GlobalCONTACT - 01/2023

ISSN:1386 0194

1

2023 (93)

International News • PFAS forever?

Fitting Background • Soft Lenses for the irregular cornea • Visual performance of Ortho-K and LASIK patients

Business + Marketing • High quality data • Setting priorities

History

Contaflex

• Casting glasses Clinical Guide for Scleral Lens Success

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11.04.23 21:41

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01.03.23 12:53

LETTER FROM THE EDITOR

Employee, where are you?

Are you having trouble finding employees? And to keep them?

the previous government had already initiated the construction

There's a specter haunting the EU – and unfortunately, it's

of new childcare facilities, an increase in child benefits, longer

very real: The shortage of skilled workers. And it's particularly

parental leave and financial incentives for women to start

noticeable in some EU countries. That's because demographic

their own businesses. It will probably take 20 years for these

change is in full swing here – and often more advanced than

measures to take root.

in other regions of the world. This poses challenges not only for the financing of pensions in European countries. It's a

France's move to implement pension reform is a sensitive

dilemma, as no one wants to work longer, but neither do they

issue, driving people into the streets. Although French women

want to forfeit their financial opportunities.

have 1.83 children per capita – a top figure in the EU – the shortage of skilled workers in France also threatens to become

The economy is also affected: Immense expertise is being lost

an ever-greater problem in the coming years.

due to the high number of future retirees, while fewer and fewer young people are entering the labor market due to the

A problem that is often observed in Spain and Portugal is the

persistently low number of children. As a result, there is a

rural depopulation. Compared with other European countries,

shortage of fresh skilled workers at all fronts. One could say

young people in Spain seem to be drawn to the cities to study

that the term "Old World" has never been so appropriate for

or work to a particularly large extent. In some regions of

Europe as it is today.

Spain, it is mainly senior citizens who live there today. Here, both countries have created attractive incentives for returnees.

Companies are therefore doing well to retain their specialists

The Portuguese government even provides bonuses to those

and maintain a healthy corporate image. Today, money alone

who move out to the provinces and sweetens the job for

is not enough to keep skilled workers, because the next one

returnees from abroad with financial incentives, such as half

might offer more flexible working hours, childcare, home

the income tax rate.

office or other interesting opportunities.

Incidentally, the Czech Republic is leading the way in the Many countries in Europe have this problem and have currently

negative trend of the shortage of skilled workers in the EU.

developed their own strategies for counteracting the impending

At the beginning of 2021, the rate of unfilled positions there

void in skilled labor and companies. Finland, for example,

was already 5%. In Austria, the main aim is to get unemployed

recently introduced a system that determines the retirement

employees back into jobs.

age depending on the year of birth: Everyone born in 1955 or later must work until 67.

One thing is clear: The urgently needed skilled workers need incentives; the problem will not be solved on its own. So be

Poland has a different concept: recruiting IT specialists from

nice to your employees! Be creative too and come up with

abroad, such as Belarus, who want to escape the dictatorship

something to retain your employees. ■

there. Polish companies also look to Latin America, Asia and Africa for suitable specialists (despite difficult work permits for foreigners).

SILKE SAGE Editor-In-Chief

The Italian Government wants to approach it from the other

silke@global-cl.com

side: Boosting the birth rate. It has been falling sharply for years. It currently stands at 1.17 children per woman – lower than during World War l. In order to boost the birth rate again and integrate women more strongly into the workplace,

GlobalCONTACT 1-23

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12.04.23 22:50

49th

EFCLIN

EUROPEAN FEDERATION OF THE

CONTACT LENS AND IOL INDUSTRIES

CONGRESS EXHIBITION

20TH – 22ND APRIL 2023 THE HAGUE, THE NETHERLANDS

VISIONARY PEOPLE INNOVATIVE SOLUTIONS PROFESSIONAL COMMUNITY

Dutch culture combined with ancient and modern science has found The Hague to be the perfect location for business and leisure time as well.

The 49th EFCLIN Congress & Exhibition takes place there from 20th – 22nd April 2023.

For an engaging lecture program, EFCLIN forum and the best trade exhibition in the business, it can’t be beaten. It’s where the Contact Lens & IOL Industry from Europe, the Far East, North America and beyond come together… will you be there?

SAVE THE DATE

www.efclin.com/congress or e-mail us on info@efclin.com

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MORE INFORMATION WEB www.efclin.com MAIL info@efclin.com PHONE +41 41 372 10 10 FACEBOOK search: EFCLIN TWITTER @EFCLIN#efclincongress ADDRESS EFCLIN | Winkelbüel 2 | CH-6043 Adligenswil | Switzerland

17.10.22 12:03 09.11.22 10:38

CONTENT

ISSN:1386 0194

LETTER FROM THE EDITOR 3

Employee, where are you?

Silke Sage

1

INTERNATIONAL NEWS

2023 (93)

International News • PFAS forever?

6

Fitting Background • Soft Lenses for the irregular cornea • Visual performance of Ortho-K and LASIK patients

10 All about markets 11 All about products

Business + Marketing • High quality data • Setting priorities

History

All about you & event dates

12 All about research

Contaflex

• Casting glasses

16 PFAS forever?

Clinical Guide for Scleral Lens Success

Hanna Diewald

19 Start acting!

01_Titel.indd 1

11.04.23 21:41

Frank Sonnenberg

INDEX TO ADVERTISERS Title: Contamac, www.contamac.com Inside front cover: Bausch + Lomb Inc.,

MANUFACTURING 20 Blocking tooling and process Erik Larsen

www.bausch.com Page 4: Efclin, www.efclin.com Page 7: K & Y Diamond Ltd, www.kydiamond.ca Page 9: AMETEK Precitech, Inc., www.precitech.com Page 15: LAMBDA-X S.A., www.lambda-x.com Page 19: OPTOCRAFT GmbH, www.optocraft.com

FITTING BACKGROUND 22 Bringing soft lenses for the irregular cornea HOME again Eef van der Worp

26 Imaging techniques – Case study Katharina Radovčić & Gina Hüsemann

28 Visual performance of Ortho-K and LASIK patients Wolfgang Sickenberger and Sebastian Marx

Page 27: Larsen Equipment Design Inc., www.larsenequipment.com Page 33: Schneider GmbH & Co. KG,

HISTORY

www.schneider-om.com

32 Casting glasses

Inside back cover: Acuity Polymers, Inc,

Hans-Walter Roth

www.acuitypolymers.com Outside back cover: DAC www.dac-intl.com

NAMES TO NOTE Diewald, Hanna

34 High quality data Elena Fomenko

Fischer, Hartmut

37

37 Setting priorities

Fomenko, Elena

34

Hüsemann, Gina

26

Hartmut Fischer

Larsen, Erik

20

Marx, Sebastian

28

Radovčić, Katharina

26

Roth, Hans-Walter

32

GlobalCONTACT 1-23

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BUSINESS + MARKETING

NEWS 40 Yellow Pages 5

12.04.23 19:29

INTERNATIONAL NEWS

All about you BostonSight introduces Lensy as educational ambassador

BostonSight’s Chief Medical Officer, drew Lensy for his young children to explain his work. His 2D drawing was transformed into a graphic and has been brought to life as a 3D plush toy.

Education is a core component of BostonSight’s mission, and Lensy’s goal is to assist in educating young patients about scleral lenses and PROSE devices. BostonSight describes Lensy as a quadrant-specific scleral lens, with lens applicators for arms and legs and says that her engaging smile and large eyes make her an exceptionally friendly tool for working with pediatric patients. Lensy was introduced to the scleral lens world at BostonSight’s 2021 and 2022 FitAcademy™ for Residents retreats, the International Congress of Scleral Contacts (ICSC) in 2022, and the Global Specialty Lens Symposium (GSLS) in January of this year. BostonSight reports that the toy has been warmly received by the eye care community, who look forward to Lensy helping introduce scleral lenses to their patients, especially in pediatric settings.

With input from Anna Maria Baglieri, OD, of Boston Children’s Hospital, who fits pediatric patients with scleral lenses, and Gail Windmueller, a Certified Child Life Specialist affiliated with Boston Children’s Hospital, BostonSight developed Lensy: A Scleral Lens Story, a picture book about the basics of scleral lenses. In the story, Lensy follows her friend, Sophie Sheep, who needs scleral lenses due to extremely

Lensy. (Picture: BostonSight

dry eyes. BostonSight is running a fundraising campaign called Give (or Get!) the Gift of Lensy. A limited number of

BostonSight, a nonprofit eye healthcare organization that

Lensy plushies and printed books are available for donation

advances the treatment of diseased and damaged corneas

to pediatric patients at PROSE Network sites via the campaign.

and dry eyes, has announced that Lensy, an animated scleral

The campaign as well as the book for digital download can

lens, will be its ambassador. Daniel C. Brocks, MD,

be found at www.bostonsight.org/give-lensy.

Change of ownership Ercon Ercon has announced that the company will continue under new ownership. Erwin Jansen, a seasoned employee, has decided to run the business as an entrepreneur. The acquisition has already been completed by a notary.

Erwin has been employed at Ercon since April 2013 and has become an important player in the organization over the years.

His financial and logistical expertise has proven crucial to the organization, and he has developed a deep understanding of Ercons’s product. One of the conditions of the acquisition for Erwin was that Erik Smidt, the founder of Ercon, had to remain connected to the company as an advisor. Erik has been advising SMEs for some time and will advise Ercon on a broad range of topics.

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Erik Smidt and Erwin Jansen. Picture: Ercon GlobalCONTACT 1-23

12.04.23 22:53

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INTERNATIONAL NEWS

John Clamp joins Contamac Ltd as Director, Strategic Projects

background and knowledge

Contamac has announced the appointment of John Clamp as

our teams continue their

Director, Strategic Projects. In this role, John will drive long-term

drive to deliver the next

strategic initiatives for the business in partnership with our R&D

generation materials. John

Group and Operations Team. John joined Contamac on 3 April

brings valuable know-how

2023, having spent 30 years at UltraVision as CTO and Joint CEO.

and unique capabilities that

During this time, John was responsible for 10+ patent families

complement the Company’s

and numerous inventive developments within lathing, moulding

extensive knowledge, in its

and hybrid manufacturing processes, as well as lens designs from

drive to deliver new and

soft keratoconic lenses to smart contact lenses incorporating

innovative materials in the

liquid crystal layers and sensors. John has also developed software

future. To be clear, John has

ranging from full system-wide applications, through to full

not joined the Company for us to make finished lenses; this is

contact lens 3D design and creation of machining files.

not something Contamac has any interest in, as that is entirely

John commented, “I’m immensely appreciative of Rob’s and his

our customers’ business. John’s finished-lens background will,

team’s support of UltraVision CLPL over many years and am

however, help us further understand the importance of our next

now very excited to join Contamac and immerse myself in the

generation products. It is John’s extensive experience in

supply side of the contact lens industry. I hope my perspective

engineering, manufacturing, design and software, coupled with

as an ex-manufacturer and customer will further enhance

his industry knowledge that is exciting to the company and will

Contamac’s renowned customer support.”

ultimately shape his role at Contamac. John will further

Robert McGregor, Managing Director at Contamac said, “I am

complement our continued drive to place our customers’ needs

delighted and honored to have John join Contamac. His extensive

at the heart of our business.”

in our industry will help

John Clamp. Picture: Contamac

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CONTACT LENS AND IOL DAC Optoform Moore Nanotech UPL Precitech Nanoform REM Vision

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11.06.19 22:53 10:55 12.04.23

INTERNATIONAL NEWS

New high-tech startup developing smart contact lenses Purdue University has announced the launch of a startup that will commercialize smart contact lenses. BVS Sight Inc. is the first company created through a partnership between Boomerang Ventures Studio, Purdue Foundry and the Purdue Research Foundation Office of Technology Commercialization. The partnership develops Purdue-related health care startups and health care-related intellectual property yet to reach the market.

Chi Hwan Lee, the Leslie A. Geddes Associate Professor of Biomedical Engineering in Purdue’s Weldon School of Biomedical Engineering, led a research team that developed new ocular technology to continuously monitor intraocular pressure (IOP) in a person’s eye. Some of the current wearable tonometers — or devices that measure the pressure inside one’s

New smart soft contact lens technology developed by a multidisciplinary team of engineers and health care researchers at Purdue University and Indiana University School of Optometry looks to gather important intraocular pressure measurements for 24-hour cycles as a way to detect glaucoma. A company called BVS Sight Inc. has been launched to develop the technology. Picture: Purdue University photo/Rebecca McElhoe.

eyes — are equipped with an integrated circuit chip, which

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leads to increased lens thickness and stiffness compared to a

demonstrated that Lee’s technology has the potential to

typical commercial soft contact lens, in many cases causing

become a new standard of care for diagnosing and managing

discomfort for patients. Lee’s device is a unique class of smart

glaucoma patients.

soft contact lenses built upon various commercial brands of

Beier will be a director on BVS Sight’s board and continue

soft contact lenses for continuous 24-hour IOP monitoring,

to support the company through his chief medical officer

even during sleep at home.

and management roles at Boomerang Studio.

Lee says that the smart soft contact lenses retain the intrinsic

Beier said BVS Sight must achieve several milestones to bring

lens features of lens power, biocompatibility, softness,

the smart contact lens technology to market, among them

transparency, wettability, oxygen transmissibility and overnight

optimizing the integrated system for patient and clinician

wearability.

use. He states the company will need to work through multiple

Dr. Eric Beier, partner and chief medical officer at Boomerang,

challenges including clinical studies, regulatory approval,

said Lee and his smart contact lens innovation piqued his

reimbursement and fundraising. Boomerang brings resources

and his colleagues’ interest for several reasons, one of them

and expertise in these areas to help its portfolio companies

being that interviews with optometrists and ophthalmologists

navigate through these complexities.

CooperVision announces 2023 Best Practices Honorees and Student Scholarship Recipients

the wants and needs of today’s patients—and they are among the best in the country because of this mindset,” said Michele

Following its annual nationwide search for current and future

Andrews, OD, Vice President of Professional and Government

leaders in optometry, CooperVision has named its 2023 Best

Affairs, Americas, CooperVision. “As always, we have great

Practices honorees and student scholarship recipients. The

things in store for our new honorees, including collaboration

initiative—now in its eighth year—honors eye care practices

and sharing their stories. We welcome them all to the Best

across the US that advance the profession through innovation,

Practices family.”

industry leadership, and providing exceptional patient care.

CooperVision expanded its Best Practices program in 2020 to

The scholarship program provides third-year optometry

include a scholarship for third-year optometry students,

students the opportunity to learn from and collaborate with

providing them the opportunity to attend the annual

some of the best in the profession. The ten new honorees join

educational summit and hear firsthand the honorees’

a prestigious group of 70 other extraordinary optometry

experiences and secrets to success. Scholarship recipients were

practices that have been featured and supported through the

selected based on their academic standing at a US optometry

initiative since 2016.

school, their demonstration of leadership and participation

“Success in optometry comes in many different forms, and we

in school or community activities, honors, and additional

love that Best Practices sheds light on practices that truly view

optometry-related experience.

challenges as opportunities. These practices are constantly

More information about this year’s honorees can be found at

evolving in response to changes not only in the industry, but in

coopervision.com/practitioner/best-practices.

GlobalCONTACT 1-23

12.04.23 22:53

WEBINARS, CONFERENCES & TRADE FAIRS 2023

EFCLIN 2023 www.efclin.com

Apr 20-22

The Hague (NL)

OCCSEE www.occsee.hr

Apr 21-23

Split (HR)

ARVO 2023 www.arvo.org

Apr 23-27

New Orleans, LA (USA)

EAOO 2023 https://eaoo.online/cms/front-page.php

May 11-14

Poznań (PL)

BCLA 2023 https://www.bcla.org.uk/

June 9-11

Manchester (UK)

Vision By Design www.orthokmeeting.com

Sep 6-10

Chicago, IL (USA)

IOFT 2023 www.ioft.jp/en-gb.html

Oct 10-12

Tokyo (JPN)

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20.03.23 19:29 12:46 12.04.23

INTERNATIONAL NEWS

All about markets Visual impairment in the older U.S. population Based on objective assessments of visual function with habitual correction in the 2021 nationally representative National Health and Aging Trends Study,

27.8% of US adults 71 years and older

Spectaris industry figures for 2022

had vision impairment (VI). Distance and near visual acuity and contrast sensitivity impairment were present in 10.3%, 22.3%, and 10.0%, respectively; a higher prevalence of VI was associated with older age, less education and income, non-white race, and Hispanic ethnicity.

According to preliminary calculations by the Spectaris industry association, German manufacturers of ophthalmic

Source: Killeen OJ, De Lott LB, Zhou Y, et al. Population Prevalence of Vision Impairment in US Adults 71 Years and Older: The National Health and Aging Trends Study. JAMA Ophthalmol. 2023;141(2):197–204. doi:10.1001/ jamaophthalmol.2022.5840

optics and consumer optics were able to

increase their sales by 2.5% to 4.87 billion euros in 2022, despite the difficult underlying conditions. Domestic business remained at the previous year's level with a value of 2.42 billion euros. The number of employees also remained unchanged at 20,600. International business, on the other hand, increased by around 5%, with foreign sales climbing to 2.45 billion euros.

Source: Spectaris

International visitors at Mido 2023 Around 35,000 visitors attended Mido 2023, 80% from Europe and 20% from the rest of the

world. This represents a

60% increase

over 2022, despite being well short of the record mark of 59,500 visitors in 2019.

Source: Mido West

Source:https://www.statista.com/chart/28744/ world-population-growth-timeline-and-forecast/ 10

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GlobalCONTACT 1-23

12.04.23 18:32

INTERNATIONAL NEWS

All about products 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 ISOcompliant 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 samplespecific data and measurement scripts from the server as well as to archive your measurement results in conformity with the standards. www.trioptics.com / sales@trioptics.com

Multifocal Lens measurement in CLE-MENTOR The Multifocal Lens measurement feature available in CLE-MENTOR provides detailed representation of the power profile for fine adjustments of the ring borders, and results are presented independently for each ring, as well as a relation of selected base and addition. This advanced functionality ensures that you have the most accurate measurements for your quality control processes. This state-of-the-art software is the perfect solution for measuring complex contact lens designs with unique precision and ease, allowing you to select up to 6 rings (zones), adjust the diameter, and position the lens for optimal measurement accuracy. In addition, NIMOevo’s most precise wavefront sensor allows you to visualize the measurement in a selection of power maps, providing you with a detailed understanding of the power distribution across the lens. This is just one of many impressive features of NIMOevo and CLE-Mentor software, making it the perfect tool for the measurement and evaluation of modern contact lenses. Let’s discuss your specific needs and challenges on the Lambda-X booth at EFCLIN 2023: April 20th to 22th in The Hague, NL. Ophthalmics.lambda-x.com / sales-ophthalmics@lambda-x.com – +32 67 79 40 80

Transforming Lives Together Full Range of Materials – Led by industry insights and developed by our in-house team of specialists, Contamac offers a complete range of contact lens and intraocular lens materials to suit all indications. This includes our Optimum family of gas permeable materials, Definitive silicone hydrogel materials, Contaflex hydrophilic soft lens materials, and our hydrophilic IOL material CI26. Each material has its own unique properties to benefit machinability, comfort and ocular health.

Educational Initiatives – We also believe that by investing in the professionals of our future, we can ensure they are fully-equipped to transform the lives of patients. Whether through publications, videos or industry events, Contamac is proud to support an exchange of knowledge within the industry. www.contamac.com / sales@contamac.co.uk

GlobalCONTACT 1-23

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12.04.23 18:33

INTERNATIONAL NEWS

All about research

Dry eye prevention, smart CL for glaucoma diagnosis and treatment, IOL for Alzheimer's diagnosis, 3D-printing of smart CL A team from the Terasaki Institute for Biomedical Innovation (TIBI) in the U.S. has developed a contact lens prototype specifically designed to prevent dry eye caused by contact lenses. Three new smart lens developments were reported by Korean scientists. A research team at POSTECH has developed a smart contact lens by combining an IOP sensor and a flexible drug delivery system to manage IOP measurement and medication administration. Collaboration among experts in mechanical engineering, materials and medicine resulted in intraocular lens technology developed for early diagnosis of Alzheimer's disease.

Another new technology is set to enable the production of smart contact lenses using 3D-printing.

By Rebekka Nurkanovic

Contact lenses to treat dry eye syndrome

tears from the contact lens's outer surface to the surface behind

A collaborative team from the Terasaki Institute for Biomedical

the lens. This leads to excessive tear evaporation and all the

Innovation (TIBI) has developed a contact lens prototype that

problems associated with CLIDE.

is specifically designed to prevent contact lens-induced dry eye

There have been previous attempts to use contact lenses in treating

(CLIDE). The researchers report that the lens alleviates this

dry eye syndrome, such as graphene-coated lenses designed to

condition by facilitating tear flow in response to normal eye

minimize moisture loss and self-moisturizing lenses stimulated

blinking and that this approach can relieve the discomfort,

with metallic electrodes. The TIBI team’s approach uses a contact

visual impairment, and risk of inflammation experienced by

lens design that incorporates microchannels to facilitate tear

contact lens users suffering from CLIDE.

flow movement and flow so that dry eye can be avoided. This

Of the 140 million contact wearers worldwide, 30%-50% suffer

flow can be achieved by pressure applied by normal eye blinking

from CLIDE. The problem arises from the insufficient flow of

so that no external devices are needed.

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GlobalCONTACT 1-23

12.04.23 19:07

INTERNATIONAL NEWS

In fabricating their contact lens prototype,

After various experiments, a configuration

the team utilized a lens mold made from

that proved effective was microchannels

a silicone polymer mixture; this allowed

with square cross-sections arrayed in a

for easy removal of the lens cast on it by

novel circular pattern on the lens surface;

gently bending the mold. The approach

this was compatible with the function and

resulted in smooth microchannels, as well

curvature of the lens and allowed for

as lenses that could be thirty times thinner

optimum liquid flow.

than previous lenses. A custom device was

The team demonstrated a proof-of-concept

used to fabricate reservoirs at the ends of

validation of their lens’ ability to guide

each microchannel for the inf low and

tear flow originating from the lens surface

outflow of liquids.

to the underside of the lens to combat dry

Innovative techniques were also utilized

eye syndrome. The team quantified these

when encapsulating the microchannels

flows and established that they were driven

in a sandwich-like assembly under a

by low-pressure levels like those from

capping lens layer. Initially, the preparation of the two lens surfaces for stronger bonding dehydrated the lenses, causing them to curl. This problem was solved by affixing the two lenses to holders using water-soluble glue. This served not only

A collaborative team from the Terasaki Institute for Biomedical Innovation (TIBI) has developed a contact lens prototype that is specially designed to prevent contact lens-induced dry eye (CLIDE). The lens alleviates this condition by facilitating tear flow in response to normal eye blinking. Picture: Terasaki Institute for Biomedical Innovation

to enable a more uniform bonding of the

normal eye blinking. Further experiments could be devised to test these lenses on animal models and in patients.

“The inventive methods that our team has employed bring a potential solution for millions of people,” said Ali Khademhosseini, TIBI’s Director and CEO. “It is the hope that

lenses but protected them from damage as well.

we may extend our efforts to bring this solution to fruition.” This

After rigorously testing their encapsulated microchannel lenses

work was supported by Cooper Vision, Inc. The results were

for stability and leakage, the lenses were subjected to a series

published in the journal Small.

of experiments using a device that the team designed to simulate a blinking eyelid. This device was integrated with the lens

DOI 10.1002/smll.202207017

prototype to create artificial eyelid pressure on the lens to

Source: Terasaki Institute for Biomedical Innovation

stimulate tear flow.

Smart contact lens that diagnoses and treats glaucoma

The IOP sensors currently available for glaucoma patients

Glaucoma is a common ocular disease in which the optic nerve

amount of drug in response to the IOP levels. The smart

malfunctions due to the increased intraocular pressure (IOP)

contact lens developed by the POSTECH team has an IOP

caused by drainage canal blocking in the eye. This condition

sensor that uses hollow nanowires made of gold. It is

narrows the peripheral vision and can lead to vision loss in

integrated with a flexible drug delivery system, wireless

severe cases. Glaucoma patients have to manage IOP levels for

power and communication system, and an application-specific

do not have the function to administer the appropriate

their life-time. Automatic monitoring and control of the IOP in these patients would significantly improve their quality of life.

Recently, a research team at POSTECH has developed a smart contact lens by combining an IOP sensor and a flexible drug delivery system to manage IOP measurement and medication administration. The team led by Professor Sei Kwang Hahn and Dr. Tae Yeon Kim (Department of Materials Science and Engineering) has developed a wireless theranostic smart contact lens for monitoring and control of intraocular pressure in glaucoma. Their findings were published in Nature Communications.

GlobalCONTACT 1-23

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Schematic illustration of a theranostic smart contact lens for glaucoma treatment. Picture: POSTECH 13

12.04.23 19:07

INTERNATIONAL NEWS

integrated circuit chip for both monitoring and control of

smart contact lenses as well. Professor Hahn who led this

IOP in glaucoma. The researchers report that the IOP sensor

study commented, "We hope the early commercialization

has exhibited high sensitivity to ocular strain, excellent

of the newly developed theranostic smart contact lens for

chemical stability, and biocompatibility. Furthermore, the

diagnosing and treating glaucoma intraocular pressure to

flexible drug delivery system can provide the on-demand

provide glaucoma patients’ compliance.”

delivery of the IOP decreasing drug timolol. The team

This study was supported by the Basic Science Research

successfully demonstrated that the theranostic smart contact

Program, the Korea Medical Device Development Fund

lens enabled the IOP measurement in real-time and the

grant, BRIDGE Research Program, and Bio & Medical

appropriate amount of drug release to match the degree of

Technology Development Program of the National Research

IOP in rabbits with glaucoma.

Foundation (NRF) funded by the Ministry of Science and

The new smart contact lens is expected to make possible

ICT, Korea.

a personalized glaucoma treatment with maximum efficacy and minimal side effects. In addition, the feedback system

DOI 10.1038/s41467-022-34597-8

would be applicable to various wearable devices other than

Source: Pohang University of Science & Technology (POSTECH)

Smart IOL technology for early-stage dementia diagnosis

biomarkers on an intraocular lens to express a signal in a

The Korea Institute of Machinery and Materials (KIMM), a

repeating shapes that are combined and recombined

non-profit government-funded research institute under the

continuously, creating visual stripes according to differences

Ministry of Science and ICT, has collaborated with with

in the overlapping shapes.

Yonsei University, Yonsei University College of Medicine

When the hydrogel pattern, to which the antibody is bound,

Yongin Severance Hospital, and Gangnam Severance Hospital,

reacts with the target biomarker, it contracts. The target

to develop an intraocular implant that can diagnose

biomarker is then detected using changes in the moiré

Alzheimer's, a degenerative brain disease, at its early stages.

signal, which are generated when the hydrogel pattern,

The results of this research study were published in the journal

which becomes narrower by the contraction response,

Bioactive Materials.

overlaps with the designated reference grid. By using a

The collaborative team focused on the characteristics of

moiré signal, detection is possible with greater sensitivity

the eye, which is directly connected to the brain, and detected

than that of other methods that directly detect change in

va r ious bioma rkers. T he resea rchers developed a n

the hydrogel pattern.

implantable biosensing system by mounting a bioresponsive

Furthermore, unlike traditional biosensors, the moiré

hydrogel-based sensing module capable of detecting various

signal-based biomarker detection method can directly detect

moiré pattern. Moiré patterns are characterized by regularly

biom a rk er s w it hout u si ng electrochemical or fluorescent labels. Since this method does not require external power or a light source, one of its advantages is that it can be implanted within the body.

KIMM plans to continue to promote further research on this technology until it can be made available for commercial use.

DOI 10.1016/j.bioactmat.2022.11.010 Source: National Research Council of Science & Technology, Korea Biomarker detection using reactive hydrogel patterns and moiré signals. Credit Korea Institute of Machinery and Materials (KIMM) 14

12_about_research.indd 14

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12.04.23 19:07

GC-Pub !AZ.ind

INTERNATIONAL NEWS

New technology for smart contact lens

phenomenon is that there is no restriction on the substrate

Dr. Seol Seung-Kwon's Smart 3D Printing Research Team

that can be used because crystallization occurs by natural

at KERI and Professor Lim-Doo Jeong's team at Ulsan

evaporation of the solvent.

National Institute of Science and Technology (UNIST)

Through the precise movement of the nozzle, the crystallization

developed core technology for smart contact lenses that can

of Prussian Blue is continuously performed, thereby forming

implement augmented reality (AR)-based navigation, with

micro-patterns. Patterns can be formed not only on f lat

a 3D printing process.

surfaces but also on curved surfaces. The research team states

In implementing AR with smart contact lenses, electrochromic

that their micro-pattern technolog y is ver y f ine (7.2

displays that can be driven with low power are suitable, and

micrometers), it can be applied to smart contact lens displays

the color "Pure Prussian Blue" is attracting attention as the

for AR, and the color is continuous and uniform.

lens’ material. The color has a high price competitiveness and

The main expected application area is navigation. Dr. Seol

quick contrast and transition between colors but in the past,

Seung-Kwon's of KERI said that the team’s achievement is a

it was coated on the substrate in the form of a film using the

development of 3D printing technology that can print

electric plating method, which limited the production of

functional micro-patterns on non-planner substrate that can

advanced displays that can express various forms of information,

commercialize advanced smart contact lenses to implement

e.g. letters, numbers or images.

AR. He is convinced that it will greatly contribute to the

The developers say that the technology of KERI-UNIST can

miniaturization and versatility of AR devices. The related

realize AR by printing micro-patterns on a lens display using

research results were published as a cover article in the journal

a 3D printer without applying voltage. Prussian blue is

Advanced Science.

crystallized through solvent evaporation in the meniscus formed between the micronozzle and the substrate. The team

DOI 10.1002/advs.202205588

reports that the great advantage of using the meniscus

Source: Korea Electrotechnology Research Institute (KERI)

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Meet us at EFCLIN 2023 April 20th-22th in The Hague, NL Ophthalmics.lambda-x.com +32 67 79 40 80 - sales-ophthalmics@lambda-x.com GC-Pub_March2023.indd 1 !AZ.indd 9 12_about_research.indd 15

24/03/2023 09:16:41 10.04.23 19:07 22:32 12.04.23

INTERNATIONAL NEWS

PFAS forever?

Long lasting chemicals – restrictions, chances and challenges For some, they are “forever chemicals” that should never be released into the environment; for others, they are necessary substances for the production of everyday consumer products or medical devices, for instance contact lenses. We are talking about per- and polyfluoroalkyl substances – in short PFAS. At first glance, two interests seem incompatible: On the one hand to save the environment and human health and on the other hand to satisfy consumer desires and to not restricting an entire industry. But one authority has now created facts. By Hanna Diewald

16

16_PFAS.indd 16

In early February 2023, the European Chemicals Agency ECHA

BROADEST RESTRICTION IN HISTORY

published a ban proposal on all PFAS – or per- and polyfluoroalkyl

According to the latest estimates, this group of substances

substances. It is a message with huge implications. A choice

comprises more than 10,000 different substances. It is the broadest

for the environment and human health but at the same time,

restriction proposal in history and many different industries are

the industry faces huge challenges and stakeholders are lobbying

affected. Among those industries that work with PFAS on a daily

for exemptions – at least for longer transition periods. But why

basis is also the ophthalmic industry. This is because PFAS are

is the topic so hotly debated?

used in spectacle lens coatings as well as in contact lenses.

GlobalCONTACT 1-23

12.04.23 19:31

INTERNATIONAL NEWS

The European Chemicals Agency (ECHA) defines PFAS as

“FOREVER CHEMICALS”

follows: “PFAS have a wide range of different physical and

Together with 15 European partner media reporters, the Forever

chemical properties. They can be gases, liquids, or solid high-

Pollution Project located more than 17,000 sites across Europe with

molecular weight polymers. Some PFAS are described as

relevant PFAS pollution, including just over 2,000 hotspots with

long-chain or short-chain, but this does not cover all of the

significant human health risks.

different kinds of structures that are present in the PFAS class,

Some PFAS are very effective at resisting heat, stains, grease and

which is very diverse. PFAS can be sorted in many ways based

water and they are used in high tonnages in a variety of applications.

on their structure”.

The majority of PFAS are persistent in the environment.

Individual PFAS had already been banned but ECHA reports

According to ECHA, “Some PFAS are known to persist in the

that global manufacturers have started to replace certain

environment longer than any other synthetic substance. As a

PFAS with other PFAS or with fluorine-free substances over

consequence of this persistence, as long as PFAS continue to be

the past decades: “This trend has been driven by the fact that

released to the environment, humans and other species will be

scientists and governments around the world first recognised

exposed to ever greater concentrations. Even if all releases of

the harmful effects of some PFAS (particularly long-chain

PFAS would cease tomorrow, they would continue to be present

PFAS) on human health and the environment. As the focus

in the environment, and humans, for generations to come”.

shifted to other PFAS, these have also been found to have

PFAS tend to pollute groundwater and drinking water. Certain

properties of concern” says the agency. This is why such a

PFAS are known to accumulate in people, animals and plants

comprehensive restriction is being discussed.

and cause toxic effects. Certain PFAS are toxic for reproduction

GlobalCONTACT 1-23

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17

12.04.23 19:31

INTERNATIONAL NEWS

and can harm the development of foetuses. Several PFAS may

and should be provided during the third party consultation of

cause cancer in humans. Some PFAS are also suspected of

the restriction proposal to substantiate a derogation. Only if

interfering with the human endocrine (hormonal) system.

substantial evidence is provided, the dossier submitters can

According to ECHA the expected mean PFAS tonnage in the

assess this and consider whether a derogation is warranted.

EEA is 49 million tonnes, leading to emissions of about 4.5

For the time being, uses between brackets should be read as

million tonnes during the manufacture and use phase when no

‘no derogation’.

action is taken. The overall annual health costs following from exposure to PFAS in Europe has been estimated in a Nordic

IMPACT ON THE OPHTHALMIC INDUSTRY

Council report from 2019 to be between €52 and 84 billion.

The potential derogation covers fluoropolymer coatings on ophthalmic lenses and fluorinated monomers used in the

ARGUMENTATION

polymer matrix of rigid gas permeable contact lenses.

The proposal states that: “Different regulatory risk management

According to Euromcontact: “An internal survey ran by

options have been considered, e.g. CLH and authorisation, but

Euromcontact showed that 3 PFAS are used to manufacture

these options follow a substance by substance approach. In contrast,

RGP contact lenses (HFPM, TFEM, BHI), for which there is

a restriction offers the possibility to define a broad chemical scope,

currently no alternative. The dossier submitters identified uses

thereby avoiding regrettable substitution of one PFAS by another

for which a derogation could be warranted, but for which the

PFAS (which may not even be engineered yet). […]

evidence base is still weak. Among them: fluoropolymers and

A restriction can cover a wide range of uses and can address

perfluoropolyethers for the use in rigid gas permeable contact

the risks arising from the manufacture and use of the substances

lenses. Additional information is needed and should be provided

as such as well as in other substances, in mixtures and in

during the consultation of the restriction proposal (March -

articles, including imported articles from outside the EU.

September 2023) to substantiate a derogation. Only if substantial

Hence, a restriction is the most appropriate and effective option

evidence is provided, the dossier submitters can reconsider

to adequately control such a large and complex group of

whether a derogation is warranted or not.”

substances which are used in numerous applications.

The chemical scope of the restriction proposal is defined as: Any substance that contains at least one fully fluorinated methyl (CF3-) or methylene (-CF2-) carbon atom (without any H/Cl/ Br/I attached to it). There are however a few exceptions.”

NEXT STEPS • January 2023: Restriction proposal submitted to ECHA • 22. March 2023: Start of a six month open consultation The European Chemicals Agency invites interested parties to send in scientific and technical information on the

CURRENT SITUATION In January 2023, Denmark, Germany, the Netherlands, Norway and Sweden submitted to ECHA a proposal for restriction on

manufacture, placing on the market and use of per- and polyfluoroalkyl substances (PFAS)

• 25. September 2023: Open consultation closes

the manufacture, placing on the market and use of around

ECHA’s scientific committees for Risk Assessment (RAC)

10.000 PFAS.

and for Socio-Economic Analysis (SEAC) will use the

Two restriction options (ROs) have been assessed. A full ban with

consultation input to evaluate the proposed restriction and

no derogations and a transition period of 18 months (RO1), and

to form an opinion on it.

a full ban with use-specific time-limited derogations (18 month transition period plus either a five or 12 year derogation period).

• Opinions of ECHAs committees sent to the European Commission

As specific information on costs of a ban of PFAS for the different actors associated with the addressed uses was scarce and mainly

SOME QUESTIONS REMAIN UNANSWERED

qualitative, the derogations and their duration were mainly

So there is still a long way to go before all questions can be

based on the availability and applicability of alternatives to

answered. For example:

PFAS.

• Which products will finally end up with exemptions?

• Is it legitimate to ban all PFAS without a proper demonstration

RO2 also includes a few time-unlimited, more general derogations, e.g. for PFAS used as active substances in Plant

that each and all of them present an unacceptable risk?

Protection Products (PPP), Biocidal Products (BP) and human

• How to ensure that production and associated environmental

and veterinary Medicinal Products (MP) but there is no general derogation for medical devices.

Besides the proposed derogations, the dossier submitters also

problems do not simply shift to other countries?

• What about the competitive disadvantage for the European n industry compared to other continents?

identified uses for which a derogation could be warranted, but for which the evidence base is weak. These uses are between brackets, which indicates that additional information is needed 18

16_PFAS.indd 18

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12.04.23 19:31

COLUMN

Start acting!

The deeper you delve into the topic of

entrepreneurship and the functioning of our economy. It

sustainability, one thing becomes clear:

could even have a strong impact on corporate strategies and

Sustainability has many dimensions. The

our understanding of the economy.

whole thing is complex. Everything is interwoven. It's more than just climate

For those who have not yet initiated their own corporate

and environmental protection. Carrying

transformation, it is helpful to exchange ideas with like-minded

on as before is no longer an option. It takes a

people. These can be found not only in the optical industry,

new way of thinking to make your company

but also in other sectors that have already begun their journey

fit for the challenges of the coming decades to

towards greater sustainability. n

align it economically, ecologically and socially.

We all have the goals, such as the so-called SDGs – the UN's Sustainable Development Goals – in front of our eyes. Where can we start and take action? Prof. Dr. Rene Schmidtpeter, economist and professor of business administration and sustainability management at the International University of Applied Sciences in Erfurt/Germany, even says that a new mindset is currently emerging as a result of the public discourse. This could have a fundamental impact on innovative

Frank Sonnenberg, head of sustainability at FOCUS magazine is a certified CSR manager (IHK), he is a member of the IG Sustainability at the international trade fair Opti Munich and a participant in the Sustainability Hub at the trade fair in January 2023. The cross-media journalist and trained optician is one of the founding members of the still young D-A-CH association CSR Manager which was launched in 2022.

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19

!AZ.indd 5 19_FrankColumn.indd 19

02.03.23 19:37 11:40 12.04.23

MANUFACTURING

Base blocker wax pattern, source: Erik Larsen

Blocking tooling and process The challenge of making an Rx product (specialty contact lens SCL) in a production environment is the wide variation of parameters. Unlike IOLs which are made in batches with no parametric variation within the batch, making SCLs can be a challenge. The goal is to provide machines and processes that allow each lens to proceed through the process without special fixtures and procedures. By Erik Larsen

In the past five years there has been a dramatic increase in the

elimination of the variation in the process. So much so, that a one

use of scleral lens designs around the in visual performance

spindle polisher will produce up to 500 back surfaces per shift.

and comfort have been nothing short of life-changing. However, with all of their advantages, scleral lenses have also presented

BLOCKING

us with some unique, never seen before, complications. If you

The static blocking process took over from traditional blocking

are making IOLs for example, making a batch of identical lenses

techniques in the mid 90's but really took off in the early 2000s

is reducing the variation in the process. There is variation from

with auto-blockers. A later milestone was the move into transfer

batch to batch, but that can be managed by a supervisor rather

blocking, then on to fully automated transfer blocking for both

than the line person. In contact lens processing, each lens is

corneal and scleral BCs. This is currently done on the same

different and can vary widely in several parameters. The variation

machine without the operator needing to adjust the machine

in parameters requires the technician to make decisions with

to accommodate variations in center thickness. The result is

each lens as to how to process it. The standard operating

an essential reduction in process variation.

procedure has changed a lot.

Two colleagues who are familiar with the concept of reduction of variation in a process have graciously lent their perspective

20

20_Erik Larsen.indd 20

POLISHING

on the subject: Mr. Pat Murphy and Mr. Nir Karpik, both of

In the mid 90's, the free-form back surface became a reality as

CooperVision Specialty Eyecare. They have been given the

did the need to polish it. The bladder system solved the individual

daunting task of coordinating the lens processes throughout

lens polish problem, and also provided a means to use just one

the family of CooperVision companies. In particular, the

bladder to polish all back surfaces. The result is an essential

standardization of the blocking tooling (arbors, chucks) and GlobalCONTACT 1-23

12.04.23 19:46

MANUFACTURING

Arbors with O rings

Blocked BC on hollow tool

Scleral front arbors

what that means. Mr. Murphy’s contribution was more generic,

with toricity. Deeper collets have been used and no toricity has

discussing the merits of blocking the lens bank to reduce

been detected at final inspection. The fact that a greater surface

distortion in the material:

area of the button is being used to distribute the gripping force

“The aim of all lens manufacturing processes is to manufacture

results in less stress (stress = force/area) being transferred to the

lenses within a controlled, consistent, repeatable and reliable

material being gripped.

process that induces as little stress as possible into the material

Materials with low modulus of elasticity exposed to the same

during all phases of the process. The control of stress on the

collet squeeze force as materials with higher modulus of elasticity

button, semi-finished and finished lens is extremely important

may result in issues. Because of all of the above potential issues

to ensuring the production of a lens within specification each

and the direct relationship between stress and modulus of

and every time. Excessive stress applied to material will result

elasticity it is recommended that the button is blocked to an

in warpage and/or stability problems.

arbour for base curve cutting. This fully eliminates the potential

Material hardness (Shore D) and Modulus of Elasticity (MN/

issue of radial stress being applied to the material. Also remember

m ) are key mechanical properties as they provide insight into

that lathe feeds, speeds and depths of cut can introduce stress

how susceptible materials are to external mechanical forces and

and heat into the material as well which may impact dimensional

2

fluctuations in temperature. Due to the mechanical properties

and optical results. Delrin or Delrin tipped arbours are preferred

of materials there are certain dos and don’ts regarding the

as these do not require heating thus eliminating another potential

manufacturing process. Careful attention to the following steps

negative input into the process. Using water-soluble wax due to

will help maximize yields and give greater satisfaction working

the non-use of solvents for cleaning the lens also may help.

with materials.

Overall, the aim is to reduce, minimize or eliminate external

Base curve lathing: Directly holding the button in the lathe

stress and variables within the process”.

may result in excessive radial stress being applied to the button.

My thanks to Pat Murphy.

In addition, these radial stresses may not be distributed evenly

In the next issue we will discuss the concept of standardization

around the circumference of the button. This could lead to

of blocking tooling. Yes, it is possible. n

warpage of the button. The result is a lens with dimensions out of specification. The difficulty with this system of holding the button is that you cannot measure the stress on the material.

Having a critical variable in the process which you cannot accurately measure is not desirable as it can lead to a process that is hard to control. If collet tension is minimal and consistent you may have no issues but as this variable cannot be measured,

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.

ideally it should be designed out of the process. Collets with depths of 0.040 inches have been seen to produce some lenses GlobalCONTACT 1-23

20_Erik Larsen.indd 21

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12.04.23 19:46

FITTING BACKGROUND

Bringing soft Lenses for the irregular cornea HOME again A home run via four bases According to the global survey of contact lens prescribing in 2022 by Eurolens Research (Fig. 1)1, about 12% of all lens fits worldwide are with rigid lenses (corneal and scleral), and an additional 2% are with orthokeratology. That also means that most lens fits are with soft lenses (86%); this is for normal eyes, of course. How about the irregular cornea? The most common type of irregular cornea is keratoconus, and hence this is by far the main indication for scleral lens wear.2 From the podium at the latest Global Specialty Lens Symposium 2023 and in many papers, it has become increasingly clear that the incidence of keratoconus may be much higher than previously thought. According to a study by Godefrooij et al3 in the Netherlands, the annual incidence of keratoconus is reported to be 1 in 7500 for the relevant age category, or 13.3 cases per 100,000. The prevalence of keratoconus in the general population was estimated to be 1:375. These values appear to be 5-fold to 10-fold higher than previously reported. In some parts of the world, such as in the Middle East, the incidence of keratoconus is considered to be even higher.4 By Eef van der Worp

22

22_Eef Article.indd 22

It is noteworthy that the landscape of keratoconus management

symmetry,6 which makes the patient more correctable with

is changing rapidly. Across Europe and increasingly in other

spectacles and soft lenses. Anecdotally, this way patients can

parts of the world, corneal cross-linking (CXL) is becoming

improve to a point that they can go from a scleral lens to a

the standard of care for young patients with progressive ectatic

custom soft lens.7

corneal disease. The mentioned study by Godefrooij reported

These developments may impact what management methods

that 25% fewer corneal transplants were performed in the 3-year

we offer and apply; glasses and certainly soft (specialty) lenses

period in which CXL became available and popular in the

may become more common as a first-line method of vision

Netherlands.5 We will most likely not see fewer keratoconus

correction. In addition, there have also been major developments

patients (supposedly more), but we will most likely see corneas

in the field of corneal transplants for keratoconus (and other

in the earlier stages of the condition. In addition, topography

diseases). While a penetrating keratoplasty (replacing the entire

and wavefront-guided excimer laser treatments are performed

cornea in its full thickness with donor tissue) not too long ago

now that can improve corneal contour and improve corneal

was standard procedure, now an array of lamellar techniques, GlobalCONTACT 1-23

12.04.23 19:49

FITTING BACKGROUND

in which only a portion of the cornea is replaced by donor tissue, are increasingly used. This can provide many advantages, one being that the corneal irregularities are far less prominent, as a part of the patients’ original cornea remains intact.

This opens up opportunities for soft specialty lens correction.

But what are the options, and in what order can they be applied?

In an algorithm by Visser et al, published in Contact Lens & Anterior Eye, the soft lens option was prominently listed as an option for ‘mild’ cases of corneal irregularity.9 The idea is that soft lenses can mask the irregularity of the cornea, at least partly. Increasing the thickness of the lens helps in that regard, but this does reduce oxygen transmissibility. A potential step to evaluate whether a soft lens will provide an adequate outcome is to perform corneal topography before and after placing the lens on the eye. By looking at the irregularity indexes such 10

Fig 1: Global contact lens survey 2022 by Eurolens Research8, - red indicates rigid lenses (corneal and scleral), orange orthokeratology.

as the I-S value (analyzing the corneal differences inferiorly and superiorly), the SAI (surface asymmetry index) and SRI

makes sense to look to the right side of the graph, as the sagittal

(surface regularity index), one can get a good sense of the

height of a keratoconic eye is greater than in normal eyes. The

potential improvement for the various options. Here, four steps

graph in figure 2 shows the daily disposables, but there are also

or ‘bases’ are defined to optimally achieve this goal.

graphs for reusable lenses and for toric lenses. The toric lens sagittal depth graph shows that toric lenses typically can offer

BASE 1 – STANDARD SOFT LENSES

slightly higher sagittal depth values (about 150 microns extra),

As a first option, standard soft lenses can and should be considered

which can be a good tool to achieve an acceptable lens fit (especially

for the mild irregular cornea. In terms of lens fit, we have better

when an astigmatic correction is desired anyway). These standard

understanding of that now than ever before. By looking at the

lenses do not offer anything special in terms of masking corneal

Pacific University soft lens sagittal depth charts,11 (Fig. 2) one

irregularities. Normally these lenses are molded. Lathe-cut lenses

can see that there are considerable differences between ‘flat’ and

can be somewhat thicker than molded lenses, though, which in

‘steep’ (or shallow and deep) lenses. In cases of keratoconus, it

theory could make a small difference (daily disposable and

SPHERICAL DAILY DISPOSABLE LENSES 4,100

CATEGORY

1

4,000

3,900

4,009

16 LENS TYPES

3,912 3,861

3,877

3,792

3,800 3,743 3,700

3,700

3,588

3,600

3,500

3,468

3,469

3,756

3,764

3,706

3,595

3,479

3,398

3,400

3,300

600 micron

3,200

3,100

3,000

1-Day AV Trueye 1-Day AV Moist 1-Day AV Oasys (9.0/14.2) (9.0/14.2) (9.0/14.3)

Dailies Aqua Com fort Plus (8.7/14.0)

Clariti 1 Day (8.6/14.1)

Miru 1 Day (8.6/14.2)

Biotru e 1 Day 1-Day AV Trueye Pro clear 1 Day Infuse (8.6/14.2) 1-Day AV Moist 1-Day AV Oasys (8.6/14.2) (8.5/14.2) (8.7/14.2) (8.5/14.2) (8.5/14.3)

Miru 1 Day (8.4/14.2)

MyDay Daily Disposab le (8.4/14.2)

Dailies Total 1 (8.5/14.1)

Precision 1 (8.3/14.2)

Fig 2: Sagittal depth values of a 16 different daily disposable lenses.11 GlobalCONTACT 1-23

22_Eef Article.indd 23

23

12.04.23 19:49

FITTING BACKGROUND

Fig 3: Ocular surface with high OC-SAG (4173 microns), which is outside the 1 standard deviation range of the normal eye (not-keratoconus). Courtesy Gerard Smits – Ralph Optiek, Amsterdam (The Netherlands)

monthly replacement molded lenses are often in the 80-micron

from center to periphery, they also can incorporate “toricity”

thickness range for a 3D lens, lathe-cut monthly and quarterly

and more complex shape characteristics on the back surface

lenses are often 100 microns or more thick for that power,

of the lens. Some of these lenses use tangential peripheral

depending on the material used) – but maybe not as much as

shapes, in line with scleral lens fitting characteristics. In essence,

you might expect.

soft lens fitting is not that different from fitting a scleral lens, using sagittal heights and (as in scleral lens fitting) allowing

BASE 2 – EXTENDED PARAMETER RANGE

for a “clearance” between the ocular surface and the lens (the

Step two in this cascade of soft lens fitting for the irregular

delta-SAG). The main difference here is that the soft lens flexes

cornea, and specifically for keratoconus, are lenses that have

and conforms to the shape of the eye because of the nature of

expanded parameters for diameter, base curve and power

the (soft) material. Special optics can be applied to the front of

options (no limitations for toric prescription, etc). These lenses

these lenses to, in theory, upgrade the visual performance.

are lathe-cut (see remark on slightly higher center thickness

Other than that, these lenses are of normal center thickness

of these lenses). For eyes that are particularly steep (stage 2 or

in line with other lathe-cut lenses – although alterations in

3 keratoconus) or flat (post-refractive surgery and often post-

lens thickness should be easily applicable. These lenses can be

graft as well), these lenses can be a welcome addition to the

made in silicone hydrogel materials, and some are offered as

arsenal of options available to contact lens practitioners in

monthly disposable lenses.

terms of lens fit. Our calculations have indicated that eyes with a sagittal height (OC-SAG measured in the horizontal meridian

BASE 4 – KERATOCONUS LENSES

and over a 15mm chord) outside the range of 3500 to

If “bases 1-3” do not provide satisfactory results, there is always

4000 microns (one standard deviation from the normal eye,

base 4: soft specialty lenses for keratoconus (Fig 4). These are

figure 3) could theoretically benefit from these lenses. Again,

specifically designed for the purpose, with the main characteristic

there are no special thickness considerations other than that

that they are thicker over the optical zone compared to normal

the lenses are lathe-cut and by default have slightly greater

lenses and are usually indicated for quarterly replacement. The

center thickness compared to molded lenses.

thickness of these lenses is typically in the 300-500 micron range, varying with lens design. Some soft keratoconus lens

24

22_Eef Article.indd 24

BASE 3 – CUSTOM-MADE LENSES

designs feature sagittal height adjustments in 100-micron

The relatively new “kids on the block” are truly custom-made

increments to accommodate the amount of corneal irregularity

lenses based on corneal topography. These lenses not only better

if needed. In their new book “Keratoconus,” Melissa Barnett

follow the shape of the ocular surface in a circular manner

et al have listed all soft lenses for the condition (chapter 21, GlobalCONTACT 1-23

12.04.23 19:49

FITTING BACKGROUND

table 21.3): 15 lenses from different manufacturers. This is a hot topic apparently, as new soft lenses for keratoconus keep emerging. Newer lens designs feature improvements such as front-surface spherical aberration control, sagittal height fitting processes, and segment management control (one or more segments can be ordered flatter or steeper).

While these lenses keep improving, eyecare practitioners need to be fully aware that they can be three times the thickness of standard lenses, and oxygen transmissibility (despite the use of silicone hydrogel materials) can be significantly reduced, so potential complications of hypoxia need to be monitored for closely. In addition, as these are quarterly replacement lenses, extra attention toward lens care and hygiene is warranted. On

LET’S BRING SOFT LENSES FOR THE IRREGULAR CORNEA HOME AGAIN. COVERING FOUR BASES, THIS COULD EASILY BE A HOME RUN

the future “wish-list” for sure are newer materials with higher oxygen permeability and improved manufacturing techniques (other than lathe-cut) to further enhance this modality.

CLOSING REMARKS In our field, we try as much as possible to make sure our work is evidence-based. But not everything in the specialty lens field can be “proven”. Evidence-based practice, by the way, does not mean that everything is required to be scientifically backed up by the literature. Evidence-based practice is defined as “a combination of the literature, clinical experience, and patient values”. And most likely, soft lenses fare well in these last two categories. At the end of the day, it is about patient satisfaction. And if a soft lens provides satisfactory results, that option should not be overlooked. Simple is sometimes better. Or, as the title of a poster and presentation by Sydney Krisa et al from Massachusetts Eye & Ear Infirmary (US) at the recent GSLS 2023 read: “your weapon of choice in early keratoconus and mild corneal scars: soft toric lenses”.13 Let’s bring soft lenses for the irregular cornea home again. Covering four bases, this could potentially be a home run for many patients. n

Fig 4: Example of a specialty (“base 4”) keratoconus lens on the eye. Courtesy Thibaut Syre (France)

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References 1 Morgan P, Efron N, et al. International Contact Lens Prescribing 2022. Contact Lens Spectrum, January 2023: 28-35.

2 Schornack MM, Fogt J, Nau A, Nau CB, Harthan JS, Cao D, Shorter E. Scleral lens prescription and management practices: Emerging consensus. Cont Lens Anterior Eye. 2023 Feb;46(1):101501.

3 Godefrooij DA, de Wit GA, Uiterwaal CS, Imhof SM, Wisse RP. Age-specific Incidence and Prevalence of Keratoconus: A Nationwide Registration Study. Am J Ophthalmol.

2017 Mar;175:169-172.

4 Staff RO. Middle Easterners Rank High for Keratoconus. Review of Optometry, Nov 2018 5 Godefrooij DA, de Wit GA, Uiterwaal CS, Imhof SM, Wisse RP. Age-specific Incidence and Prevalence of Keratoconus: A Nationwide Registration Study. Am J Ophthalmol.

2017 Mar;175:169-172.

6 Nattis AS, Rosenberg ED, Donnenfeld ED. One-year visual and astigmatic outcomes of keratoconus patients following sequential crosslinking and topography-guided surface ablation: the TOPOLINK study. J Cataract Refract Surg. 2020 Apr;46(4):507-516.

7 Gelles JD. Cornea and Laser Eye Institute-Hersh Vision Group and CLEI Center for Keratoconus, Teaneck, NJ; and Department of Ophthalmology, Rutgers-New Jersey Medical School, Newark, NJ. Personal communication.

8 Morgan P, Efron N, et al. International Contact Lens Prescribing 2022. Contact Lens Spectrum, January 2023: 28-35.

9 Visser ES et al. Objective and subjective evaluation of the performance of medical contact lenses fitted using a contact lens selection algorithm. Cont Lens Anterior Eye. 2016 Aug;39(4):298-306.

10 De Vecht A, Schut B. Top(o)tips voor de contactlens- en optometriepraktijk. Webinar.

Oct 10, 2022.

11 Van der Worp E, Lampa M, Kinoshita B, Fujimoto MJ, Coldrick BJ, Caroline PJ. Variation in sag values in daily disposable, reusable and toric soft contact lenses. Cont Lens Anterior Eye. Jan 2021 (44) 101386.

12 Barnett, Lee, Mannis. Non-surgical management of keratoconus. In ‘Keratonus’, Izquierdo, Henriquez, Mark Mannis (Eds) 2022. ISBN: 9780323759786 13 Krisa S, Deakins I, Watts A. Your Weapon of Choice in Early Keratoconus and Mild Corneal Scars: Soft Toric Lenses. Poster #103 & Rapid-Fire Session GSLS 2023 Las Vegas (US)

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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FITTING BACKGROUND

Imaging Techniques Photo presentation: Students present their findings

Photographers Katharina Radovčić & Gina Hüsemann (HFAK, Cologne, Germany)

What can be seen here?

1

Superficial punctate in the lower corneal area due to incomplete blinking, colored with fluorescein.

Imaging technique Slit Lamp (Haag-Streit BQ 900, Koeniz, Schweiz) Figure 1: Diffuse illumination, 6.3 x magnification Figure 2: Fluorescence observation, 16 x magnification Figure 3+4: Optical slit, 16 x magnification

Finding During routine examination of the anterior segment of the eye of a

2

patient (female, 25 years), inspection of the cornea reveals defects in the inferior region of the cornea. A general overview initially shows an inconspicuous eye (Fig. 1).

In the next step, the tear film is colored with fluorescein to view confluent specks as well as individual specks under blue illumination with a yellow filter (Fig. 2). If the defects are only in the epithelial layer, they can heal again.

In addition, when viewed with fluorescence, a separating edge becomes visible. This dark edge is associated with an incomplete blink.

An incomplete blink prevents sufficient wetting of the cornea, which is why the inked tear film cannot be optimally distributed.

3

Characteristics Due to the poorly lubricated cornea, slight lesions may also occur. Two scars are made visible with the optical slit (Fig. 3).

Due to the permanent dryness, the cornea experiences a permanent lack of oxygen supply (hypoxia), which is why blood vessels for oxygen supply already grow into the cornea (Fig. 4).

Further procedure The patient is recommended to use eye drops with hyaluron to support

4

the healing process of the surface defects. In addition, eyelid blink training can serve as another possible measure to improve the lubrication of the cornea and thus improve the oxygen supply to the cornea.

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12.04.23 00:01

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12.04.23 13:24

FITTING BACKGROUND

Visual performance of Ortho-K and LASIK patients – with regard to legal requirements of driver license in comparison to a normal population in Germany The so called fitness to drive related to vision isn´t harmonized. The visual standards for driving vary across European countries from a visual acuity (VA) of 0.5 to 1.0. Different systems and protocols are in place to screen drivers’ vision both for acquisition and renewal of driving licenses. The ECOO (The European Council of Optometry and Optics) reported those differences in a consensus paper published in 2017.1 For a regular car driving license a candidate should reach a monocular VA of 0.7 and a binocular VA of 1.0 at a vision screening. The majority of candidates are in the age group around 18 years and the measurements are typically conducted by a qualified optician using standardized vision tests. It is documented if the test result is achieved with or without visual aid. However, it is not requested to ask for or to document, which kind of visual aid was used if this was the case. It is also not intended to ask if a screening candidate has a history of refractive surgery such as Lasik. This unregulated situation results in an insufficient documentation, which becomes also visible for orthokeratology contact lens wearers. The screening candidate performs and may pass the test without contact lenses on eye but needs them during the night to achieve the Ortho-K effect. The investigators are unsure if they should document that the test is performed with or without the usage of a visual aid. This counts for the case, that they are aware that the screening candidate is using Ortho-K lenses which must not be, because there is a free choice where the vision test is performed. By Wolfgang Sickenberger and Sebastian Marx

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FITTING BACKGROUND

Beside these regulative issues, it has to be mentioned that the vision of a person who passed the vision screening test to achieve the fitness to drive, will for sure change during the life time period.

In some Asian countries and some European countries like Italy a repeated vision screening test is mandatory in specific time intervals. There is no duty to repeat a vision screening test in Europe for car and motorcycle drivers in general. For the group of Ortho-K lens wearers it was controversially discussed if they may drive at all due to the reversible nature of the procedure.

Non-controlled orthokeratology studies showed a stable condition after the initial adaptation in the case of a correct use of the lenses. 2,3,4 In order to create a scientific basis to conduct a fair discussion a retrospective study was performed5 by ophthalmologists

FOR THE GROUP OF ORTHO-K LENS WEARERS IT WAS CONTROVERSIALLY DISCUSSED IF THEY MAY DRIVE AT ALL DUE TO THE REVERSIBLE NATURE OF THE PROCEDURE.

and optometrists taking into account the German Driving Permit Ordinance (FeV) and the recommendations of the German Ophthalmological Society (DOG).6 GlobalCONTACT 1-23

00_Marx_4P.indd 29

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FITTING BACKGROUND

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00_Marx_4P.indd 30

STUDY CONTENT

and Ortho-K treats not the entire cornea but an ametropia

This following section reflects the key elements of a peer

specific central part. The low luminance level at night leads

reviewed publication. In this mentioned study the fitness to

to increased pupil size, maybe bigger than the treated area,

drive of Ortho-K users and LASIK patients were compared

which may potentially compromise vision under night driving

to an emmetropic population divided into two age groups.

conditions. In addition, the personal evaluation of vision and

In addition to photopic VA as well as vision under mesopic

satisfaction of the subjects were captured by the questionnaire

condition was assessed with and without glare according the

NEI‑RQL‑42.

FeV and DOG guidelines.

Following mean VA values were yielded: 0.05 ± 0.14 logMAR

Overall, 333 eyes of 167 subjects were assessed. 65 subjects were

for the LASIK group, -0.05 ± 0.14 logMAR for the reference

habitual wearers of orthokeratology contact lenses and 60

group and 0.05 ± 0.14 logMAR for the Ortho-K group. A VA

subjects were treated by LASIK. All of them had a pre-treatment

of +0.05 logMAR corresponds to a decimal value of 0.89 and

VA of more than 0.7 and both groups showed a similar mean

a VA of -0.05 logMAR corresponds to 1.12. The pass rate pass

value of pre-treatment ametropia. A reference group with 42

rate according recommended test criteria of the German

subjects used glasses, contact lenses or none of them if they

Ophthalmological Society using contrast a ratio 1:5 with and

were emmetropic. The follow-up time was 22.8 ± 11.9 months.

without glare should following results for the three groups:

It can be mentioned that the data for the Ortho-K users was

71.7% for the LASIK group, 95.2% for the reference group and

captured six to eight hours post lens removal at the day of the

92.3% for the Ortho-K group. The subjective evaluation of the

follow up visit. The measurement of the visual acuity was

visual performance is displayed in figure 1. It shows a similar

based on DIN standard 58220 part 3 and the ISO standard

evaluation with small differences among the groups.

8596. The Mesotest II (Oculus Optikgeräte, Wetzlar) was used

In conclusion the study investigators found no clinical relevant

for testing contrast sensitivity under mesopic conditions and

VA difference between the Ortho-K and the Lasik group. The

glare contrast sensitivity. This was of interest because LASIK

results of this study show on a secured level that, from the point GlobalCONTACT 1-23

12.04.23 19:00

FITTING BACKGROUND

Fig 1: Subjective evaluation of vision

of view of the legal requirements (FeV), 3 out of 4 persons in all comparison groups are fit to drive. This stands in line with previous studies on conventionally corrected test subjects. The Mesotest II results showed high pass rates in all test groups.

Similar subjective findings of RQL-42 questionnaire across all groups were captured that shows that neither the LASIK patients nor the Ortho-K users feel more compromises than the nontreated reference group.

CONCLUSION Overall this study showed that the visual performance of LASIK and Ortho-K correction is on a comparable high level compared to normal population. There are no significant limitations of the driving ability in OK and Lasik groups in the sense of the driving license ordinance. Interestingly the senior age group (over 40) of the normal population showed the highest numbers of visual limitations for achieving the driver license! However,

5 Uthoff, D.; Hebestedt, K.; Duncker, G.; Sickenberger, H.: Multizentrische Studie zur Fahreignungsbegutachtung von LASIK- und Orthokeratologie-Patienten im Vergleich zu konventionell korrigierten Personen, Klinische Monatsblätter für Augenheilkunde 2013; 230(03): 255 – 264, DOI: 10.1055/s-0032-1328253 6 Deutsche Ophthalmologische Gesellschaft e.V. Empfehlungen der Deutschen Ophthalmologischen Gesellschaft und des Berufverbandes der Augenärzte Deutschlands zur Fahreignungsbegutachtung im Straßenverkehr, 5. Aufl., 2011. Im Internet: http://www.dog.org/wp-content/uploads/2009/09/Empfehlungsschrift2011-endversion.pdf; Stand:09. 12. 2011

Wolfgang Sickenberger is Professor of Physiological Optics at the Ernst Abbe University of Applied Sciences in Jena. He has headed the Optometry / Ophthalmotechnology / Vision Science program there since 2004. In 2005 he founded the research institute JENVIS Research. His teaching and research focus is on optometry, sports vision, contactology and dry eye. In addition to numerous international and national lectures and publications, he is also internationally known as a technical book author. He is the recipient of various national and international awards and honors.

there is still a current need for a better regulation in order to close gaps. n

References 1 https://www.ecoo.info/wp-content/uploads/2017/01/Visual-Standards-for-Drivingin-Europe-Consensus-Paper-January-2017....pdf, available on 10th February 2023 2 Berke, A.; Starfinger, A.: Erfahrungen mit 24 Monaten Orthokerotologie; Die Kontaktlinse 12/2004; pages 05-10 3 Berke, A.; Bruckmann, P.: Veränderungen der Hornhaut nach Orthokeratologie; Optometrie 02/2003; pages 20-25 4 Berke, A; Schulze, A.: Tageszeitliche Veränderungen von Sehschärfe und sphärischem Äquivalent unter Berücksichtigung der Fahrerlaubnis-Verordnung; Optometrie 03/2005; pages 02-06

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00_Marx_4P.indd 31

Sebastian Marx is a graduate of the Ernst Abbe University in Jena. Since 2005 he has been working at the research institute JENVIS Research, where he is responsible for project development and coordination. He is a member of the International Association of Contact Lens Lecturers IACLE. Since 2006 he has been a lecturer at the FH-Jena and in 2009 he also took over the responsibility at Jenalens Kontaktlinsenstudio. Sebastian Marx is author of professional articles and speaker at national and international congresses and was awarded the Peter-Abel Research Prize in 2010 together with the team of JENVIS Research. He obtained the PhD degree in Biophysics from the Faculty of Physics, Sofia University.

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12.04.23 19:00

HISTORY

Casting glasses Compensation for irregular corneas Towards the end of the 17th century, it was already known that optical errors of the eye, caused for example by irregularities of the corneal contour, could be compensated for by putting the head in a water-filled glass sphere. Technically, this could be done, but in practice it could hardly be sustained for any length of time. Nevertheless, the principle of the contact lens is ultimately based on this basic y Hans-Walter Roth idea, which originated with Leonardo da Vinci. B

32

32_Roth.indd 32

It was not until it became possible to wear small glass bowls

bowls, however, it was necessary to largely adapt the inner

on a f luid cushion directly on the eye that it was possible to

surface of the glass sheet to the anterior surface of the cornea.

create a homogeneous retinal image, for example in the

Air bubbles in the tear film caused mechanical as well as

presence of corneal scars. For compensation with small glass

optical irritation, at the same time they acted like foreign GlobalCONTACT 1-23

12.04.23 19:52

RZ_AZ !AZ.ind

HISTORY

bodies and lead to stray light. In order to achieve the most

keratoconus patients or accident victims were saved from

accurate possible template for the manufacture of such

blindness. Today, computer-controlled corneal topography

"contact glasses", a special sensitive casting technique was

allows corneal astigmatism to be detected with high precision

required. The conjunctiva, cornea and sclera had to be

and the optimal base curve of the contact lens to be calculated

precisely molded. Initially, plaster was used for this purpose,

from this.

but it caused massive irritation to the eye. Only the use of

This small box with different sized molds comes from the

plastic-based impression materials, developed for dentists,

company Müller-Welt in Stuttgart, Germany. Not all of them

led to a useful result, although not all plastics proved to be

are still preserved; one or the other may have broken during

compatible with the eye.

the procedure. The box belonged to the workplace of a leading

In the laboratory, the cast was carefully covered with plaster

Stuttgart ophthalmologist from the pre-war period, his

so that a copy of the anterior eye contour was created. This

descendants now donated it to the collection on the history

was now used as a mold for the inner surface or base of the

of the eye and vision. n

contact lens. For this purpose, the molds were covered with a glass melt, after cooling the edges were reduced to the desired lens diameter and the refraction, if necessary, was ground into the front surface of the lens.

The decisive breakthrough in contact optics came when Plexiglas became the first transparent plastic on the market.

Now it was sufficient to heat the mold and press a PMMA disk over it. After cooling, this could then be easily reworked on the lathe. For decades, this method was a leader in the

Dr. Hans-Walter Roth, Ophthalmologist and Director of the Contact Lens Research Institute in Ulm, Germany, is the author of numerous publications and books on the physiology of the contact lens and the history of eyesight. He is a city councilor of the city of Ulm, specializing in education, social affairs, art and culture. He is also the founder of the Ulm Hospital for the Poor..

treatment of irregular corneal anterior surfaces, and countless

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27.02.2023 11:22:59 12.04.23 02.03.23 19:52 11:44

BUSINESS+MARKETING

High quality data – for successful AI projects and positive corporate culture Artificial Intelligence (AI) is still considered a promising technology that can drive the innovation engine. Many areas, such as medicine and healthcare, but also trade, transport, industry and administration, are finding revolutionary uses for AI. Expectations for AI are high; after all, innovative courage wants to be rewarded. The "Future of Health" study by Roland Berger[1] shows: AI as a technology is predicted to cause the greatest impact in healthcare by 2026, closely followed by sensor-based monitoring, which can also lead to even more accurate analyses with the help of AI. B y Elena Fomenko

Analytics are already scoring high on expectations, such as for

and accuracy of the respective systems perform. Various factors

screening and diagnosis. However, there is a number of obstacles

influence this, such as the respective configuration, the amount

along the way that need to be overcome if the data project is

and distribution of the training and test data, or the frequency

not to end with insufficient insights and thus disillusionment.

of the tests (epochs). From the observations of the tests,

The key is good data quality.

conclusions can be drawn as to which model type best fits the predefined question.

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34_DataQuality.indd 34

PREPARATION IS EVERYTHING

However, the systems and also their analyses can only be as

The course for success is already set during planning before

good as the underlying data basis, the definition of the problem

the start of the actual AI project. The problem has to be defined

in connection with the selected model. The underlying

in as much detail as possible, just like the goal, because: The

algorithms are developed by humans who are subject to cognitive

problem definition determines the AI model. Within the model

biases or prejudices. These algorithms, in turn, are presented

type, it is usually necessary to experiment between different

with data sets for training, which have also been selected by

model instances so that the best model emerges. The model

people who are not free from prejudice and value, and patterns

can then be trained and thus it forms the technical core of any

are derived from them. This "bias" can lead to limited analyses,

AI system. There are already existing systems that can be used,

or even to discriminatory or racist results. Everything that the

but companies can also create their own models. It can also be

AI is supposed to learn must be taught to it based on the training

useful to test in advance with different models how the prediction

data – and since, for example, the development team is not GlobalCONTACT 1-23

12.04.23 19:53

BUSINESS+MARKETING

always diverse and thus brings in different aspects, special care

influencing factors and training parameters. A third option

must be taken here.

would be to use synthetic, i.e. generated data.

CREATING A SOLID DATABASE STEP BY STEP

REAL VS. GENERATED DATA

Data is therefore the critical foundation for the success of

If real, personal data is required for the project, the training

any AI project. When selecting test and training data, project

and test data must be anonymized and pseudonymized. Project

managers must ask themselves three questions: What data

managers must then carefully check whether the data modified

and in what quality do I need for my use case? Which data

in this way is still meaningful enough for training. When

and data sources are available to me? What additional data

collecting new data, the permission of the respective person

do I need?

could be obtained in accordance with the relevant data

If the data is not yet available, it must be collected again within

protection regulation (e.g., GDPR in Europe). Collaboration

a specified period or obtained from external sources, such as

with project partners and the use of the cloud for data storage

open-source sites or so-called data marketplaces. Data protection

require special attention in terms of data protection. If

aspects must of course be taken into account.

companies make use of synthetic data, they have to be correctly

There is also the option of selecting models that can be trained

distributed according to the problem and map a representative

with little data – however, this requires the support of data

cross-section of the real data to be expected. Once the AI has

scientists who have the appropriate knowledge of models,

been trained with synthetic data, the step into application with

GlobalCONTACT 1-23

34_DataQuality.indd 35

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BUSINESS+MARKETING

real data requires close validation and monitoring. The guiding

AI systems should therefore always have cleansed data in the

principle "The AI can only learn from the fed data and patterns!"

correct format so that they produce correct results.

must always remain in mind to avoid negative learning effects.

PUBLIC VS. PRIVATE CLOUD QUALITY OF THE TEST AND TRAINING DATA

An AI project also involves deciding whether the computationally

The data provided to the AI for learning must always be of high

intensive data volume should be hosted on premise in the data

quality, regardless of whether it is real or synthetic. "Crap-in/

center or in the cloud, and then whether it should be a public

crap-out" applies to every intelligent and smart system – with

or private cloud. External experts can be called in more easily

faulty and incorrect data, only unreliable or incomprehensible

for the public cloud and the computing power can be scaled

results can emerge. The merging of the data is in itself important;

more quickly. Yet, gut feeling is often still the deciding factor,

this is referred to as the ETL process, short for Extract, Transform,

with machine and sensor data being regarded as less critical

and Load. The following criteria can be applied to data quality:

in a public cloud, while personal data is supposedly better protected in the private cloud. However, security must be

• Completeness.

guaranteed in both variants, gut feeling or not.

This refers to various dimensions. Data sets are considered complete when content and data have been completely

THE RIGHT EXPERTISE, THE RIGHT ROLES

transferred in an ETL process. Representation of completeness

Another common misconception about AI projects is that they

is based on the company's business rules.

are purely technological. It is not enough for IT and contracted service providers to set up a turnkey system and the rest runs

• Correctness.

If the data set matches reality, it is considered correct.

by itself. Project managers can get the necessary expertise on models, AI systems or tools from outside, but they must have experts in-house who at least have an understanding of the

• Consistency.

training data and the interpretation of results. It is often

A data set must not have any logical contradictions within

necessary to break up outdated data structures in order to

itself or with other data sets within a data source.

access all data and improve data quality. It often turns into a real change project, because then not only data silos but also

• Uniqueness.

deeply rooted processes have to be torn down and restructured.

If the (real) objects described by the data set are represented

Data quality must not be the responsibility of just one abstract

only once, they are considered unique.

person or group in a department, but of a data or information owner. The decisive factor here is that data quality assurance

• Conformity.

The data conforms to the defined format.

is not regarded as an "on-top" task, but is recognized as a promising and business-critical foundation. It is therefore also about changes in the corporate culture and the definition of

• Validity.

The data corresponds to the defined value ranges.

common goals. The need for action becomes clear in the specific AI project, but it has an impact on the entire company.

Companies should see AI projects as a creative process that

Potential sources of error may include:

takes time and resources, but can also drive innovation and

• • • • • •

be profitable for the team and the company. n

Zero values Outliers Duplicates

[1] ht tps://content.rola ndberger.com/hubfs/07_presse/R B _

Incorrect spellings

PUB_21_003_FOC_Future_of_Health3_E_ONLINE.pdf

Multiple languages Semantic problems

However, there are rules that can be used to determine and improve the quality of the data. Formal technical rules can be implemented in the software to check whether the data set is complete by means of a simple formula. In terms of content, plausibility checks provide support as early as the input stage by preventing incorrect entries.

Data quality tools can also help to clean up duplicates, for example, or to avoid address errors when entering customer data.

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Elena Fomenko is a senior data scientist and data thinking exper t at Detecon International’s Digital Engineering Center.

Her mission is to lead and support clients from various industries in successful datadriven product development. She has a unique combination of technical skills in data science and extensive experience in conceptual development of innovative products. Prior to Detecon, she worked at Telekom Innovation Laboratories in the Smart Data Analytics team and at T-Systems in the IoT Analytics team.

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BUSINESS+MARKETING

Setting priorities Targeted and always one after another You know the problem that the tasks grow over your head and you have the feeling that you are doing lots of things, but there is no land in sight. In order not to sink in the sea of many challenges, there is only one option: you have to set priorities. In doing so, you need to keep your goals in mind and incorporate them into a time management system. But self-discipline is also indispensable. By Hartmut Fischer

DO NOT LET EMOTIONS RULE

THE KEY FACTORS

There are tasks that no one likes to do and therefore puts them

The prioritization of tasks is based on two key factors: time

on the back burner. This leads to such tasks ending up at the

and money. This is relatively easy if the tasks can be freely

bottom of the priority list. Prioritization influenced by emotions

planned and can be dispensed with without jeopardizing

in this way does not lead to success in the most effective way

business operations (possibly for the time being).

– in many cases it even leads to a dead end. That's why you

It is difficult when a goal is set that is indispensable for the

should check at every step whether you were guided by facts

company. In this case, it must be clarified in advance whether

or by emotions. Because ultimately, the time factor – which

the financial resources are available or whether the company

cannot usually be influenced – and your own free evaluation

can handle corresponding external financing. If this is not the

determine the prioritization.

case, savings potential must be sought elsewhere.

In addition, there are tasks that are completed as part of the daily

Even if the task is of existential importance to your business,

routine without questioning their importance. When you tackle

you should not put yourself under time pressure. Processes

the topic of "working more effectively", you should first evaluate

that are completed in a hurry almost always do not lead to the

all recurring, unexamined tasks according to their importance.

goal, but to unnecessary costs.

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TASK IMPORTANT

YES

TASK URGENT?

YES

PRIORITY A: IMMEDIATELY, DO IT YOURSELF

NO NO PRIORITY B: TAKE CARE OF LATER, DELEGATE

TASK URGENT

A-B-C-METHOD NO

PRIORITY C: DELEGATE

AGREEING ON BINDING PRIORITIES

At the top of the list are the tasks that play the biggest role in

To get a project done by a group, you need to set binding

achieving the goals. If prerequisites are necessary for this that

priorities in a schedule. It is crucial for success that everyone

still have to be created, these naturally have priority. Often, one

adheres to this specification. You should therefore create a

particularly important aspect is not sufficiently illuminated:

priority instruction that shows when certain work will start,

Feasibility. If it only becomes apparent during the ongoing process

be completed and who is responsible for it. Particularly in the

that the tasks are not feasible or represent too high a risk for

case of longer processes, it is important that you regularly

operations, a lot of time and effort has been invested without the

monitor compliance with the agreed deadlines.

goal being achieved. This results in unnecessary costs that could have been avoided with a realistic implementation check.

TIME AND EXPERTISE When you set priorities, it doesn't just mean setting a timeline.

You also have to determine which employee has the necessary competence to solve the task delegated to him. If the employee is not able to complete the requirements placed on him or her in the desired time, it is not only your priority plan that will fail. It can quickly happen that the employee – who is otherwise so important for the company – is demotivated by the perceived

THE PRIORITIZATION OF TASKS IS BASED ON TWO KEY FACTORS: TIME AND MONEY.

"failure" and thus slackens altogether.

During a process, the bases on which the prioritization was made may change. For longer-term processes, you should

DAILY ROUTINE ORGANIZED QUICKLY

therefore check at regular intervals whether the basis on which

The first prioritization is the daily agenda. Here are the various

you set the priorities has changed and whether an adjustment

tasks that need to be done independently, that are evaluated

of your prioritization is necessary.

and timed. If possible, put all tasks to the test. Especially the daily recurring activities are often done "automatically" without

38

37_Fischer.indd 38

GOAL ORIENTED

evaluating them according to their importance or necessity.

The priorities of a task are always based on the set goal.

For the evaluation of the daily routines one uses often the "ABC

It is therefore important that you describe this goal in

method". This involves determining what you will do yourself

as much detail as possible. In most cases, the individual

immediately (priority A), what can be done later or delegated

tasks that you need to prioritize already follow from

(priority B) and what will definitely be delegated (priority C).

this description.

Proceed according to the following scheme.

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BUSINESS+MARKETING

What you can delegate depends largely on the staff to whom

outside capital, the question arises as to whether the planned

you can delegate. The level of information of the individual

course of action is sensible and, above all, purposeful (see

employees plays at least as important a role as their skills.

intermediate step). If alternatives are available, compare them.

Therefore, consider whether it makes sense to hold regular

In doing so, you should also bear in mind that it may make

meetings to exchange information. The better informed your

sense to cut back on the defined target if this means that the

employees are, the more you can delegate to your staff.

liquidity of your business can be protected.

Step 3: Chronological order After you have clarified necessity and funding, you put the

THE FIRST PRIORITIZATION IS THE DAILY AGENDA.

individual steps in chronological order. You start with the goal and then proceed backwards. Since you cannot yet foresee how long it will take to work through the entire process, mark the goal with 0 and calculate backwards in days: goal = 0, measure 10 = 0-3, measure 9 = measure 10-2, measure 8= measure 9-1, etc. would be an example.

The various steps of a project are linked to each other. One task

PRIORITIZING PROJECTS

can only be completed when another has already been completed.

Projects are also about the effective achievement of goals.

To create a structure, you therefore need to break down the

However, an acquisition in itself does not represent a goal. The

individual tasks as much as possible to create the flow.

goal is, for example, to increase sales in a certain segment. In

However, you do not have to go into the last detail if the task

this context, an acquisition would be one way of achieving the

is delegated as a block. For example, if a room is to be expanded

goal. An alternative could also be, for example, the streamlining

and an adjoining room has to be painted for this purpose, you

of processes (lean management).

specify by when a decision must be made as to which painter will do it and by when he must have completed the work.

Step 1: Goal description

To complete the timeline prioritization, ask yourself the

Before you go to the actual prioritization, you should precisely

following questions about each task:

define and determine the goal. Then check whether the financial and human resources are available to achieve the goal. If not,

• Is the task absolutely necessary to achieve the goal? If not,

you need to weigh up whether the expected revenues justify

mark this task so that you can perhaps postpone it in favor

additional investments or are justifiable for your business. Only

of a more important task or do without it.

if these prerequisites are given, you determine the details of the target scenario. To do this, note down all the work steps (without prioritizing).

• Where does the task need to be placed in the timeline?

• If this section is occupied in the timeline, check whether the tasks can be processed in parallel in the time period.

If this is not possible, the measure that contributes most to

INTERMEDIATE STEP: WHEN SEVERAL OPTIONS PRESENT THEMSELVES

achieving the goal has priority.

There are often cases when one wants to start projects whose

In this way, you work through measure by measure until you

results are "nice to have". That is why the first question in

have developed the optimum sequence. Since the sequence is

determining financial viability is whether there is an economic

often changed, you should preferably create the list in a

necessity. The long-term perspective must also be considered.

spreadsheet program (e.g. Excel). n

Whether the boom for individual products or brands will continue in the next few years is an open question in the medium to long term. However, the fact that service will play an increasingly important role in the future – not least as a result of internet trading – is almost certain. So whether additional exhibition space makes sense remains an open question.

Investments in staff training and development are likely to have a more positive impact on sales.

Step 2: Financial feasibility

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.

Once you have decided on a project, you need to check whether it can be financed. In particular, when you need to borrow GlobalCONTACT 1-23

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