OPH the RECORD
In this issue: ARTISAN Family 25 years timeline IOL overview ARTISAN/ARTIFLEX vs. ICL and Cachet OPHTEC on Social
media
Find OPHTEC
Is s u e d b y O P H TE C BV | E S C RS Edition 2012 | #8
17 Dr. M. Maita
On the ARTISAN Family
6 Dr. I. Ahmed Every micron makes a difference
8 Dr. S. Fukuoka
Japan: Land of the rising lens
6 ARTISAN Myopia 25 years!
OPHTEC founder Anneke Worst and President and CEO Erik-Jan Worst reflect
ARTISAN PIOL 25 years
We hope to see you at our booth at the ESCRS in Milan, booth # S136
www.ophtec.com
Your Toric IOL should not rotate like the clock. It’s TIME to experience the ONLY Toric IOLs that won’t rotate:
ARTISAN ® & ARTIFLEX ® Toric PIOLs
www.ophtec.com
content 3. ARTISAN® Family Timeline
A historical overview
4. Running a business the Worst way: Never a dull moment
Interview with OPHTEC founder Mrs. Anneke Worst and President & CEO Erik-Jan Worst
6. Every micron makes a difference
Interview with Dr. I. Ahmed
8. Japan: Land of the rising lens
Interview with Dr. S. Fukuoka
11. IOL overview
Dear reader, Twenty five years ago, the first ARTISAN lens for myopia was implanted. Its clinical success has continued to prove itself as one of the world safest,
13. Find OPHTEC / OPHTEC on Social Media
most effective IOL designs, with the broadest application of any IOL design
14. Iris-fixated PIOLs in children
And so, it is with pride that we present our celebratory issue of the
17. ARTISAN® Family
and error, of hope and frustration, of innovation and acceptance, we
Interview with Dr. M. Maita
- phakic, aphakic, pediatric and trauma.
OphTheRecord. A lively company filled to the brim with stories of trial think this issue will inspire you for the future. In short: enjoy!
19. ARTISAN®/ARTIFLEX® vs. ICL & Cachet
ARTISAN Myopia 25th anniversary
Colofon
http://www.youtube.com/ophtecbv
OphTheRecord is published by OPHTEC BV Interviews: Marij Thiecke, Concept & Copy, Haren Editorial: Roelien den Besten, Jérôme Fissiaux, Jim Simms, Anna Bilstra, Gitty Geertsma E-mail: r.den.besten@ophtec.com Graphic design: www.mennoschreuder.nl Print: Scholma Druk, Bedum All rights reserved. © OPHTEC BV 2012 PO Box 398 | 9700 AJ | Groningen | The Netherlands T: +31 50 525 1944 | F: +31 50 525 4386 | www.ophtec.com
ARTISAN® Family Time Line
1986
How did OPHTEC get the idea to produce a special intraocular lens for the correction of myopia, hyperopia and astigmatism? Let’s go on a short tour.
Around 1986 “Radial Keratotomy”, a new technique to correct myopia, was gaining popularity. In one of the Dutch magazines the method of making tiny incisions in the cornea was extensively propagated, but most of the Dutch ophthalmologists heavily criticized the technique. A group of ophthalmologists, participating in the Flaine Implant Meeting, shared a gloomy concern with regards to this new development in Refractive Surgery.
Jan Worst presented a solution. “Refractive errors can be corrected much safer and efficacious by implanting an iris fixated IOL in front of the natural lens. He told his colleagues that he had implanted an occlusion lens in a phakic eye of a patient with incurable double vision. Every year he controlled the natural lens on possible opacities. No problems or side-effects were reported! Yes, naturally an empirical, scientific posture had to be upheld with a this amazing statistic of only one case, but nevertheless,
OPH THE RECORD 3
Running a business the Worst way: ‘Never a dull moment’ An interview with OPHTEC founder Anneke Worst and OPHTEC CEO Erik-Jan Worst ARTISAN Family Time Line Continued Among the members of the Group an inquiry was set up to find out to which requirements such a lens should meet to be acceptable. This information would allow the impatiently waiting OPHTEC technical staff to go ahead with their project. It was shown that correction of -20 diopters could be realized with this product. Good news when compared with the “radial keratotomy” which could not correct more than 5 diopters of myopia.
4 OPH THE RECORD
OPHTEC started making drawings and calculations and succeeded to produce a totally new biconcave lens, meeting the requirements. To guarantee a safe distance to the natural lens and the endothelium, it was decided to recommend an anterior chamber (AC) depth of 3.5 mm.
G.L. van der Heyde of the Free University in Amsterdam developed a formula with which the IOL power could be calculated, based on the corneal curvature, the depth of the anterior chamber and the power of the spectacles to be corrected. It proved to be an essential contribution.
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‘W
hen I met Jan Worst, I knew my life would be filled with creative activity and wonder. I was right. Our life is indeed filled to the brim with amazing discoveries, broad insight, fun, happiness, frustration and success. Boredom was and is simply not an option. Retirement? Not until I’m pushing daisies.’ Anneke Worst, former director, co-pioneer, marketing specialist, ambassador, and enthusiastic generalist has lived together ‘many, many years’ with the man she came to know, respect and love as a creative scholar. Their son, Erik-Jan, has been with OPHTEC since 1992: ‘Was I jumping for joy when asked to join the company? No. My life was already filled with more eye surgeons and innovators with well-meant advice at the kitchen table than I could accommodate for. OPHTEC was not an option. Or so I thought. Yet here I am. And I wouldn’t want it otherwise. I’m proud to say that in 25 years OPHTEC has grown into a true Dutch company, operating globally on a personal basis. We’re here to stay.’
I manned it, making new connections, finding ways to make our business grow. Everything was so simple, so deeply dependent on contents alone.’
Never change the winning concept of iris fixation Mrs. Worst: ‘The OPHTEC history started with instruments and cataract lenses. And then, in 1986, the new myopia lens with iris fixation was born as a concept inside Jan’s head. The lens was developed in our company and ready for use. However, lenses put over natural lenses in otherwise healthy eyes, with only a few sutures to prevent problems initially made Jan hesitant. He stuck to his story and theory though, witnessed the success in the first patients of a colleague while I tried to interest colleagues into performing clinical tests. I think our conviction – sticking to our story - is an important basis for our current success.
‘Retirement? Not until I’m pushing daisies’
How does water work its way up 15 meters of tree? Why adhere to social pressure or conventions? How can we make people see better? Meet Prof. dr. Jan Worst, Anneke Worst’s husband. Known to many as the creative mind always figuring out how things work, from trees to other wonders of nature, say, eyes. With new ideas surfacing preferably at 3 am, says Mrs. Worst, smiling. ‘Unfortunately, Jan Worst is no longer in the front line, but his commitment remains. As does mine. In 2000 we handed over the general management of the company to our son, which makes me proud - yet, when asked, I feel no hesitation whatsoever to be opinioned, to help make OPHTEC grow from the sidelines. I know everything that is going on, and when asked, I open my mouth. This is what drives me and it’s called dedication.’
For instance, our ARTISAN aphakia lens is now the number one backup lens in cataract surgery. So, amidst all novelties, the ‘old ‘claw lens has, to our surprise, become extremely popular. The design, through all modifications, is simple yet perfect. Why make matters more complicated? So: never change the winning concept of iris fixation.’
Relentless energy
Built from scratch and PMMA
When asked about the history of OPHTEC, Mrs. Worst’s eyes immediately brighten: ‘In the beginning, there were no head quarters, a board of directors was not in sight, FDA-approval and worldwide ambassadors were simply not part of our scope. At the onset of the 60s there was our belief, there was relentless energy dedicated to explaining our theories during congresses, and of course there was our booth.
Sticking to your concept is exactly how and why OPHTEC survives between harsh global marketing strategies, sleek brochures, and expensive workshops. Erik-Jan explains: ‘Certainly, more and more people develop cataract or opt for refractive surgery. That fact alone helps our business, of course. Also, I think our medical standards and innovative outlook stand out. And we do have a special factor which greatly
contributes to our success. I think OPHTEC is all about genuine dedicated quality, devoid of empty promises and impersonal sales rallies. When deciding for OPHTEC, you know you join the ‘Worst’ club – no pun intended. How this fact of life exactly works I don’t know. We see to it that we only co-operate with people who think the OPHTEC way, who share the same outlook on the world. People who are in for innovation, for making people see better, for academic discourses on further improvement. No, there is absolutely no need to put that into some glossy mission statement. I feel pride and enthusiasm when talking about ‘the business’ my parents and their colleagues built from scratch and PMMA.’
Rewarding Erik-Jan now manages the innovative firm. ‘We are expanding more and more. We now have a new office in South Korea, and it is amazing that our lenses, my father’s invention, are taking root there. How our expansion strategy works? Well, our eye surgeons work globally. When we feel there is enough chemistry and a professional outlook on matters, we simply start. Of course, our products can only be used by schooled professionals, so the standard we set is very, very high. Also, like I did when I joined the firm, you learn by doing, by asking, by trying to pick the minds of the ‘eye people’. Of course, we need to grow. Our products are fine, but we need to grow into a true customer-oriented company. Also, we are looking into collaborations in more and more countries, as the slow FDA and US apparatus is simply not worth the energy we put into it. So many people in the US would benefit from our lenses, and the FDA rules and regulations are not helping. That is frustrating.’
Go with the flow Erik-Jan concludes: ‘On a personal basis, putting the medical pieces together was not so much the issue. Also, working together with my parents has never been a problem. It more or less went naturally. We tend to go with the flow with our practical, dedicated scholars worldwide. The way we operate, is very rewarding: People tend to be creative, open to co-operation, to innovation. Running a business is not too complex. You simply see to it that your numbers add up. It’s what drives the business, your shared set of beliefs, that helps define success for everyone involved.’
OPH THE RECORD 5
Artisanal science according to Ike Ahmed: Every micron makes a difference ARTISAN Family Time Line Continued
OPHTEC produced a small series of lenses and offered them to Jan Worst, who refused to implant the lenses in healthy eyes. His colleague Fechner from Germany however considered it a brilliant idea and implanted the lenses in both eyes of 7 patients. His patients who had been wearing spectacles varying from -6 dpt to –19 dpt felt on top of the world with the result.
6 OPH THE RECORD
Fechner implanted the first lens of -18 diopters, which was baptized Worst-Fechner Iris Claw lens on the 5th of November 1986. After the first successful implantations, he continued with another 6 patients. A three-month moratorium was then declared to find out how these binocular implantations would develop.
By the end of march 1987 OPHTEC organised a group of 10 Dutch ophthalmologists to visit Fechners hospital and critically examine all 7 patients. The 3 professors Breebaart, Greve and van Rij and the 7 participants of the Flaine ski-meeting were quite sceptical. However, after having examined the patients they couldn’t do but admit that this lens promised a lot of success for the future.
1987
Ike Ahmed is a well-known eye surgeon practicing in Ontario, Canada. He boldly goes where many eye surgeons dare or will not go. His specialty: glaucoma and almost lost cases. Ahmed: ‘In any profession, the ‘why’ behind your ways has to be apparent: to yourself, your colleagues and your patients. It should always be crystal clear why you live, act and work the way you do. I operate on people that sometimes come to me as a last resort. My mission, and that of my colleagues and trainees, lies in making these and other complex cases result in a ‘routine’ outcome. Thus, we perform mini miracles every day and are at the same time humbled by the boundaries of our profession.’ Ahmed has been a practicing eye surgeon for 10 years: ‘From an early age, I knew that being a surgeon was to be my way of life. Beside the atmosphere that seemed very tempting, reconstructing and building with your own hands on the smallest possible scale, with the largest possible impact, seemed ideal to me. And it truly is. For me, being an eye surgeon is a combination of science, art, passion, enthusiasm and intuition. Our field is continuing to develop in many fascinating ways. Automation and new instrumentation makes eye surgery even less invasive and more predictable. This is particularly important in optimizing the results of glaucoma surgery and rebuilding the anterior segment of the eye.’
Why? That’s why! ‘I always try to address the ‘why’ of doing things. Being a teacher definitely keeps me on my toes, and in the operating room I always ask my trainees to challenge conventional wisdom and understand why we are doing this from the small to the big. For example, ‘why I hold my forceps in such and such a way.’ This constant ‘why’ in my mind always helps me along, as well as
the development of new instrumentation. I love being a doctor, and I love engineering new tools that help my patients. I do think that digging deeper in approaching problems is an important success in the management of complex surgical cases. This is also true when a seemingly routine procedure turns out to be complex, or takes an unexpected twist. Understand and handling matters as they come, in a professional and educated way is an important factor in being a good doctor.’
‘The ‘why’ behind your ways has to be apparent’ Humble ‘I see many patients with serious high risk complicated cases who have already consulted 3 or 4 other doctors. They are often debilitated because of the impact of their visual disability, or in some cases the physical appearance of their eye. Also, they are anxious: ‘will this guy be able to help me?’ In many cases of trauma, glaucoma and complex cataracts I know I can help to make a difference. But every day, my colleagues and myself are humbled by cases that are simply not to treat. Delivering that message is difficult. And pushing our profession to develop ways to help these complex patients is also the answer to an important ‘why’ question: why bother developing? That question is answered every single day.’
1989 Jan Worst realized that this surgical intervention could well be a blessing for his patients. He performed his first lens implantation a short time afterwards. Directions for use of the lens were subsequently made: Jan Worst put much emphasis on a proper understanding of the anatomy of the iris. He warned specifically for the use of lenses with fixation in the anterior chamber. And so, in 1989 OPHTEC organised the first training course with wetlab for the lens.
Pioneer ‘So, my colleagues and I keep trying to develop the field. A pioneer in the true sense of the word is, of course, Jan Worst. His iris-fixated ARTISAN lens has been a brilliant innovation for complex eyes and as a phakic IOL platform. Although in general, endocapsular IOL placement is preferred, when capsular support is insufficient, the anterior iris is an excellent place for alternative fixation. This is an AC IOL without angle fixation or sizing issues, and without the challenges of suturing or fixating a PC IOL to the posterior iris or sclera. The iris-claw permits stable fixation of the lens, performed in a very efficient manner with minimal tissue manipulation or suture requirement. I like to use the microforceps to aid in fixation, although many techniques have been described. We have been very pleased with its use in aphakia and in IOL exchange for subluxed IOLs.’
More Study, More Work ‘We have published our techniques and results with the ARTISAN lens, and more multi-center work is being done. Further development of devices and techniques will eventually provide answers to managing complex eyes. For me, the passion never ends.’
Iqbal Ike K. Ahmed, MD Assistant Professor, University of Toronto Clinical Assistant Professor, University of Utah Fellowship Director, Glaucoma & Anterior Segment Surgery (GAASS) Fellowship, University of Toronto Research Fellowship Director, University of Toronto, Department of Ophthalmology and Vision Sciences Credit Valley EyeCare, Mississauga, Ontario
The first publications of Fechner, Worst and van der Heyde appeared that same year and the interest in this phakic lens grew rapidly. We looked critically at the results and discovered one item that needed to be improved: the high rim of the optic. The biconcave lens with high optic was replaced by a lens with a convexconcave optic. This solution would definitively reduce cases of “haloes” and “glare”. Also, the new lens could be made for higher dioptric powers. The new lens was baptized Worst Myopia Claw lens.
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Dr. Fukuoka in action
Japan: Land of the rising lens Sachiko Fukuoka is the general manager of the Tane Memorial Eye Hospital in Osaka, Japan. She also is an avid user of ARTISAN and ARTIFLEX lenses. For Dutch based OPHTEC, more than enough reason to reach out to Osaka, and learn more about Japan from a visual point of view.
8 OPH THE RECORD
B
ecoming an ophthalmologist and the general manager of an eye hospital isn’t something Sachiko Fukuoka dreamt of since kindergarten. ‘I was talked into becoming an eye surgeon by my best friend in college. Yes, I know, that doesn’t sound like my profession was jumpstarted by early age visions or epiphanies. Nevertheless, I have no regrets whatsoever. I love my profession and wouldn’t have it any other way. My patients show me their best smile when a precise procedure by my hand leaves them with perfect or near perfect vision. That is so rewarding. What else can I say!’
High satisfaction
number of surgeries is over 5400 per year. We offer cataract surgery, vitreoretinal surgery, glaucoma surgery, corneal transplantation, refractive surgery, Dacryocysto rhinostomy, ocular plastic surgery, and so on. We have been using the ARTISAN since June, 2010 and the ARTIFLEX since March, 2011.’
Fukuoka continues: ‘For patients, the quality of vision is excellent because of no change of postoperative corneal shape. Also, PMMA causes very clear vision with high satisfaction. The ARTIFLEX IOL is made of silicone, so inflammation may occur in the anterior chamber. However, there are advantages: implantation can be done with small incision with faster operating time, and the stability of the anterior chamber during the procedure is good. Although implantation of an ARTISAN lens involves a large incision, the advantage of having a PMMA lens more than compensates for this slight disadvantage.’
Advantages
What are the advantages of ARTISAN and ARTIFLEX lenses according to Dr. Fukuoka? ‘Well, both lenses can correct high myopia hyperopia, and severe astigmatism that LASIK cannot accommodate for. These lenses are especially reliable to use in cases with astigmatism because the IOLs can be fixed Working in Japan stable on the iris without rotation. Also, A daily reward is important for Fukuoka, anterior chamber phakic IOLs cause much as the system she operates in, is not perfectly fitted to the needs of hard working less cataract because there is sufficient distance between the IOL and the natural female doctors: ‘I think the work environlens. And my list of advantages doesn’t stop. ment is still not well established enough The position of iris-claw anterior chamber for female Japanese doctors to maintain a healthy balance between work and family, IOL is better than that of angle-supported anterior chamber IOL because of the sufficient especially if you have a small child. While distance from the corneal endothelium. the number of female ophthalmologists Moreover, because adverse rotation of the who perform surgeries is on the increase, IOL is barely seen, the IOLs are applicable most female ophthalmologists who have a child to raise are occupied in an ambulatory even in high myopia with astigmatism. The IOLs are also convex-concave, so there practice without performing surgery.’ is a rare possibility to hit the natural lens during the implantation under miotic Allround eye hospital condition. There is very little refractive Fukuoka: ‘One of the largest ophthalmic regression, and the refraction is stable for specialized hospitals in Osaka, the Tane Memorial Eye Hospital opened its doors in a long period. And, with phakic IOLs, there are no risks for postoperative corneal com1988. We have 65 beds, 4 operation rooms plications, like keratoectasia or dry eye, and 19 ophthalmologists. The number of conditions sometimes seen in LASIK.’ outpatients is over 400 per day and the
ARTISAN Family Time Line Continued In 1991 OPHTEC started a European Clinical Study. Prof. van Rij selected Monika Landesz to collect and analyze the data of patients operated by Jan Worst. Her meticulous supervision was highly appreciated by him. She incorporated all the data in her thesis.
No unnecessary tension ‘When it comes to the enclavation needle I used, sometimes I experienced dispersement of pigment cells of iris and the postoperative atrophy or defect of iris pigmentation with using needles or forceps to grasp the iris. Furthermore, during grasping the iris with forceps, if the forceps was moved too much toward the pupil, angle recession or bleeding may occur. With the VacuFix enclavation system, the iris can aspirate without unnecessary tension, so there is no possibility of angle recession, bleeding, and only a rare chance to cause iris atrophy or defect of pigmentation. However, usually Asian people have a small palpebral fissure, so I do think that it might be better to have a smaller VacuFix enclavation system.’
>>
Unfortunately, soon afterwards the company was taken over by a large company and after several merges, which took years of delay, the much anticipated clinical study had not even started. In 1996 we took the important decision to do it ourselves, the OPHTEC way, in the USA. OPHTEC USA Inc was founded and cleared the way to set up a clinical study on our own.
In the meantime OPHTEC made an agreement with the American company IntraOptics in order to set up a clinical study in the USA according to FDA guidelines. The company designed a huge sign for the AAO meeting of that year; WORST MYOPIA CLAW, designed for stable fixation.
1996
1991
In 1997, a group of American ophthalmologists interested in participating in the US clinical study visited the Netherlands to convince themselves of the merits of the Myopia lens and to learn the technique of implantation of iris fixated lenses. It took to 1998 before OPHTEC USA could start the Multicenter Study.
1997
In the meantime, the name ARTISAN was introduced to recognize the abilities of the ophthalmic surgeon perform this special surgery. It seemed a bad idea to go on using the name “Worst” Myopia Claw lens. “Worst”, the worst! Would you believe it!
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OPH THE RECORD 9
Eye surgery in Japan Japan has a universal health system providing relatively equal quality of medical service to everyone. However, this system does not apply to refractive surgery. Patients undergo refractive surgery at their own expense. • Certified phakic IOL specialists: 100 (for anterior chamber type), 81 (for posterior chamber type) • Estimated performed surgeries (2011): approximately 700 (for anterior chamber type), approximately 1250 (for posterior chamber type)
Sachiko Fukuoka, M.D. 2011 - Present: General Manager Tane Memorial Eye Hospital Osaka, Japan
• Number of ophthalmologists (2010): approximately 13,700 • Number of cataract surgeries (2010): approximately 1,295,000 • Estimated number of LASIK surgeries: approximately 450,000 in 2008 and 230,000 in 2011. LASIK is the most commonly performed refractive surgery today in Japan. However, the number of cases is decreasing in the past few years, because of the deterioration in economic conditions, seismic influence, and mass communication of the incident of spreading infections among a large number of patients with LASIK which was performed under unhygienic conditions at a certain facility in 2009. • In many facilities, from creation of the corneal flap to the end of the LASIK procedure, microkeratome has now been replaced to femtosecond laser technology.
Case Study ARTIFLEX Toric
A 39-year-old female visited our hospital to apply for LASIK surgery. Her visual acuities (VAs) were OD: 0.01 (1.0 x S -11.5 D C -2.5 D Ax 10), OS: 0.01 (1.2 x S -13.25 D C -2.5 D Ax 170). Her anterior chamber depths were OD: 3.07 mm and OS: 3.15 mm. Her corneal thicknesses were OD: 547 um and OS: 542 um, so LASIK was not applicable and implantation of iris-claw anterior chamber phakic IOL procedure was performed. The implanted lenses were OD: ARTIFLEX Toric S -12.0 D C -2.0 D Ax 10, OS: ARTISAN Toric S -13.5 D C -2.0 D Ax 170.
ARTISAN Toric These pictures are postop 1 day. No defect of iris pigmentation, but shows subconjunctival haemorrhage and suture.
Her VAs one day after the surgery were OD: (1.2 x IOL) (1.2 x IOL x S +0.75 D C -1.0 D Ax 10), OS: (0.9 x IOL) (1.2 x IOL x S +1.5 D C -3.0 D Ax 5). Because left eye had a postoperative astigmatism, laser suturelysis was performed one week postoperatively. Her VAs one month after the surgery were getting better as follows: OD: (1.2 x IOL) (1.2 x IOL x S +0.5 D C -0.75 D Ax 90), OS: (1.5 x IOL) (2.0 x IOL x C -0.75 D Ax 90).
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Intraocular Lenses selection Phakic IOLs
ARTIFLEX® Toric PIOL
P iris fixation P small incision P no rotation post op P large optical zone
Aphakic IOLs
Optic:
6.0 mm
Haptics:
Iris Fix®
Overall diameter: 8.5 mm Dioptric range:
-1.0 D to -13.5 D in combination with a cylinder of -1.0 D to -5.0 D
ARTISAN® Aphakia | Model 205
P iris fixation P backup lens P long clinical experience P predictable, stable, reliable
Aniridia Lenses
5.4 mm
Haptics:
Iris Fix®
Overall diameter: 8.5 mm Dioptric range:
2.0 D to 30.0 D (1.0 D increments) 14.5 D to 24.5 D (0.5 D increments)
Optic:
3.0 - 6.0 mm
Haptics:
C-loop
Aniridia | Model 311
P iris reconstruction and optic correction P sclera and sulcus fixation P safe, stable, reliable
Cataract IOLs
Optic:
Body diameter: 9.0 mm Overall diameter: 13.75 mm Dioptric range:
0.0 D and 1.0 D to 30.0 D
(0.5 D increments)
QuadrimaX™ | Aspheric Hydrophilic Acrylic | Model 545
P micro incision: 1.8 mm P aspherical surface
Optic:
5.7 - 6.0 mm | biconvex aspherical surface | square edge 360º
Haptics:
4 closed loops | 8˚angulation
Overall diameter: 10.5 - 11.0 mm Dioptric range:
5.0 D to 35.0 D (1.0 D increments) 14.5 D to 25.5 D (0.5 D increments)
More OPHTEC (P)IOLs through www.ophtec.com OPH THE RECORD 11
Preloaded Capsular Tension Ring in a single use injector
NEW
RingJect
™
The RingJect™ system is an OPHTEC preloaded Capsular Tension Ring
(CTR) in a single use injector. The CTR is prepositioned in the injector
and is designed to be self-loading for the surgeon’s convenience. The OPHTEC CTR is a high precision medical device for insertion
in the capsular bag and made from highly flexible compression molded polymethylmethacrylate (PMMA). Clockwise or counter-
clockwise insertion is possible. The RingJect™ system is provided in a sterile blister, ready for use.
OPHTEC Capsular Tension Rings are indicated for the stabilization of the capsular bag in the presence of weakened or compromised zonules.
RingJect video:
Features & Benefits Preloaded:
• Self-loading, single packaging a valuable addition to your surgical armamentarium
Injector:
• Sterile, ready to use • Total control includes action/retraction mechanism • Implantation - clockwise or counter clockwise indicators on injector • Long small tip especially convenient in cases of deep set eyes
Capsular Tension Ring:
• Circular expansion and stabilization of the capsular bag
RingJect PC375 | CTR Model 275 12/10 Compression: From 12 mm to 10 mm Material: Available in: Overall Ø:
PMMA | Flexible Ring Clear PMMA 12 mm
• Safe IOL centration in eyes with zonular dehiscence • Prevents IOL decentration after capsular shrinking • Stabilized conditions during phaco-emulsification surgery • Reduced risk of capsular fibrosis • Improved visual acuity when implanted along with premium IOL
References: Price FW, Mackool RD, Miller KM, Koch P, Oetting TA, Johnson AT. Interim results of the United States Investigational Device Study of the Ophtec Capsular Tension Ring. Ophthalmology 2005; 112: 460-5. Alió JL, Elkady B, Ortiz D, Bernabeu G. Microincision multifocal intraocular lens with and without a capsular tension ring Optical quality and clinical outcomes. J Cataract Refract Surgery 2008; 34:1468-75.
12 OPH THE RECORD
RingJect PC376 | CTR Model 276 13/11 Compression: From 13 mm to 11 mm Material: Available in: Overall Ø:
PMMA | Flexible Ring Clear PMMA 13 mm
Find OPHTEC
OPHTEC
in your region/country:
on social media Like our Facebook page and stay in touch: www.facebook.com/ophtec
The Netherlands (head office) OPHTEC BV Schweitzerlaan 15 9728 NR Groningen The Netherlands Tel. +3150 5251944 Fax +31505254386 info@ophtec.com
North America OPHTEC USA Inc. 6421 Congress Ave. Suite 112 Boca Raton FL 33487 USA Tel: +1 561 989-8767 rick.mccarley@usa.ophtec.com
Asia Pacific OPHTEC Asia-Pacific CO. Ltd. Flat 9D Willow Mansion 22 Taikoo wan Road Taikoo Shing HONG KONG Tel: +852 28871762 alex@ophtec-ap.com
South Africa OPHTEC South Africa (Pty) Ltd Visiomed Office Park Building 1 Unit 4, 269 Beyers Naude Drive Blackheath Ext.1 Johannesburg Tel: +27 105903135 deon@ophtec.co.za
Germany OPHTEC GmbH Drögensee 12 a 22397 Hamburg Germany Tel: +49 40 60096 978 a.lindstaedt@de.ophtec.com Japan OPHTEC Japan Inc. 2-7-29, Kitaaoyama Minato-ku, Tokyo 107-0061 Tel: +81 35919 4366 yamada@ophtec-ap.com OPHTEC Portugal tel: +351915141958 s.bayan@prt.ophtec.com
Visit our video library on YouTube to watch surgeries, patient information and company information: www.youtube.com/ophtecbv
South Korea OPHTEC South Korea 7th FL. YungJeon Building 154-10, SamSeoung-Dong, GangNam-Gu, Seoul, 135-879 Tel: 82-2-508-0522 y.m.goo@kr.ophtec.com Spain OPHTEC España SL C/ Azalea, 1 Edif. B Planta 1 Oficina 3 Miniparc I- El Soto 28109 Alcobendas Madrid Tel: 900 993 174 y.hernandez@es.ophtec.com
Ophtec Global sales meeting
The OPHTEC annual global sales meeting took place July 16th - 18th in Groningen the Netherlands. Participants (L-R) Hiromasa Yamada (Japan), Young Mo Goo (South Korea), Rick McCarley (USA), Alex Lee (Hong Kong), Anneke Worst (Ophtec founder), Arno Lindstädt (Germany ), Yvonne Hernandez (Spain), Erik-Jan Worst (CEO & President), Sandra Bayan (Portugal), Jérôme Fissiaux (Director Sales), Susanne Bouwmeester (Executive Secretary), Jim Simms (global marketing), Geke Hoekstra (Director HR), Deon van Wijk (South Africa).
ARTISAN Family Time Line Continued In the following years, OPHTEC developed toric lenses to correct astigmatism as well as foldable ARTIFLEX lenses, manufactured from a flexible material allowing implantation through a smaller incision. Every time a serious clinical study was initiated to safeguard (guarantee) the safety and efficacy of a new product. OPHTEC owes much gratitude to the ophthalmologists , who have actively participated in these clinical studies.
2004
In 2004 OPHTEC obtained the first “FDA approval” for a phakic IOL during a blood-curdling meeting in Washington, where the PMA was accepted with 7 against 6 votes. It was a close touch and go.
Well, we did it!
Innovation is all about vision. In this respect Camille Budo and his tremendous enthusiasm have to be named here. Budo assisted in giving a major push in the popularity of the ARTISAN and ARTIFLEX lenses. An early adaptor in the flesh, it has been his special merit to believe in the OPHTEC lens concept as when OPHTEC was not yet a household name. He has given Jan Worst tremendous support. He was never bothered when a colleague asked him for support or when we asked him to read a paper, assist with wetlabs or courses, even when it was on the other end of the world. His surgical skills are known all over the world. He made the most exquisite instruction films. Honestly well-deserved he received nominated to OPHTEC’s first Ambassador of the Year Award in 2004.
>>>>>>>> OPH THE RECORD 13
14 OPH THE RECORD
Implantation of iris-fixated phakic IOLs in children
By Erwin Bouwman, clinical department
© Tjeerd de Faber, MD
Purpose The purpose of this document is to provide surgeons with information about phakic iris-fixated IOLs in paediatric patients. Indications, important safety aspects, potential complications and results from literature will be discussed in this paper. The information could help the surgeon in his decision regarding ARTISAN lens implantation in children and it gives an indication of the postoperative results that can be expected. OPHTEC has not performed any studies that can provide arguments to support or discourage PIOL implantation in children.
Anisometropia & amblyopia in children Anisometropia is the condition in which eyes have unequal refractive power. Untreated, it can adversely affect the development of binocular vision in infants and children if there is a large difference in clarity between the two eyes. The brain will often suppress the vision of the blurrier eye which leads to the development of amblyopia. This is one of the most common causes of visual loss in childhood. Strict compliance with therapy is essential for successful amblyopia treatment and restoration of vision. A variety of treatment options are available such as spectacle correction, contact lenses and patching therapy. In cases of high anisometropic ametropia (> 10.0 D), spectacle correction is not the most ideal therapy because it can induce aniseikonia and secondary loss of sensory binocular fusion. Contact lens therapy may lead to better results in these patients1,2.
Surgical options for patients who are noncompliant to traditional treatment In some cases paediatric patients are non-compliant with traditional treatment. Intervention is essential in these patients to achieve full visual function because failure to intervene early may result in irreversible long-term visual loss. Surgeons can consider refractive surgery as a treatment option in these patients. It can be distinguished in two types: refractive surgery with an intraocular lens and corneal refractive laser surgery. However, there is no clear consensus on paediatric refractive surgery and it is still considered controversial – the ARTISAN lens has only been extensively studied in adults and the use in children is still considered experimental.
For which indications can a PIOL implantation be considered? A small number of articles have been published about the use of phakic iris-fixated IOLs in paediatric patients; a search in PubMed resulted in 9 publications3-11. The indications for lens implantation in these articles were: • • •
High myopic or hyperopic anisometropia (non-compliant to traditional treatment) Bilateral high ametropia (non-compliant to traditional treatment) Secondary high refractive amblyopia (non-compliant to traditional treatment)
There is no known consensus about the minimum age for phakic lens implantation. An important aspect is the difficulty to follow-up instructions for young children regarding rubbing the eyes. To our knowledge, the youngest patient described in literature is a 3 year old high anisometropic child9. At four years post-op, the visual acuity was 20/30 and the endothelial cell count was similar to the nonoperated fellow eye. Needless to say, surgeons should carefully weigh the risks and benefits in such young patients.
Results in literature Efficacy Iris-fixated lenses have been extensively studied in adults, but only a few articles relate to the use of these PIOLs in children3-11 and the majority concerns single case studies. The publications of Pirouzian, Alio and Tychsen describe the results of ARTISAN implantations in young anisometropic and amblyopic patients in a semi-large patient group: In the study of Pirouzian et al.4, all 7 eyes improved 6 or more lines of Snellen CDVA at the end of the three year follow-up. Mean CDVA improved from 1.18 ± 0.2 LogMAR pre-operatively to 0.30 ± 0.14 LogMAR. A study by Alio et al.3 showed that the mean pre-op CDVA improved from 0.84 ± 0.52 LogMAR pre-operatively to 0.36 ± 0.38 LogMAR at the 5 year follow-up. Tychsen8 showed a 60-fold improvement in visual acuity (from 20/3400 to 20/57 Snellen) in a study with 20 high ametropic eyes from children with neurobehavioral disorders.
OPH THE RECORD 15
The publications show that refractive surgery with an iris-fixated IOL appears to be an effective option in paediatric patients to improve the visual acuity. The visual outcome in these patients cannot be compared with the standard phakic IOL patient due to the underlying pathologies. Lack of achieving 20/20 vision usually stems from a number of factors including ocular motor misalignments, intractable amblyopia, foveopathies, retinopathies etc5. In order to achieve complete visual rehabilitation, regular follow-up is mandatory. For the amblyopic patients, eye patching therapy or strabismus surgery after PIOL implantation is crucial for achieving optimal clinical results3.
Before considering PIOL implantation in paediatric patients, the risks, benefits and alternatives, as well as the necessity for long-term follow-up should be carefully weighed. The same complications as for adults may be observed in children. Careful patient selection and follow-up of these patients in order to monitor the cornea endothelium is essential, as well as an instruction to both parents and patient that eye rubbing should be avoided. With these precautions taken, the literature states that the ARTISAN lens can be a safe and efficient solution also for children.
References: 1. Winn B, Ackerley RG, Brown CA, Murray FK, Prais J, St John MF. Endothelium Reduced aniseikonia in axial anisometropia with contact lens In both studies of Pirouzian4 and Alio3, the effect of iris-fixated correction. Ophthalmic Physiol Opt. 1988;8(3):341-4. lens implantation on the corneal endothelial cells was assessed. 2. Lubkin V, Kramer P, Meininger D, Shippman S, Bennett G, The endothelial cell loss varied over the course of 3 to 5 years Visintainer P. Aniseikonia in relation to strabismus, between 6.5% and 15.2%. In some of these patients the cell loss stabilised over time, but there were also patients with continuing anisometropia and amblyopia. Binocul Vis Strabismus Q. 1999;14(3):203-7. cell loss. A clear indication for the continuing cell loss could not 3. Alió JL, Toffaha BT, Laria C, Piñero DP. Lens Implantation for be determined. It is assumed however that extensive eye-rubbing has a negative effect on the endothelium9,10 and research in adults Treatment of Anisometropia and Amblyopia in ChildrenChildren: 5-year Follow-up. J Refract Surg. 2011; Feb 1:1-8. showed a correlation between endothelial cell loss and the critical distance (smallest distance between edge of the PIOL and endothe- 4. Pirouzian A, Ip KC. Anterior chamber phakic intraocular lens implantation in children to treat severe anisometropic myopia and lium)12, possibly eye rubbing or small critical distances are also amblyopia: 3-year clinical results. the cause for cell loss in these children. It is difficult to give a J Cataract Refract Surgery 2010; Sep;36(9):1486-93. clear recommendation about the minimum critical distance or anterior chamber depth, especially for very young children when 5. Pirouzian A. Pediatric phakic intraocular lens surgery: review of clinical studies. Ophthalmology Times, Europe 2010; 21(4):249-54. examinations are difficult to perform and the eye morphology 6. Pirouzian A, Ip KC, O’Halloran HS. Phakic anterior chamber will still change. For those reasons, the authors report that the intraocular lens (Verisyse) implantation in children for treatment endothelium should be monitored continuously after ARTISAN of severe ansiometropia myopia and amblyopia: Six-month pilot implantation. clincial trial and review of literature. Clin Ophthalmol. 2009;3:367-71. 7. Tychsen L, Hoekel J, Ghasia F, Yoon-Huang G. Phakic intraocular Potential complications lens correction of high ametropia in children with neurobehavioral The risk factors for children and adults are similar, although disorders. Journal of AAPOS 2008; 12(3):282-9. intraocular surgery in children is more prone to inflammatory reactions10. An additional factor that has to be taken into account 8. Tychsen L. Refractive surgery for children: excimer laser, phakic is the myopic shift that occurs as the patient ages, due to an increase intraocular lens, and clear lens extraction. Ophthalmology Times, Europe 2008; 19(4):342-8. in axial length. Especially with lens implantation in young children 9. Assil KK, Sturm JM, Chang SH Verisyse intraocular lens implantation or with high myopia, additional correction with glasses or contact in a child with anisometropic amblyopia: Four-year follow-up. lenses may be necessary over time, in extreme cases it can be J Cataract Refract Surgery 2007; 33(11):1958-6. decided to exchange the IOL11. 10. Saxena R, Van Minderhout HM, Luyten GP Anterior chamber 3-11 iris-fixated phakic intraocular lens for animesotropic amblyopia. were not severe: The complications described in the articles J Cataract Refract Surgery 2003; 29(4): 835-8. • Cases of flare (disappeared within days after surgery)4,9 • 1 case of iridocyclitis after implantation (resolved after treatment)3 11. Chipont EM, Garcia-Hermosa P, Alio JL. Reversal of myopic anisometropic amblyopia with phakic intraocular lens implantation. • Increased endothelial cell loss3,4,10 J Refract Surg. 2001; 17(4): 460-2. • 1 case of IOL exchange7 12. Doors M, Berendschot T, Webers C, Nuijts R. Model to Predict Endothelial Cell Loss after Iris-fixated Phakic Intraocular Lens Surgical procedure The surgical procedure for ARTISAN lens implantation in children Implantation. Invest Ophthalmol Vis Sci. 2010; Nov;36(11):1897-904. does not differ from the procedure in adults. As mentioned above, the patient should be prepared to expect a postoperative shift in refraction in some cases – although not as severe as in pediatric cataract cases. Conclusion Early intervention is essential in a subpopulation of children who are non-compliant to spectacle wear or contact lens therapy and have highly significant anisometropia, bilateral high ametropia or high amblyopia. Small case series have shown significant improvement in visual acuity in these patients after implantation of an iris-fixated IOL.
16 OPH THE RECORD
For more information see: Publications on www.ophtec.com
Dr. Massimo Di Maita (Italy) on the ARTISAN family lenses ®
Could you describe the Ophthalmic Unit of Casa di Cura “Mater Dei” The ophthalmology unit I am responsible for is a modest size facility, but it is both modern and efficient. My staff comprises two ophthalmologists, one ophthalmic assistant, three nurses and one administrator. About 1500 anterior segment procedures (cornea and lens refractive surgery) are performed every year.
Indeed, besides the benefits offered by ARTISAN Rigid, ARTIFLEX can be implanted with a smaller incision (3.2 mm v/s 5.5 mm) and profits of a bigger optics.
You have been using the ARTISAN and ARTIFLEX lens implant for over 10 years. What are your experiences? I had been using ARTISAN for almost fifteen years and if I am praising it after all this time, it’s because my own experience You are Director of a national importance leads me to consider ARTISAN as the preCorneal Topography and Refractive Surgery mium P-IOL with phakic patients affected Training Program. Could you tell us about by medium/severe myopia associated (or this program? not) with medium severe astigmatism. My first “Corneal Topography” training course took place in 1998. Since then, the How known is the ARTISAN/ARTIFLEX importance of topography has increased so implant in your country? much that it has become one of the crucial ARTISAN/ARTIFLEX implant is very well diagnostic exams during ophthalmic known in Italy, thanks to the possibility to examination, particularly during anterior diversify its application field. segment post-op. That’s why six years ago I renamed my course as: “Corneal Topography How do you select patients for the and Refractive Surgery”. ARTISAN/ ARTIFLEX procedure? Concerning patient selection, I implant: OPHTEC is celebrating the 25 ARTISAN • ARTIFLEX in patient affected by medium/ myopia anniversary – the refractive severe myopia, aged less than forty if implant Iol used for 25 years. According experiencing contact lenses intolerance. to you, how unique is this in the world of • When the patient is affected by a severe Ophthalmology/Refractive surgery? astigmatism, an ARTIFLEX toric can now No doubt ARTISAN IOL’s peculiarity comes be implanted. from its design and his positioning inside • ARTISAN in aphakic patients. the anterior chamber. OPHTEC did a good job in keeping it up-to-date over the years Can you provide some tips for surgeons but also in maintaining its original feawho start using the ARTISAN and tures at one time. ARTIFLEX lenses?
ARTISAN Family Time Line Continued The interest for the ARTISAN and ARTIFLEX lenses has spread around the world for a number of special qualities: • The lenses are fixated to the iris! • The fixation technique has never been changed in 25 years • The lenses can be meticulously centered on the pupil • Once fixated rotation is impossible, so that they are outstanding lenses for the correction of astigmatism • The lenses have proven to be safe and efficacious
Enclavation is undoubtedly the most crucial step of ARTISAN implantation, therefore, I’d suggest to take special care in performing the side port, so that the enclavation needle reaches the enclavation site smoothly. What is your favorite way to spend a day off? Going to the seaside or taking an excursion on Etna (the volcano towering over my hometown, Catania) with my wife and my kids.
Dr. Massimo Di Maita (Italy) Director of the Ophthalmic Unit of Casa di Cura “Mater Dei” in Catania and who has up to today has performed around 40.000 surgeries. Dr. Di Maita has been an ARTISAN user since 2001; he has implanted about 200 iris fixation IOLs and, among them, at least 60 foldable ones.
And….after 25 years the story has only just begun! OPH THE RECORD 17
QuadrimaX
™
1.8 mm
>> Extended diopter range
QuadrimaX™ Hydrophilic Acrylic IOL PC545
incision
Lens type:
One piece IOL | In the bag fixation Biconvex | aspherical surface | Square edge 360˚
Total diameter:
10.50 to 11.0 mm*
Optic diameter:
5.7 / 6.0 mm*
Lens material:
Hydrophilic Acrylic
Haptics:
4 closed loops
Angulation:
8˚
Refractive index:
1.46
AC depth:
4.96 mm
A-constant:
118.0 (ultrasound) 118.4 (laser interference, SRK/T)
Available powers:
+5.0 D to +35.0 D (1.0 D increments) +14.5 D to +25.5 D (0.5 D increments)
* depends on dioptre
Implantable with OPHTEC DualTec™ and Medicel injectors
© J. Swart, MD
implantation video - C. Budo
ARTISAN /ARTIFLEX Papers/Posters during the ESCRS ®
®
J. Cazal, MD | FP-2865
C. Peris, MD | FP-3459
G. Muñoz, MD
Two years follow-up after implantation of iris claw family intraocular lens in phakic eyes by a novel surgeon Monday 8.30 Space 3
ARTISAN Aphakia for treatment of spontaneous late in-the-bag intraocular lens subluxation Wednesday, Sep 12, 8:18 AM Brown Hall 3 (South Wing, Level 2)
Posters | POS-2986 ARTIFLEX toric phakic intraocular lens for myopic astigmatism
Posters | POS-3004 Iris-claw ARTISAN Toric phakic intraocular lens for high mixed astigmatism. Two year follow-up
Posters | POS-3475 Optical and visual quality of spheric and toric ARTIFLEX. A pilot study
Posters | POS-3009 ARTISAN aphakia solution for chronic ocular pain, iris atrophy and pupil ovalization
Posters | POS-3524 Machine learning for keratoconus patients
18 OPH THE RECORD
Posters | POS-2990 ARTIFLEX phakic intraocular lens versus femtosecond laser in situ keratomileusis for moderate myopia
ARTISAN /ARTIFLEX vs. ICL, Cachet, Natural Ageing & Standard Cataract ®
®
Annual Endothelial cell loss ARTISAN/ARTIFLEX
ICL
Cachet
Cataract
Natural aging
Myopia, Toric and Hyperopia: 1.58%, 0.68% and 1.77% respectively 10 yrs. data1.
The average annual cell loss for ICL in literature was 1.92%1.
3.3% at 6 months, 1.1 at 5 yrs. ONLY 159 patients followed2.
2.5% per year for at least 10 years after surgery, with or without a lens implant3.
adult cornea decreases at a rate of 0.6% per year4.
One size fits all eyes exactly
4 sizes - fits no eye exactly
4 sizes - fits no eye exactly
Sulcus issues
NA
Surgeon choice
Anatomy decides
Anatomy decides
NA
NA
Does not rotate or tilt, 5. after 24hr good vision
Can rotate and tilt and long visual recovery6.
No Toric option
NA
NA
3.2mm
3.2mm
3.2mm
1.8mm – 3.5mm
NA
Clinical History
25 yrs, fixation method has been unchanged
15 yrs. - design changed 5 times to address complications
5 yrs.
NA
NA
Control of lens position
Easy to confirm
Difficult to confirm
Easy to confirm
Difficult
NA
Main concern with design
Surgical learning curve, requires millimeters of clearance
Sizing, centration, limited clearance in sulcus - only microns of clearance in sulcus
Sizing, centration, and angle related complications
Capsule/sulcus issues
NA
Annual Endothelial cell loss Sizing Centration Toric stability Incision size
1. White paper on www.ophtec.com (ARTISAN® and ARTIFLEX® Phakic IOLs:Clinical Evidence Continues to Support Biocompatibility and Design Features. Comprehensive overview of literature: Endothelial cell change after Artisan/Artiflex implantation) 2. Alcon Cachet: Field Safety Notice (data from official study) 3. http://www.fda.gov/ohrms/dockets/ac/04/briefing/4026b1_FDA%20SUMMARY.FINAL1.htm 4. Bourne WM, Nelson LR, Hodge DO. Central corneal endothelial cell changes over a ten-year period. Invest Ophthalmol Vis Sci 1997;38:779-82 5. Tehrani M, Dick HB, Schwenn O, Blom E, Schmidt AH, Koch HR. Postoperative astigmatism and rotational stability after artisan toric phakic intraocular lens implantation. J Cataract Refract Surg. 2003 Sep;29(9):1761-6. 6. Mori T, Yokoyama S, Kojima T, Isogai N, Ito M, Horai R, Nakamura T, Ichikawa K. Factors affecting rotation of a posterior chamber collagen copolymer toric phakic intraocular lens. Cataract Refract Surg. 2012 Apr;38(4):568-73
Agenda 2012 / 2013 September 8-12
Milan
Italy
ESCRS
September 26-29
Barcelona
Spain
SEO
November 2
Groningen
The Netherlands
ARTISAN Aphakia course
November 10-13
Chicago
USA
AAO
November 28-30
Brussels
Belgium
OB
December 1
Taipei
ROC-Taiwan
Taiwan Ophthalmological Society and HKOS
December 7-8
Groningen
The Netherlands
ARTISAN & ARTIFLEX course
January 17-20
Hyderabad
India
APAO and All India
January 31, February 1-2
Elche
Spain
Faco Elche
February 15-17
Warsaw
Poland
W-ESCRS
March 14-17
Cape Town
South Africa
OSSA
March 20-22
Groningen
The Netherlands
NOG
April 19-23
San Francisco
USA
ASCRS
May 11-14
Paris
France
SFO
May 22-25
Barcelona
Spain
SECOIR
June 13-15
Nuremberg
Germany
DOC
June 27-29
Tokyo
Japan
JSCRS
September 25-28
Tenerife
Spain
SEO
Oktober 5-9
Amsterdam
The Netherlands
ESCRS
OPH THE RECORD 19
The ARTISAN® Family is here to stay
ARTISAN® FAMILY BENEFITS P IRIS FIXATION P LARGE OPTIC SIZE P ONE SIZE FITS ALL P CONTROLLED POSITIONING P SUFFICIENT DISTANCE FROM ENDOTHELIUM & CRYSTALLINE LENS P HIGH POWER RANGE & VARIOUS APPLICATIONS P REVERSIBLE P LONG TERM RESULTS* P FDA APPROVED** *See ‘Articles of Interest’ **ARTISAN® Myopia 2004
www.ophtec.com