reports on scleral lenses in the 1960s. In the previous edition of GlobalCONTACT, an entire article titled ‘Under Pressure’ was devoted to this topic. To summarize, there is a beautiful but delicate balance between the amount of fluid that is produced by the ciliary body (which is located at the base of the crystalline lens) and the amount of drainage at the trabecular meshwork (located at the base of the iris anteriorly, in the corner that the iris forms with the cornea). Could scleral lens wear impact this delicate balance? The take-home message for clinical practice is that scleral lenses could alter IOP to some degree. But definite conclusions cannot be drawn at this point based on the current evidence, the CLEAR paper states. Avoiding scleral lenses in patients who have progressive glaucoma seems to make sense but is not always easy. Sclerals are typically not worn ‘for fun’: there is

CLINICIANS AROUND THE WORLD AGREE THAT IF YOU ALIGN THE SCLERAL LENS BETTER WITH THE OCULAR SURFACE, FEWER PROBLEMS ARISE AND THE CHANCE OF SCLERAL LENS SUCCESS INCREASES.

usually a major indication to wear these lenses, and the benefits should be weighed against the risks – while monitoring visual fields and optic nerve head changes. But in some other cases, alternatives, including corneal GPs, hybrids or soft custom lenses, can potentially be considered. Whether lens design options, including non-symmetrical lens design, are beneficial and could alleviate the problem remains to be seen.

IN CLOSING

It has been quite a journey with scleral lenses over the last couple of decades, but it seems clear that ‘A Star Is Born’ in our specialty lens arena: scleral lenses. While the ocular surface shape issues ‘have been solved’ to a large degree, safety issues remain an important point of focus. Going backstage with scleral lenses, it seems like some of the bigger obstacles, including the oxygen debate, have now settled. Other problems such as MDF and conjunctival prolapse are a nuisance, but there are options to try to alleviate this; for example, aligning the scleral lens better with the ocular surface could alleviate those problems to some degree, but they cannot always be solved. Regarding MK – which is our biggest concern in contact lens practice, including scleral lens practice – as with any lens modality, that should have our greatest attention. Thicker lenses and an added (stagnant) fluid tear layer behind the lens are unavoidable and may be disadvantageous in this regard. But most important seems to be compliance and hygiene, including proper cleaning of the lenses, the lens cases and the lens applicators as well as avoiding any tap water use in the care regimen to avoid an infection and to provide the safest scleral lens wearing environment as much as possible. We can really make a difference as a joint responsibility: of the patient, the practice (eye care practitioner and staff) and the industry together.

In the next ‘episode’ in the trilogy on specialty lens safety, overnight orthokeratology will be highlighted. Stay tuned. Stay safe. n

References

[1] DeNaeyer G, Sanders D, van der Worp E, Jedlicka J, Michaud L, Morrison S. Qualitative Assessment of Scleral Shape Patterns Using a New Wide Field Ocular Surface Elevation Topographer. JCLRS. 16 Nov 2017

[2] Van der Worp E. Safety First. Contact Lens Spectrum. April 2022;..-..

[3] Fisher D, Collins MJ, Vincent SJ. Fluid Reservoir Thickness and Corneal Edema during Open-eye Scleral Lens Wear. Optom Vis Sci. 2020 Sep;97(9):683-689. doi: 10.1097/OPX.0000000000001558. PMID: 32932398.

[4] W alker MK, Bergmanson JP, Miller WL, Marsack JD, Johnson LA. Complications and fitting challenges associated with scleral contact lenses: A review. Cont Lens Anterior Eye. 2016 Apr;39(2):88-96. doi: 10.1016/j.clae.2015.08.003. Epub 2015 Sep 2. PMID: 26341076.

[5] S kidmore KV, Walker MK, Marsack JD, Bergmanson JPG, Miller WL. A measure of tear inflow in habitual scleral lens wearers with and without midday fogging. Cont Lens Anterior Eye. 2019 Feb;42(1):36-42. doi: 10.1016/j.clae.2018.10.009. Epub 2018 Nov 16. PMID: 30455083; PMCID: PMC6340712.

[6] F isher D, Collins MJ, Vincent SJ. Conjunctival prolapse during open eye scleral lens wear. Cont Lens Anterior Eye. 2021 Feb;44(1):115-119. doi: 10.1016/j.clae.2020.09.001. Epub 2020 Oct 2. PMID: 33012674.

[7] Carracedo G, Wang Z, Serramito-Blanco M, Martin-Gil A, Carballo-Alvarez J, Pintor J. Ocular Surface Temperature During Scleral Lens Wearing in Patients With Keratoconus. Eye Contact Lens. 2017 Nov;43(6):346351. doi: 10.1097/ICL.0000000000000273. PMID: 27203795.

[8] Macedo-de-Araújo RJ, Serramito-Blanco M, van der Worp E, Carracedo G, González-Méijome JM. Differences between Inferior and Superior Bulbar Conjunctiva Goblet Cells in Scleral Lens Wearers: A Pilot Study. Optom Vis Sci. 2020 Sep;97(9):726-731. doi: 10.1097/ OPX.0000000000001575. PMID: 32941332.

[9] Van der Worp E. Safety First. Contact Lens Spectrum. April 2022: 28-33

[10] B arnett M, Courey C, Fadel D, Lee K, Michaud L, Montani G, van der Worp E, Vincent SJ, Walker M, Bilkhu P, Morgan PB. CLEAR - Scleral lenses. Cont Lens Anterior Eye. 2021 Apr;44(2):270-288. doi: 10.1016/j. clae.2021.02.001. Epub 2021 Mar 25. PMID: 33775380.

[11] S horter E, Schornack M, Harthan J, Nau A, Fogt J, Cao D, Nau C. Keratoconus Patient Satisfaction and Care Burden with Corneal Gaspermeable and Scleral Lenses. Optom Vis Sci. 2020 Sep;97(9):790-796. doi: 10.1097/OPX.0000000000001565. PMID: 32941334.

Eef van der Worp, BOptom, PhD, FAAO, FIACLE, FBCLA, FSLS is an educator and researcher. He received his optometry degree from the Hogeschool van Utrecht in the Netherlands (NL) and has served as a head of the contact lens department at the school for over eight years. He received his PhD from the University of Maastricht (NL) in 2008. He is a fellow of the AAO, IACLE, BCLA and the SLS. He is currently adjunct Professor at the University of Montreal University College of Optometry (CA) and adjunct assistant Professor at Pacific University College of Optometry (Oregon, USA). He lectures extensively worldwide and is a guest lecturer at a number of Universities in the US and Europe.

[12] S chornack MM, Pyle J, Patel SV. Scleral lenses in the management of ocular surface disease. Ophthalmology. 2014 Jul;121(7):1398-405. doi: 10.1016/j.ophtha.2014.01.028. Epub 2014 Mar 14. PMID: 24630687.

[13] K reps EO, Pesudovs K, Claerhout I, Koppen C. Mini-Scleral Lenses Improve Vision-Related Quality of Life in Keratoconus. Cornea. 2021 Jul 1;40(7):859-864. doi: 10.1097/ICO.0000000000002518. PMID: 32947413.

[14] Macedo-de-Araújo RJ, van der Worp E, González-Méijome JM. A one-year prospective study on scleral lens wear success. Cont Lens Anterior Eye. 2020 Dec;43(6):553-561. doi: 10.1016/j.clae.2019.10.140. Epub 2019 Nov 14. PMID: 31734087.

Expert talk on MDR

Appeal for a rapid European solution

The application of the MDR is mandatory as of May 26, 2021. The issue still poses challenges for companies and many still need clarification on how the requirements can be implemented without harming their business. This is nicely illustrated by the fact that EFLCIN offers yet another workshop on the topic of MDR preparation at their 2022 congress. At a recent panel, it was expressed how severe the consequences of MDR could be, not only for the companies involved, but also for the patients, in the worst case scenario.

"Brussels – we have a problem!" Corinna Mutter, Regulatory Affairs Manager at the German industry association Spectaris, summed up the event with these urgent words. Organized by the Baden-Württemberg Ministry of Health and Economics, the Brüsseler Gespräche (Brussels talks) gathered voices from the medical device industry, EU and state policy makers, and industry associations. The search for the best solutions to overcome the implementation difficulties of the MDR was thus given new impetus and at the same time concrete recommendations for action were contributed.

In the course of the debate, industry and state politicians appealed to the EU Commission for a rapid European solution, because as Mutter emphasized, we are only seeing the tip of the iceberg of product discontinuations due to the MDR. However, these are already having a tangible impact on patient care. The question is how the worst consequences for all those affected can still be prevented.

The MDR entails far-reaching changes for all economic actors and especially for manufacturers of medical devices. Every single medical device must be completely re-evaluated for compliance under the MDR – the majority of which are longestablished and safe existing products. This increase in certification effort presents companies with enormous challenges that are not always feasible in practice, exacerbated by often rising costs. The Baden-Württemberg state government has therefore commissioned experts to develop recommendations

for action that show how the implementation of the MDR can succeed. Part of these recommendations is to support those companies that manufacture indispensable medical devices and whose loss threatens or has already caused gaps in supply due to a lack of alternatives.

DISCONTINUATION OF IMPORTANT MEDICAL DEVICES

The burdens are not only momentous for the manufacturers of medical devices. Mutter emphasized in her presentation that the MDR-related discontinuation of important medical devices contradicts the goals explicitly formulated in the regulation of ensuring a high level of safety and health protection while promoting innovation. Both goals are inextricably linked and must be pursued with equal priority and in parallel so that patients can continue to receive optimal care in the future. The urgent plea towards Brussels and the member states is therefore to act now. Seeking a solution via national special approvals is not viable, Mutter said. This is because these are neither designed for the long term nor for EU-wide or global marketing, and they also do not enable any innovative new developments. Spectaris takes a positive view of the fact that the European Commission has set up a task force. However, the association emphasizes that little is yet known about the exact scope and its work assignment and that its focus must be to ensure the supply of existing and niche products even after 2024. n

Ultra-Dk contact lenses

The role of the Dk value

The market for contact lenses is ever growing and the requirements and demands from the users and clinicians are extensive; disposable, comfortable, increased wear time, overnight wear, corneal reshaping, handling (cleaning, ease of use), cost, geometric and optical properties, and high oxygen permeability. While Efron wrote an obituary for rigid gas permeable (RGP) lenses over a decade ago, the use, applications, and design technologies of RGPs has continued to grow and expand. [1]

By Lachlan Hoy and Millie Meegan

The evolution of hard/rigid contact lens material started with glass in 1887, non-gas permeable polymethyl methacrylate (PMMA) in the 1940’s, and the first rigid gas permeable material in the 1970’s. Although Efron’s prediction may not have come to pass, there has been a lack of material innovation for RGP lenses over the past decade. It has taken industry veterans, Dan Bell, Jim Bonafini and Jonathan Jacobson combining to form Acuity Polymers, Inc., to deliver the world’s first ultra-Dk gas permeable material Acuity 200 (fluoroxyfocon A). Material innovation considers factors such as the mechanical properties, lens thickness, wettability, water content, and oxygen permeability. To deliver the desired properties material scientists innovate more than just the polymer itself, rather the refinement of the polymerisation recipe (e.g. temperature, initiator type, vessel used). The team at Acuity Polymers have delivered not only ultra-Dk, but a material with exceptional wettability, stability, durability, and deposit resistance.

Dk is the permeability of a material to oxygen, and coupled with lens thickness (t), it determines how much oxygen reaches the cornea through a specific contact lens (Dk/t). [2] Insufficient oxygen to the cornea creates both short- and long-term physiological changes, such as endothelial blebs, oedema, limbal injection, and corneal vascularisation. [3] To avoid corneal oedema, a Dk/t of 24 for daily wear and 87 for extended wear has been proposed. [3] To avoid anoxia, this DK/t value is 35 during open eye and 125 during closed eye. The Acuity 200 ultra-Dk polymer is of particular interest in the overnight orthokeratology due to closed eye overnight wear, scleral contact lenses due to the increased lens thickness of the lens and increased tear fluid reservoir thickness, corneal graft, and the correction of extreme ametropia.

ORTHOKERATOLOGY

Because the cornea is an avascular site, it relies on atmospheric oxygen to maintain normal metabolic activity. In orthokeratology,

Fig. 1: Acuity GP contact lens material prototypes. Image courtesy of Acuity Polymers.

there are reduced levels of oxygen available to the cornea while the eyes are closed. [4] This is exacerbated by the use of a contact lens, which acts as another barrier between the cornea and its oxygen supply. Though Holden and Mertz defined the minimum oxygen transmissibility for overnight contact lens wear to be 87, recent studies suggest that this value was underestimated. [5] The typical thickness of an orthokeratology lens is 0.2 mm, hence to avoid corneal oedema with closed eye overnight wear, the Dk of the material would need to be greater than 174. It’s critical that an orthokeratology lens allows as much oxygen to pass as possible to prevent hypoxia, and the Dk value chosen should therefore be based not on this minimum oxygen transmissibility value, but on a maximum. When the cornea doesn’t receive enough atmospheric oxygen, a number of physiological changes occur, including corneal oedema. [6, 7] A cornea with less swelling is more responsive to surface hydrostatic forces induced by orthokeratology and

therefore more likely to take the desired shape. [8] Although relatively low levels of central corneal oedema occur in overnight orthokeratology lens wear (probably due to competing hydrostatic forces – tear film pressure anteriorly and intraocular pressure posteriorly), what corneal oedema does arise can be minimised by using higher Dk materials. [7] In fact, Lum & Swarbrick found that lenses made from higher Dk material acting on the same cornea had a tendency to overcorrect by an average of +0.50D in comparison to lenses of the same design made of lower Dk material. [8] Wearers of orthokeratology lenses made of materials with Dk 100 and Dk 163 consistently improved unaided visual acuity, refractive error and apical flattening to a greater degree than those wearing lower-Dk materials of 58 and 85 on each review, with one study finding a statistically significant improvement in VA persisting over the two weeks. [8, 9]

SCLERAL LENSES

Modern scleral lenses have contributed to a resurgence in rigid gas permeable material use through the therapeutic treatment of the ocular surface, visual restoration of the irregular cornea and the correction of astigmatism. [10] While scleral lenses are life-changing for many wearers, they generate hypoxic stress as the contact lens

Fig. 2: Orthokeratology lens on eye.

Fig. 3: OCT of scleral contact lens.

and the underlying tear reservoir act as barriers to atmospheric oxygen. [11] Unlike corneal RGPs, no further oxygen is transmitted by movement of the tear film, as the tear reservoir is fairly stagnant. [12] Furthermore, most of the therapeutic and visual restoration indications are in eyes with compromised cornea and ocular surface that often cannot tolerate oxygen deprivation (e.g. corneal graft, Stevens-Jonson syndrome, corneal ectasia). [12–14]

Scleral lens wearers with keratoconus and corneal graft tend to experience an increase in corneal thickness due to oedema by an average of 2-4% throughout the day. [15, 16] This may seem insignificant as the cornea swells by 4.5% overnight with eye closure but recovers once awake over the course of the next hour. [15] However, the hypoxia-related stress secondary to scleral lens wear occurs rapidly, within the first 45 mins and can last for up to 150 mins after removal. [17] Furthermore, as scleral lenses are worn to reduce ocular pain and in visual restoration unachievable with spectacles, wearers have a tendency to wear their lenses for long hours, often inserting straight after waking and only removing the lenses just before bed. As a result, there is little time for the cornea to recover from the physiological oedema it endures overnight before lens-induced oedema begins. While the scleral lens induced oedema is low grade, the long-term physiological effects are unclear. [12]

It has been observed that scleral lenses with Dk values >163 minimise oxygen depletion in the cornea, and theoretical models have approximated that to minimise hypoxic stress, scleral lenses should be manufactured from materials with Dk ≥150, lens thickness ≤250 um and tear reservoir 100150 um. [11,18,19] The evidence is clear that the highest Dk material available should be used when possible.

CORNEAL RIGID GAS PERMEABLE

As disposable contact lenses dominate the correction of most ametropia, corneal RGP lenses are typically reserved for extreme ametropia, and irregular cornea. The correction of extreme ametropia requires high BVP thick lenses. As

discussed above, thick lenses reduce oxygen permeability, and therefore should be made of the highest Dk possible to minimise any hypoxic stress.

CORNEAL GRAFT

While the most obvious sign of hypoxia is in the stroma (corneal oedema), oxygen deprivation also occurs at the epithelial and endothelial levels. [20, 21] While the epithelium is able to regenerate and recover from hypoxic stress, the same cannot be said for endothelial cells. This is particularly pertinent for corneal graft recipients (PK and DALK). The average age of corneal graft donors is 65, a demographic that is vulnerable to endothelial cell dysfunction and dystrophies. [22]

Hypoxia serves to exacerbate the endothelial disease process and drives neovascularisation and inflammation, increasing the likelihood of graft rejection and ultimately shortening the lifespan of the graft. Unfortunately, many corneal grafts have resulting major and irregular astigmatism and require contact lenses to restore visual quality. Every effort must be made to minimise any hypoxic or inflammatory stress on these eyes by using the highest Dk material possible and using corneal RGP lenses where possible. However, sometimes the irregularity reaches a point where corneal lenses are unable to be fit and a scleral lens is the only option precluding regraft. Using an ultra-Dk material allows scleral lenses to be fitted in the application of corneal graft with greater confidence in the long term health and survival of the tissue.

Fig. 5: Vascularisation of a corneal graft.

Fig. 4: A corneal Acuity 200 +18.00D for aphakia.

DK IS THE PERMEABILITY OF A MATERIAL TO OXYGEN, AND COUPLED WITH LENS THICKNESS (T), IT DETERMINES HOW MUCH OXYGEN REACHES THE CORNEA THROUGH A SPECIFIC CONTACT LENS (DK/T).

CASE REPORT

A 76-year-old female had penetrating keratoplasty in 1976 for keratoconus. While the central cornea was clear, there was 24D of corneal astigmatism, and the junction of the graft was cloudy with existing neovascularisation superior and nasal. She was fitted with a scleral lens made of Acuity 200 material in 2018.

EyeSpace Scleral

9.0/4150 μm/39°/17.5 7.0/4550 μm/40° BVP: +6.00D / -10.50D x 180.0 °

The lens provided excellent vision, the cornea remains clear, and there has been no evidence of advancing neovascularisation. The graft continues to survive and she remains happy wearing contact lenses. n

Millie Meegan

Imaging techniques

Photo presentation: HFAK Students present their findings

Photograph

What can be seen here?

Vascularisation after prolonged wear of silicone hydrogel contact lenses.

Imaging technique:

Image 1: General overview of the right eye (6.3x magnification)

Image 2: Visualisation of vascularisation with diffuse illumination (25x magnification)

Image 3: Visualisation of ghost vessles with regredient illumination (25x magnification)

Image 4: Visualisation of receding blood, regredient illumination (25x magnification)

Finding:

During a routine follow-up of a test person (female, 24 years) wearing soft, silicone hydrogel daily lenses, the right eye looks inconspicuous at first glance (image 1). At higher magnification, vascularisation becomes visible in the right eye (superior 2 o'clock).

Characteristics:

During corneal hypoxia, vascularisation occurs to provide additional oxygen supply. This is probably due to the tight fit of the silicone hydogel contact lens (image 2).

Further procedure:

In order to prevent further progress of the vascularisation, the test person was ordered to immediately abstain from contact lenses for four weeks. Already after two weeks, the blood vessels were seen to be only partially filled. What remains are bloodless capillary vessels called ghost vessles (image 3). Image 4 clearly shows that lens abstinence is still recommended, as the blood has not yet retreated. Subsequently, a new fitting of the contact lenses is recommended. A fitting of RGP contact lenses is advantageous here in order to minimise the risk of renewed vascularisation.

1

Jessica Hein & Leonie Müller Professional School for Optometry in Cologne (HFAK)

Larsen Equipment

In 2004, Keith Parker and I opened Advanced Vision Technologies (AVT). At that time, the economy was going through a very bad recession and as a result, it was impossible for a new business starting up to get a loan. We immediately reached out to Erik and Pam at Larsen Equipment to get refurbished equipment to use in our Laboratory. As AVT’s business grew, we invested in many different pieces of new equipment from Larsen Equipment and this helped us grow into one of the Premiere Labs in the United States. Our success is due in part to Erik and his Team with their state-of-the-art equipment and maintenance of their products. AVT is forever grateful for Larsen Equipment’s support of AVT. It is great to know AVT is working with Industry leaders with the Larsen Equipment and their Team!

Janine Bungo, VicePresident

QUALITY MANAGER: RANDY MINGOY

I have known Erik Larsen since 1992. Since then I have used just about every piece of equipment his company has built. My experience with Erik and the Larsen team has been one of great appreciation as they have always helped me in my needs of fully understanding equipment used to manufacture quality contact lenses. Erik has also been able to engineer any part needed for me even it was a custom part. Erik (Larsen Equipment) has been and still is a pioneer in the contact lens and optical industry, and I am thankful to him for his support over the years.

Randy Mingoy Quality Manager

PRESIDENT: KEITH PARKER

I have had the pleasure of working with Erik since the beginning of Larsen Equipment. The first piece of equipment, a 6 spindle horizontal arm polisher revolutionized our production of GP contact lenses. Through the years, I watched his business grow as he and his team listened to our Industry needs and developed now numerous products not only simplifying many tasks of manufacturing but improving the consistency of quality in our finished products. Innovation has been an ongoing experience of our Company only made possible through the innovation of necessary equipment developed and made available by the Larsen team.

Advanced

Vision Technologies

DIRECTOR OF OPERATIONS: JORDAN GOBEL

There can be a lot of moving parts when it comes to managing operations, so it is key to have reliable precision equipment that assists in overall efficiency. Larsen Equipment delivers just that! I have been utilizing Larsen manufacturing equipment for over 15+ years and have yet to run into an issue they could not resolve. I am a satisfied owner of bladder polishers, edge roller’s and auto-blockers etc. Each one of these units greatly assists in the reduction of rejects and manufacturing waste. Their ability to customize and retrofit specific tools certainly sets them apart from the competition. Larsen stands behind their equipment with a knowledgeable staff that provides exceptional service. Simply put, we are a better laboratory because of our relationship with the folks at Larsen.

Jordan Gobel

Director of Operations/Consultant

Advanced Vision Technologies

Larsen Equipment is a family owned business hosting a team of willing Staff all having the attitude of serving their Customer’s needs. As a Customer, we are made to feel like we have a friend in the business helping us develop a more efficient process allowing our Company to deliver better products for our Customers.

Our success of AVT simply could not have been possible without the help, assistance and dedication of Larsen Equipment. I will be forever grateful for my opportunity to work with Erik and his very capable Staff.

Keith Parker President

969 S. Kipling Parkway, Lakewood, CO 80226 Phone: 303-384-1111   888-393-5374 Fax: 303-384-1124 www.AVTLENS.com

Euromcontact market data report 2021

Soft contact lens and lens care markets in Europe

The European federation of national associations and international companies of contact lens and lens care manufacturers, Euromcontact, has released their new market report. The statistics report covers 34 countries in 2021, in comparison to 32 countries reported in 2020. Since 2003, the federation has provided the framework for statistics on market data and analysis based on a collection and compilation of data using an independent company.

Euromcontact collected data for daily disposables (DD), weekly/ bi-weekly and monthly (W/B&M) and conventional soft (CS) CLs in 34 countries. Four are in pairs (Belgium with Luxemburg and UK with Ireland), this makes for 32 countries/clusters in total. Not all countries had data in all segments for 2021 and/or 2020, though, mainly in CS. All countries had data for weekly/ bi-weekly and monthly and daily disposables in both years.

Contributing companies (2021)

ALCON Avizor

Bausch & Lomb CooperVision

Johnson & Johnson Vision Care mark’ennovy Menicon (Europe)

DATA COLLECTION

The headquarters of the participating companies submitted each quarter the numbers of lenses sold (units) and their market value (lenses and lens care products) at ex-manufacturers’ prices (sum of the invoiced prices, so called shipping or sell in data) to an independent company. This company then removed manufacturerspecific information and returned the aggregated numbers by country, segment, sub-segment etc. for each country to Euromcontact and the participating companies. The collection covered all soft lens and lens care market segments. For non-Euro currency countries, the year’s exchange was fixed on 2nd January for the whole year. Past years’ values were adjusted to the current (2021) exchange rate of the Euro. The participating companies believe they cover around 80% to 90% of the disposable/planned

replacement CL market in the covered countries. The coverage of the conventional lenses was not so great anymore, as this market is mainly served by local/regional manufacturers.

WEARER BASE

Tab. 1: Contributing companies (2021) Tab. 2: Wearer

The number of people who wear CLs within a market is called the ‘wearer base’ and is presented in the report as the fraction of CL wearers within the 15 to 64 years old segment of the population. The report calculated the number of soft CL wearers using the 2021 units (one CL) sales divided by an assumed annual consumption. The wearer base was calculated for daily disposables, weekly/bi-weekly and monthly replacement lenses (W/B-W&M) and conventional soft lenses (all other replacement frequencies, CS).

2021 Market size (in '000 EUR)

For each lens category and for each country, the number of wearers was calculated by taking the yearly figure of units sold and dividing them by an assumed annual ‘consumption’ rate per wearer. For consistency reasons, these values were kept constant at 350 CLs per year for daily disposables, 26 CL per year for W/B-W&M CLs and 2.7 CLs per year for CS CLs. The number of wearers for each category and country was then divided by the population of 15- to 64-year-olds for each country or region, to provide a wearer base value as a proportion of the population of 15-64-year olds (in %) per country and in total. The eleven countries and regions evaluated in this article are listed in table 2. Across all 34 markets there are 21.7 million wearers (+10.3%). 56% of them use daily disposables, 43.9% weekly/bi-weekly and monthly replacement lenses, and 0.07% conventional soft lenses.

GROWTH IN SOFT CONTACT LENSES MARKET

In 2021, the market value of soft contact lenses (SCLs) at industry to eye care professionals (ECPs) level grew by 14.3% to € 1,991 million. The comparable total (data in ’21 & ’20) is the same, € 1,991 million, but shows a growth of 14.6%. The eleven countries reported here (Tab. 2) represent 75.3% (comparable basis) of the total value collected. The CL market

for the reported countries grew by 10.8%, to € 1,499 million. In the eleven markets daily disposables grew by 13.3% and weekly/bi-weekly and monthly by 8.6%, CS declined (-62.9%).

The CL market for all 32/34 markets showed daily disposables growing at 16.6%, W/B-W&M at 12.5%, and CS declining at -81.4% (-63.0% on a comparable basis, i.e. only looking at markets that had data in both years).

The split between segments (by value) for the total 34/32 markets is 56.0 % for daily disposables, 43.9% for W/B-W&M and 0.07 % for CS. For the eleven it is 59.1% for daily disposables, 40.8% for W/B-W&M and 0.09% for CS.

With a total of 13.6% (-0.6%) of the 15-64 years old population wearing CLs, Denmark is leading the penetration ranks, ahead of Sweden (12.2%, -1.9%) and Norway (12.1%, +4.0%). Lowest among the eleven is Germany (4.2%, +10%), next is Spain (4.3%; +22.1%).

HIGH SHARE IN SIHY AND DECLINE IN LENS CARE MARKET

Figure 2: Split of Market (all 34 collected, value, in %) 2021

Silicone Hydrogels (SiHy) are now at 84.6 % value share in the W/B-W&M segment (across all 34 countries/32 clusters) and range from 79.3% in Italy up to 95.2% in Norway in the reported eleven countries.

The total lens care market declined by 0.04% to € 198 million for all 34 countries/32 clusters. All countries but Egypt and the Kingdom of Saudi Arabia had total data for 2021, but not all had data for all segments in one or both years (2021/2020). Total value grew 0.8%, when looking at the total where data was available in both years. In the eleven countries, the total care market was € 138 million (-4.0%).

DD-W/B&M-CS wearers in population 15-64 years of age 2021 vs. 2020 (for values of 2020 see also table 2). Soft lens wearer base values for each country or region assessed, presented by lens category and in total (with comparison to 2020). Penetration expressed as % of total.

Figure 3: DD-W/B&M-CS wearers in population 15 - 64 years of age 2021 vs. 2020 (for values of 2020 see also table 5)

Soft lens wearer base values for each country or region assessed, presented by lens category and in total (with comparison to 2020). Penetration expressed as % of total

The report can be found on the Euromcontact webpage.

Contact lens market (value) in the eleven assessed markets (Tab. 2) Split of market (all 34 collected, value, in %) 2021

Self-determined salaries –crazy or a viable concept?

Interview with Timm Urschinger

The topic of salaries for employees, civil servants or even income for the self-employed is – quite apart from the discussion about the minimum wage or fair gender pay – a sensitive issue. In some countries and companies it is taboo to talk about it – as well as among friends or family – in other countries or companies people talk very openely about it and/or the salaries are transparent. And then there are a few companies where employees can even determine for themselves how much they earn. Like at Livesciences, a 17-member consulting team that not only takes innovative approaches with clients, but is also willing to experiment in its own organization – with regard to structures and strategies. We asked co-founder and CEO Timm Urschinger about their experience in the team and what he would recommend to companies.

Mr. Urschinger, a few years ago you started to look closely at selfdetermined salaries and introduced them in your company. How did this “crazy” idea come about?

From the very first moment, we as a company focused on self-organization, based on Frederic Laloux's book “Reinventing Organizations” and the “Teal principles” described there. Of course, I have not always worked in such an environment – and

all my colleagues had previously been at home in more traditional organizations. So, as consultants, in our previous lives before Livesciences, salaries were set in a more traditional way by management. Of course, there were always discussions, but by defining a lot of KPIs as well as clear documentation, most people at least had the impression that it really was a more or less fair remuneration.

After setting up Livesciences in a self-organized way, we felt that this was not the right approach. We met with other selforganized companies (Holacracy, Sociocracy, et al.) and tried to learn from them how they approached the difficult and thorny issue of salaries and remuneration. Back in 2016 and 2017, we had a “big” round of discussions – four of us at Livesciences at the time – and found a first viable path. But as early as around the turn of 2018/19, with eight people, we felt like we needed to do something different that was really more self-organized and less consensus-driven. What we learned from the other self-organized companies is that there is no “one size fits all'” approach to salaries and remuneration. It was and still is a hotly debated topic across all networks. No one seems to know the secret formula.

But why are salaries so critical and sensitive? After all, we all have to earn a living.

In organizations – regardless of the industry and size – I have made the experience that it is usually not so much about the actual amount of money that ends up in my private bank account, but rather about subjectively perceived fairness. “My colleague who works much less, earns more money than I do, that's not fair!” Such thoughts can probably never be completely avoided, but at least you do not want them to have a negative impact on the company.

The other reason is, of course, recognition and appreciation for all the work I do. Salary is probably one of the biggest components that affects whether I feel valued by the company and my colleagues. Even if I hear positive feedback throughout the year, I probably won´t be able to let go of my negative thoughts if appreciation isn´t reflected in my remunaration. Because we are not immune to such thoughts either, we wanted to avoid this dilemma and use our principles as a “Teal” company for salary definition as well: self-organized, self-responsible and self-determined. Our corporate philosophy Liveline states anyway that everyone acts as an entrepreneur and so the decision was quickly made in one of our governance meetings. What wasn´t so easy was discussing the extent to which we would dictate what the “consulting process” should look like or even how our remuneration should be defined.

Base salaries only? Bonuses calculated based on KPIs? Discretionary calculated bonuses? Dynamic salaries based on hours worked or something else? Finally, here's what we decided:

• Everyone decides on their own salary -> self-determined salaries.

• The “consulting process” is defined for remuneration in such a way that you have to get advice from everyone in the company (i.e. seven other people) on what they think you should earn.

• Building on the “everyone is an entrepreneur” principle, remuneration should consist of base salary + risk bonus.

• The risk bonus should not be calculated based on individual KPIs, but based on individual risk tolerance and companywide success for the year. (We are all in the same boat, so why have different bonus levels).

EVEN IF I HEAR POSITIVE FEEDBACK THROUGHOUT THE YEAR, I PROBABLY WON'T BE ABLE TO LET GO OF MY NEGATIVE THOUGHTS IF APPRECIATION ISN'T REFLECTED IN MY REMUNARATION.

m m Urschinger , co-founder and C E O of LIVEsciences.

And what did that look like in practice?

How did you implement the whole thing in concrete terms?

At Livesciences, we have said consultation process that we always follow when making decisions. For the salaries we set ourselves, we agreed that it makes sense (at least at the time with eight people) to define that everyone asks everyone else for advice – and we agreed to make this completely transparent.

How could I give meaningful advice to someone I haven´t worked with much in the past year? Nevertheless, we thought it was a good idea to do it this way. Subjectively perceived fairness is also more emotional than rational.

The second step in our “consulting process” was a meeting where we proceeded according to the speed dating principle.

In our case, we “met” with everyone who gave advice and to whom I gave advice. In doing so, I told them how I arrived at the number, which I entered into the sheet.

My counterpart would try to understand my motives – without discussing whether they thought they were reasonable or correct. And vice versa. Simply asking questions to create understanding rather than debating is an effective method in many constellations.

So we created a Google sheet with an 8x8 matrix where I would make suggestions to everyone else and myself. This is a number that represents the monthly salary of the person in question. This means that I enter a number for myself (my salary, just for reference and to make sure I´m not biased to only think about my salary when I get everyone else´s input), and then for everyone else. This already caused some turmoil and discussion.

In a third step of the process, I spent another week thinking about what felt right for me personally in terms of salary, and then made a decision that we all shared with each other at a short meeting the week after our speed dating. Transparency, to me, is a critical factor in the successful setup of a selforganized team.

And what have you learned in the team so far in this process?

Or rather, where is the journey going in the future?

The fear of giving advice to people I hadn´t worked with much before quickly faded. “Just do it” is probably a good tip for this part of the process as well. Interestingly, we didn´t and don´t

SIMPLY ASKING QUESTIONS TO CREATE UNDERSTANDING RATHER THAN DEBATING IS AN EFFECTIVE METHOD IN MANY CONSTELLATIONS.

have a wide range in our numbers. The proposals were all pretty close, but the reasons were often very different. I think this simply reflected our different values, experiences and preferences. This is something that was not transparent in our company before, but has been a source of many good discussions and insights for us so far. Even today with a few years of experience, the risk-based bonus is always a special challenge. For this, the consulting process has clearly proven itself and we are coming to good decisions more and more quickly compared to the past. Incidentally, this also applies to new employees. Nevertheless, we check from year to year whether we keep the process or whether there are tensions and we discard the process again or try something completely different. Finally, “Teal” also means being flexible and open to new creative and innovative solutions. That´s why I´m always interested in other people´ experiences with salaries and remuneration to learn more for our setup and approach for the next years.

Thank you for the interview. n

Timm Urschinger is co-founder and CEO of Livesciences (livesciences. com). After his studies and several years with a well-known pharmaceutical company in Switzerland and in consulting, he decided to start his own company. His experience in managing global programs and transformation has awakened in him a passion for developing pragmatic and innovative solutions – for his own company and for customers. New organizational models like Teal play just as big a role as self-leadership and that people finally experience meaning and fun in their professional lives again. Feel free to reach out at timm.urschinger@livesciences.com

EVEN TODAY WITH A FEW YEARS OF EXPERIENCE, THE RISK-BASED BONUS IS ALWAYS A SPECIAL CHALLENGE.

Ultra Precision Diamond Tools

DAC International, Inc. Headquarters: 6390 Rose Lane Carpinteria, CA 93013 USA

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APEX DIAMOND PRODUCTS LIMITED Unit 10, Bartleet Road, Washford Industrial Estate, Redditch,Worcestershire B98 0DQ United Kingdom

APEX DIAMOND PRODUCTS LIMITED www.apexdiamond.co.uk

Phone: +44(0)1527 529011 sales@apexdiamond.co.uk www.apexdiamond.co.uk

“Diamonds for all purposes” v1_58007_ADVERT_60MM_X_80MM_APEXDIAMOND.indd 1 12/11/2019 10:18

Diamond Tools

Contamac LTD Carlton House, Shire Hill Saffron Walden Essex CB11 3AU United Kingdom

Phone: +44 1799 514800 sales@contamac.co.uk www.contamac.com

K & Y Diamond Ltd. 1801 Boul Saint Regis Dollard-des-Ormeaux (Quebec) Canada H9B 2M9

Phone: +1 514 676 0640 Fax: +1 514 676 0645

sales@kydiamond.ca www.kydiamond.ca

LAMBDA-X S.A. Avenue Robert Schuman 102 B-1400 Nivelles Belgium

Phone: +32 67 79 40 80 Fax: +32 67 55 27 91 info@lambda-x.com www.lambda-x.com

Instruments

Phone:

Larsen Equipment Design 1117 N.W. 52nd Street Seattle, WA 98107 USA

Phone: +1 206 789 5121 Fax: +1 206 789 7756

erik@larsenequipment.com www.larsenequipment.com

Machinery and Tools

OPTOCRAFT GmbH Am Weichselgarten 7 D-91058 Erlangen Germany

Phone: +49 9131 691500 Fax: +49 9131 691511 sales@optocraft.de www.optocraft.de Instruments

MISUPCOTM

MisupcoTM Inc. 1378 Osceola Avenue Saint Paul, MN 55105 USA

MisupcoTM Inc. 1378 Osceola Avenue Saint Paul, MN 55105 USA

Phone: +1 651 353 8632 Fax: +1 651 698 0719 www.misupco.com mikef@misupco.com

Phone: +1 651 353 8632 Fax: +1 651 698 0719

mikef@misupco.com www.misupco.com

SCHNEIDER GmbH & Co. KG

Biegenstrasse 8 –12 35112 Fronhausen Germany

SCHNEIDER GmbH & Co. KG Biegenstrasse 8 –12 35112 Fronhausen Germany

Phone: +49 (64 26) 96 96-0 Fax: +49 (64 26) 96 96-100 info@schneider-om.com www.schneider-om.com

Phone: +49 (64 26) 96 96-0 Fax: +49 (64 26) 96 96-100 info@schneider-om.com www.schneider-om.com

Phone: +49(0)208-306683-00 Fax: +49(0)208-306683-99 www.global-cl.com info@global-cl.com

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EDITOR-IN-CHIEF Dipl.-Ing (FH) Silke Sage silke@global-cl.com britta@mafo-optics.com

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ocus@126.com Skype: jennywang611

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