PH THE RECORD O P H TH E R E CO R D i s p u b l i s hed by OPHTEC BV | September 2010 | #6
In this issue: Introducing VacuFixâ„˘ | Pseudoexfoliation Syndrome | Pediatric Artisan Aphakia Session in Boston | Dr. Erik Mertens about Capsular Tension Rings | Dr. Frank Salamun on the new Luna | Aniridia IOLs under clinical investigation in the US | Patient Design IOLs
Dr Dan Alexandre Lebuisson M.D. chief of the Hôpital Foch eyes unit and medical director of the famous Clinique de la Vision in Paris, about Ophthalmology in France
“Ophthalmology in France is very dynamic. More than 550.000 cataract
cases are treated every year and just last year, around 120.000 refractive surgeries were performed.
Relatively, there are only few private clinics in France (There are just six in Paris, of which three are very small) and the job of optometrist does not exist, so the MD takes care of most investigations himself. This leads to
10% of all ophthalmologists being responsible for 80% of all eye surgeries.
In other words, they have not been able to respond to the growing popular demand. Since two years however, orthoptists are granted to practise
investigations under supervision of an MD. This allows the surgeons to
focus on surgery more and more. The quality and efficiency of health care is further enhanced by many new regulations and high-level education programs, which are successfully applied to practices very quickly.
Health care costs are still a problem. Although the government allows
all main ocular diseases to be operated free of charge, refractive surgery,
mainly and particularly, is still non-refundable. Situations like these cause many people to add a private insurance to their basic package. Our team
Colofon OphTheRecord is published by OPHTEC BV Interviews: Kim Sauter, Tekst & Training Amsterdam;
is continuously improving the reputation of refractive surgery through the combination of high surgical skills and top-notch technology.
This is proven by the growing word of mouth referrals that come from satisfied customers.
Marij Thiecke, Concept & Copy Editorial: Roelien den Besten, Wubbien Fokkema, Jérôme Fissiaux, Siham Ayad, Walter Nazaire, Anna Bilstra, Gitty Geerstma, Sylvia Gamio e-mail: firstname.lastname@example.org Artwork: Menno Schreuder - email@example.com Print: Scholma druk, Bedum Photo page 1 and 2/3 of the Sacré Coeur and the Eiffel Tower © Paris Tourist Office | Photographe: David Lefranc All rights reserved. ©OPHTEC BV 2010 P.O. Box 398 | 9700 AJ | Groningen
My clinic has experience with OPHTEC’s PIOLs for ten years. Their high quality in terms of precision, stability and safety is due to a great
know-how, and personal attention on their part. The Artiflex Toric is a major upgrade. It requires no additional training and generates great results fast. The Artisan and Artiflex lenses have greatly improved
refractive results: perfect centration, no contact with the natural lens, biocompatibility.
T: +31 50 525 1944 | F: +31 50 525 4386
I hope you will enjoy your stay in Paris and at the ESCRS congress!”
Dr Dan Alexandre Lebuisson M.D.
Preface Dear friends and partners, I always look forward to September, the month when the ESCRS Congress takes place. To me that is the highlight of the congresses
every year; it is inspiring, very useful from a business point of view,
but it is also a social event where I meet and strengthen the bonds with many old as well as new contacts.
At the ESCRS in September we will introduce our new VacuFix, a
system originally created by OPHTEC, but further developed and tested in Switzerland. It is a device which simplifies the iris enclavation of
the phakic and aphakic Artisan/Artiflex lenses. The research question, “How can I lift the iris tissue without using forcerps or a needle”, led
to the VacuFix, a revolutionary suction system. The initial experiences
with the device have been very positive. You can read about this in this
issue of “OphTheRecord”. Dr. Grob (Vista Clinic, Binningen, Switzerland)
4. Pseudoexfoliation Syndrome
Prof. Rupert Menapace; interview
6. Pediatric Artisan Aphakia Session in Boston 8. OPHTEC News 9. Capsular Tension Ring
Dr. Erik Mertens, MD; interview
10. Introducing VacuFix; Quick, Precise, Stable & Safe
Dr. Michael Grob; interview
12. Position of OPHTEC IOLs among competitive Products 13. Seeing better has become much easier; The new Luna
discloses his experiences with the new enclavation system.
Our Artisan Aphakic lens, as well as our Capsular Tension Ring, is
14. OPHTEC Patient Design Lenses
implanted frequently among patients with a Pseudoexfoliation
syndrome. Although already described in 1918, it has received a lot of publicity lately because of recent findings. Prof. Menapace (Medical
University of Vienna, Austria) is an expert in the field of this syndrome, will update you in this issue on the current state of affairs.
Our hydrophobic aspheric lens, the Luna, has now been part of our
Dr. Frank Salamun; interview
15. Model 311 Artificial Iris lens under clinical investigation in the US
Agenda 2010 | 2011
product range for a year. Dr. Salamun (Medicinski Center VID, Nova
something about ophthalmology in Slovenia in general.
As a manufacturer, to simply know your product is better than
others doesn’t mean it is any less satisfying when this is explicitly
confirmed by users of that product. That’s why we were very keen to
Artisan Aphakia Course Groningen (NL)
ask Dr. Erik Mertens (Medipolis Health Centre, Antwerp, Belgium) to
explain in detail why OPHTEC’s Capsular Tension Ring proved to be
that of other colleagues who discuss their work in this issue.
You can find all this and more in this new issue of OphTheRecord;
ESCRS Congress in Paris.
Port Elizabeth (S. Africa)
San Diego (USA)
Gorica, Slovenia) shares his experiences with this lens, and is telling
the best product in his test. Take advantage of his knowledge and
we hope you enjoy reading it, and we look forward to seeing you at the
Erik-Jan Worst, OPHTEC President and CEO
OPH THE RECORD 3
Pseudoexfoliation syndrome an interview with prof. rupert menapace (medical university of vienna austria)
Phakic eyes. Left: faintly visible PFX-material visualized by oblique slitbeam illumination; right: massive membranous deposits typically concentric (top), and with the peripheral margin detached (bottom).
Pseudoexfoliation syndrome (PFX or PEX) is a common ocular manifestation of a systemic disease. The extracellular matrix produces excessive proteins which deposits on the structures of the eye, such as lens epithelium, pupillary border, iridocorneal angle, zonules and on IOLs. John Lindbergh described PFX in the form of grayish flecks at the pupillary border for the first time in 1918. How well known is the disorder since then? Is there more interest in the disease these days? Recent finding suggest that Pseudoexfoliation syndrome is a generalized disorder particularly affecting elastic microfibrils. It is characterized by the production of abnormal extracellular material
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which progressively accumulates in the eye, but also in many other organs and tissues. Knowledge has tremendously increased during the last years about the genetic background and systemic implications. The Lindbergh Society is coordinating ophthalmic and systemic, as well as basic research on PFX and is regularly organizing comprehensive symposia at international congresses. What triggered your interest for PFX? A special case perhaps? How have you earned your credits on the subject? Apart from my focus on cataract and reconstructive anterior segment surgery, I have been running the surgical glaucoma service at the Vienna Medical University for many years. PFX eyes are generally diseased
eyes which deserve special treatment and precautions to avoid both intraoperative and postoperative complications. The posterior capsule being thinner and the zonules weaker, and the cortex more adhesive to the capsular bag, the risk of zonular or capsular damage is increased. Pupillary dilatation may be very poor. The surgical challenge to avoid both intraand postoperative complications is what triggered my particular interest in PFX. What are the consequences of PFX for the eye? Do all patients with PFX develop cataract and/or glaucoma? The incidence of cataract formation, particularly nuclear opacification, is significantly increased. Though PFX syndrome does not always develop into PFX glaucoma, the latter constitutes about 25% of all open-angle glaucomas and represents the most common identifiable cause of glaucoma overall. PFX syndroma may develop into a severe and progressive type of glaucoma with a generally poor prognosis due to high intraocular pressure levels and fluctuations in the diurnal pressure curve. When cataract surgery is performed on a PFX eye, ovalization of the capsular bag and stretch folds in the posterior capsule enhance PCO formation, and anterior capsule fibrosis may be fierce, leading to rhexis phimosis and zonular distension. In the long run, the zonular apparatus tends to progressively fail, resulting in odonesis and final subluxation or even luxation of the bag-IOL-complex into the vitreous cavity. How can you diagnose a patient with PFX? The PFX material can be detected under adequate slitlamp illumination on the anterior lens capsule, which may be difficult with poor mydriasis. White, fluffy material may be also be found on the pupil margin and as so-called SanpaolesiÂ´s line in the chamber angle. To your knowledge, is PFX often overlooked? What can be the consequences for the patient? Unfortunately, PFX syndrome or glaucoma is often overlooked. Realizing theses entities is important for the cataract surgeon, since surgery must be particularly gentle to minimize intraoperative
complications, and measures must be envisaged to avoid the above-mentioned postoperative complications. After PFX has been diagnosed, does it have to be managed, and how? An insufficiently dilating pupil must be extended by gentle stretching, multiple partial iridotomies, or a pupillary dilatator. If the zonules are weak, implantation of a capsular tension ring is highly recommended. It avoids bag ovalization and stretch folds and allows easy refixation of the bag-IOLcomplex should zonular disintegration end up in progressive odonesis or dislocation. At the end of surgery, a too large rhexisoptic overlap must be reduced to a minimum by secondarily enlarging the rhexis opening with forceps by closely following the implanted IOL optic. In addition, rhexis contraction may be counteracted by removing the lens epithelium from the anterior capsule with a curette. Is management of cataract in eyes with PFX the same as in eyes without PFX? As the nucleus is often hard and the cortex very adherent to the capsule, lens-capsule hydrodissection must be thorough and followed by gentle rotation in order to completely sever all adhesions. Zonular stress must be minimized during phacoemulsification, and special attention paid to the posterior capsule as it tends to bulge forward. In case of excessive general weakness of the zonules, or the occurrence of a localized dehiscence, a capsular tension ring should be inserted before continuing phacoemulsification. Residual cortical strands must be peeled off tangentially, thus minimizing centripetal traction on the zonules. Since zonular weakness may be progressive, with the average time span until dislocation being about 7 years, the patients should be advised to regularly check the eye for wobbling vision and in case consult the doctor. Has the best solution for cataract treatment in PFX patient been developed yet or do you have any wishes for the future? With the availability of pupillary dilatators, capsular tension rings, and micro-instruments
Prof. Rupert Menapace is the director of the Outpatient Cataract Unit at the Medical University of Vienna, Austria. He has previously run the surgical glaucoma service and is now focusing on complicated cataract and reconstructive anterior segment surgery. He is Consultation Section Co-Editor of the Journal of Cataract and Refractive Surgery and Editorial Member of the American Journal of Ophthalmology. He has published 190 peer-reviewed articles, and has been lecturing at the Lindbergh Society symposia at various international congresses.
for capsular surgery, the procedure has become much safer and better controlled. Modern suturing techniques for refixation of a subluxed bag-IOL-complex (see upcoming Consultation Section in the JCRS August 2010 issue), and lens implants for iris fixation for cases not amenable to refixation have completed the surgical armamentarium. My wish for the future therefore is that the impact of PFX is generally realized and the potential of the techniques and instruments described be fully exploited to the good of the patient. OPH THE RECORD 5
Pediatric Artisan Aphakia session in Boston for many surgeons around the world, the artisan aphakia iol is the #1 backup lens for cataract cases in adults. pediatric surgeons
seem particularly interested in this lens, as it may be the best option for treatment of complicated cataract cases in children who suffer from trauma or congenital cataracts. these are cases where, to begin with, conventional spectacle and/or contact lens treatment
are not feasible options for visual rehabilitation due to non-compliance or intolerance by the young patient. in addition these cases present with compromised zonules and an unstable or subluxed capsular bag where a regular in the bag pciol is not indicated for surgical treatment. By Sylvia Gamio
In these complicated cases, pediatric surgeons would usually have a choice of either suturing a PCIOL to the sclera/iris or of implanting an angle-fixated ACIOL. Due to sizing concerns, in growing children especially, angle-supported ACIOLs are not the ideal treatment option. With these lenses it is important to get sizing right in adults to avoid endothelial cell loss, angle closure, lens rotation etc. This makes sizing in children even more critical. Surgeons have usually stayed away from this option and resorted to scleral or iris suturing of PCIOLs, however this too is not an ideal treatment. Sutures do not last forever and when dealing with children, pediatric surgeons want the treatment to last many years or as long as possible to avoid going back into the OR multiple times. With scleral or iris sutures there is a good possibility of having a very young patient come back every 10-15 years (or earlier) to have the lens re-sutured in order to prevent or correct suture breakage, PCIOL subluxation, and more extensive or complicated surgery for both the patient and the surgeon.
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It is in search of a better treatment option for their young patients, that these pediatric surgeons are looking to the Artisan Aphakia IOL. The Artisan Aphakia IOL has been implanted for many years around the world and has a proven track record. It is stable, reliable, and predictable. Unlike angle supported ACIOLs there is no critical sizing issue, which would lead to safety concerns regarding the endothelium and/or angle. Also, as with all Artisan lenses there are no sutures used to fixate or center the lens in place as there are with PCIOLs. The Artisan Aphakia IOL is an iris-fixated ACIOL and is available in a range of powers from +2.0 D to +30.0D, and in 3 different sizes. The lens has a total diameter of 8.5mm with an optic of 5mm and total body diameter of 5.4mm. There are two pediatric versions of the lens available in the following sizes; 7.5mm total diameter with an optic/body of 4.4mm, and 6.5mm total diameter with an optic/body of 4.4mm.
With the invitation of Dr. Danielle Ledoux of Childrenâ€™s Hospital Boston, OPHTEC USA organized a presentation and wet lab focusing on the use of the Artisan Aphakia IOL in children. The session was held at the Massachusetts Eye and Ear Infirmary, a teaching hospital of Harvard University, in Boston, Massachusetts during the ASCRS congress in April. Participants included mostly pediatric ophthalmic surgeons from Harvard University as well as Dr. Ed Wilson and colleagues from the renowned Storm Eye Institute in South Carolina, and Dr. Rob Spector, a certified Artisan user, from Philadelphia, PA. The presentation was held in the boardroom of Mass Eye and Ear, overlooking the Charles River that runs through Boston. Rick McCarley, President of OPHTEC USA, gave the initial presentation. He gave the introductions and presented the history of the lens and its current status in the US market. The Artisan Aphakia lens is not currently FDA approved for use in either
adults or children. Surgeons however, are able to access the lens via FDA Compassionate Use Exemption approval on a case-by-case basis. The participants expressed concern over the Compassionate Use process, as they perceive it as burdensome due to the amount of paperwork that must be submitted and the waiting period of approximately 30-45 days for approval from the FDA. Most all the surgeons were interested in participating in a study which would facilitate access to the lens and eventually lead to itâ€™s FDA approval Dr. Ed Wilson even mentioned the possibility of such a study during a Pediatric Cataract Session, which he later moderated at the ASCRS congress, when the Artisan Aphakia lens was mentioned as a solution to complicated cataract cases in children. OPHTEC USA is currently working with some of these participants from the session to develop a protocol for the study in hopes to start a clinical trial that would study the lens in both adults and children in order to eventually seek FDA approval. The next presentation was given by Artisan Ambassador Dr. Camille Budo from Belgium. Dr. Budo presented case studies of nine pediatric patients implanted with the Artisan Aphakia lens in Europe. The case studies presented seemed to support the tendency of myopization in children related with the growth of the eye. This gave rise to a discussion on lens power calculation for these cases. There was a general agreement not to shoot for emmetropia as a target when treating children, but instead to leave the patient a bit hyperopic to account for a shift toward myopia as the child ages and the eye grows. It is important to remember this when calculating lens power for use in children. Also discussed was the possibility of implanting 2 IOLs. One IOL would be placed in the bag (in cases where this is possible), and another in the sulcus or even the anterior chamber. Later in life, as the child grows, the sulcus or anterior chamber IOL could be explanted, leaving only the PC IOL and correcting for the myopic shift. After both presentations and discussion, the surgeons moved downstairs for the wet lab portion of the session. The participants were appreciative of Dr. Budoâ€™s years of
experience with the Artisan lens, and found his knowledge and assistance during the wet lab especially helpful. He provided valuable tips regarding the implantation technique and answered many questions. The surgeons practiced the enclavation procedure with both the adult lens (8.5mm) and pediatric lenses (7.5mm or 6.5mm), using both the enclavation needle and enclavation forceps. Most found they preferred the enclavation forceps, especially when keeping in mind an aphakic eye. It is also important to note with regards to incision size, that although the optic size of the adult Artisan Aphakia lens is 5mm, the actual width of the lens body is 5.4mm. Overall the session was well received and the participants were genuinely interested in the lens. Some mentioned they had seen
cases in the past where this lens would have been their choice of treatment, and are glad to now know they can access the lens for their patients. They are excited about the possibility of a study being opened to have greater access to the lens, and look forward to the day when it is FDA approved. A few of the participating surgeons gave presentations themselves during sessions at the ASCRS congress, where the Artisan Aphakia lens was mentioned. Since the ASCRS, OPHTEC USA has begun to receive inquiries from other pediatric surgeons both in the United States and Canada regarding Artisan training and from certified Artisan surgeons regarding lens availability. The word is starting to spread about the use of this lens in complicated pediatric cataract cases.
AC 205 Artisan Aphakia Specifications Lens material:
5.4 mm | Biconvex*
115.0 (ultrasound); 115.7 (estimated value for IOLMaster)
+2.0 D to +30.0 D (1.0 D increments ) +14.5 D to +24.5 D (0.5 D increments )
Artisan Pediatric Aphakia 4.4/6.5 and 4.4/7.5 designed for small eyes
+2.0 D to +9.0 D Plano-convex
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OPHTEC opens site in Tokyo
ESCRS 2009 Artisan Ambassador Award conferred to Professor Jan Venter Optical Express, London
Prof. Jan Venter (2nd from right) among other ambassadors Dr. Budo and Prof. Marinho. Left: Erik-Jan Worst (OPHTEC) Left to right: OPHTEC President and CEO Erik-Jan Worst, Dr. Arai, OPHTEC Japan director Mr. Yamada, Dr. Tsubota.
After recent expansions in Madrid and Johannesburg, OPHTEC opened its own site in Tokyo. After Europe, North America and Africa, it’s the turn of the Far East - on 1 April 2010 the Japanese site of OPHTEC became a reality. ‘Just as our ancestors 400 years ago, we see this as a wonderful challenge to expand our trading activities to this country. With our own Japanese site, staffed with a Japanese crew led by Hiromasa Yamada, we expect our products to take up an important place in the refraction surgery arena of Japan within the next few years.’ says OPHTEC President and CEO Erik-Jan Worst.
In 2009 the Artisan ambassador award is rewarded to Prof. Jan Venter (UK). According to OPHTEC CEO Erik-Jan Worst Prof. Venter has deserved this award because of his outstanding support of the Artisan/ Artiflex concept through the years. The presentation of this award took place during OPHTEC’s annual ESCRS user meeting in Barcelona September 13th 2009.
Update in the Oculus Pentacam 3D PIOL simulation software By Joerg Iwanczuk, Product Manager at Oculus
The 3D PIOL simulation software for phakic IOLs was launched 4 years ago to support surgeons in their pre-operative diagnostic evaluation. After entering the patient’s refraction and selecting the respective PIOL model from the database the software calculates the required refractive power of the PIOL using the van de Heyde formula. A 3D calculation is performed to simulate the post-op position of the selected PIOL considering the individual anterior chamber structures. The minimum clearances from PIOL to endothelium, iris and crystalline lens are shown in every Scheimpflug image and are additionally displayed in coloured maps. The surgeon can do final corrections of the PIOL position by drag and drop in terms of height, tilt and centration. Besides the simulation of the post-op position the age related changes in the anterior segment caused by the growing of the crystalline lens are simulated too. The PIOL position up to 30 years in advance can be simulated and shown to patients. The database now contains all available phakic IOL models including the latest developed and launched, the toric Artiflex. The update of the software is free of charge to the users.
8 OPH THE RECORD
Oculus Pentacam 3D PIOL simulation software interface
Accommodating IOLs with a smooth rear lens capsule: a minor operation leading to better vision thanks to OPHTEC’s Capsular Tension Ring
erik mertens has worked as an ophthalmologist in antwerp for 15 years. during a recent study into accommodating iols for a major manufacturer of lenses, he discovered that tensing the rear lens capsule and stabilizing the lens bag by means of ophtec’s capsular tension ring leads to better, predictable results. both rear and distant vision for the patient are improved in this way. mertens: ‘the excellent results compensate for the extra operation and costs.’ By Marij Thiecke
>> CTR Specifications Dr. Erik Mertens
Strong capsular bag Mertens: ‘I’ve been working together with a large manufacturer of lenses since 2000. One problem that often occurs when lenses are implanted is that the lens decentres because the capsular bag shrinks asymmetrically or lifts after the natural lens has been removed. This reduces the quality of the patient’s vision. From the patient’s point of view, the operation has “failed”. During my research into accommodating IOLs, I discovered that OPHTEC’s CTRs in particular help to ensure that the capsular bag remains centred, leading to better vision and less aftercare treatment. Three other types of CTR were not always fitted successfully, which meant that the CTR had to be removed. In that case they usually had not developed fully or optimally. So, there’s something in the production process of OPHTEC’s CTR that makes it ideal. I’d like to find out the exact ingredients for this CTR, but I realize that this is OPHTEC’s secret.’
All non-monofocal operations Mertens continues: ‘I now use the OPHTEC CTR for all non-monofocal operations (in other words, for premium IOLs), because of the predictability and the better result that is achieved. When calculating the formula for the perfect fitting of the lens, there’s always a factor of uncertainty. That factor is reduced by means of a simple procedure: by tensing the rear of the lens bag, the lens will be less likely to move. There’s better contact between the implant lens and the rear of the lens bag.’ Extra operation ‘A reason for not using CTR - the operation is not common practice - would be that it involves an extra operation, during which part of the eye, such as the lens bag, could be damaged. Another reason would be that the additional costs don’t justify the operation. I disagree with those arguments. A ‘failed’ decentred lens is often followed by
From 12 mm to 10 mm
PMMA | Flexible ring
From 13 mm to 11 mm
PMMA | Flexible ring
Available in Clear and Brown PMMA a second operation, which is equally invasive, or the patient reverts to glasses. So that also leads to an additional medical intervention, or the patient has to return, after all, to wearing glasses. A 2-minute job with the supplied injector makes it a smooth procedure which I would fully recommend to ophthalmologists.’ OPH THE RECORD 9
Quick, Precise, Stable & Safe any eye surgeon who has ever implanted an iris claw lens knows that it is not easy, because you have to work your hands independently. but also because you never know exactly how much iris tissue you have captured on the tip of your needle. or whether the tissue will stay there, while you are busy with your other hand. although surgeons may take pride in the fact that they are dexterous and skilled enough to implant the lens successfully, it is worthwhile to look for ways to make the procedure more safe and simple. is it a coincidence that the solution to these problems comes from switzerland? By Kim Sauters
The credits should go to Marcus Kleger, one of the driving forces behind the success of OPHTEC lenses in Switzerland. ‘He is very good at optical calculations and deeply interested in the physics of optical devices. He is also very motivated and has helped us to adopt new lenses and techniques.’ These praising words come from dr. Grob, head of department of the Laser Vista Clinic in Binningen, Switzerland. Dr. Grob sums up: ‘Thanks to Marcus Kleger, we were early adopters of the Artisan and of the toric Artiflex lens, months before the official launch. And in 2008, he introduced us to vacuum enclavation, a very elegant method.’
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‘Look, this is what it is all about.’ In his hand dr. Grob shows a small tube with an opening at the end, and looks at it fondly.‘This instrument makes my work both easier and more secure. How?’ He picks up a needle and holds it in his other hand, as if balancing both in comparison. ‘With a needle, you do not know exactly how much iris tissue you have on the top of your needle; you have to extrapolate it. But with this vacuum enclavation tube the amount of tissue you hold can be calculated very precisely, as it simply depends on the diameter of the tube you use and the amount of suction you apply. The success is replicable.’
‘Also , keeping the iris tissue on the tip of your needle demands bimanual dexterity as the tissue may slip off while you are also busy with your other hand. With vacuum enclavation, you gain liberty and stability: once you have sucked in the iris tissue with the tube, that hand is safe and you can concentrate on the other hand.’ He puts the needle down. ‘For beginning surgeons it really is much easier to implant iris claw lenses using vacuum enclavation. But experienced surgeons also benefit. The advantage can be summed up in this one very important word: speed. The
VacuFix™ enclavation system exists of two handles, one for the right enclavation, one for the left. They are distinguishable by colour, orange and purple.
quicker one works, the less invasive the operation is. And the less invasive one works, all the more quickly the eye will recover. So it is more secure to use this tube, more precise, more efficient and, of course, it means more comfort for the recovering patient.’ Dr. Grob pauses a moment and rotates the tube prototype in his hand. ‘And last, but not least’, he resumes, ‘when working with toric lenses, vacuum enclavation has a particularly important advantage: a toric lens must be in the right axial alignment. In other words, you have to fixate the lens exactly where you have marked the cornea. With vacuum enclavation you know for sure that it is 100% oriented.’ It can’t be as easy as the surgeon-in-chief makes it seem. But dr. Grob laughs: ‘No, really: it is almost self-instructive. Believe me.’ It comes as no surprise then, that the two prototype sets at Vista Clinic have been in constant use ever since the clinic received them in 2008. This is Switzerland. The country of the precision of William Tell, the multi-functionality of the Swiss pocket-knife and the reward of clear vision because of the stunning scenery. The question springs to mind if dr. Grob considers himself to be a pioneer, always aiming for precision, eager to try out new techniques. But this shot misses its target and dr. Grob looks a bit doubtful. ‘I myself am not the pioneering type,’ he rejects politely. ‘My colleague and owner of Vista Clinics, dr. Haefliger, is more of a pioneer. He has always had a very active international network, looking for what is new on the horizon. Although I am attracted to this approach, my own style is to take advantage of different treatment options and to filter out the disadvantages. I focus mainly on the surgery. About 10% of my work consists of doing clinical research. I am simply looking for the safest methods.’
Dr. Grob is a critical man. When asked for possible downsides or points of improvement for the products he works with, he doesn’t hesitate. For instance when he compares the cachet lens to the iris claw lens. ‘We have worked with the cachet lens for three to four months now. Its refractive success seems to be ok, but it is not usable for astigmatic corrections and therefore cannot cover the whole field of refractive surgery. What I personally dislike, is that the cachet lens is closer to the back surface of the cornea, due to the vaulting of the lens. The space between the crystalline lens and the cachet lens is wider. It is more anterior in the eye. You cannot be sure if the distance to the cornea is stable. There could be more mobility if the patient rubs his eye.’ ‘The fixation properties of iris claw lenses on the other hand, are fabulous’, dr. Grob continues. ‘You always know where your lens sticks. That it stays exactly where you put it. With chamber angle fixated lenses, you cannot check easily, you cannot see the whole lens without looking through a gonioscopy lens. With a phakic lens like Artisan, you take one glance and you see it’s there. Also there are very little long term risks for the corneal endothelium and for glaucoma. It’s stable and it’s safe. That is what I like.’ Quick, precise, stable and safe. These words seem to characterize the work ideals of dr. Grob as a surgeon and ophthalmologist. And every new product has to pass these prerequisites and to meet these standards. ‘I am quite fond of the toric Artiflex lens,’ he declares to our relief. ‘We got the opportunity to work with it in 2008, before the official launch.’ Dr. Grob patiently lists its properties: the visual acuity, precise calculations, the success for patients. Patients feel comfortable and recover very quickly, thanks to the small incision.
Laser Vista Clinic is the refractive branch of Vista Clinic: a group of eye surgery clinics located in Zurich, Basel and several smaller places in Switzerland. The laser clinic has three main locations, where 1500 corneal laser operations take place every year and around 600 intra-ocular refractive operations. About a third of these patients get phakic lenses, mainly Artisan and Artiflex. Dr. Michael Grob is working at the Vista Klinik since 1997. Head of department since 2009.
Moreover, you do not have to suture and so you avoid the risk of creating astigmatism by the tension of the suture.’ The delicate act of balancing innovation and security seems just the way to please the Swiss public. They are generally low-risk taking and very well-insured. Dr. Grob’s Vista Clinic fits in to this culture perfectly. What are the challenges of his company in Switzerland? ‘Swiss are not very mobile. You have to go to the places where the patients are,’ states Grob. ‘The market is quite full. Swiss people are rather reluctant in terms of refractive surgery, and more so in rural areas than the city. The information is available, but they remain very low-risk taking, maybe more so than in other countries. They see the work we do as esthetic, comfort surgery, a luxury. We have to reassure them constantly, to counter the idea that it could harm their eye-sight. Whereas we know that with every new development we can offer just the opposite of that. I am not a risk-taking man. Quite the contrary.’
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Position of OPHTEC PIOLs among competitive products Artisan/Artiflex Material Sizing
Centration in eye Rotational Stability Visibility with slit lamp Interference with eye anatomy
(OPHTEC) Iris fixated
(Staar) Sulcus fixated
(Alcon) Angle supported
PMMA / Polysiloxane
Collamer (0.2% porcine material)
Acrysof material (hydrophobic acrylic)
One size fits all
Depending on sulcus to sulcus
Depending on chamber angle to angle
• Myopia • Hyperopia • Myopic and hyperopic astigmatism
• Myopia • Hyperopia • Myopic astigmatism
Determined by surgeon, over pupil in visual axis
Not influenced by surgeon
Not influenced by surgeon
Haptics not visible in sulcus
Haptics not visible in chamber angle without gonioscopy
No cataract risk, no ischemia, good clearance with endothelium
Close to crystalline lens, no ischemia, far away from endothelium
Far away from crystalline lens, ischemia with previous angle supported lenses
The Artisan and Artiflex iris fixated lenses differ from all other intraocular lenses in many respects: • While all other PIOLs have to be adjusted to the internal dimension of the eye, like sulcus to sulcus, the iris fixated lenses are one-size fits all. •
The iris claw fixation principle allows the surgeon to position the lens in the best location. The lenses do not have to be centered in the middle of the eye but can be placed exactly over the pupil, also when the pupil is decentered.
The iris fixated lenses are fixated in the virtually immobile mid peripheral iris stroma, still allowing dilatation of the pupil. They are not interfering with the terminal end arteries in the chamber angle and far away from the crystalline lens. The safety of the fixation principle is proven by the long track record; iris fixated lenses have been used since 1978.
Endothelial cell (EC) loss is an often discussed topic in phakic lenses. Multicenter studies with Artisan and Artiflex showed an average EC loss around 1 percent after 2 years and a study with 10 years follow-up showed an acceptable annual cell loss of 0.9 percent. A further detail: the iris that is captured between the claws functions as natural bridge between lens and endothelium, therewith prohibiting touch between haptics and endothelium.
The iris fixated design platform allows for many applications. The principle can be used for phakic and aphakic IOLs, iris reconstruction lenses and pupil occluders. The possibility to fixate the lens in any desired axis and the absence of rotation makes the iris fixated lenses especially suitable for toric lenses. The possibility to start with aphakic lenses allows the inexperienced surgeon to get used to the fixation principle in the anterior chamber without worrying about the crystalline lens.
• Fixation of the iris fixated lenses is easier with the new Vacufix vacuum enclavation system.
12 OPH THE RECORD
The new Luna: seeing better has become much easier By: Marij Thiecke
>> Luna Specifications
Dr. Frank Salamun
Dr. Frank Salamun is an ophthalmologist with vision. The fourth pioneer in row to introduce Slovenia’s cataract population to the potential of phaco-emulsifocation, he now refines and redefines his overall techniques as a dedicated physician from his clinic, Medicinski center Vid (www.vid.si). From this clinic, which he developed 8 years ago, he performs around 1,000 eye surgeries a year. As a trusted client of OPHTEC, Salamun has now implanted more than 500 of the new Luna aspheric IOL’s since September 2009. Salamun: ‘the Luna is an excellent product. It sits stable in the bag of the eye and does not move. The learning curve for the ophthalmologist is somewhat longer, but the result is excellent vision for the patient: seeing better has become much easier.’ Trustworthy Frank Salamun: ‘With 3,000 square metres, 3 fully equipped operating theatres, and 20 professionals around the premises, the clinic I opened 8 years ago is a medical center in the true sense of the word. Moreover, it is very appealing to the eye. Which, for an eye clinic, is an added bonus. Maybe I should elaborate a bit, as I am aware not every reader will be fully informed on medical and architectural developments in Slovenia in the last decade or so. For one, we made a very conscious decision some years ago to start building beautiful buildings in Slovenia. I personally think that beauty enhances a general sense of trustworthiness. And of course, that trustworthiness has to be redefined every day by satisfied patients and customers within the walls of my clinic. I use part of my clinic, the operating rooms are rented by other high quality surgeons and therapists, varying from internal to aesthetic medicine.’
Good system Salamun continues: ‘The healthcare system in Slovenia functions well, in a political system hovering mostly healthily between socialism and capitalism. There is one healthcare insurance company where every citizen is insured. This leaves both the patient and the physician well cared for. Eye care especially is well developed, thanks to our connections with an American company that made phaco-emulsification in Slovenia possible. There are 2 University clinics in Slovenia, and more than one half of eye visits and cataract surgeries are performed in private clinics.’ Choices ‘When I was in medical school in Slovenia, there were not many democratic choices. Becoming an eye surgeon became a calling only after I was allotted to the only free space available. But: I haven’t had a moment’s regret. And now, with my own beautiful and well equipped medical facility, I can honestly say that I am very happy, both with the choices the system made for me and my own choices. Such as the choice for OPHTEC. I started using Artisan lenses 15 years ago. As I am very precise, which comes in handy when your operating surface is measured in square millimetres, I was immediately struck with the service level at OPHTEC. As a result, we have been OPHTEC’s distributor for Slovenia for the past 10 years.’ Learning curve ‘When their Luna was presented September 2009, I did not feel any hesitation in using it. And so far, the results are very good. For the patient, the great advantage of this aspheric lens is the absence of glistening,
One piece IOL In the bag fixation Biconvex Aspherical surface Square edge 360˚
10.40 to 10.90 mm*
5.7 / 6.0 mm*
4 closed loops
119.0 (ultrasound) 119.4 (laser interference)
+10.0 D to +30.0 D (1.0 D increments)
+14.5 D to +25.5 D (0.5 D increments)
* Depends on diopter
and minimal aberrations. In eyespeak: after the first 500 implants, I have encountered 0 decentration, 0 PCO and 0 glistening. The procedure itself is pretty straightforward, although the learning curve is a bit longer. The hydrophobic material is somewhat more resistant, making the unfolding time around 10 seconds: a little longer than regular IOLs. Which technique works best for me? First, I make an incision of 2,5 mm: the standard. But in order to let the allow the resistant material the time it needs to unfold, I work bimanually. I use a Sinskey hook to protect the epithel, after the injection of methylcellulose I put the Luna through the injector, and during unfolding I remove viscoelastic behind the IOL which is very easy and unique among all other lenses. Then I press the eye, hydrating the wound. At the end, my patient leaves the building with healthy vision. So Luna: welcome to the family!’
OPH THE RECORD 13
OPHTEC patient design lenses By Anna Bilstra
apart from the standard product range in refractive, cataract and iris reconstruction lenses, ophtec manufactures lenses to meet the special needs of a special patient. these patient design lenses can differ from the standard products in dimension, lens power or color. All kinds of patient design lenses have been ordered in 2009. For instance: an Artisan Iris Reconstruction lens in a specific shape to cover an iris defect, a pupil occluder, an Artisan Aphakia lens with a cylinder, or a black colored iris reconstruction lens for dark brown eyes. To get insight in your experiences with our specially designed products, we sent questionnaires to different surgeons who ordered a lens in 2009. At the moment, most of the questionnaires have been returned and we are happy with the information that you provided! Experiences with occluder lenses A large part of the ordered products concerned lenses with an occluder function either an Artisan Occluder, a sulcus fixated PMMA cataract (PC 292) or Aniridia Lens II iris reconstruction lens. All in black, without optic or hole to cover the pupil in case of diplopia or for cosmetic reason in an eye without visual function with a white cataract. In all cases the patients were satisfied with the treatment of diplopia and with the cosmetic results. In one case a repositioning of the sulcus fixated lens was needed but the surgeon reported excellent results afterwards.
Experiences with colored material of iris reconstruction lenses What we learned from feedback of earlier cases is that our blue, brown and green implants appear somewhat brighter in the eye than before implantation. Especially in darker eyes, this could lead to unsatisfying cosmetic results. The recent experiences confirmed that black lenses offer a good alternative in dark brown eyes - the patients were very satisfied with the cosmetic outcomes. Just as important: the glare and photophia complaints had resolved after implantation.
The waiting time is around 14 weeks. To facilitate clear and fast communication, we updated the patient design request form in such a way that you are able to clearly communicate your requests. The form is available on request.
New forms Each patient design lens is unique, that is why it takes some time to deliver it.
A summary of the Model 311 Aniridia Lens II study is included in this edition of OphTheRecord (see page 15).
The Aniridia Lens II Not all iris reconstruction lenses are custom made. The Aniridia Lens II is a PMMA sulcus or sclera fixated lens which is CE approved. Currently, an FDA trial is performed in the USA.
Examples of OPHTEC’s patient design lenses • Artisan Aphakia with a cylinder (producible in 3.5 D) • Artisan pupil occluders in different sizes • Black colored PC 292 and ANI II lenses (sulcus fixated PMMA lenses) without optic to function as a pupil occluder • Aniridia Lens II iris reconstruction lenses in black • Aniridia Lens II reconstruction lenses in different overall or body dimensions • Iris Prosthetic System (IPS) elements • Artisan reconstruction lenses
From left to right: Artisan Pupil Occluder, IPS double and single elements and an Aniridia IOL II
14 OPH THE RECORD
Model 311 Artificial Iris lens is under clinical investigation in the US By Sylvia Gamio
Currently in the US, the Model 311 Artificial Iris lens is under clinical investigation. An IDE for this lens was opened in 2002 and a total of 437 patients have been implanted with the Model 311 in the US so far. This includes patients in the primary study, substudy (includes patients with preoperative or planned corneal transplants), Continued Access Study (which opened enrollment to other investigators), and Compassionate Use approvals (for subjects that did not meet study inclusion/exclusion criteria).
Model 311 Aniridia Lens II
The study requires 3 years of postoperative follow-up for all subjects in the primary and substudy, and one year postoperative
follow-up for Continued Access Study subjects. OPHTEC USA plans to complete 3 years of follow-up on all primary patients in 2010. The lens is indicated for the treatment of visual disturbances resulting from partial or total absence of the iris. Glare, Starbursts, and Photophobia as well as other visual disturbances are subjectively measured/ graded in severity preoperatively and at every postoperative exam. Thus far, the study has shown a significant decrease in visual disturbances experienced by the subjects. For example, in the primary study, 61.6% of subjects reported severe daytime glare preoperatively. The rate dropped to only 1.4% of subjects experiencing daytime Glare at 3 years postoperative. Severe daytime photophobia was also reduced significantly, from 58.1% preoperatively to 5.8% at 3 years postop. In addition to the reduction of visual disturbances, uncorrected visual acuity seemed to improve. In the primary study, 7.0% of subjects saw 20/40 or better
uncorrected preoperatively. At 3 years postop, the rate increased to 24.6%. Best Spectacle Corrected Distance Visual Acuity remained the same or slightly improved. Preoperatively 57% of subjects in the primary study saw 20/40 or better corrected, and 62.3% saw 20/40 or better at 3 years postoperative. There is an increased rate of adverse events in this study, but they do not seem to be lens related. The adverse events in this study are mostly related to the preoperative condition of the eye. Most all subjects suffered from severe trauma or from congenital aniridia. This correlates with the most frequently reported adverse events of corneal graft failure, and preoperative glaucoma requiring surgical intervention. Surgeons appreciate the color choices and power range available with the Model 311 when compared to other similar lenses, and are looking forward to when the lens becomes FDA approved. OPHTEC USA hopes to file for FDA approval sometime in late 2010 to early 2011.
Hydrofobic Acrylic asferical IOL
QuadrimaXâ„˘ Hydrophilic Acrylic asferical IOL
Hydrophilic & hydrophobic aspherical IOLs OPHTEC | Cataract Surgery OPH THE RECORD 15
Meet us at the ESCRS Congress // booth # 172
The jump to perfection in refractive surgery
Artiflex TORIC PIOL NEW >> VacuFix™ vacuum system for a perfect enclavation
• best positioning and centration of the (P)IOL • fixed reproducable amount of iris tissue
Ophthalmic products, interviews, news and more www.ophtec.com