GlobalCONTACT - 01/2021

ISSN:1386 0194

1

2021 (86)

Report • Euromcontact market data report 2020

Fitting Background • Customizing myopia treatment

Business + Marketing • The cloud

Modern modalities require boundless imagination and limitless capabilities. Re-writing the rules on Hyper Dk materials, Optimum Infinite offers Hyper Dk that retains rigidity and provides excellent wettability for immeasurable opportunities to support your lens designs.

Interview • Johannes Pfund – Our industry in changing time

Technology • Using ultrasonic cleaning for RGP contact lenses

Hyper Dk

Optimised Rigidity

Excellent Wettability

optimum-infinite.com

Eyepress Fachmedien GmbH Saarner Str. 151, 45479 Mülheim a. d. Ruhr

NOW AVAILABLE AT YOUR APP STORE 01_Titel.indd 1

21.03.21 22:06

World Leader in GP Materials Decades of Trusted Quality Global Recognition of Boston Brand Name Support for our Laboratory Partners Educational Resources for Eye Care Professionals

Visit us at www.fit-boston.eu 2018_12_19_bl_anzeige.indd 2 !AZ.indd 4

19.12.18 10:57 12.03.19 13:49

LETTER FROM THE EDITOR

Weathering the storm After more than a year in the corona pandemic, including

Last but not least, the pandemic has caused a rethink in

several weeks of lockdown, it's time to look not only back but

many businesses. In order to bring customers into the store

also forward. In the vast majority of industries, the deep

in a controlled manner, appointments have to be made. What

V-curve from spring 2020 is strikingly visible in sales diagrams.

previously seemed quite unthinkable for some contact lens

The (ophthalmic) optical industry was not spared. But the

fitters pays off. These appointments allow more time for the

figures also recovered quickly in many countries. Because

individual. Those who take time for their customers/patients,

vision is important. So important, in fact, that opticians and

value their individuality and are interested in a customized

optometrists were allowed to keep their practices open in

solution for them, could look forward to continued good

many countries.

business. And this is also ref lected in current figures (Eurolens). RGPs remain on a stable plateau overall, albeit

They could perform eye tests, fit contact lenses and sell

a f lat one.

glasses. And while the cash registers may be ringing there, other industries have experienced (and are currently

People are now spending much more time in front of screens,

experiencing) historic sales slumps, which will certainly

which is particularly challenging for the eyes. Poor vision

also result in some bankruptcies after high losses. It is still

may continue to increase in the medium term due to more

not possible to predict exactly how long this tense situation

home office work. So in addition to health, modality and

will last. After all, according to Euromcontact data, there

customized geometry, comfort continues to play a big role in

was a drop of around 9.6% compared with the previous year

contact lenses.

(industry to ECP).

Calculations are always made at the end. Let's talk again in The contact lens industry thus got off lightly – given the

a year's time.... hopefully with a good résumé. ■

circumstances. Nevertheless, it is worthwhile to study the figures from 2020 closely. One of the "winners" was the segment of disposable lenses. These can be delivered home quite easily – whether we like it or not – without even setting foot outside the door. The bare figures do not reveal the extent to which contact lens fitters are involved here. This is because online sales also had a share in the figures.

In these times when even groceries are purchased online, a pack of monthly contact lenses is quickly added to the digital

SILKE SAGE

shopping cart. It would be very unfavorable for traditional

Editor-In-Chief

fitters if sales were to drift further into online retail. After

silke@global-cl.com

all, the industry needs qualified and passionate optometrists to fit specialty lenses. Therefore, customer loyalty is an important issue even in times of a pandemic. Specialty contact lenses offer opportunities for this.

GlobalCONTACT 1-21

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ULTRA-PRECISE AND ECONOMICAL MANUFACTURING OF CONTACT LENSES AND IOL

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Both machines can be easily integrated with an optional automation system.

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RZ_AZ_UPC100 V_UPCnano_Global-Contact_062020_10x297mm_4c_engl.indd 1 !AZ.indd 5

25.06.2020 17:38:13 26.06.20 10:59

CONTENT

ISSN:1386 0194

LETTER FROM THE EDITOR 3

Weathering the storm Silke Sage

1

INTERNATIONAL NEWS

2021 (86)

Report • Euromcontact market data report 2020

Fitting Background • Customizing myopia treatment

Business + Marketing • Cloud security

Technology

Optimised Rigidity

9

All about products & event dates

12 Johannes Pfund – Our industry in changing time

Excellent Wettability

Silke Sage

optimum-infinite.com

• Using ultrasonic cleaning for RGP contact lenses

All about markets

INTERVIEW

Interview Hyper Dk

All about you

8

10 All about research

Modern modalities require boundless imagination and limitless capabilities. Re-writing the rules on Hyper Dk materials, Optimum Infinite offers Hyper Dk that retains rigidity and provides excellent wettability for immeasurable opportunities to support your lens designs.

• Johannes Pfund – our industry in changing time

6

20 Carolin Truckenbrod – First reference curve for refraction in Central Europe created Hanna Diewald & Rebekka Nurkanovic

Eyepress Fachmedien GmbH Saarner Str. 151, 45479 Mülheim a. d. Ruhr

NOW AVAILABLE AT YOUR APP STORE

FITTING BACKGROUND INDEX TO ADVERTISERS Title: Contamac, www.contamac.com

Inside front cover: Bausch + Lomb Inc., www.bausch.com Page 4: Schneider GmbH & Co. KG, www.schneider-om.com Page 15: K & Y Diamond Ltd, www.kydiamond.ca Page 19: OPTOCRAFT GmbH, www.optocraft.com Page 29: LAMBDA-X S.A.,

16 Customizing myopia treatment Eef van der Worp

23 Imaging techniques – case study Lukas Metzger, Danyon Keutgen

TECHNOLOGY 24 Using ultrasonic cleaning for RGP contact lenses Bruno Fantony, Alejandro Cubel Yuste

MANUFACTURING 28 Edge polishing or edge rolling Erik Larsen

www.lambda-x.com Page 31: Optimec Systems Ltd., www.optimecsystems.com

RESEARCH 30 Study links protein causing Alzheimer’s disease with common sight loss

Page 33: AMETEK Precitech, Inc., www.precitech.com Page 39: Larsen Equipment Design Inc., www.larsenequipment.com

COLUMN 32 OutLOOK Eef van der Worp

Page 43: GlobalCONTACT, www.gclabsite.com Inside back cover: Efclin, www.efclin.com

HISTORY 34 Contact lens care Hans-Walter Roth

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

NAMES TO NOTE Brandstätter, Manfred

44

Fantony, Bruno

24

Fischer, Hartmut

40

Keutgen, Danyon

23

Larsen, Erik

28

Metzger, Lukas

23

Roth, Hans-Walter

34

van der Worp, Eef 16, 32 Yuste, Alejandro Cubel GlobalCONTACT 1-21

05_Content.indd 5

24

REPORT 36 Euromcontact market data report 2020 BUSINESS + MARKETING 40 The cloud Hartmut Fischer

44 A situational learning organization Manfred Brandstätter

NEWS 48 Yellow Pages 5

21.03.21 22:13

INTERNATIONAL NEWS

All about you PROSE recipient launched nonprofit to support young patients BostonSight has shared an inspiring story about a PROSE Network patient.

Over a treatment period of six months, Alyssa and Dr. Michelle Lee

Alyssa Carfi had a brainstem cavernoma, a condition where blood vessels

at Weill Cornell Medical Center worked on fitting a PROSE device

are clustered together, and in her case,

which is a rigid, gas-permeable specialty lens that rests on the sclera

lodged deep in her brainstem. The

of the eye and vaults over the cornea. The vaulted reservoir is filled

condition caused bleeding in her

with a preservative-free saline solution, which continually bathes the

brainstem multiple times. Just three

eye in a tear-like environment. Because of their strong material

days after graduating high school, Alyssa

construction, the devices protect the surface of the eye.

went in for surgery. Based on their

Today, eight years later, Alyssa feels lucky that she was able to receive the

location, brainstem cavernomas can

PROSE treatment and has launched the Brave Minds Project, a 501(c)(3)

cause significant surgical challenges.

nonprofit that supports teen and young adults living with brain and

Following her surgery, Alyssa had facial

brainstem conditions. The organization aims to help patients and their

paralysis, affecting her eyelid and ability

families from diagnosis through recovery by offering financial support for

to open and close her right eye. She was

therapies and off-setting medical costs such as PROSE, providing community

unable to blink, leaving her right eyelid

connection, and delivering goods that are sent to patients in the hospital

permanently open.

and to their siblings. Read Alyssa’s full story on www.bostonsight.org

Dr. lee and Alyssa with Patient

GPLI Practitioner of the Year & Educator of the Year 2021

The first to be honored with the new

The GP Lens Institute's has named Dr. Jason Jedlicka as its 2021

award Educator of the Year, Dr. Daniel

Practitioner of the Year and Dr. Daniel Fuller as Educator of the Year.

Fuller is professor and chief of the

A renown scleral lens innovator, educator, author, and lecturer, Dr. Jason

Contact Lens Service, Southern College

Jedlicka is currently chief of the Contact Lens Service at the Indiana University

of Optometry. He is a diplomate in the

School of Optometry. He is a diplomate in the Cornea, Contact Lenses &

Cornea, Contact Lenses & Refractive

Refractive Technologies Section of the American Academy of Optometry

Technologies Section of the American

and is a co-founder and past president of the Scleral Lens Education Society

Academy of Optometry and is currently vice-president of the Scleral Lens

as well as an advisory board member of the GP Lens Institute.

Education Society and an advisory board member of the GP Lens Institute.

BostonSight appoints scientific advisory board

Demi Niforos, MS, Vice President of Biostatistics and Statistical

BostonSight announced that they have formed a scientific advisory

Programming at eClinical Solutions; Michael Raizman, MD, a

board comprising medical experts to help guide BostonSight’s robust

practitioner at Ophthalmic Consultants of Boston and Associate

research initiatives.

Professor of Ophthalmology at Tufts University School of Medicine;

“As leaders in the eye health industry, we’re excited to bring together

Ali Djalilian, MD, Professor of Ophthalmology, Cornea Service and

medical experts to provide expertise and guidance as we plan future

Director of the Stem Cell Therapy and Corneal Tissue Engineering

studies that will advance the understanding, treatment, and care of complex

Laboratory at Illinois Eye and Ear Infirmary; and Gloria B. Chiu, OD,

corneal disease”, said Sara Yost, BostonSight President and CEO.

FAAO, FSLS, Associate Professor of Clinical Ophthalmology at the

The BostonSight Scientific Advisory Board, chaired by Dan Brocks,

USC Roski Eye Institute, Department of Ophthalmology at the University

MD, BostonSight’s Chief Medical Officer, includes Yost along with

of Southern California Keck School of Medicine.

Dr. Jason G. Jedlicka

CLMA has elected a new president On December 12, 2020, a new CLMA president was elected. Josh Adams (Valley Contax) succeeded Kurtis Brown (DAC intl.) as the 27th president. Josh Adams follows in the footsteps of Janice Adams, who served as CLMA president from 2006 to 2008. GlobalCONTACT congratulates!

Josh Adams

6

06_All About You.indd 6

GlobalCONTACT 1-21

21.03.21 22:14

INTERNATIONAL NEWS

The Passing of an industry icon: Milton S. Kallas

but Milt’s many strengths included the ability to quickly learn

He was often described as “one of a kind”, dedicated, detail-oriented,

new skills – and pass those skills onto others – so therefore, he

kind, and hard-working; he was always beloved. The contact lens

embraced the benefits of computers long before they became

world lost an important part of what makes our industry so special

commonplace.

with the passing of Milt Kallas. Milt died peacefully on March 2, 2021 in Pleasanton, California at the age of 77. He is survived by

His work ethic, dedication, and attention to detail were legendary.

his loving wife of 46 years, Marion, his son Matthew, and his

According to his long-time colleague Jonathan Jacobson, “Those

daughter Mollie.

of you who attended trade shows or conferences at which Milt was present will know that Milt was always the first to show up at the

Milt’s professional career in contact lenses began in the early 1990s

booth and the first in the seminar room, checking to see that all

with Polymer Technology Corporation (PTC). After the acquisition

had been done to ensure a smooth operation. And Milt reveled

of PTC by Bausch + Lomb, he served as Regional

in this too … knowing that he was always the

Sales Manager for 17 years for The Boston Group.

first on the spot. As one whose job it was to

He left Bausch + Lomb in 2008 but never actually

worry that things were done correctly and on

left the contact left industry. He was very

time, it was always reassuring to know that

inf luential in helping Menicon America in

Milt was on site. Details were Milt’s fixation.”

numerous GP initiatives while establishing his His family always came first and he loved his

own consulting company.

wife and was very proud of his children. And Milt Kallas was a beloved long-time industry

his extended family are most appreciative of the

professional, mentor, and friend to so many

impact he has had on their life. He mentored so

in the contact lens field worldwide. Known

many people in the industry and part of his

as “Uncle Miltie” for his kind, generous, and

legacy will be the quality of the individuals and

positive demeanor, he was well known for his

the impact they have had on the contact lens

selfless devotion to helping others and worked tirelessly to answer

profession as a direct or indirect result of the influence of Milt Kallas.

questions, return phone calls and emails (in record time!), working to ensure excellent customer support, while training his sales

By Ed Bennett

team how to use the various reports and computer programs.

Acknowledgements: John Hibbs, Jonathan Jacobson, Jay Woychick,

This is especially significant as computers were in their infancy

David Bland, David Moreira, and Craig Norman

Letter to the Editor The use of lead scleral shells In the 3-2020 (85) edition of GlobalCONTACT, Dr Hans-Walter Roth

“Six shells of different sizes are supplied for both right and left eyes.

published three excellent photographs of a small set of scleral contact

Transparent duplicates of each size are included with the set. Trial

shells which comprised six pairs of PMMA shells, one for each eye,

fittings are made with transparent shells until a fair fit is obtained, the

together with corresponding lead shells.

corresponding lead shell is then inserted and worn during treatment.”

Some readers of this magazine may have wondered about the purpose

As the lead shells were worn for only a brief period, a fitting set of six

of the lead shells. An essential clue about their use is provided in the

pairs was sufficient to find one which was large enough while providing

photograph of the ‘instruction manual’ in which they are identified

some clearance of the cornea. Clement Clarke of London, a firm that

as ‘shields’. Since lead can provide shielding against high-energy sources

supplied a wide range of ophthalmic instruments and devices,

of radiation such as gamma rays and x-rays, shells made from this

manufactured the fitting set mentioned by these authors.

metal have been used to protect the eye when malignant tumours in orbital region were subjected to radiotherapy.

Reference: Jenkin, L and Tyler-Jones, R, (1964). Theory and Practice of Contact Lens Fitting, p124-5, The Hatton Press Ltd, London.

More than 55 years ago, Jenkin and Tyler Jones wrote the following, which appears to be an exact description of Dr Roth’s shells:

GlobalCONTACT 1-21

06_All About You.indd 7

Richard M Pearson

7

21.03.21 22:14

INTERNATIONAL NEWS

All about markets Income of optometrists

Data created worldwide

Japan is the highest paying country for optometrists

The total amount of data created, captured, copied, and

with

consumed in the world is forecast to increase rapidly, reaching

in 2020. The rapid development of digitalization contributes to

£98,252 /$136,469 per year,

the ever-growing global data sphere.

closely followed by Denmark (£97,066/$134,822). Last in the list

59 zettabytes

of top ten highest paying countries is Italy with £ 67,203/$ 93,343 per year.

statista.com/statistics/871513/worldwide-data-created/

Lenstore, the global health analysis.

[Exchange rate £ to $ on March 9, 2021]

Consumer spending Out of 401 polled prescription



contact lens wearers in the USA

Environment

4.0

9%

GfK reveals that

78%

3.5 3.0

stayed about the same for 72% and 19% spent less money on contact lenses.

2.5

Billion Euros

spent more money on contact lenses during the COVID-19 pandemic. Spending While 50% conducted their purchases mostly in person, 24% equally in-person and online, and 25% mostly online during COVID-19, 61% said they would make their purchases mostly in person and only 20% would still favor online purchasing after the pandemic is over.

2.0 1.5 1.0

of US consumers say it is important for companies to be environmentally responsible, while 44% believe that Italy government – not individuals – should address environmental 3.663 problems. The study shows that Baby Boomers and women are more likely to think that companies should step up.

Germany

0.5

The Vision Council, Healthcare Behavior and Consumer Spending Insights

1.245

GfK Consumer Life

0

during COVID-19, presented January 2021.

Ireland

1.548

Top three export countries

4.0

3.5

3.5

3.0

3.0

2.5

2.5

2.0

Billion Euros

Billion Euros

TOP THREE EUROPEAN IMPORT AND EXPORT COUNTRIES OF OPTICAL PRODUCTS* 4.0

Italy

3.663

1.5 1.0

Germany

1.548

0.5 0

Top three export countries

Ireland

1.245

2.0 1.5 1.0

Germany

France

1.537

1.464

0.5 0

Italy

1.307

Top three import countries

*Including spectacle lenses, frames, sunglasses, contact lenses and binoculars imported and exported to countries worldwide. Source: Eurostat, Spectaris 8

4.0 08_All About Markets.indd 8

GlobalCONTACT 1-21

21.03.21 22:21

INDUSTRY NEWS

All about products Optimum Infinite - Infinite Possibilities Modern modalities such as Sclerals and Orthokeratology have been propelled into the forefront of practitioners’ attention in recent years.

However, traditional high/hyper Dk materials struggle to meet the requirements of these growing modalities. In contrast to previous technologies, Optimum Infinite offers hyper Dk (180Dk) that retains rigidity, provides excellent wettability and is durable during lens handling and wear, and of course, it is easy to machine. Optimum Infinite changes the paradigm so you don't have to compromise when using hyper Dk materials. Contamac's expert R&D chemists have rewritten the rules on Hyper Dk materials to give you infinite possibilities. sales@contamac.co.uk, www.contamac.com

TRIOPTICS: 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. info@trioptics.com, www.trioptics.com

WEBINARS, CONFERENCES & TRADE FAIRS 2021 & 2022 (due to the corona crisis, please check via the websites whether the event takes place)

EAOO Helsinki 2021

Apr 23-25

online event

https://e.eventos.fi/events/naery/helsinki-2021/home

ARVO 2021

May 1-7

online event

www.arvo.org/annual-meeting/

Virtual Ortho-K Boot Camp

May 12

online event

www.orthokmeeting.com

BCLA 2021

June 13-14

online event

www.bcla.org.uk

ICSC 2021

July 23-24

Fort Lauderdale, FL (USA)

www.icscmeeting.com

Sep 4

online

www.eclso.eu

Oct 18-20

Tokyo (JPN)

www.ioft.jp/en-gb.html

NCC 2022

Mar 13-14

Eindhoven (NL)

www.contactlenscongress.com/en/

EFCLIN 2022

Apr 28-22

TBA (South Europe)

www.efclin.com

ECLSO 2021 Symposium & statutory meetings IOFT 2021 International Optical Fair Tokyo

GlobalCONTACT 1-21

09_All About Products.indd 9

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19.03.21 18:47

INTERNATIONAL NEWS

All about research

Studies on safety, eye health monitoring and myopia progression Two of the following contact lens studies have focused on children in the past year. While one aimed to clarify how safe soft contact lenses are for children, the other looked at the effect of contact lenses on myopia progression in children. There's also news from the field of contact lens development – a smart CL that shows potential for eye health monitoring.

Safety of paediatric soft contact lens wear

fitted while eight to twelve years old with various SCL designs, prescriptions and replacement schedules, and observed through to age 16. Compared to AE results derived exclusively from clinical trials, these data are thought to be more generalizable to real world experiences as myopia control soft contact lenses are prescribed more widely to young patients.

Clinical records from office visits with potential AEs were independently reviewed by an adjudication panel to determine a consensus diagnosis. The current findings are very similar to but slightly lower than rates reported in previous studies of similar age groups, possibly attributed to the higher proportion of daily disposable lenses in the current study. The

Robin Chalmers et al. have examined the safety of wearing

study found the annualized incidence rate of inflammatory

soft contact lenses for children . The research was funded

events was less than one percent per year of wear. The majority

by CooperVision Corporation and was initiated to support

of events were conjunctivitis or foreign body abrasions, reflective

CooperVision's regulatory submissions of MiSight 1 day

of this young population.

contact lenses.

The authors note that the study found a lower rate of microbial

The study measured the rate of adverse events (AE) in children

keratitis (7.4/10,000 years of wear) with a tighter confidence

who were prescribed soft contact lenses before they turned

interval than other pediatric post-market studies. That rate

13 years old to establish wearing safety among that age group.

has been found to be comparable to established rates of microbial

The review documented AE details from clinical practice charts

keratitis in adults.

[1]

and clinical trial data of 963 children and observed 2,713 years of wear across 4,611 visits. The evaluated subjects were first 10

10_AllAboutResearch.indd 10

Sources: abstract of study [1], EurekAlert 2020-12-10 [2] GlobalCONTACT 1-21

19.03.21 17:43

INTERNATIONAL NEWS

Smart contact lens sensor POC eye health monitoring

This contact lens features periodic nanostructures within the poly(2-hydroxyethyl methacrylate) (pHEMA) hydrogel matrix, resulting in bright, tunable structural colors ranging from red to green to blue.

The structurally colored contact lens sensor is made solely from a biocompatible hydrogel, without the addition of any chemical pigments, thus exhibiting biosafety and comfort for wearable applications.

The spacings of periodic nanostructures within the pHEMA

Early diagnosis is important for avoiding severe eye problems,

hydrogel are sensitive to changes in moisture and pressure,

such as exophthalmia or glaucoma. Such diagnoses rely on

leading to real-time color changes in the contact lens.

facile and reliable monitoring of several features with pathologic

Zhao Qilong, first author of the study, reports that its color

relevance, such as the amount of tears and intraocular pressure.

will not change over time in normal eye-simulation conditions

Current methods usually require complex procedures and

but changes from red to blue in a xerophthalmia-simulation

instruments operated by professionals, causing difficulties for

condition in about 25 minutes.

point-of-care (POC) ophthalmic health monitoring.

Additionally, a linear decrease in the wavelength of the reflectance

A research group led by Prof. Du Xuemin from the Shenzhen

peak of the "smart" cosmetic contact lens is observed when

Institutes of Advanced Technology (SIAT) of the Chinese

human intraocular pressure changes in the pathological range.

Academy of Sciences has developed a "smart" contact lens

It can potentially be used for point-of-care (POC) diagnosis of

that can show real-time changes in moisture and pressure by

xerophthalmia and high intraocular pressure disease.

altering colors. The results were published in the Journal of Materials Chemistry B [3].

Source: Abstract of study [3], EurekAlert 2020-02-18 [4]

Effects of contact lenses on myopia progression in children Nearsightedness tends to begin between the ages of eight and ten and progresses up to about age 18.

In a trial, conducted by Jeffrey Walline et al. at Ohio State and the University of Houston, almost 300 nearsighted children age 7-11 years were randomized into one of three groups of contact-lens wearers: single vision or multifocal prescriptions with a medium reading add of 1.50 diopters or a high add of 2.50 diopters. The

progression by 43 percent when compared to single-vision

findings were published in the Journal of the American Medical

contact lenses.

Association . The study was funded by the National Eye Institute,

The researchers were aware of the need to balance the reduction

part of the National Institutes of Health, and supported by Bausch

of eye growth with any risks associated with subjecting children

+ Lomb, which provided contact lens solutions.

to strong reading power long before they need that level of

As a group, the participants' average prescription at the start

correction. When testing their ability to read gray letters on a

of the study was -2.39 diopters. After three years, both the

white background, there was a two-letter difference between

degree of myopia progression and the extent of eye growth

single-vision lens wearers and those wearing multifocal lenses.

were lower in the kids who had worn the high-add lenses. On

The research team is continuing to follow the same participants,

average, the three-year eye growth among kids with the high-add

treating them all with the high-add bifocal lenses for two years

bifocals was .23 millimeters less than in kids wearing single-

and then switching them all to single-vision contact lenses in

vision lenses. Medium-add lenses did not slow eye growth any

order to evaluate the permanence of the treatment effect.

[5]

more than single vision lenses. A bifocal contact lens prescription with the highest near-work correction slowed nearsightedness

Sources: Abstract of study [5], EurekAlert 2020-08-11 [6]

Referenzen: [1] Chalmers, RL, McNally, JJ, Chamberlain, P, & Keay, L. Adverse event rates in the retrospective cohort study of safety of paediatric soft contact lens wear: the ReCSS study. Ophthalmic Physiol Opt. 2020. https://doi.org/10.1111/opo.12753, [2] https://www.eurekalert.org/pub_ releases/2020-12/mc-lso120820.php, [3] Wang, Y., Zhao, Q., Du, X. Structurally coloured contact lens sensor for point-of-care ophthalmic health monitoring. J. Mater. Chem. B, 2020, 8, 3519-3526. https://doi.org/10.1039/C9TB02389E, [4] https://www.eurekalert.org/pub_releases/2020-02/ caos-scl021820.php, [5] Walline JJ, Walker MK, Mutti DO, et al. Effect of High Add Power, Medium Add Power, or Single-Vision Contact Lenses on Myopia Progression in Children: The BLINK Randomized Clinical Trial. JAMA. 2020;324(6):571–580. doi:10.1001/jama.2020.10834, [6] https://www.eurekalert.org/pub_releases/2020-08/osu-ynk080620.php GlobalCONTACT 1-21

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19.03.21 17:43

INTERVIEW

Our industry in changing time Interview with Dr. Johannes Pfund As a board member of EFCLIN and managing director of Optocraft, Johannes Pfund has experience of different aspects of our industry. In an interview with GlobalCONTACT, the doctor of physics shares insights into changes at EFCLIN and looks back on the extraordinary year 2020. He also outlines possible scenarios for 2021 and – on the occasion of Optocraft's 20th anniversary – looks back on the milestones of his own company to date. By Silke Sage

GlobalCONTACT: You have been a member of the board of EFCLIN

The Manufacturers’ Forum always risked being a front

since 2017. What were your expectations when you joined?

panel, with the panel of experts on the podium and the

Pfund: My motivation was a mixture of curiosity and my

other attendees sitting in the auditorium. Sometimes it

inner desire to play a part in professional associations and

seemed as if the audience was reluctant to contribute because

networks. I have long been active in a photonics network, and

they did not want to give the impression that they didn’t

EFCLIN interested me because I wanted to understand how

understand everything. We thought about how the forum

the contact lens industry works, what the specific challenges

could be made more lively and communicative. The approach

are and also to get to know the customer side. Another aspect

we came up with was to stop asking people individually

was – and still is – that I wanted to contribute my knowledge

where their challenges lay and instead try to identify topics

of other industries.

of common interest and create a format where short stimulating introductory lectures would be followed by

GlobalCONTACT: What has changed at EFCLIN since 2017?

round-table discussions. The outcome of these discussions

Pfund: It’s not just one person alone on a board who gets

was then again summarized, leading in turn to new topics

things done. Martina Clifford was elected to the board at the

for discussion. This format has proved to offer a great deal

same time as I was and she has a completely different

of freedom and, in most cases, resulted in new topics of

background to me. Right from the start we brought in our

interest for future events.

respective ideas and worked on changes together. Also, thinking about the future beyond the next congress and

GlobalCONTACT: What does a digital Manufacturers’ Forum look like?

strategic planning interests me.

Pfund: At first we tried to somehow adapt this format to the

GlobalCONTACT: What is your main focus and which areas are you

suffer and that it would be better to focus on a “physical

responsible for?

Manufacturers’ Forum” as part of the congress in 2022. The

Pfund: As a physicist with a doctorate in metrology, aspheric

good news is that we are working closely together in the board

digital world. But we soon concluded that spontaneity would

lenses test engineering and precision optics, it seemed

and with some volunteers to stay in contact with the

logical for me to focus more on technical

community, so that we can offer interesting

matters for the Manufacturers Forum and

topics in the form of short webinars month

shed light on these topics. As the founder

by month. We will continue to provide up-to-date information on these

and owner of my own business, I am also acutely aware of the need to

activities.

attract start-ups and small businesses to become members of EFCLIN at

GlobalCONTACT: How was 2020 from

an early stage.

your perspective as a board member?

In order to breathe new life into the

What particular challenges did you have

Manufacturers’ Forum, Erik Smidt,

to face?

Pfund: 2020 was an amazing year. As

Peter Vermeulen and I have jointly built on ideas from the experience and suggestions from the community. This has already progressed through several evolutionary

in other years, we started with intensive

D r. J o

hannes Pf un

d

discussions and planning of how the EFCLIN Congress should be organized and the allocation of

stages. Our aim is to create a lively discussion forum around

tasks. But we all know how this ended – in the cancelation of

appropriate topics which should also be an enjoyable

the event. It was a very hard decision but one that had to be

experience.

made. We initially thought about how the congress could go

12

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19.03.21 07:52

INTERVIEW

ahead in spite of everything, e.g. with a sort of hybrid or video format, but no satisfactory solution could be found.

In March, just before the lockdown in Germany, we also held a one-and-a-half-day workshop on strategic topics.

Funnily enough one of the question which came up was, "How can we digitize EFCLIN; how can we best stay in contact with the community?" At the time no one could have imagined what a positive accelerator the pandemic would prove to be in this regard. As already mentioned, we have now set up a monthly digital program for 2021 – that’s how fast things can change.

The remainder of 2020 was very much dominated by crisis management. The center of our attention was on the 2021 Congress: should we go ahead with it or not; and, if so, how should it be planned? After all there’s much more to the organization and cancellation of a congress than meets the eye. Marion Beeler did an amazing job in this regard. In coordination with the board,

Dr. Johannes Pfund at EFCLIN Congress & Exhibition

she had to juggle with a lot of imponderables – in March no one could have foreseen how Corona would pan out.

One characteristic of 2020 was that not only was there a

boost in innovation. It may also benefit the end customer in

pandemic a problem, but the MDR was also coming into force.

terms of new, exciting products.

This is an awkward topic for many people and particularly for

For our industry-wide network it is of course different, because

smaller companies. In terms of communication with EFCLIN

the more companies merge, the greater the risk that

as an institution, this issue certainly took precedence over the

subsequently of the two, three or four former companies only

pandemic. Maybe this was because its effect is likely to be more

one EFCLIN member will remain. The challenge for EFCLIN

permanent. The MDR will keep the industry busy for a long

is to retain its critical mass. For the moment, this is still ok,

time to come.

but thought needs to be given to how to maintain the growth of EFCLIN in the future.

GlobalCONTACT: MDR from the point of view of measurement technology. Do you feel that manufacturers have a lot of catching

GlobalCONTACT: What is your forecast for the industry for the

up to do?

current year?

Pfund: There is currently something like "transformation

Pfund: This year, as with last year in particular, experience

pains". The new MDR has to be integrated into your existing

shows that forecasts are likely to be wrong. Thus I prefer

processes and that means an initial investment. However, for

to think in terms of scenarios. At the moment I see two

every product there is also a recurring investment. As I see it,

alternative scenarios: If we assume a seasonal decline in

for each product certified, the effort required for documentation

the number of infections for March to May and assume that

and quality assurance will be significantly higher than before.

vaccination is successful, then we can hope that the infection

This will increase costs which have to be recovered somehow,

rate will not increase as drastically again next winter. For

leading to questions such as: Can I raise the price of contact

manufacturers of customer specific contact lenses, this

lenses as a result of this? How do I continue to do business with

could mean that customers return in droves, manufacturers

the new cost structure? The MDR remains an ongoing issue

have plenty of work and this in turn will lead to the recovery

and each individual has to position himself with his product

of production figures for the companies concerned. It could

portfolio in such a way that it is easy to manage from an

even mean demand suddenly exceeding capacity and

organizational point of view.

production reaching its limit; perhaps a luxury problem from today's perspective.

GlobalCONTACT: In the past year, many smaller labs have been

There may also be a catch-up effect in the area of specialist

bought by industry giants. What are the consequences for the

and IOL lenses. Remember that cataract operations have

association?

been d i f f icu lt or i mpossible to per for m for some

Pfund: I think one should consider two different aspects. The

considerable period because some “routine operations”

trend that smaller companies are being bought by larger

were not possible or at least difficult due to the overload

companies or grouping together is a real opportunity for the

of pandemic-related cases in hospitals. This would be the

entrepreneurs in these companies and could lead to a major

promising scenario.

GlobalCONTACT 1-21

12_JohannesPfund.indd 13

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19.03.21 07:52

Photo: Silke Sage

INTERVIEW

EFCLIN Board from left: Dr. Johannes Pfund (Optocraft), Armin Duddek (Prolens), Martina Clifford (ODC Industries), Tanja Malkus (Bausch + Lomb), Marion Beeler-Kaupke (ED), Peter Vermeulen (Opthecs Europ B.V.), Gareth Browne (Contamac).

A less promising scenario would occur if mutations were

Hartmann SHSLab wavefront sensor, which I developed as

to arise. What if there was a mutation that not only spread

part of my doctorate.

faster but was also more deadly; or against which the

We founded the company without any major investment,

vaccines proved ineffective? It would mean that everything

so to speak with the feet on the ground. We just moved

would start all over again. This would be the pessimistic

into a small room, started going to trade fairs and landed

scenario – but one also has to be prepared for it. What

an order here or there. Starting off with the small SHSLab

should the new business model look like in the case of

sensor, we gradually evolved in the direction of instrument

this scenario?

technology; our first market was more in optics testing.

For example, we got a good order from a manufacturer of

GlobalCONTACT: How do you think the industry would have to

high-quality binoculars for birdwatchers and rif le scopes

position itself to prepare for such future scenarios?

for hunters. Thus we managed to get established and

Pfund: The manufacturers of daily contact lenses are certainly

continued to grow organically.

already well positioned. Their production is automated at every

Another milestone came around 2008 when we launched

stage and customers can buy what is in stock on the Internet.

SHSOphthalmic in the contact lens market. It was fascinating

For the manufacturers of specialty or customized lenses, the

to learn the ropes of this industry. In the precision world,

lens fitting process at the contact lens fitters or optometrists

everything revolves around ultimate accuracy, whereas in

needs to become faster, easier and more straightforward.

the contact lens field things are structured very differently.

For this industry, the aim must also be to streamline and

The optics themselves are usually far less precise with regard

automate production processes wherever possible.

to the wavefront, but they require answers to completely different questions, such as: “Does the lens have the correct

GlobalCONTACT: Optocraft will be 20 years old this year. With your

base curve? Does it scratch the eye? Does the lens have the

background in precision optics, what have been the milestones for

correct refractive power, even when measured several times

your company?

after repeated handling? What is its refractive power at

Pfund: One key milestone of course was when we set up

different temperatures?”

Optocraft in 2001. I founded Optocraft together with another

Entry into the market for intra-ocular lens manufacturers also

physics graduate from the faculty of optics at Erlangen

went hand in hand at the time. Interestingly, the 11979-2

University. Our initial product was a small sensor, the Shack-

regulations and others brought this market much closer to

14

12_JohannesPfund.indd 14

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19.03.21 07:52

!AZ.ind

INTERVIEW

what we were used to dealing with in precision optics in terms

distribution across the lens – for example for multifocal

of measurement technology.

contact lenses. A rapid growth in expertise relating to

Be that as it may, we apply our expertise gained in other fields

measurement technology and its application can be observed

to the contact lens and intra-ocular lens markets and we are

in such companies today. With regard to measurement

constantly advancing our technology and the performance of

technology, they now also have a much better understanding

our instruments.

of what is possible and how procedures and results should be interpreted.

GlobalCONTACT: In your opinion, what has been the biggest change in the field of contact lenses and IOLs over the past 20 years?

GlobalCONTACT: How do you intend to mark this 20th anniversary?

Pfund: We first had to get to know how the ophthalmic

Pfund: Due to the uncertain situation regarding the pandemic,

market works, how an operator in production ticks, what

things are difficult to plan. Either we will celebrate virtually

he needs, how and under what conditions he works. We

with a few bottles of whiskey and champagne, or – and we truly

then learned how to adapt our devices to these requirements.

hope this will be possible – we will hold a "family party" outdoors

At the same time our potential customers, i.e. the lens

in summer, and repeat this later in autumn with business

manufacturers, have evolved too. They have changed their

partners and employees in a more formal setting.

approach and gained a much better understanding of the

During the course of the year, we will also run various

fact that digital measuring devices offer an opportunity.

promotional campaigns in the market, but I don't want to say

They have become aware that simply measuring a refractive

any more about that just now.

power is only one approach, and that there are also other hot topics, such as measuring t he refractive power

GlobalCONTACT: Thank you for the interview! 

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11.06.19 07:52 10:55 19.03.21

FITTING BACKGROUND Myopia Treatment

Photo: Silke Sage

Customizing myopia treatment ‘The ABCs of myopia management: from atropine to Zernike polynomials’ Recently, the Global Specialty Lens Symposium (GSLS) was held online with a staggering 4000 delegates registered and with 83 countries represented – truly a ‘global’ symposium. I was put in charge of the myopia session, to be the myopia management moderator, so to speak. The panel was an exhibition of global excellence, with a constant flow around the globe, swinging back and forth from the east coast of Australia (Scott Read from the Queensland University of Technology in Brisbane and Kate Gifford of myopiaprofile.com) to the Netherlands (Jan Roelof Polling from Erasmus MC in Rotterdam) and North America (Langis Michaud, Université de Montréal in Canada). By Eef van der Worp

INSIDE THE BOX

16

16_Eef.indd 16

Wang et al in JAMA Ophthalmology looked into this and found

It is no secret that myopia is increasing, quite drastically in

indeed that in the 123.535 children included in the study, a

fact, worldwide. But what may be new is that during the year

substantial myopic shift was seen (approximately −0.3D) in

2020, and presumably because of home confinement during

the school-based screenings in 2020 compared with previous

the COVID-19 pandemic, concerns have been raised about

years (2015-2019) for younger children aged 6 (−0.32 D), 7

whether this home confinement may have worsened the burden

(−0.28 D), and 8 (−0.29 D) years. Numerous limitations warrant

of myopia owing to both decreased time spent outdoors and

caution in the interpretation of these associations, including

increased screen time at home. In short: our kids have been

use of non-cycloplegic refraction and lack of orthokeratology

‘living in a box,’ at least partly, during the last year. A study by

history or ocular biometry data. But the authors do conclude GlobalCONTACT 1-21

19.03.21 11:46

Myopia Treatment FITTING BACKGROUND

Fig.1: Orthokeratologie. Picture: Massimo Ferrara

that home confinement during the COVID-19 pandemic appears

ATROPINE

to be associated with a significant myopic shift for children

What this means for pharmaceutical intervention (basically

aged 6 to 8 years. And that younger children’s refractive status

atropine drops currently) is to look at the optimal concentration.

may be more sensitive to environmental changes than that of

Kate Giffford and Jan Roelof Polling shed some light on this.

older children, given that younger children are in a critical

The latest research shows that higher concentrations of atropine

period for the development of myopia.

seem to be the most effective (and less rebound effect after

DON’T BE MEAN

treatment is tapered), at the cost, of course, of more side effects including reduced accommodation, pupil size enlargement

With this in mind, and as a starting point, the panel at GSLS

(hence photophobia), irritation and possibly headaches. And

tried to analyse what is the best way in clinical practice to

a low 0,01% concentration may unfortunately not meet the

reduce myopia progression to the max, while staying on the

expectations we have of it.

safe and ethical side of things. The first appraisal made was a very important and critical one: don’t be mean! We hear all

How effective a certain concentration of atropine is for a given

these stories about ‘50%’ or ‘60%’ reduction, also with new

child can be best monitored by following the axial length

spectacle lenses now for myopia management. But what does

growth charts, almost like what we have for children’s height

this really mean? Work by Noel Brennan and Mark Bullimore,

every time we visit the paediatrician (see figure 2). Basically,

originally posted at ARVO 2019, has shown that these numbers

if the child is diverting from the designated path or line ‘upward,’

are very relative in nature. First and foremost, it is important

it is time to upgrade the atropine concentration; but if the kid

to realize that these are all average (or ‘mean’) numbers. ECPs

is ‘lower’ than the designated line – then it is time to decrease

can never present, promote or promise this in that way to

atropine concentration and/or to add additional intervention

patients and parents. Furthermore, even if these numbers of

methods such as optical intervention. This is a really nice way

reduction are met, it is only the case within a relatively short

of following and monitoring myopia progression, with at least

period of time. Let’s say for convenience and to avoid complex

some kind of apparent control over the potential outcome.

discussion about that (hot) topic that the bulk of the treatment in myopic children needs to take place between the ages of 8 and 12 years. That is a pretty narrow window of opportunity.

OPTICAL INTERVENTION In this categor y, our number one ‘champion’ is still orthokeratology, which has the longest track record and good

What this also means is that we need to do everything we can

evidence in the literature. However, here too, customization

to get as much treatment in during that limited time frame.

to optimize the outcome seems warranted. The myopia-reducing

Depending on the child and the situation, this could mean that

effect of orthokeratology was pretty much found by accident

we need to combine treatments if/where possible to get the

using standard orthokeratology lenses. We can most probably

most out of it in terms of efficiency. The session at GSLS showed

‘upgrade’ the effectiveness of the modality by first looking at

that not only do we need to customize the treatment for each

the optical zone treatment diameter on the cornea and the

child, we also need to customize the intervention method –

power profiles achieved. Langis Michaud and Kate Gifford

optical or not – to the max.

explored ways of doing this. First, optical zone diameters should

GlobalCONTACT 1-21

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19.03.21 11:46

FITTING BACKGROUND Myopia Treatment

Fig. 1: Axial length growth chart. Source: Erasmus MC, Rotterdam

not be too large to be effective; ideally, they should be limited

distances in the lens: a primary focal distance for far vision

and customized to roughly the pupil zone area. But the optical

(i.e., the myopia correction) and a secondary plus power to

treatment zone shouldn’t be too small either: there is a small

slow eye growth (either a concentric design, aspheric design

sweet spot between being too small and too large.

or Fresnel design). These designs aim to introduce positive/ myopic defocus to the retinal image. Optically, most lens

Furthermore, in essence orthokeratology converts peripheral

designs tend to introduce increased levels of positive

hyperopia into relative peripheral myopia for low to average

spherical aberration. This is pretty complex, however, and

myopic eyes. The degree of relative peripheral myopia increases

the amount of defocus induced will depend on a range of

with the magnitude of central myopia that is corrected, Langis

factors, including lens design, interactions with the eye’s

Michaud explained. Kate Gifford warned against not correcting

natural optics, pupil size and accommodation and, lastly,

low myopes with orthokeratology though, as there is not enough

lens (de-)centration.

F

evidence to say that it would be less effective in low myopia.

Natural accommodation of the human eye alters the eye’s What seemed relatively new to many delegates was the optics

normal optics and introduces negative spherical aberration.

side of things and how important spherical aberrations and

This would reduce the amount of peripheral myopic defocus.

other higher-order aberration measurements are and their

Accommodation through the lens influences the myopic vs.

implementation in myopia management. The good thing is

hyperopic stimulus to human eye growth. This is where

that it is all optics, which is (or should be) our core business.

‘Zernike polynomials’ come in, which describe complex

With respect to slowing myopia progression, the most important

aberrations of the eye. According to Scott Read, optimising

advantage of orthokeratology over either spectacles or soft

soft contact lens designs for increased myopia control efficacy

contact lenses is that orthokeratology can induce very large

may be possible if these lenses are customized to the

optical effects in moderate to high myopes. But there is a need

individual child. Langis Michaud took it ‘one step up’ from

to customise orthokeratology fitting, according to Langis

here by looking at choroidal thickness in the human retina

Michaud, to optimise the outcome. The optical profile and the

in response to different optical profiles provided by soft

treatment zone diameter can be altered, and back-toric lens

lenses for myopia management. He coined the term ‘dose

design can be used to optimize the result.

response’ in this regard: by varying the amount of peripheral

A POSITIVE NOTE ON NEGATIVE LEVELS OF SPHERICAL ABERRATION

18

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‘plus,’ the myopia reduction effect can be optimized. The newest BLINK study results show that with higher add power, typically a more significant rate of myopia progression

According to Scott Read’s presentation, soft contact lenses

reduction can be achieved. Studies at the Université de

to slow myopia progression make use of two or more focal

Montréal also show the same results as well as that the GlobalCONTACT 1-21

19.03.21 11:46

!AZ.ind

Myopia Treatment FITTING BACKGROUND

treatment zone diameter can significantly inf luence the choroidal thickness (larger treatment zones result in reduced choroidal volume – which means longer eyes). They even found quadrant-specific differences in this regard, with a high inter-subject variability (threshold). This screams for customized designs to be developed.

CUSTOMISING TREATMENT If this session made one thing clear, it is that we not only need to customise the treatment for myopia (chosing the right option in the right situation) but also that we will need to further customise the treatment (e.g. increase efficiency by looking at concentrations of atropine and/or optimize optical profiles).

In other words: it starts with the children and their individual needs and circumstances. Within that frame, and within a narrow window of time, we need to carefully chose the myopia management method for the individual. And within each category, it seems like we’ll have to customize the treatment itself as well – in atropine concentration and in terms of aberrations corrected and applied. Especially within the optical intervention methods, there is a lot to gain in that regard within our industry.

References: [1] Brennan NA, Toubouti YM, Cheng X, Bullimore MA. Efficacy in myopia control. Prog Retin Eye Res. 2020 Nov 27:100923.

[2] Tideman JWL, Polling JR, Vingerling JR, Jaddoe VWV, Williams C, Guggenheim JA, Klaver CCW. Axial length growth and the risk of developing myopia in European children. Acta Ophthalmol.

2018 May;96(3):301-309.

[3] Wang J, Li Y, Musch DC, Wei N, Qi X, Ding G, Li X, Li J, Song L, Zhang Y, Ning Y, Zeng X, Hua N, Li S, Qian X. Progression of Myopia in School-Aged Children After COVID-19 Home Confinement. JAMA Ophthalmol. 2021 Jan 14: e206239.

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.

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18.02.21 11:46 12:47 19.03.21

INTERVIEW

First reference curve for refraction in Central Europe created Myopia progression is much higher in China and Korea than in Germany Reference percentile curves are commonly used in pediatric practice in order to estimate body height and weight development. They are used as a screening tool to assess the development and well-being of children and percentiles are also useful to monitor the development of ametropia in children.

Recently, Carolin Truckenbrod and a team of researchers created the first reference curve for refraction in Central Europe and they investigated the extent to which differences exist in refractive development in children in Germany and Central Asia. The researchers published their findings in March 2020. GlobalCONTACT has summarized the key findings and has spoken with researcher Carolin Truckenbrod about the study background. B y Hanna Diewald & Rebekka Nurkanovic 20

20_Truckenbrod.indd 20

GlobalCONTACT 1-21

19.03.21 08:03

INTERVIEW

"IN THE LOWER PERCENTILES WE CAN GENERALLY SEE AN ­INCREASE IN MYOPIA, BUT THIS IS MUCH MORE PRONOUNCED IN THE ASIAN COUNTRIES."

GlobalCONTACT: Your analysis is part of the Life Child-study. What

GlobalCONTACT: What were the challenges in data collection and

was the background to the study?

how did you solve them?

Truckenbrod: LIFE Child is a cohort sequential design study

Truckenbrod: With small children it is always a challenge to

that was established in 2011 as part of the Leipzig Research

encourage them to participate. It is important to find an

Centre for Civilization Diseases (LIFE). The measurements are

approach to the children and to make sure that they are not

carried out by the LIFE Child ambulance. The study by Prof.

afraid of the technical devices and then sit still for a short time.

Dr. Wieland Kiess and Prof. Dr. Antje Körner has set the goal

However, I was only partly involved in the data collection

of examining healthy child development from pregnancy to

provided by LIFE Child.

early adulthood. The questions to answer are which factors influence child development positively or negatively.

GlobalCONTACT: Were there any limitations to the

In this context, a large amount of data is

comparability of the data?

Truckenbrod: Unfortunately, the refraction

collected, which can be analyzed by scientists worldwide via a project

data were collected without cycloplegia.

agreement.

Since this is not a pure eye study, but the development of the child in general is the focus at LIFE Child, cycloplegia

GlobalCONTACT: How can interested parties benefit from these data sets?

would influence the subsequent tests

Truckenbrod: Anyone interested in

too much. In order to achieve better

evaluating data from the LIFE Child

comparability with other studies, we

Study can contact the study clinic team

tried to approximate data collected with

via the following website: home.uni-

cycloplegia with the help of a formula.

leipzig.de/lifechild/project-request/ GlobalCONTACT: What is your involvement in the study?

C aro

l i n Tr u c k e n b r o d

GlobalCONTACT: What is the main conclusion from your findings?

Truckenbrod: As a doctoral candidate at the University of

Truckenbrod: At the age of five, the refraction percentiles between

Leipzig, I may analyze data from the Life Child cohort via a

Asian countries and our data are still very similar. Thereafter,

project agreement. I also participated in the collection of the

the refraction developed significantly differently, with the upper

data for a while.

percentiles developing in parallel with the hyperopic children.

In the lower percentiles we can generally see an increase in

GlobalCONTACT: Why are centile charts for refractive development

myopia, but this is much more pronounced in the Asian countries.

important? What is the benefit for pediatricians?

Truckenbrod: Pediatricians already use percentile curves for

GlobalCONTACT: What questions should be explored next?

weight and height to assess the child's development. They allow

Truckenbrod: Our next project is the observation of axial

a simple risk factor analysis for the occurrence of certain

length growth in children.

developmental abnormalities. More and more pediatricians are also performing automated refraction measurements on

GlobalCONTACT: Thank you for the interview.

children. The percentile curves of the refraction allow pediatricians to assess the measurement results more quickly.

GlobalCONTACT 1-21

20_Truckenbrod.indd 21

The study is presented on the following page. >> 21

19.03.21 08:03

INTERVIEW

STUDY DESIGN

general myopic trend was seen in the 3rd centile, which was

The researchers measured non-cycloplegic refraction in

-2.46D for boys and -2.98D for girls. For both genders, the

1999 children, of which 1046 were male and 953 female,

median became less than zero at the age of 10 years but did

aged 3 to 18 years. The autorefraction without cycloplegia

not become myopic (less than -0.5D) up to the age of 18.

was carried out with the wavefront aberrometer Zeiss i.

The analysis presents the first reference curve for refraction in

Profiler plus, which is based on a Hartmann-Shack sensor.

Central Europe. In comparison to data from China and Korea,

The refractive error was analyzed at a 3 mm pupil and a

there is only little difference at the age of 5 years in all centiles

vertex distance of 12 mm.

which then increases continuously.

Three measurements of each eye were carried out for each

For all ethnicities, a trend towards myopia with increasing age

patient. After autorefraction the uncorrected visual acuity

could be observed, but myopia progression is much higher in

(UCVA) and the best corrected visual acuity (BCVA) were

China and Korea than in Germany. The most marked differences

obtained using the Zeiss i.Polatest1 with the spherocylindrical

can be seen in the lower centiles. 

combination measured with the Zeiss i.Profiler plus. For children from 3 to 6 years and older children who were not

The complete study was first published on: journals.plos.org/plosone/

able to read, Colt Symbols were used, for the older children

article?id=10.1371/journal.pone.0230291

letters.

According to the WHO guidelines for attained growth curves,

References:

the refraction is presented as a continuous function of age. This

•

Chen Y, Zhang J, Morgan IG, He M (2016) Identifying Children

results in smoother curves than using age intervals and provides

at Risk of High Myopia Using Population Centile Curves of

better comparableness. The GAMLSS model allows for creating

Refraction. PloS one 11 (12): e0167642. https://doi.org/10.1371/

such reference curves from continuous variables. For statistical analysis, the software R[1], by the R foundation, with the

journal.pone.0167642 •

additional package “gamlss” was used.

Sankaridurg P, He X, Naduvilath T, Lv M, Ho A et al. (2017) Comparison of noncycloplegic and cycloplegic autorefraction in categorizing refractive error data in children. Acta ophthalmologica

RESULTS AND CONCLUSION

95 (7): e633– e640. https://doi.org/10.1111/aos.13569

The results showed that there were only little differences for

•

Truckenbrod C, Meigen C, Brandt M, Vogel M, Wahl S, Jurkutat

all centiles between the genders at 3 years and a general trend

A, et al. (2020) Reference curves for refraction in a German cohort

towards more myopia with increasing age. For the 97th centile

of healthy children and adolescents. PLoS ONE 15 (3): e0230291.

and the 3 centile, girls showed higher myopia/ less hyperopia

https://doi.org/10.1371/journal.pone.0230291

rd

than boys.

Between the age of 3 and 18, the median refraction became -0.68D and -0.74D more myopic for boys and girls, respectively.

Footnote:

At the same time, the 97 centile for boys changed +0.29D

[1] For further information please visit: www.r-project.org/about.html

th

towards hyperopia and in girls -0.52D towards myopia. A

3rd, 50th, 97th centile reference curves of refraction over age for boys. The dashed lines represent the data of the LIFE Child study, the dotted lines the data of the LIFE Child study transferred by the calculation of Sakaridurg et al. into comparable data for cycloplegia and the continous lines show the results of the RESC study from a city in China. Source: PLOS ONE

22

20_Truckenbrod.indd 22

3rd, 50th, 97th centile reference curves of refraction over age for girls. The dashed lines represent the data of the LIFE Child study, the dotted lines the data of the LIFE Child study transferred by the calculation of Sakaridurg et al. into comparable data for cycloplegia and the continous lines show the results of the RESC study from a city in China. Source: PLOS ONE

GlobalCONTACT 1-21

19.03.21 08:03

FITTING BACKGROUND

Imaging techniques Photo presentation: HFAK students present their findings in GlobalCONTACT

Photograph Lukas Metzger und Danyon Keutgen, HFAK (Higher College for Optometry, Cologne, Germany)

What can you see here?

Corneal injuries caused by foreign bodies under a contact lens

Imaging technique:

1

Image 1: Slitlamp: Diffuse lighting, 10 x magnification, blue light filter and yellow filter (Haag-Streit BQ 900, Koeniz, Schweiz) Image 2: Slitlamp: Optical section, 16 x magnification (Haag-Streit BQ 900, Koeniz, Schweiz)

Finding: After insertion of an RGP contact lens, redness of the conjunctiva followed very quickly; as well as pain reactions of the test person (21 years, male). The subject described a scratchy feeling of the contact lens when blinking. A fitting with RGPs was no longer possible on this day, which is why the contact lens was immediately removed.

The cornea of the subject was treated with fluorescein to visualize specks or other lesions (figure 1). Visible are a large amount of specks temporally, which resemble a starry sky.

The indentations of the cornea are possible scratch marks of the foreign body that may have been on the posterior surface of the RGP lens.

The depth of the lesions was assessed using a section at 16 x magnification. The injured area was examined without blue light and without yellow filter. Due to the fluorescein, the lesions are now filled in color and the depths can be seen (figure 2). The injured area was fortunately only in the epithelium.

2

Further procedure: The subject was given eye drops to help regenerate the cornea. One day later at follow-up, no more specks were visible and the epithelium had fully recovered.

GlobalCONTACT 1-21

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19.03.21 08:06

TECHNOLOGY Ultrasonic Cleaning

Using ultrasonic cleaning for RGP contact lenses Function and benefits With the popularization of orthokeratology and the revival of scleral lenses, RGP lenses represent an important sector for manufacturers of special contact lenses. Their manufacture requires the use of a very sophisticated machine park: nanometric precision lathes, oscillating tools to produce asymmetric geometries, robotization of pallet loading, electronic transfers of information to machines, calibration devices, and plasma surface treatment. By Bruno Fantony and Alejandro Cubel Yuste

It is surprising to find at the end of the production line a process

Diagnostic ultrasounds have a frequency between 1 and

that has not evolved: lens cleaning. In most cases, this is done

10 MHz. They make it possible to determine the characteristics

by hand using microfiber cloths, cleaning fluids and physiological

of the environment they pass through. These properties are

saline or distilled rinsing water. Small ultrasonic cleaning tanks

used for example in medical imaging.

are often used for different operations during manufacturing.

For information, the human voice is between 125 and 4000 Hz,

This cleaning process is often poorly understood. Its optimal

the most audible frequencies being between 250 and 3000 Hz

application allows a substantial gain in quality and profitability.

(1 Hertz being one cycle per second).

ULTRASOUND

PRINCIPLE OF ULTRASOUND PROPAGATION

Ultrasounds are vibratory waves with a frequency between

Ultrasonic waves travel in a liquid medium in a sinusoidal

16,000 Hertz (or 16 kHz) and 10 MHz. They have the properties

fashion, creating waves of compression/depression. An ultrasonic

of elastic waves. Their propagation is almost optical, with little

cleaning device consists of an electronic power generator and

diffraction. They are not audible to the human ear.

piezoelectric transducers. The transducers convert electrical energy into mechanical energy by their vibrations which are

24

24_Fantony.indd 24

Ultrasounds are divided into 2 categories:

transmitted to the bottom of the tank. The number of transducers

Power ultrasounds have a frequency between 16 kHz and

is variable depending on the size of the tank.

1 MHz. They can cause physical and chemical changes and are

These vibrations produce ultrasonic waves. When these

mainly used for cleaning.

meet an object, the disturbances in the wave train will create GlobalCONTACT 1-21

21.03.21 22:51

Ultrasonic Cleaning TECHNOLOGY

a phenomenon called cavitation. A large amount of air

FREQUENCY

bubbles is generated. These bubbles grow during the

Frequency plays an important role: at low frequency (20-

depression phase and then are compressed during the reverse

30 kHz) larger bubbles (~ 12 microns) are produced with high

phase. Their size, which ranges from 1 to 15 microns, depends

power when they implode. This frequency range is suitable

on the frequency. During these movements of depression

for removing heavy soiling. Areas of application: mechanical

and compression the temperature in the bubbles increases

components, injection molds and engine parts, among others.

until they implode, producing a micro-brushing at the

At higher frequencies (40 - 60 kHz) the diameter of the bubbles

molecular level which removes all the residues on the surface

is smaller (~ 8 to 4 microns) with a lower force. This frequency

of the part to be cleaned.

range is suitable for delicate cleaning. Areas of application:

During this implosion, it was calculated that the temperature

medical, surgical, optical, and electronic components.

in the center of the bubble could reach 4700 ºC and the pressure 1000 bar. The gas jet can reach a speed of 400 km/h.

THE POWER Power is related to the range of motion produced by the

This explains the gradual increase in temperature in an

transducers. The adhesion of the transducer to the bottom of

ultrasonic bath.

the tank is a key element in the durability of the device. The

The whole point of ultrasonic cleaning lies in this concentration

technique of hot bonding of the transducers allows for greater

of energy, because by using globally low powers, we achieve

regularity of cleaning and better longevity than the cold bonding

incredibly significant local energy releases!

used for low-end devices.

GlobalCONTACT 1-21

24_Fantony.indd 25

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21.03.21 22:51

TECHNOLOGY Ultrasonic Cleaning

DETERGENT Pure water is unsuitable for ultrasonic cleaning. It is recommended

compensated for by an increase in either mechanical action, temperature, or time. Or by a combination of these three elements.

to add detergent to it. This will reduce the difference in surface tension between the water and the object to be cleaned, allowing a better effect of cavitation by bringing the bubbles closer to the surface. The composition of the detergent depends on the impurities to be cleaned and the object.

TEMPERATURE 40 ºC to 80 ºC are optimal temperatures: the viscosity and density of the liquid decrease and the pressure in the bubbles increases, which increases the effect of cavitation. Depending on the object to be cleaned, temperature control of the liquid is necessary due to the heating caused by cavitation.

RINSING

that of ophthalmic lenses. In this field, ultrasonic cleaning is systematically used for washing lenses before a surface treatment: hard coating or anti-reflective coating. This allows optimum

are different methods such as stirring the water, bubbling

cleanliness without the risk of scratching the surface. The process

systems, etc. which allow better elimination of the product.

is automated to ensure consistent quality throughout the day.

Usually, demineralized water is used.

For RGP lenses, ultrasonic cleaning can be used for the

Dr Herbert Sinner (1900-1988) developed in 1959 a theory on cleaning based on the action of four elements: temperature, chemicals, mechanical action, and cleaning time. According to Sinner, for a good result, a decrease in one of the elements must be offset by one or more of the others. Thus, a decrease in chemicals must be

24_Fantony.indd 26

A field close to that of the manufacture of RGP contact lenses is

Rinsing is necessary to remove all traces of detergent. There

SINNER'S CIRCLE

26

SPECIAL FEATURES OF CLEANING RGP LENSES

following steps:

• After polishing the back surface, before inspection.

• For deblocking, especially for lenses attached to a plastic arbor with soluble wax.

• After deblocking before final control.

• After the final inspection, before packaging.

• Before plasma treatment.

GlobalCONTACT 1-21

21.03.21 22:51

Ultrasonic Cleaning TECHNOLOGY

FREQUENCY The ultrasonic frequency must be between 40 and 60 kHz.

TOOLS Exposing an RGP lens to ultrasound for too long without performing the right process and using non recommended tools can create marks on the surface. Stainless steel tools in the form of individual baskets allow processing of several contact lenses of different diameters at the same time.

TEMPERATURE The working temperature should not exceed 50 °C. Above 50 °C there are risks of deformation of certain RGP materials. The ultrasonic tank should incorporate a controlled and monitored heating system prepared to avoid overheating.

DETERGENT Using a certified ultrasonic detergent speeds up cleaning. In this

is constant throughout the working day, without manual

case rinsing with DI water is necessary. Ideally the rinsing should

intervention apart from placing and unloading the lenses.

be done in two separate tanks to have a minimum of contaminant in the last tank. The mineral content of this water must be less than

CONCLUSIONS

50 mg/l. Specific detergents for plastic medical devices should be

Manual cleaning of RGP lenses during manufacture does

preferred. The detergent concentration is significantly lower than

not guarantee optimum cleanliness. The judicious use of

that used for manual cleaning. It is generally one to two percent.

ultrasonic cleaning devices leads to a gain in quality. As with

SINNER CIRCLE

ophthalmic lenses, repeatability of cleaning operations can be achieved by automating the process. Staff are relieved of

In the case of RGP lenses, the mechanical action is fixed by

repetitive and monotonous work, thus devoting themselves

ultrasound frequency. The temperature can be increased to a

to more rewarding tasks. n

certain limit. A decrease or even a removal of the detergent must be compensated by an increase in time.

QUALITY OF CLEANING An object must be clean before any disinfection or before any treatment. The effect of the conditioning solution on the lens will be optimal if no trace of pollutant remains. Most of the wettability problems will thus be avoided. Likewise, treatment with oxygen

Bruno Fantony is an optometrist. He was Director of the Techno-Lens contact lens and ophthalmic lens manufacturing laboratory in Switzerland from 1987 to 2012. Currently he works as an independent consultant for various laboratories at Fantony LC.

plasma will be more homogeneous over the entire contact lens surface.

AUTOMATING As with ophthalmic lenses, it is possible to automate the entire cleaning procedure by using a multistage system. The dimensions of the device should be reduced to fit easily into the laboratory.

It consists of several cleaning and rinsing tanks as well as a filtered air-drying tank. A robot transports the tools containing the lenses to the different vats.

A digital control allows the robot's movements, temperatures, and treatment times to be programmed. In this way, cleanliness GlobalCONTACT 1-21

24_Fantony.indd 27

Alejandro Cubel Yuste is an expert in ultrasonic cleaning solutions in both commercial and technical fields. He worked as Technical-Commercial Director of a cleaning equipment and technologies company from 2002 to 2009. He has been the co-founder and Chief Executive Officer of BRIO Ultrasonics since 2009 and is also the co-developer of the patented BRIO high-performance ultrasonic cleaning technology.

27

21.03.21 22:51

MANUFACTURING

Edge polishing or edge rolling Contouring lens edges We introduced our new edging machine at the annual CLMA Zoom meeting in January of 2021. It is called an edge roller, meaning that it contours the lens edge profile. This is different from our edge polishing machine that is intended to polish lathe profiled edges. B y Erik Larsen We developed the edger roller in response to labs needing

a challenge, especially if the edge follows an undulating

to work with lenses that do not have the edges lathe

surface or has a notch to avoid a scleral elevation. Many

profiled and require aggressive action to remove the sharp

specialty corneal and scleral lenses require some attention

edge. While it is commonplace to lathe profile rotationally

to the detail of the edge prof ile that a lathe cannot

A symmetric edges, non-rotationally symmetric edges pose

E

accommodate.

F

2

1

M DESIRED PROFILE

B

1. UNCUT

B

2. FACED OFF

3. RADIUSED

LENS EDGE CROSS SECTIONS UNLESS OTHERWISE SPECIFIED:

A

MATERIAL FINISH REQUIRED

2

28

28_ErikLarsen.indd 28

LARSEN EQUIPMENT DESIGN INC

DIMENSIONS ARE IN INCHES TOLERANCES: FRACTIONAL: 1/32 ANGULAR: 1º FIRST PLACE DECIMAL: 0.030 TWO PLACE DECIMAL: 0.010 THREE PLACE DECIMAL: 0.005 FOURTH PLACE DECIMAL: 0.001

1117 NW 52 ST SEATTLE,WA 98107

DRAWN BY

SV

REVISED

SCALE: 10:1

A

APPROVED BY DATE REVISION #

1

GlobalCONTACT 1-21

22.03.21 10:08

!AZ.ind

MANUFACTURING

In the past, most of the edge material that needed to be removed

In researching this article, I talked to colleagues to see if they

was ground away with a diamond coated beveling radius and/

rolled the edge in the un-cut form. The answer was: some do,

or inverted cone tool to approximate the desired edge profile.

some don’t. They either lathe profile (preferred method) or

Then the lens would be mounted on the edge roller or would

grind the edge by hand to the approximate profile before rolling

be finished by hand. The task required a skilled operator. Since

the edge. Rolling the edge for an un-cut edge takes several

the edger profile affects comfort, it is important to have

minutes and adjustments to the edging machine are required

consistent edge profiles. The manual procedure caused variation

to achieve the desired profile.

from one lens to another and from one operator to another. A consistent profile is especially important for replacement lenses to maintain comfort.

WHAT IS THE EFFECT OF POLISH GRIT SIZE ON CYCLE TIME?

The figure shows the edge of a typical lens on the left (1). The

Most polishes utilize an average grit size of .5 to 1.5 microns.

“un-cut” diametered shape is shown. It is clear from the diagram

According to my colleagues, a coarser grit size removes more

that there is a lot of material to be removed in order to achieve the

material, yielding a shorter cycle time. In the case of edge

radiused edge profile.

rolling a scleral lens, an even coarser grit size, say 5 microns,

In the middle (2) it shows the edge with the bottom of the lens

may be useful since the goal is to grind away the material. There

faced off tangent to a radius. Facing off the lens removes about

may be some concern about a 5-micron grit polish leaving

80% of the lens material on its way to a radiused edge as shown

marks, but it is worth testing that out.

on the right (3).

Our new edge roller provides a more aggressive process to

Even if you do not have full edge profiling capability on your

contour the edge of a lens. When the irregular edge presents

lathe(s), facing the lens off will remove most of the material.

a challenge to achieve the desired edge profile, the edge roller

Using the lathe is a precision method to remove this material.

will help with that process. n

This method will work well for rotationally symmetric lenses.

Non-rotationally symmetric lenses will require more work.

EDGE ROLLING SCLERAL LENSES The amount of the material to be removed on a scleral lens can be as much as ten times that of a corneal lens. This is due to

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.

the increased edge thickness of about three times that of a corneal lens and twice the diameter. So, facing a scleral lens will remove much more material as compared to a corneal lens.

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!AZ.indd 8 28_ErikLarsen.indd 29

04.03.21 10:08 17:25 22.03.21

RESEARCH

Study links protein causing ­Alzheimer’s disease with common sight loss Newly published research has revealed a close link between proteins associated with Alzheimer’s disease and age-related sight loss. The findings could open the way to new treatments for patients with deteriorating vision and through this study, the scientists believe they could reduce the need for using animals in future research into blinding conditions.

30

30_Alzheimer.indd 30

Amyloid beta (Aβ) proteins are the primary driver of Alzheimer’s

The research team exposed RPE cells of normal mouse eyes

disease but also begin to collect in the retina as people get older.

and in culture to Aβ. The mouse model enabled the team to

Donor eyes from patients who suffered from age-related macular

look at the effect the protein has in living eye tissue, using

degeneration (AMD), the most common cause of blindness

non-i nva sive i ma g i ng tech n ique s t hat a re u sed i n

amongst adults in the UK, have been shown to contain high

ophthalmology clinics. Their findings showed that the mouse

levels of Aβ in their retinas.

eyes developed retinal pathology that was strikingly similar

This new study, published in the journal Cells, builds on previous

to AMD in humans.

research which shows that Aβ collects around a cell layer called

Dr Arjuna Ratnayaka, a lecturer in vision sciences at the

the retinal pigment epithelium (RPE), to establish what damage

University of Southampton, who led the study said, “This was

these toxic proteins cause RPE cells.

an important study which also showed that mouse numbers GlobalCONTACT 1-21

19.03.21 08:10

!AZ.ind

RESEARCH

used for experiments of this kind can be significantly reduced in the future. We were able to develop a robust model to study AMD-like retinal pathology driven by Aβ without using transgenic animals, which are often used by researchers in the field. Transgenic or genetically engineered mice can take up to a year and typically longer, before Aβ causes pathology in the retina, which we can achieve within two weeks. This reduces

THEIR FINDINGS SHOWED THAT THE MOUSE EYES DEVELOPED RETINAL PATHOLOGY THAT WAS STRIKINGLY SIMILAR TO AMD IN HUMANS.

the need to develop more transgenic models and improves animal welfare.”

The investigators also used the cell models, which further reduced the use of mice in these experiments, to show that the toxic Aβ proteins entered RPE cells and rapidly collected in lysosomes, the waste disposal system for the cells. Whilst the

The researchers hope that one of the next steps could be for

cells performed their usual function of increasing enzymes

anti-amyloid beta drugs, previously trialled in Alzheimer’s

within lysosomes to breakdown this unwanted cargo, the study

patients, to be re-purposed and trialled as a possible treatment

found that around 85% of Aβ still remained within lysosomes,

for age-related macular degeneration. As the regulators in the

meaning that over time the toxic molecules would continue to

USA and the European Union have already given approval for

accumulate inside RPE cells.

many of these drugs, this is an area that could be explored

Furthermore, the researchers discovered that once lysosomes

relatively quickly.

had been invaded by Aβ, around 20% fewer lysosomes were

The study may also help wider efforts to largely by-pass the use

available to breakdown photoreceptor outer segments, a role

of animal experimentation where possible, so some aspects of

they routinely perform as part of the daily visual cycle.

testing new clinical treatments can transition directly from

Dr Ratnayaka added, “This is a further indication of how cells

cell models to patients.

in the eye can deteriorate over time because of these toxic

This research was funded by the National Centre for the

molecules collecting inside RPE cells. This could be a new

Replacement Refinement & Reduction of animals in research

pathway that no-one has explored before. Our discoveries have

(NC3Rs). n

also strengthened the link between diseases of the eye and the brain. The eye is part of the brain and we have shown how Aβ,

Acknoledgement: The study “Oligomeric Aβ1-42 Induces an AMD-Like

which is known to drive major neurological conditions such

Phenotype and Accumulates in Lysosomes to Impair RPE Function”

as Alzheimer’s disease, can also cause significant damage to

has been published in Cells with DOI https://doi.org/10.3390/

cells in the retina.”

cells10020413.

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26.02.21 08:10 15:37 19.03.21

COLUMN

OutLOOK It’s probably best to leave 2020 behind, especially ‘in hindsight’… . Let’s take a look forward into this vision industry of contact lenses – starting by going back to look at the 2020 survey data from Eurolens Research and the great work of Phil Morgan and colleagues at the University of Manchester (UK). By Eef van der Worp Despite the pandemic, they still managed to analyse the annual

to the US (84% of lens fits are with SH there). But generally, since

survey results, which have run over two decades now.

the introduction of SH for daily wear (DW) in 2004, a steady

Information was gathered from 25 countries with a total of

increase is seen (see graph) in almost all countries. Another

13.311 contact lens fits in 2020. It is important to note that this

interesting trend is with regard to daily disposables (DDs); the

survey provides information about contact lens fits (new and

ratio of DDs versus reusables is now almost 50-50: 46%-54% to

refits), this is not market data on what is worn and sold. But it

be exact and increasing in favour of DDs. It will not be long it

is presumed that information about current lens fits can hint

seems before DDs outperform reusable lenses in that regard.

at market shares of the future.

Here though, remarkable differences can be seen between markets

SILICONE HYDROGEL LENSES DOMINATE

– even within relatively small geographical regions such as Europe, significant differences are reported, with Russia (8%), Bulgaria,

One of the trends is that silicone hydrogel (SH) lenses dominate

Greece (13%), and Spain (22%) all seriously below the benchmark,

the market of soft lenses now; worldwide, 72% of all soft lens fits

while 68% of soft lens fits in Denmark are with DDs.

are with SH. This is pretty similar and within a relatively narrow

About half of the presbyopic lens wearers are fitted with a multifocal

band for most European countries but is lagging a tad compared

lens, according to the survey results, while 10% in that age group get monovision (the rest only get a distance correction, with presumably reading glasses for near). The highest newcomer in the list is the scleral lens: 3% of all registered lens fits are with sclerals, which now has finally earned its own category in the annual survey.

It is not so much the absolute value in percentage that is of interest (the contact lens specialist returning the survey form may not per se always be the average eye care practitioner), but here again it may be the trend that is of interest. Of all rigid lens fits, 6% are indicated to have a myopia control purpose, while this is true for 2% of all soft lens fits – but with large differences again between countries, and with a huge potential maybe going forward.

WHAT WILL 2021 BRING US? Silicone hydrogel prescribing since 2000 for 17 markets in 2020. Data points are three-year moving averages.

32

32_EefColumn.indd 32

I won’t dare to make any predictions after the turmoil of last year. But in terms of contact lenses, is seems that the GlobalCONTACT 1-21

19.03.21 12:35

!AZ.ind

COLUMN

trends started (DDs and SH) are likely to continue. Sclerals

All in all, it doesn’t seem like a very daring proposition to say

always will stay a niche market, but while (based on pure

that the outlook for this part of the vision industry does not

speculation) in the US there may come a point when some

look bad at all in general, with great challenges but certainly

saturation is reached in the market (although many have

opportunities ahead of us. Hope to SEE you all in 2021

been expecting a plateau for years), in Europe there may

somewhere. LOOK forward to it. 

be room for improvement and an increase in lens fits as the modality has not nearly reached its full potential in

Reference

the region compared to the US. Myopia management with

Morgen et al – International Contact Lens Prescribing in 2020 – Contact

contact lenses has just scratched t he sur face, w it h

Lens Spectrum Jan. 2021. https://www.clspectrum.com/issues/2021/

orthokeratology having the best track record in the optical

january-2021/international-contact-lens-prescribing-in-2020

intervention category to date. On average, in all markets with substantial rigid lens fitting proportions, 22% of all rigid lens fits are orthokeratology – but with huge differences again (Spain reports 46% of all rigid lens fits being for orthokeratology). It is pretty likely that a new trend will start to emerge in the coming year, and years, regarding ‘soft lenses for myopia management’. A very positive outlook to both correct and to preserve vision. For more on this topic, and the potential, see the myopia article and Global Specialty Lens Symposium coverage in this edition of GlobalCONTACT on page 16ff. The full report on the Eurolens Research Survey was published in the January 2021 edition of Contact Lens Spectrum.

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.

Advertisement

!AZ.indd 5 32_EefColumn.indd 33

20.03.20 12:35 17:54 19.03.21

HISTORY

This small bottle labeled "HaftschalenPflegemittel" is a relic from the early years of contact optics. Its contents, a 10% peroxide solution, were indeed good for inactivating bacteria, fungi and viruses.

The label says: Contact-"shell"- care product Clean and disinfect the lens with the cleaning agent before insertion. Put a drop in the shell, gently clean between thumb and forefinger. Rinse well in clear, preferably running water. Do not apply solution directly into the eye, it burns!

Contact lens care Series on the Roth Collection The triumphant advance of soft contact lenses began 50 years ago, and in the meantime they have proven their worth as an alternative visual aid for millions of people, replacing glasses. After first attempts towards the end of the 19th century with the so-called "contact glasses" to compensate for corneal staphyloma, today known as keratoconus, there is now no refractive anomaly that cannot be treated with a contact lens. In addition, numerous corneal diseases or consequences of accidents can be treated with soft lenses as a bandage or as transparent dressing. By Dr. Hans-Walter Roth 34

34_Roth.indd 34

GlobalCONTACT 1-21

19.03.21 08:16

HISTORY

It was recognized quite early on that the tolerability of a

carefully neutralized before inserting the lens. This was

contact lens depends essentially on careful cleaning and

done either with a second solution containing catalase or

disinfection. Incorrect lens care led to inflammation of the

elegantly with a platinum strip as a catalyst. Those who

anterior segments of the eye. Most feared was the corneal

mixed up peroxide and catalase in the hectic morning

ulcer, which in extreme cases could lead to the loss of the eye.

insertion, or even forgot the latter, usually ended up in the

Especially in the time before the discovery of antibiotics, the

ophthalmology emergency room.

course of the disease was usually fatal.

Therefore, not only a compatible contact lens material had to be searched for, but also a suitable care system had to be found. It became apparent that the disinfectants used in surgery at the time could sufficiently disinfect the lenses, which were initially still made of glass. However, with the introduction of PMMA as lens material, this was no longer advisable. Above all, the hydrocarbon compounds led to opacification of the material, and preparations containing iodine discolored the lens.

SOME OF THE LENSES, WHICH WERE STILL EXPENSIVE AT THE TIME, DISAPPEARED FOREVER DOWN THE DRAIN.

Thus, in the end, only hydrogen peroxide remained for lens care. It was dispensed by the pharmacist in dark vials to prevent

An American contact lens manufacturer therefore relied on

the peroxide from decomposing due to light. A pipette with a

heat sterilization. Small stoves and heat-resistant lens containers

rubber teat, as is still used today, made it possible to remove

were offered for this purpose. The advantage was that the risk

the peroxide from the bottle. One to two drops each were to

of an allergic reaction from care products was avoided. The

be applied to the inner surface of the lens and rubbed in with

problem, however, was that before the lens could be inserted,

the finger. Adhering substances from the environment or the

it had to cool down and, above all, that dangerous microbes

tear fluid could be removed satisfactorily in this way. The only

could be transferred by removing it with dirty fingers. When

difficulties were with lipids, which often stuck stubbornly to

asked how to manage the heat, for example when camping

the surface and could only be removed with soapy water. Some

without a power outlet, one was told to heat the lens in the

household dishwashing detergents were misused for lens

camping stove. If the added breakfast egg was hard, the soft

cleaning. After this procedure, it was absolutely necessary to

lense would be sterile.

wash the lens and container with plenty of clean water, and some of the lenses, which were still expensive at the time,

This small bottle labeled "Haftschalen-Pf legemittel" is a

disappeared forever down the drain.

relic from the early years of contact optics. Its contents, a 10% peroxide solution, were indeed good for inactivating bacteria, fungi and viruses. But if the solution accidentally got into the eye, it left tearful hours until the corneal epithelium, which had been burned, finally healed. n

THUS, IN THE END, ONLY HYDROGEN PEROXIDE REMAINED FOR LENS CARE. If residues of the peroxide remained on the finger or the

Dr. Hans-Walter Roth Institut für Wissenschaftliche Kontaktoptik Ulm E-mail: institut.roth.ulm@t-online.de

lens, the removal of the contact lens was already painfully pre-prog ra m med . T he solut ion, i n t he com mercia l concentration of 10%, accidentally applied to the eye, burned terribly and at t he same time destroyed t he cornea l epithelium. Even after dilution, the peroxide still had to be GlobalCONTACT 1-21

34_Roth.indd 35

35

19.03.21 08:16

REPORT

A comparison of European soft contact lens and lens care markets Euromcontact market data report 2020 The new Euromcontact market report for 2020 is now available. The European federation of national associations and international companies of contact lens and lens care manufacturers has run a syndicated market data analysis since 2003. The data collection covers all soft lens and lens care market segments. To facilitate trend observation, the current report closely follows the earlier ones.

The total data collection covers 33 countries, two of which are

is called the ‘wearer base’ and is presented in the report as the

tied with another one to form two clusters (Belgium &

fraction of CL wearers within the 15 to 64 years old population.

Luxembourg and United Kingdom & Ireland). The report covers

The report calculates the number of soft contact lens wearers

only the eleven major countries, while sometimes referencing

using the 2020 unit (one CL) sales divided by an assumed

to the total 31/33 data.

annual consumption.

DATA COLLECTION AND WEARER BASES The headquarters of the participating companies submit each quarter the numbers of lenses sold and their market value (lenses and lens care products) at ex-manufacturers’ prices to an independent company. The collection covers all soft lens and lens care market segments. The participating companies believe they cover around 80 to 90% of the disposable/planned

36

36_EuromContact.indd 36

The wearer base is calculated for the following soft contact lens categories:

• daily disposable (DD) • weekly/bi-weekly and monthly replacement lenses (W/B&M) • conventional soft lenses (all other replacement frequencies than the above, CS)

GENERAL

replacement contact lens market in the covered countries.

The reported countries represent 75.9% of the total value

The number of people who wear contact lenses within a market

collected. In the difficult year of COVID-19 lockdowns, daily GlobalCONTACT 1-21

22.03.21 10:02

REPORT

Contributing companies (2020)

disposables declined 10.6% in value, while W/B&M declined a bit less, at -8.8%, and conventional soft lenses declined (-24.6%

ALCON

Avizor

on a comparable basis, i.e. only looking at markets that had

Bausch & Lomb

CooperVision

Johnson & Johnson Vision Care

mark’ennovy

data in both years) for all 33 markets.

Denmark has the highest penetration (13.6%, -7.2%), followed

Menicon (Europe)

by Sweden (12.4%, -15.53%) and Norway, which grew 4.7% to 11.7%. Next are the Netherlands at 8.6% (-1.3%) and the United Kingdom & Ireland (8.5%, -6.1%). Lowest among the eleven is

is 58.1% for DD, 41.3% for W/B&M and 0.6% for CS.

heavily COVID impacted Spain (3.5%, -14.5%), not far behind

Daily disposables are worn by more than 10% in Denmark

Germany (3.8%, -7.8%).

(10.5%), and more than 5% in Sweden (6.7%) and Norway (8.1%).

The total value of lenses across all 31/33 markets declined by

DD wearers in % of total wearers are 77.2% in Denmark and

9.6% to € 1’813 million on a comparable basis. The total for the

69.6% in Norway. W/B&M is the strongest segment in the

eleven countries reported declined by 9.1% to € 1’376 millions.

market (% of all wearers) in Spain (77.2%) and Germany (74.8%).

The strongest decline among the reported countries was in Italy

SILICONE-HYDROGEL LENSES AND LENS CARE PRODUCTS

(-19.8%), Sweden (-14.7%) and Spain (-13.7%), while the Netherlands (+1.4%) and Norway (+1.8%) even grew. The biggest market, United Kingdom & Ireland, declined only 5.1%. This is

Over the past years, daily disposables and silicone-hydrogels

even more than decline in units (-3.8%), showing that the currency

(SiHy) contact lenses were important drivers for the contact

effect was not favorable either. This robustness may be due to

lens market. SiHy are now at 86.4% value share in the W/B&M

the high amount of subscriptions in the United Kingdom &

segment (across all 33 countries).

Ireland. This means automatic home delivery with monthly

Among the eleven countries in the report, Norway (95.0%) has

direct debit payment, thus not requiring open shops. The report

the highest percentage of SiHy among the W/W- B&M, followed

considers it likely that physical after care visits were postponed.

by Spain (93.0%) and United Kingdom & Ireland (91.7%). The

The decline in daily disposables may be due to less occasional

rate is the lowest in Italy (74.8%).

wear of these contact lenses when going out or doing sports,

For the lens care products market only values are reported,

as these activities were restricted under COVID-19 lockdowns.

while milliliters were also collected. Different bottle sizes and usage quantities needed per system and case do not allow for

DAILY DISPOSABLES

a simple ‘units’ system. Nine segments were collected but the

The split in the segments by value for the total 31/33 markets

report looks at total CLC, total soft disinfecting and the largest

is: 55.0% for daily disposables, 44.6% for W/B&M and 0.4% for

segments Hydrogen peroxide (HP) based solutions/systems

conventional soft lenses. For the eleven reported countries it

and Multipurpose (MPS) solutions only.

Daily disposable

Weekly/Bi-weekly

Conventional

All types

Change from

(DD) ‘20

(W/B-W&M) ‘20

Soft (CS) ‘20

(Total) ‘20

2019 for Total

Denmark (DK)

10.52%

3.04%

0.06%

13.62%

-7.24%

Sweden (SE)

6.66%

5.74%

0.00%

12.40%

-15.53%

Norway (NO)

8.11%

3.52%

0.02%

11.65%

4.69%

Netherlands (NL)

2.34%

6.26%

0.02%

8.62%

-1.26%

United Kingdom & Ireland (UK-IE)

5.03%

3.40%

0.02%

8.45%

-6.13%

Switzerland (CH)

4.28%

3.97%

0.01%

8.26%

-3.55%

Belgium & Luxembourg (BE-LU)

2.10%

3.10%

0.02%

5.23%

-6.52%

France (FR)

1.44%

3.03%

0.02%

4.50%

-7.34%

Italy (IT)

2.40%

1.47%

0.02%

3.89%

-20.39%

Germany (DE)

0.93%

2.86%

0.03%

3.82%

-7.80%

Spain (ES)

0.76%

2.71%

0.04%

3.51%

-14.50%

Total 11

2.53%

3.01%

0.02%

5.56%

-9.06%

T 31

1.22%

1.87%

0.01%

3.10%

-7.20%

Country/ Region

Wearer Penetration by segment for population 15 - 64 years of age.

GlobalCONTACT 1-21

36_EuromContact.indd 37

37

22.03.21 10:02

REPORT

ES

6.27

FR

5.14

5.1%

IT

3.20

-5.9% -11.8%

-6.7%

NL

3.02

NO

8.76

3.3%

SE

11.27

-8.6%

6.143

-13.9%

UK-IE

Table 4: Size of the 2020 MPS segment versus the HP one by country (decline means HP gained share, positive change indicates MPS gained share)

2020 Split of Market (Value) in % of Total

0.4%

44.6%

2020 Split of Market (Value) in % of Total 55.0%

0.4% W/B-W&M

DD

CS

44.6%

Figure 1: Contact Lens Market (Value) in the 11 assessed markets Contact lens market (value) in the eleven assessed markets.

Split of market (all 33 collected, value, in %) 2020.

55.0%

Figure 2: Split of Market (all 33 collected, value, in %) 2020

The total lens care products market across all 31/33 markets

per wearer. This ignores the fact that some do wear their

declined by 6.4% and had a volume of € 204 million (on a

W/B-W&M contact lenses on an extended or even on a

comparable basis the decline is 10.6%). In the eleven markets

continuous wear basis and thus do not use lens care products.

it declined by 9.9%, total value is € 144 million. Total soft

This annual value (ship-in prices) of lens care per wearer is

disinfection (HP and MPS) makes up 78.3% (81.9% with

highest in Switzerland and lowest in the United Kingdom &

data in both years) of the total lens care products market

Ireland among the eleven reported. There can be several

(31/33).

reasons. The prices in Switzerland may be higher, the wearers

ANNUAL LENS CARE VALUE PER WEARER

in Switzerland using more bottles in a year or it may be W/B-W&M DD are CS a combination. Another option is the mix between less

W/B-W&M wearers, as well as conventional soft lenses wearers use MPS or HP solutions to disinfect and store their contact

expensive MPS and more expensive HP (in Switzerland total

Figure 3: DD-W/B&M-CS wearers in population 15 - 64 years of age 2020 vs. 2019 valuesthan of 2020total see also tablewhile 5) HP value is (for higher MPS, in milliliters MPS

Soft lens wearer base values for each country or region assessed, presented by lens category

lenses when not worn. Therefore, when taking the total is bigger). and soft in total (with comparison to 2019). Penetration expressed as % of total population of 15 to 64 years of age.

disinfecting (combined value of the MPS and HP) and dividing

Read the full market data report, including a comparison of

it by the number of the W/B&M plus the conventional soft

the total cost of the different systems for the eye care professional,

www. euromcontact.org. n

Figure 2: Split of Market (all 33atcollected, value, in %) 2020

lenses wearers, one can calculate an annual lens care value

Soft lens wearer base values for each country or region assessed, presented by 15 lens-category and of in total comparison to 2019).

Figure 3: DD-W/B&M-CS wearers in population 64 years age(with 2020 vs. 2019 Penetration expressed as % of total population of 15 to 64 years of age.

(for values of 2020 see also table 5)

38

36_EuromContact.indd 38

Soft lens wearer base values for each country or region assessed, presented by lens category GlobalCONTACT 1-21 and in total (with comparison to 2019). Penetration expressed as % of total population of 15 to 64 years of age.

22.03.21 10:02

PR-Advert

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, Vice President

PRESIDENT: KEITH PARKER

QUALITY MANAGER: RANDY MINGOY I have known Erik Larsen since 1992. Since then I have used

I have had the pleasure of working Erik since the beginning of

just about every piece of equipment his company has built. My

Larsen Equipment. The first piece of equipment, a 6 spindle

experience with Erik and the Larsen team has been one of great

horizontal arm polisher revolutionized our production of GP

appreciation as they have always helped me in my needs of

contact lenses. Through the years, I watched his business grow

fully understanding equipment used to manufacture quality

as he and his team listened to our Industry needs and developed

contact lenses. Erik has also been able to engineer any part

now numerous products not only simplifying many tasks of

needed for me even it was a custom part.

manufacturing but improving the consistency of quality in

Erik (Larsen equipment) has been and still is a pioneer in the

our finished products. Innovation has been an ongoing

contact lens and optical industry, and I am thankful to him

experience of our Company only made possible through the

for his support over the years.

innovation of necessary equipment developed and made Randy Mingoy

available by the Larsen team.

Quality Manager

Larsen Equipment is a family owned business hosting a team

Advanced Vision Technologies

of willing Staff all having the attitude of serving their

DIRECTOR OF OPERATIONS: JORDAN GOBEL

Customer’s needs. As a Customer, we are made to feel like we have a friend in the business helping us develop a more

There can be a lot of moving parts when it comes to managing

efficient process allowing our Company to deliver better

operations, so it is key to have reliable precision equipment

products for our Customers.

that assists in overall efficiency. Larsen Equipment delivers just

Our success of AVT simply could not have been possible without

that! I have been utilizing Larsen manufacturing equipment

the help, assistance and dedication of Larsen Equipment. I

for over 15+ years and have yet to run in to an issue they could

will be forever grateful for my opportunity to work with Erik

not resolve. I am a satisfied owner of bladder polishers, edge

and his very capable Staff.

roller’s and auto-blockers etc. Each one of these units greatly

Keith Parker

assist in the reduction of rejects and manufacturing waste.

President

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 GlobalCONTACT 1-21

PR_Larsen.indd 39

969 S. Kipling Parkway, Lakewood, CO 80226 Phone: 303-384-1111 888-393-5374 Fax: 303-384-1124 www.AVTLENS.com 39

19.03.21 15:05

BUSINESS + MARKETING

The cloud

Many companies plan to outsource all or parts of their IT infrastructure, and especially data, to the cloud.

A cloud solution for data and IT infrastructure is a simple and economical solution. But there are a few things to consider to ensure that there are no breakdowns during data migration. Particularly important aspects are described in this article. By Hartmut Fischer

USING THE ADVANTAGES OF THE CLOUD SOLUTION Companies are increasingly storing their IT, at least in part,

Depending on the country, you have to observe special

in a cloud. There are some arguments in favor of using this

regulations. For instance in Germany: whenever it comes to

solution. For example, it is no longer necessary to invest in

personal data, the General Data Protection Regulation (DSGVO)

your own hardware and software for repeated new purchases.

has an important say. According to this regulation, data may

In addition, the cloud solution – if used correctly – can be made

only be stored on servers within the EU. For servers outside

more flexible, which accelerates internal and external processes

the EU, it must be ensured that they are operated in accordance

and contributes to cost reduction – at least in the long term.

with EU data protection law.

However, a number of conditions must be met to ensure that

However, it is often difficult to prove this in case of doubt. For

the benefits are not cancelled out by disadvantages or even put

example, the server could be in a country from which German

the company in a bad position. These include, above all, the

privacy advocates cannot get any information. You should

clustering of data. All data must be processed and archived

therefore make sure that the cloud provider guarantees that

according to the cluster defined for it. It is clear from the

its servers are located within the EU.

structure that not all data should be stored in a cloud.

Particularly sensitive and secret data should, for example, be

Encryption of the data is also important when choosing a cloud

memory stick) and e.g. be kept in the safe. Remember to make

provider. These must be encrypted before they are transferred

backup copies of this data, which are also backed up – but

and only stored in encrypted form in the cloud. In this way,

stored in a different location than the original data.

the information is protected from unauthorized access right

As a principle, only data that is currently in use should be stored in the cloud. The cloud solution is too expensive for

40_Fischer_Cloud.indd 40

SAFETY FIRST

saved on an external manual data carrier (hard drive, USB

TAKE ONLY ACTIVE DATA INTO THE CLOUD

40

BE CAREFUL WITH PERSONAL DATA

from the start, because the data can only be decrypted again with the corresponding access data.

IT ALL DEPENDS ON THE PASSWORD

archiving. This information should then be archived cost-

The respective password is also crucial for the security of the

effectively on your own server as a backup.

data, as it allows the data to be decrypted or used again.

GlobalCONTACT 1-21

22.03.21 10:06

BUSINESS + MARKETING

Unfortunately, passwords are still handled very carelessly in

ACCESS STRUCTURE

many companies. In order to achieve the highest level of security,

In principle, the cloud should also run a program that logs and

you should observe the following rules:

stores the respective accesses. This is helpful, for example, if data has been changed or evidence of the storage of personal

• A password should consist of at least twelve characters that • • • •

data is required (DSGVO or the European regulation GDPR).

are not in any logical order.

When data is stored in a cloud, it must be ensured that tax-

Do not use any words or sequences of letters on the keyboard.

relevant documents, for example, are kept in accordance with

Integrate special characters.

the statutory regulations.

Never give passwords to unauthorized persons.

The cloud you are using should generate automatic backups of

Do not make any “cheat sheets”.

your data. The backup data should be stored on a different server than the one on which the original data is stored. However, if

Many people find it difficult to do without a cheat sheet. But

your company is located in the EU, not least for data protection

there is a trick that can be used to remember passwords that

reasons, both servers should be located within the EU or verifiably

are still difficult to crack. Take a sentence and use the first few

operated according to EU data protection regulations.

letters of each word as a password. The sentence should also

If technical breakdowns occur, which cannot be ruled out even

contain numbers, which are replaced in the password by the

with a cloud, the backup is automatically loaded so that no

special characters above the number. For example: ­­“I married

interruptions can paralyze operations. Ask the provider how

my wife Alice on May 16, 1966” would result in the password

many backups are created.

“ImmwAoM!&!)&&”.

The great advantage of the cloud solution is that data can be

THIS SHOULD BE REGULATED BY CONTRACT

accessed from all locations. However, there is also a danger

If you decide to use a cloud, you should make sure that the

here: people who should not actually be able to access the

contract with the provider includes the following points in

information gain access to the data. This is why we should take

addition to specifying the contractual partners.

a very close look at the access structure of the data stored in

The central point of the contract is the description of the

the cloud. Employees should be granted access rights according

subject matter of the contract. Basically, this is the provision

to the following scheme:

of software by the cloud operator and your access authorization to the data center. It should be agreed that the cloud operator

• • • •

Data with the right to change them.

must always provide you with the current version of the

Data that the employee can only read.

agreed software.

Data that the employee can only read and download.

In addition, it should be clearly regulated when updates are

Data to which the employee only has access with the consent

created and that you are informed when updates are installed.

of the supervisor.

When updates are applied, you should also be informed of the

• Data that he/she cannot access.

GlobalCONTACT 1-21

40_Fischer_Cloud.indd 41

reasons for this.

41

22.03.21 10:06

BUSINESS + MARKETING

The cloud operator should be liable for ensuring that the usability

In general, the following models are possible:

of the stored data is guaranteed at all times. In addition, a

• User-related: a fee is charged per user, regardless of how

hotline should be available to you. In most cases, a precise definition of the hotline tasks is necessary. Depending on the extent to which the hotline can be used, you may have to expect additional costs.

often they access the cloud.

• Fixed price per period (quarter, month, year).

• Consumption-related: only services called up are charged (pay per use).

• Mixed models from the above options.

Additional services can also be booked. Clear cost agreements should be made for this. Possible options are for example:

It also has to be specified when the payments are to be made (advance payment, partial payment, subsequent settlement).

• Transfer or synchronization of your application programs with the programs of the cloud provider.

• Consideration of your wishes on the side of the cloud provider's software.

• Handling of data migration upon termination of the contractual relationship (change management).

• Employee training.

The contract period also has to be regulated. For example, an initially unlimited term can be agreed upon, which is ended by termination. Here it must be specified when a term ends if it is terminated (for example at the end of the year if it is terminated at least three months in advance). A limited time can also be agreed upon, which is automatically extended if it is not canceled at a certain point in time.

In any case, the written form should be agreed upon for a

In addition, the scope of use must be defined. The scope of use

termination. In addition, it should be regulated in which cases

also includes the question of whether you implement your own

there is a special right of termination. Moreover, the following

client software on your employees' computers or whether you

has to be clarified in the contract:

can access the cloud software online.

Also clarify contractually how many simultaneous accesses will be allowed. It is possible that the rental price increases the higher you set the number of simultaneous accesses. Nevertheless,

• Confidential treatment of the data stored in the cloud.

• Guaranteed data security (especially backup regulation).

• Warranty for material and legal defects.

the number of accesses should be selected so that operational disruptions are excluded.

Furthermore, the general contractual clauses (place of

Also define how data protection is guaranteed. In particular,

juris­d iction, severability clause, etc.) have to be taken into

it must be clearly regulated how the provisions of protection

account. 

regulations are taken into account and observed. In this context, it should also be bindingly agreed that the servers of the cloud operator are located in an area that abides by the applicable laws and regulations or are operated in accordance with them.

Of course, the remuneration and payment methods must also

Hartmut Fischer has been a freelance journalist for the past 13 years, specializing in SMEs and retail issues. As a coach, he also advises companies on communication issues.

be determined. Which payment model is right for you must be decided on an individual basis.

42

40_Fischer_Cloud.indd 42

GlobalCONTACT 1-21

22.03.21 10:06

app.global-cl.com

READ FOR FREE

EAZ_App.indd 3

03.11.20 11:46

BUSINESS + MARKETING

A situational learning organization An indicator for sustainable commitment to change in companies An situational learning organization (SLO) is able to learn new patterns of action situationally which help organizations to cope better with new situations. Moreover, an SLO has the potential to harness the natural motivation of employees and creates conditions for genuine teamwork. By Manfred Brandstätter

THE PRINCIPLES OF AN SLO

An SLO is often used in projects as an indicator to recognize

A situational self-learning organization (SLO):

that the company, after a completed change project, is able to

... is characterized by a maximum amount of members who

further develop itself continuously through self-learning and

think about the future of the company and consequently participate actively in the development of the company or take responsibility for it (self-organization and responsibility). ... perceives reality as it is and tries to develop new coping strategies instead of relying on old ones (systems thinking and integration). ... aligns its work design with the needs of its customers (decentralized decision-making and control).

to adapt to the changes. [4]

A SITUATIONAL LEARNING ORGANIZATION – FROM THE PERSPECTIVE OF SYSTEMS THEORY AND NEUROLOGY “You can’t teach an old dog new tricks.” The discovery of the neuroplasticity of our brain has removed the scientific basis for this popular saying. Neuroplasticity describes the ability of our

... believes in the intrinsically existing potential of people and

brain to change synapses, nerve cells or entire brain areas for

organizations for performance and further development

the purpose of optimizing ongoing processes. This ability forms

(human image Y and modern leadership).

the basis of our ability to learn – well into adulthood. This requires confrontation with and successful management of new situations.

It would be misleading and even wrong to claim that an SLO can

An SLO can be viewed from the perspective of Niklas ­Luhmann's

be packed into an organizational model or indeed to call it an

sociological systems theory, as well as explained on the basis of

organizational model in its own right. Rather, an SLO sees itself

recent findings in neurobiology – the neuroplasticity of our brain.

as a living, fluid organism that is constantly being reshaped in an interplay between trial and error and learning, between improving

44

44_SLO.indd 44

THE SYSTEMS THEORY PERSPECTIVE

what has been tried and tested and creating something new.

The sociologist and social theorist Niklas Luhmann attributes the

What underlies any SLO are principles on which it bases its

ability of autopoiesis, i.e. the ability to maintain and renew

thinking and actions. Thus, an SLO does not describe a new

themselves, not only to biological organisms, but also to psychological

organizational form, but is rather an attribute, such as beautiful;

and social systems. Thus, from a systems theory perspective,

it is therefore the ascription of an organization in the sense of

business organizations are also structured in such a way that they

self-learning.

can (re-)constitute themselves perpetually from their own elements.

GlobalCONTACT 1-21

22.03.21 10:07

BUSINESS + MARKETING

According to Luhmann, this behavior of an organization – if

responsibility is understood as a social process in which the

one also allows this as a manager – is a function of an inner

leader sees it as his or her task to create the best possible

mode of self-generation, which is perpetuated by the processing

framework to enable self-organization. Extrinsic incentives to

of one’s own behavior towards oneself and one’s environment.

promote motivation or instructions that dictate how tasks are

From a systems theory point of view, nothing would stand in

to be completed are alien to an SLO. Rather, an SLO consistently

the way of situational learning in organizations. [12]

promotes a culture of trust: through proactive trust (trust does

THE NEUROLOGICAL PERSPECTIVE

not have to be earned over a long period of time) and by encouraging self-control rather than exercising power through

Neurology also gives the green light for lifelong learning. Not

control systems or hierarchies.

only has the phenomenon of neuroplasticity of our brain proven

By consciously encouraging self-control, an SLO sets in motion

that lifelong learning is theoretically possible. The ability of our

continuous development triggered by those people who work

brain to remember successes also supports this process. The

directly on the processes and projects. They recognize potentials

messenger substances released in the midbrain during successful

and can contribute decisively to finding solutions. In an SLO,

problem solution act like fertilizer on nerve cells and stimulate

improvements are not prescribed top-down.

the continuation and new formation of connections.

In this way, all those nerve cell connections that have proven

SELF-ORGANIZATION AND RESPONSIBILITY

to be suitable are strengthened and expanded. The next time

People have the ability to organize themselves and take

a problem arises, the behavioral pattern anchored in the brain

responsibility. It is necessary to create framework conditions

can be called upon, and we not only solve the problem faster,

that allow them to exercise these abilities.

but often better as well. [8]

The Y concept of human beings grants all participants

CONCEPTION OF MAN AND LEADERSHIP AS A SOCIAL PROCESS

responsibility for themselves and for creating their own lives, and thus also the duty to actively participate in shaping and assuming responsibility. An SLO creates the conditions for

Every person is naturally motivated and willing to perform.

this with “genuine” teamwork: defined role descriptions ensure

The task of the leader is to create framework conditions so that

clarity about rights and duties, jointly developed goals and

this potential can unfold. [13]

rules provide orientation, and ritualized events promote

The idea of SLOs is based on Douglas McGregor's conception of

reflection and further development.

man. In the 1960s, he revolutionized the discussion about motivation and performance by contrasting the then widespread

DECENTRALIZED DECISION AND CONTROL

image of man X with the image of man Y (figure 1). The latter

Organizations need to put the needs of the customer at the

assumes that people are by nature willing, ready to perform and

center of their considerations. Decisions must be made where

able to learn, and that these intrinsic characteristics cannot be

contextual and expert knowledge is available.

developed into competencies through control and instruction,

If decisions are made by those people who are directly confronted

but through autonomy, personal responsibility and a sense of

with the problems and usually also have the most extensive

purpose.

contextual and expert knowledge for the respective situation,

This perspective on the nature of human beings also significantly

then this creates speed and most often customer satisfaction.

shapes the understanding of leadership in an SLO: leadership

Market and customer orientation coupled with high performance

Fig. 1: Comparison of human concept. X and Y. GlobalCONTACT 1-21

44_SLO.indd 45

45

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are the goals of an SLO. To achieve this, it promotes structures

In the corporate world, VUCA describes a perpetually changing

that place the customer and his needs at the center of considerations

present or future that completely undermines known causal

and allow fast action and decision-making paths. An SLO knows

relationships: past experience is no longer useful in VUCA,

that these structures also have to be adapted and partly reinvented

and best-practice examples or tried-and-tested strategies are

continuously. All those events within an organization that

of very limited use, if any, for solving problems. Planning is

support self-reflection are conducive to this.

hardly possible anymore. These phenomena are being accelerated

SYSTEMS THINKING AND INTEGRATION

by the advance of digitization.

This situation is intensified by the possibilities offered by the

Problem solutions of our time can neither be found in the minds

new media, which on the one hand can lead to a more mature

of a few decision-makers, nor are they simple and linear. In a

formation of opinion, but on the other hand also increases the

time of paradigm shift, integration and versatility must be lived.

feeling of insecurity.

An SLO accepts that a complex world cannot be met with linear,

The situational, self-learning organization is a concept for

simple answers. Instead, it is important to train people to think

organizations of any size and industry which recognizes the

and act in interdependencies: planning and controlling,

parameters of a VUCA world and responds accordingly. As figure

experimenting and learning, improving what has been tried and

2 shows, the complexity and stability of the environment or

tested, and creating something new. The solutions of the past

organization influence the way the company is managed. A less

are usually no good for this. Solution approaches in an SLO

complex and therefore more stable environment, such as we found

emerge from interactions with stakeholders, involving different

at the beginning of the 20th century, required different coping

personalities, preferences or thinking styles, in interdisciplinary

strategies than the context and organizations of today: planning

and inter-functional teams. Simple rules, clear priorities and

effectiveness decreased drastically in the last hundred years, the

deliberate restraint can be conducive to this.

ability to adapt permanently, which was professionalized in the context of lean management and agile environments, is still

SITUATIONAL SELF-LEARNING – THE COPING STRATEGY IN VUCA

necessary, but not sufficient. Adaptability does not ensure stability in the company. Even high innovation potential cannot do that.

“Evolution has built learning capacity into us and did not intend an

The organization of the future has to master situational pattern

off button.” [6] VUCA is an acronym for volatile, uncertain, complex

change. It must be able to find new solutions in rapidly changing

and ambiguous. It is often used to describe the modern, digitized

circumstances repeatedly. The ability to successfully manage both

world. The acronym has its origin in the linguistic usage of the

the norm (for instance, in the form of standardized processes) and

American military. There, the term was adopted for a new situation

the state of exception (for instance, in the form of agile short-term

after the Cold War. New strategies were required as a result.

adjustments or projects) will increasingly take center stage.

Fig. 2: Relationship between the stability of the environment and the way the company is managed.

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BUSINESS + MARKETING

On the way to this organizational maturity, there are no tried-andtested solutions available. VUCA is increasingly undermining causal relationships. Individual, novel solutions are necessary. Companies can only meet these requirements if they understand how to learn situationally. What companies need to rediscover is their ability to learn: from situations, individually and sustainably.

Fig. 3: Ritualized cycle of self-learning.

The situational learning organization believes in its inherent potential to evolve. Throughout the history

and informal (lived) structures in traditionally organized

of civilization, this biologically inherent potential has helped

companies is fundamentally less pronounced than in flexible,

people to change and develop over and over again. This potential

agile, i.e. self-learning, and autonomous team and management

must be activated through targeted framework conditions and

structures. The way towards this, in addition to the formats listed

through an appropriate culture and leadership.

in the longer version of this text in the GlobalCONTACT app,

HOW TO SUPPORT SELF-LEARNING IN COMPANIES

can be via so-called shelter projects [5] or via a gradual increase of agile projects and processes. Positive experiences of those

“Experimentation and trial and error is the new mantra in

involved help to increase acceptance. Acceptance also comes

leadership circles”. [3] All agile formats, frameworks and methods,

with success. For this reason, the agile formats, frameworks and

such as Scrum, Scribble, Design Thinking, Kanban, Management

methods also place great emphasis on continuous improvement

3.0, and many more, create frameworks and thereby new forms

through processes such as retrospectives.

of cooperation that enable ritualized trial and error,

The path to an attractive SLO that performs well in dynamic

experimentation, and situational self-learning from the insights

markets therefore involves interplay of impulses from the teams

gained, and/or increase problem-solving competence. Based on

as well as the management culture. This is the only way to

the PLAN-DO-CHECK-ADAPT cycle [7], the “ritualized cycle

ensure that true congruence of formal and informal structures

of self-learning” – as it is established in modern working

can be achieved, and that the potential for situational self-

methods – is shown in figure 3.

learning can be harnessed.

The principles of an SLO largely align with the principles and values of the agile manifesto. [1] All agile formats, frameworks, and methods believe in intrinsically motivated people who are willing to perform, in the need to bring in the knowledge and skills of all stakeholders to face the modern world, and in the potential for further development in any organization. They provide the stimulus that supports this change because it exemplifies self-organization, adaptability, and a culture of responsibility.

People react differently to restricted opportunities for development.

Editor´s note: This is an abridged version of the article. You can find the full-length text in the GlobalCONTACT app. It includes, among other things, a checklist that you can use to see how far along the road to an SLO your company already is, as well as referenced sources and literature for further exploration of the topic.

Translator's note: Quotes have been translated from the German version of this text.

Illustrations: Sandra Brandstätter

While some withdraw, resign internally or officially, others seek (at least temporary) opportunities to fulfill their motivation and ideas. These makeshift structures do not, of course, utilize formal structures in the company’s organizational, operational or decisionmaking framework. Instead, they rely on internal agreements, experiments, exemptions, project formats and a great deal of initiative and, in some cases, risk-taking on the part of those involved. This can be perfectly permissible for a certain period of time and can also provide necessary impulses. In the long term, however, the goal of corporate management should be to achieve a high degree of congruence between formal and informal structures.

Experience from many years of organizational design has shown that the degree of congruence between formal (documented) GlobalCONTACT 1-21

44_SLO.indd 47

Manfred Brandstätter is an organization designer and business trainer as well as a founding member and lecturer of a business management university course. For more than twenty years, he has worked as the responsible person for organizational projects in national and international companies. In addition, he was managing director of start-up companies in Germany and Austria. For many years he has also been passing on his experience in workshops and trainings. He lives in Bonn, Germany, and is the author of various publications with a focus on "self-efficacy in organizations". He has overall responsibility for developing Scribble, the method collection for agile process management.

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