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of Refractive Surgery and Presbyopia Correction Supplement September 2010EUROTIMES ESCRS ™ Supported by an unrestricted educational grant from

L ooking back to the early days of laser vision correction, it is amazing to see how far this life-changing surgical procedure has come, in a relatively short period of time. When the excimer laser first became available commercially in 1981, it was being explored for industrial use by IBM, among others. Its interaction with the cornea showed extraordinary potential for corneal refractive surgery. At the time, refractive surgery consisted of radial keratotomy (RK), other incisional procedures, and keratomileusis. In its heyday, there were 250,000 RK procedures performed annually in the US alone. “The fact that so many people were willing to have RK, which was less accurate and less stable than desired, is remarkable,” says Stephen L Trokel MD. “It speaks to the strong drive that patients have to get rid of their glasses.” Keratomileusis, developed in the 1960s by José Barraquer, was a complex, technically demanding procedure that was prone to complications and never achieved much popularity. “I think we have to give Barraquer tremendous credit for recognising that the cornea could be reshaped to correct vision,” says Dr Trokel. “He just didn’t have the right instrument to make it successful.” The right instrument was the excimer laser. In 1983, Dr Trokel published a landmark paper on excimer laser-cornea interactions, describing how the excimer laser could be used to remove precise amounts of corneal tissue with smooth, uniform surfaces and no thermal effect on adjacent tissues1. Over the next few years, he would also demonstrate that rabbit and monkey corneas treated with the laser healed clearly. Dr Trokel worked closely with engineer Charles Munnerlyn, who believed strongly in using the excimer laser to directly reshape the cornea. Munnerlyn quantified the relationship between tissue removal, optical zone size, and optical effects, creating a formula for tissue removal that is still in use today. “I expected excimer laser lamellar refractive surgery to be able to reshape the cornea more safely and accurately than RK,” says Dr Trokel. “But I never imagined it would be capable of the degree of safety and accuracy we see with current technology.” Human clinical applications The first person to use an excimer laser clinically was Theo Seiler MD, in 1985 in Germany, where he performed a relaxing keratotomy for a highly astigmatic patient. A number of other European and American surgeons also did early RK work with the laser. Marguerite McDonald MD, performed the first PRK procedures in human eyes. Her extensive animal and human studies in New Orleans established the clinical protocols for laser refractive surgery and demonstrated that surgeons could achieve predictable refractive change with the laser2. Interest in the excimer laser rapidly swung away from RK towards PRK, and in quick succession, laser in situ keratomileusis, or LASIK. It is believed that the first people to perform a rudimentary LASIK procedure were a group of Russian doctors in Novosibirsk led by Alexander M Razhev and V P Chebotaev. Using a homemade prototype laser under a flap cut with a trephine, they treated four highly myopic eyes in 1988. Lucio Buratto of Italy also tried to use the excimer laser to refine Barraquer’s keratomileusis procedure by ablating the underside of the cap. Gholam Peyman MD, described the LASIK procedure in a 1989 patent. Clearly, the pieces for LASIK were already in place. “Ioannis Pallikaris MD, PhD, deserves credit for putting those pieces together,” says Dr Trokel. “He recognised three things: one, that you could ablate tissue under a hinged flap; two, the need for an automated mechanical microkeratome with a guard to preserve the hinge as it cut the flap; and three, that the ablation should be performed in the stromal bed, rather than on the underside of the flap, as many others believed.” Prof Pallikaris coined the name LASIK and showed that it was clinically feasible. “And with the exception of replacing the mechanical microkeratome with a femtosecond laser, that is the procedure that has stood the test of time,” Dr Trokel says. The following year, in 1991, José Güell MD, began performing sighted eye LASIK procedures in Europe. Stephen Slade MD, Stephen Brint MD, and Fred Kremer MD, who learned the technique from Buratto and other European surgeons, led the LASIK revolution in the US, where it quickly became popular with patients and surgeons. In 1996, there were 20,000 laser vision correction procedures performed in the US. Within just 10 years, there were close to one million each year, mostly LASIK. European surgeons also rapidly adopted LASIK in the late 1990s. Worldwide, more than 12 million people have benefited from LASIK. Laser vision correction has been gradually refined over the years. “One of the challenges from the beginning was how to keep the eye still and deliver the laser treatment exactly where you wanted it on the cornea throughout a relatively long exposure time,” Dr Trokel explains. The development of reliable, real-time tracking brought with it a huge improvement in outcomes, as did the introduction of wavefront aberrometry. Wavefront analysis helped surgeons and researchers better understand the optics of the eye – and when that analysis could be used to drive treatments, outcomes improved. 20 Years of LASIK Driving the Future of Refractive Surgery and Presbyopia Correction The Evolution of Laser Vision Correction 1 “Worldwide, more than 12 million people have benefited from LASIK” Wavefront analysis reveals unique higher order aberration patterns across three patients with equivalent spherical equivalents

Michael Knorz MD Stephen L Trokel MD Evolution of Custom LASIK With the growth of LASIK, it became apparent that the procedure itself was actually inducing some quality-of-vision problems, even as it corrected sphere and cylinder. Wavefront aberrometry, based on the adaptive optics used by astrophysicists to improve telescope images, provided the answers. A variety of aberrometers or wavefront sensors were developed for ophthalmic use, including Tscherning, Hartmann-Shack, ray tracing, skiaskopy, and other types of systems, many of them developed in Germany. As diagnostic devices, these aberrometers provided important new information about vision, quality of vision, and higher-order aberrations, both naturally present and those induced by surgery. By 2003, wavefront-guided LASIK could be performed with several commercially available laser systems. “With each of the laser systems, we saw that wavefront-guided ablations outperformed conventional ablations,” says Michael Knorz, MD, who performed the first LASIK procedures in Germany and later trained LASIK surgeons in many countries. Not surprisingly, the adoption of custom LASIK was rapid, with the majority of surgeons performing the procedure on at least some of their patients that year, even if they didn’t choose a custom procedure for all patients. There is now a long list of studies, including many conducted by the US military, showing better results with wavefront-guided LASIK compared to conventional LASIK. Furthermore, large studies of wavefront-guided LASIK have demonstrated better than 20/20 outcomes in the vast majority of patients3. Today, Prof Knorz performs wavefront aberrometry on all his laser refractive surgery patients and is able to perform an all-laser, wavefront-guided procedure in nearly every case. The latest wavefront-guided laser algorithms, Prof Knorz says, are very sophisticated at minimising the induction of aberrations and preventing night vision problems. “That’s one of the main reasons for enhanced safety of LASIK and better results. With truly custom procedures, we are able to deliver on the promise of excellent vision with minimal risk,” he says. Advancements in flap making technology have also benefitted patients by limiting complications and increasing the predictability and consistency of the flap depth. “I believe strongly that future advances will be built upon the foundations of wavefront-guided custom ablation and thin femtosecond laser flaps,” Prof Knorz says. Therapeutic applications For many, the Holy Grail of advancements in laser refractive surgery has been the development of technologies and procedures for therapeutic cases. “Laser vision correction presents a great opportunity to fix refractive and cataract surgery mistakes, turning unhappy patients into happy or less unhappy ones,” says Julian D Stevens FRCS, FRCOphth, of Moorfields Eye Hospital in London. For example, he has been using high-definition wavefront sensing and wavefront-guided ablations to reduce residual cylinder and resolve subjective complaints in pseudophakes with malpositioned toric IOLs. “In one case I treated, the RMS value (0.58), and particularly coma, were very high, which correlated with the patient’s symptoms,” he says. In this case, a wavefront-guided procedure was able to normalise the point spread function and resolve the patient’s complaints. In 245 therapeutic procedures he has performed, wavefront-guided retreatments dramatically improved total aberrations and higher- order aberrations after prior surgery. He has been able to improve outcomes in cases with very high cylinder, severe aberrations from AK incisions close to the optical axis, decentred ablations, and in patients with multifocal IOLs. He has also employed therapeutic, topography-guided ablations to help children with corneal scars, extremely high astigmatism, and poor visual outcomes following penetrating injuries. Even in these topography-guided treatments, wavefront aberrometry is important for correct registration of the treatment. “The more complex the eye, the more important accurate registration becomes,” Dr Stevens says. “If you mis-register a complex wavefront shape, the problems are just magnified,” he says. Iris registration with cyclotorsion and pupil shift compensation has greatly improved results in complex cases. In the future, Dr Stevens hopes that dynamic rotational tracking and parallax compensation will continue that trend. Dr Trokel is vice-chair and professor of clinical ophthalmology at Columbia University College of Physicians and Surgeons. Contact him at: trokel@columbia.edu. Prof Knorz is the founder and medical director of the FreeVis LASIK Center in Mannheim, Germany, and a professor of ophthalmology at the University of Heidelberg, Medical Faculty Mannheim, Germany. Contact him at: knorz@eyes.de. Dr Stevens is a consultant and ophthalmic surgeon at Moorfields Eye Hospital in London. Contact him at: jds@uk.com. References: 1. Trokel SL, Srinivasan R, Braren B. Excimer laser surgery of the cornea. Am J Ophthalmol 1983;96:710-5. 2. McDonald MB, Liu JC, Byrd TJ, et al. Central photorefractive keratectomy for myopia: partially sighted and normally sighted eyes. Ophthalmology 1991;98:1327-37. 3. Schallhorn SC, Venter JA. One-month outcomes of wavefront-guided LASIK for low to moderate myopia with the VISX STAR S4 laser in 32,569 eyes. J Refract Surg 2009;25 (Suppl):S634-41. 2Driving the Future of Refractive Surgery and Presbyopia Correction Julian D Stevens FRCS, FRCOphth Analysis of laser vision correction outcomes reveals continuous improvement in treatment predictability as technology develops

The Evolution of Femtosecond Laser Technology The femtosecond laser has already revolutionised several procedures and many more applications are in the pipeline F emtosecond laser flaps, which I originally thought would be an option for a few, have rapidly become the standard in our practice. They have enhanced the safety of LASIK and broadened its appeal to patients. Compared to microkeratomes, the femtosecond laser allows us to more consistently achieve a thin flap with a thick residual stromal bed. The latest innovations in side-cut architecture may further reduce the biomechanical disruption of the cornea. But other applications of femtosecond laser technology – for corneal implants, keratoplasty and other transplants, and in the fields of cataract, glaucoma, and even retina – hold even greater potential, I believe. Corneal rings The femtosecond laser is ideally suited to automated dissection of channels for corneal ring segments for the treatment of keratoconus and ectasia, and eventually for presbyopia-correcting cornea implants. The early, larger ring segments, such as Intacs (Addition Technology), were relatively easy to implant with guided dissection of the tunnels, but unfortunately had limited effect. The later generation of smaller diameter rings like the Ferrara ring (Ferrara Ophthalmics) and KeraRing intrastromal corneal ring segments (Mediphacos) are more versatile and effective, but quite difficult to implant properly. With manual dissection of the channels, not only does one have a tendency to spiral towards the pupil, but the channels also typically end up more superficial than intended, making the implants more prone to extrude. Since we began making the channels with a femtosecond laser, our extrusion rate has dropped from about 10 per cent to virtually zero. Moreover, we are seeing better results, more refined nomograms, and a much more sophisticated understanding of how these devices can be used in the cornea, now that placement is no longer an uncontrolled variable. Corneal transplantation Several new techniques have revolutionised the cornea field. Traditional penetrating keratoplasty (PK), which we have performed successfully for many years, is now being overtaken by deep anterior lamellar keratoplasty (DALK), Descemet’s stripping automated endothelial keratoplasty (DSAEK), and femtosecond laser-assisted penetrating keratoplasty (FLAPK), thanks to the better results and faster recovery that can be achieved with all those procedures. Despite the initial logistical challenges of incorporating the femtosecond laser into PK surgery, laser tissue dissection has proved to be a true advancement over manual dissection. Suddenly, the laser makes it possible to create far more complex shapes (eg, mushroom, top hat, and zig-zag) than we could ever cut before. Corneal surgeons are still evaluating the best graft shapes for specific types of procedures and pathologies, but the femtosecond laser opens up great potential for improved graft stability and better and faster visual recovery. With the current applications alone, the development of femtosecond lasers has progressed to the point where asking “Do I need a femtosecond laser?” is like asking whether a surgeon needs a scalpel. Of course, the answer is “yes”. Future trends Today’s femtosecond lasers are significantly faster than the original 15 KHz models – and I do not think we have yet reached the limit of this technology, in terms of speed. Faster speeds reduce the amount of energy needed and will eventually allow us to apply the lasers to deep- cornea applications such as DALK. Femtosecond laser capsulotomies for cataract surgery have been much publicised. To me, this application has limited appeal. It is not a great improvement over what a good surgeon can already do, quickly, with a much simpler tool. Softening a hard nucleus in a challenging cataract case is more appealing. And potential laser softening of a presbyopic lens to allow it to maintain accommodation as the patient ages is more exciting still – provided it works without inducing a cataract. I believe that in addition to cataract, we will also someday see glaucoma and retina applications for femtosecond lasers. After all, there are many ophthalmic uses for any precision cutting tool, which is what the femtosecond laser is. We have only to identify the appropriate methods of delivery. Dr Barraquer is medical director of the Barraquer Ophthalmology Center in Barcelona, Spain, associate professor of ophthalmology at the Autonomous University of Barcelona, and director of the J Barraquer Chair for Eye Research. Contact him at: rib@co-barraquer.es. 3Driving the Future of Refractive Surgery and Presbyopia Correction Rafael Barraquer MD, PhD Refining LASIK Outcomes with Flap Architecture Eric D Donnenfeld MD Reverse side cut improves flap stability and severed nerve apposition, which improves corneal sensation and reduces dry eye. Our recent studies, which we presented at the ASCRS 2010 Annual Meeting, demonstrate that reverse side cuts create a bevel in apposition that provides better biomechanical stability as shown by Michael Knorz in his 2008 peer review article in the Journal of Refractive Surgery. In addition, our recent study evaluated the effect of an elliptical flap with reverse side cut on corneal sensation after LASIK. For the prospective open label trial, 20 eyes of 10 consecutive patients who underwent bilateral simultaneous LASIK using elliptical/reverse side cut flaps (150˚) iFS, 150 kHZ) and 4mm hinges were compared to 20 eyes of 10 consecutive patients who underwent bilateral simultaneous LASIK using round flaps with 70˚ flaps and 3mm hinges. The study demonstrated that the reverse side-cuts provide better apposition of the corneal nerves because the flap and the bed are in better apposition with a more rapid return of corneal sensation and a reduced risk of postoperative dry eye. Dr Donnenfeld is in practice at Ophthalmic Consultants of Long Island, in Rockville Centre, NY. Contact him at: EDDoph@aol.com. Elliptical flaps with a reverse side-cut result in more rapid return of corneal sensation than conventional flaps

Data analysis demonstrates the superb visual results and high rates of patient satisfaction I n a recent retrospective review in the Journal of Refractive Surgery (JRS) of more than 32,000 myopic wavefront-guided LASIK treatments at Optical Express an impressive 71.6 per cent achieved UCVA of 20/16 or better at one month, with 91.8 per cent seeing 20/20 or better . Results were reviewed for all eyes in the central database that were treated in 2008, had one-month results available, and met the study criteria of a preoperative manifest spherical equivalent of ≤ 6.00 D, preoperative cylinder of ≤ 6.00 D, a refractive target of emmetropia, and no prior refractive procedures. In total, 32,569 eyes of 17,713 patients were included. At one month, the mean defocus equivalent was 0.27 ±0.31 D and the mean manifest cylinder was -0.17 ±0.26 D. Among the patients who underwent bilateral LASIK, 88.8 per cent achieved 20/16 or better uncorrected binocular vision and 98.1 per cent were 20/20 or better. The rate of complications was very low, at 0.64 per cent. Even among the few eyes with serious complications, no eye had postoperative BSCVA worse than 20/40. How were such excellent results achieved? Clearly, the study is too large to be biased by the results of just one particularly good or experienced surgeon. In fact, the procedures were performed by 30 different surgeons at 41 centres, using standardised protocols and a general principle of striving for excellence. Based on these data, we can say that it is reasonable to expect most low to moderate myopes will achieve better than 20/20 uncorrected vision following LASIK, particularly with the advanced refractive technology used in these treatments, including femtosecond laser flaps and wavefront-guided ablations. Patient satisfaction In a separate JRS study, responses were analysed for 13,655 patients who completed a computer-based satisfaction questionnaire at their one-month postoperative visit. This analysis included patients ranging from age 18 to 71 who had LASIK or surface ablation for refractive errors ranging from -11.63 to +6.00 D manifest spherical equivalent. The great majority of patients (95 per cent) said they were “satisfied” or “very satisfied” with their visual outcome. About 75 per cent said their vision was better than they expected preoperatively, 83 per cent said it was better than their vision with spectacles or contact lenses before surgery, and more than 94 per cent said that laser vision correction had “changed their lives for the better.” These are remarkable results that are testament to the impact that laser vision correction can have on patients’ quality of life and satisfaction with their vision. Conclusions Our standards for excellence in refractive surgery are rapidly moving beyond previous expectations. Large data sets like those Optical Express has made available have the potential to enhance our understanding of laser vision correction in many ways, to the benefit of the entire refractive surgery community and that of our patients. Prof Dick is the German medical director of Optical Express, a member of the Optical Express International Medical Advisory Board (IMAB) and professor of ophthalmology, chairman and head of the University Eye Clinic in Bochum, Germany. Contact him at: burkhard.dick@kk-bochum.de. Raising the Bar for Refractive Surgery Burkhard Dick MD, PhD Driving the Future of Refractive Surgery and Presbyopia Correction Wavefront-guided vs. Wavefront-optimised Edward Manche MD We recently conducted a prospective, contralateral study comparing wavefront-guided LASIK with the AMO iLASIK platform to wavefront-optimised LASIK with the Alcon Allegretto Wave Eye-Q excimer laser system (400 Hz). The study was not funded by either laser manufacturer. Ninety eyes of 45 patients were enrolled. All had 9.2mm diameter, 105-micron flaps made with the IntraLase FS laser. The subjects were typical myopes, with an average age of 38 (range 24-55), and mean manifest spherical equivalent of -4.56 ± 1.97 D in the wavefront-guided (WFG) group and -4.70 ± 1.73 D in the wavefront-optimised (WFO) group. Preoperative cylinder and higher order aberrations were quite similar between the two groups in the contralateral study. Overall, results were excellent, with more than three-quarters of patients in both groups achieving final results of better than 20/20 uncorrected vision. However, the WFG group had significantly better UCVA at all time points compared to the WFO group, less induction of total HOA, coma, and trefoil, and better predictability. The WFG platform also performed better on cylinder correction, leaving residual cylinder of +0.16 ± 0.23, compared to +0.23 ± 0.33 D in the WFO group. There were no statistically significant differences in low-contrast acuity (either five per cent or 25 per cent) or safety between the two groups. The results of this study demonstrate how far laser vision correction has come in its short history. Today’s lasers are capable of truly excellent results. The study demonstrates that wavefront-guided and wavefront-optimised treatments both produce excellent clinical outcomes. The study also shows that wavefront-guided treatments have an advantage in the percentage of eyes achieving UCVA at 20/16 or better, lower postoperative residual cylinder and less induction of higher order aberrations. Dr Manche is director of cornea and refractive surgery and professor of ophthalmology at the Stanford University School of Medicine. He does not have a financial relationship with any of the companies mentioned in this article. Contact him at: edward.manche@stanford.edu. At one day post-op over three-quarters of patients achieved 20/20 or better UCVA 4

Surgery and the Ocular Surface Beatrice Cochener MD 5 I n anterior segment surgery, we have reached a level of success once not even thought possible. With premium IOLs and microincisional techniques, our cataract surgery patients can achieve excellent uncorrected vision at all distances. Laser refractive surgery patients are now routinely achieving better than 20/20, “super vision” results, thanks to personalised, wavefront-guided ablations that address both lower- and higher-order aberrations. But despite all the technological and surgical advances, outcomes continue to be limited by insufficient attention to the quality of the ocular surface. About half of our cataract patients and up to one-third of our LASIK patients have significant preoperative ocular surface disease (OSD) including dry eye, blepharitis, and ocular allergy. In my experience, they are also the leading source of patient dissatisfaction after refractive corneal or lenticular surgery. Preoperative measures I ask patients to answer a questionnaire to help me assess any OSD symptoms that they may not be directly complaining about. During the preoperative exam, I examine the epithelium closely, looking particularly for any evidence of basement membrane dystrophies. I also examine the conjunctivae, limbus, papillae, meibomian glands, and the facial skin. None of our traditional tear film tests is effective in assessing all the layers of the tear film. Schirmer’s testing is diagnostic only for significant aqueous deficiency, while lissamine green staining and tear break-up time may be more helpful in identifying problems with the mucin layer. Hyperosmolarity is closely linked to tear instability in ocular surface disease1. Unlike more complex laboratory testing, a new in-office device (TearLab Corp) is easy to use and requires a minute amount of tears, yet has very similar specificity, sensitivity, and predictive value to laboratory osmolarity testing. It detects and quantifies aqueous or evaporative deficiency with a mean value of 275 to 400 mOsm/L. When there are signs of ocular surface disease, artificial tears are the first line of treatment. For moderate dry eye and for eyes undergoing corneal surgery, I particularly like tears containing hyaluronate and sulfate chondroitin because they offer the advantages of remaining longer on the eye and of helping the wound healing process. Depending on the severity and etiology of dry eye, I may also use punctal occlusion, eyelid hygiene, topical steroids, topical cyclosporine and/or nutritional supplementation in addition to tears to maximise the health of the ocular surface before surgery. Intraoperative measures High quality viscoelastics protect the endothelium during surgery, and the surgeon should make every effort to protect the cornea and conjunctivae from trauma, as well. In a LASIK procedure, the resection of the corneal flap severs nerves that are crucial to the production of healthy tears. This was described by Steve Wilson as LASIK-induced neurotrophic epitheliopathy2. In normal eyes, this effect is transient and relatively asymptomatic. Corneal sensation and tear production quickly return to normal levels with corneal remodeling and the re-innervation of the flap. However, if the patient has chronic, progressive OSD prior to surgery, the duration of symptoms can be much longer. Surgical choices in LASIK are important, too. The natural horizontal distribution of nerves in the cornea has led to some discussion of the best location for the hinge of a LASIK flap. Although more study is required, a superior hinge could lead to double nerve damage (at 3 and 9 o’clock) compared to a nasal hinge that would sever nerves only on one side. A femtosecond laser flap may be advisable to avoid the goblet and mucin cell damage and tiny surface irregularities that can be caused by microkeratome suction pressure. Femtosecond flaps may also promote faster re-innervation by better apposition of the nerves in the flap to those in the stromal bed. Postoperative treatment and prevention Following corneal laser surgery, I recommend artificial tears for two to four months to improve comfort and facilitate surface repair. For patients with OSD, I like to reinforce the tear regimen by adding other agents, such as topical cyclosporine. Of course, knowing this in advance and starting treatment before surgery results in easier postoperative management. We need to educate those patients with OSD that they have a chronic condition which existed pre-operatively and will require long- term maintenance. In summary, ocular surface disease is not a contraindication for surgery. As surgeons, we should not underestimate the degree to which the ocular surface and tear film can influence visual outcomes, patient satisfaction, and quality of life, particularly with the high expectations that we now have for both corneal and lenticular refractive surgery. Prof Cochener is professor and chairman of ophthalmology at the University of Brest, France. She currently serves as president of the French Society of Ophthalmology (SFO). Contact her at: beatrice.cochener@lamard.fr. References: 1. Liu H, Begley C, Chen M, et al. A link between tear instability and hyperosmolarity in dry eye. Invest Ophthalmol Vis Sci. 2009;50(8):3671-9. 2. Wilson SE. Laser in situ keratomileusis-induced (presumed) neurotrophic epitheliopathy. Ophthalmology 2001;108(6):1082-7. Driving the Future of Refractive Surgery and Presbyopia Correction Attention to ocular surface before, during, and after surgery can improve results, increase patient satisfaction, and avoid unwanted complications Lissamine green staining of the cornea/conjunctiva is indicative of mucin layer deficiencies and should be a warning sign for ocular surface disorders

6 S mooth cutting and enhanced followability to improve cataract removal, helps to ensure excellent postoperative outcomes for patients. It is important to use a system that provides flexibility for physician preferences while being very responsive and using minimal energy, which contributes to faster patient recovery and a high safety profile. Venturi or peristaltic Both the venturi and peristaltic fluidic approaches have distinct advantages. With the venturi pump, the vacuum is always on and thus it employs fast, efficient vacuum. The venturi approach is ideal for cortex removal, vitrectomy, viscoelastic removal, and quadrant removal. However, there is a risk of capsule rupture. Frequently, retinal surgeons prefer venturi. With a peristaltic approach, vacuum, flow, and rise time are all separate. It provides safety and control and is ideal for nuclear fragmentation, and epinuclear cleanup. However, it is less efficient. This is often the anterior segment surgeon preference. System benefits A dual pump system offers the possibility to use the best of both worlds because the surgeon can switch back and forth, in a single procedure, between peristaltic for nuclear fragmentation and venturi for quadrant removal. Then for irrigation and aspiration the surgeon can select either venturi or peristaltic, and go back to venturi for OVD. I prefer the safety and control of the peristaltic pump for grooving and the efficiency of the venturi pump for removing the quadrants. I have found that having both pump options in the same system has made cataract surgery more effective, especially when removing hard nuclei. This type of system also gives the surgeon more control during phaco. The nucleus stays at the phaco tip and does not jump around in the eye. Therefore, cataract removal is very effective while being smooth and controlled at the same time. Versatility and control It is also important to use a system that has simultaneous blending of transversal and longitudinal energy modalities to optimise efficiency. This delivers smoother, more efficient energy and has higher frequency cutting and a larger stroke path which contributes to a high safety profile. A non-zero start for vacuum, power, and aspiration is a key advantage as it provides surgeons with increased efficiency, enhanced control and responsiveness, and more precise control over power parameters. In addition, a variable venturi vacuum ramp provides surgeons with increased control for venturi applications, and the ability to approach materials with safer, lower vacuum levels. Excellent internal monitoring also helps minimise the surge in the eye so there is no trampoline effect. The cold advantage Studies have shown that the colder the phaco the safer the surgery and that there is a reduced risk of thermal wound burn. Cold phaco provides a host of advantages, such as: tighter incisions; greater anterior chamber stability; more efficient phaco; reduced endothelial cell loss; less intraocular inflammation; and more rapid visual rehabilitation. Based on all of these important criteria, I use the Signature system with the Ellips FX upgrade in my practice. Overall the Signature system allows the surgeon maximum control and versatility for the phaco procedure while ensuring a safer surgical environment. Dr Auffarth is acting chairman, Department of Ophthalmology, University of Heidelberg, in Heidelberg,Germany. He can be reached at: gerd. auffarth@med.uni-heidelberg.de. Gerd Auffarth MD Driving the Future of Refractive Surgery and Presbyopia Correction Dual-Pump Fluidics offer Versatility and Responsiveness By combining peristaltic and venturi technology in one system surgeons have the ability to customise the procedure to fit their technique Comparing venturi and peristaltic pump benefits “I prefer the safety and control of the peristaltic pump for grooving and the efficiency of the venturi pump for removing the quadrants”

7 I mproved quantity and quality of vision is the goal of any ocular surgery. One of the primary decisions a surgeon has to make in regards to those outcomes is the type of material that will be used in the implant. Even with a perfect procedure and excellent lens optics, if the material degrades over time the patient will not receive the best long-term visual quality results. Today the Alcon AcrySof single piece SN60WF is the most frequently implanted IOL. Some surgeons might ask why they should even try to do better. The answer: to avoid the possibility of glistenings or vacuoles from developing in the lens and also to reduce the incidence of posterior capsular opacification. Research has shown that some patients implanted with the hydrophilic AcrySof single-piece SN60WF experience vacuoles and glistening that affect quality of vision over time1. Glistenings can cause a loss in contrast sensitivity. For example, one study showed that eyes without glistenings were found to have a 40 per cent increase in contrast sensitivity at high spatial frequencies2. As surgeons we do not want this glistening-effect to happen to our patients and there is no way of knowing which patients might develop glistening or how severe they will be. Therefore, surgeons will want to select a lens that is hydrophobic, and vacuole-free. Clinical findings We recently evaluated 400 consecutive implantations of the Tecnis 1-Piece lens with a six-month and one-year follow-up period. Each IOL implantation was recorded. Posterior capsule opacification (PCO), centration of the lens, and glistening in the material were assessed. We found that the unfolding of the lenses was smooth and extremely reproducible. No glistenings were observed inside the acrylic material and no IOL decentration occurred. Another study conducted by my colleague Marion Blaizeau compared the Tecnis 1-Piece and the AcrySof SN60WF. The results showed that the Tecnis had fewer post-op corneal aberrations and fewer total aberrations than the AcrySof lens. In addition, the Tecnis patients had improved post-op visual acuity. These superior results were possible due to some of the unique features and benefits of the Tecnis lens. Advanced lens design A well-performing and long-lasting IOL with an excellent quality of the biomaterial that provides quality of vision and PCO prevention is optimal. The Tecnis 1-Piece is easy-to-implant that has a proven bag-friendly coplanar delivery and bag stability. Its reduced centre thickness for a slim lens profile additionally facilitates implantation and the polished haptic loops reduce friction and enable controlled, gentle unfolding of the lens in the capsular bag. This next-generation lens is made of a proven hydrophobic acrylic material, which is vacuole and calcification free. One comparison study found that it was the clearest optic material of all the IOLs tested3. In addition, the Tecnis allows for the transmission of healthy blue light, which provides for the best scotopic sensitivity and optimal circadian rhythms. The wavefront-designed optic lens rejuvenates vision by correcting spherical aberration to essentially zero. Other unique elements of the one-piece lens include a 360° barrier edge. The barrier edge has uninterrupted contact with the posterior capsular bag even at the haptic-optic junction to prevent PCO. The design also allows for an improved benefit in centration, unlike traditionally one-piece lenses. The Tecnis lens is a versatile, easy-to-use lens that reduces spherical aberration, improves functional vision, and has proven night-driving simulator performance. Choosing the next-generation glistening-free lens is one way to help ensure long-term visual quality for your patients. Prof Colin is chairman of the University Hospital Ophthalmology Department in Bordeaux. He can be reached at: joseph.colin@chu-bordeaux.fr. References 1. Christiansen G, Durcan FJ, Olson RJ, Christiansen K. Glistenings in the AcrySof intraocular lens: pilot study. J Cataract Refract Surg. 2001 May;27(5):728-33 2. Gunenc U, Oner FH, Tongal S, Ferliel M. J Cataract Refract Surg. 2001. Effects on visual function of glistenings and folding marks in AcrySof intraocular lenses. J Cataract Refract Surg. 2001 Oct;27(10):1611-4. 3. Tognetto D, Toto L, Sanguinetti G, Ravalico G. Glistenings in foldable intraocular lenses. J Cataract Refract Surg. 2002 Jul;28(7):1211-6. The Importance of Lens Clarity Driving the Future of Refractive Surgery and Presbyopia Correction Latest generation acrylic lens is glistening-free and remains stable over time Image 1 is a slit lamp photograph showing an eye with a ReSTOR multifocal IOL with severe glistenings. Glistenings of this intensity can not only degrade image quality but can also result in a loss of its multifocality. (The image was submitted to the Apple Laboratory by Dr Ibrahim F Hepsen and provided here courtesy of David J Apple, MD.) Image 2 is a photomicrograph of an AcrySof blue-blocking lens showing multiple microvacuoles or glistenings Visual acuity results differ as pupil size changes Joseph Colin MD

Second-generation Accommodative Lens Advances Dual-optic lens technology provides functional visual acuity over a range of distances, including a more natural near vision 8 N ext-generation accommodative IOLs provide improved long-term accommodation leading to enhanced near vision compared to some first-generation accommodative lenses or multifocals, according to international results from studies performed in South America. My colleagues Victor Bohorquez MD, Ricardo Alarcon MD, Andrea Galvis MD, and I conducted a randomised masked clinical study that compared the performance and outcomes of the Synchrony (Abbott Medical Optics Inc, Santa Ana, Calif.) and ReSTOR (Alcon, Ft. Worth, Texas) lenses. The study included 100 patients: 50 Synchrony OU and 50 ReSTOR OU. Clinical tests, such as a 12-month visual acuity measurement of monocular and binocular with and without distance correction were performed. International results The Synchrony performed well with reading speed, contrast sensitivity, and functional visual acuity over a range of distances. Overall, patients implanted with Synchrony showed better uncorrected vision at all distances. At one year 82 per cent of Synchrony patients reached 20/25 distance, 20/32 intermediate and 20/32 near, while 53.5 per cent of ReSTOR eyes did. While 97.4 per cent of Synchrony patients reached 20/25 distance, 20/40 intermediate, and 20/40 near compared to 76.7 per cent of ReSTOR patients. In addition, the Synchrony patients had significantly better mean distance corrected visual acuity at 60cm, 80cm, 1M, and 2M than ReSTOR. Acuity was similar at 40cm and 4M. At one year, Synchrony patients also had significantly better contrast sensitivity in mesopic and photopic conditions. With regard to visual quality, there were significantly lower rates of haloes with Synchrony vs. ReSTOR at one year. No Synchrony patient complained of severe/ very severe haloes or glare compared with the ReSTOR patients who had these complaints. Two-year follow-up data on the Synchrony lens from Dr Alarcon demonstrate 95 per cent of the Synchrony patients had better than 20/40 distance corrected near visual acuity than ReSTOR patients. Two-year data from Dr Bohorquez also show that Synchrony patients experience good reading speeds at smaller font sizes (0.3 and below, equivalent to 20/40 or better). This is very encouraging data from this unique next-generation lens. Second-generation lens features The Synchrony has a 5.5mm high plus anterior optic of +32 D, coupled to a 6.0mm negatively powered posterior optic. A spring-activated mechanism separates the two lenses. The haptics separate the lenses at a given distance under constriction of the capsule, and during relaxation of the capsule following accommodative effort anterior movement of the positive anterior optic produces increased power for near tasks. The lens represents a significant advancement in the ability to use standard thin lens optics to change focal length. For instance, the focal distance can be changed by slightly moving a plus lens relative to a minus lens a certain distance and that will provide a change in the focal point. Unlike first-generation accommodative lenses, the Synchrony fills the capsular bag and maintains the relative volume of the previous natural human lenses. As a result, it more naturally mimics the physiological state of the relationship between the ciliary body, the zonules and the translated optomechanical movement that occurs during the accommodative response. The surgical technique for implanting the Synchrony is standard cataract surgery with close attention given to the anterior capsulotomy, which must be well centred and small. The capsulotomy must be intact because it creates a mechanical system that will be under tension. The lens is then inserted through a 3.8mm incision using an injector system that injects the posterior optic first, followed by the anterior optic. The post-op regimen also is similar to standard cataract surgery. Overall Synchrony patients achieve excellent recovery of intermediate and near vision, which is very natural. This natural facility of near vision is different than the near vision with the previous generation of accommodative lenses and patients have reported high satisfaction. As such it is a welcome addition to the surgeon’s armamentarium. Dr Ossma is in practice in Cali, Colombia. He can be reached at: ossma@me.com Ivan Ossma MD Driving the Future of Refractive Surgery and Presbyopia Correction The dual-optic accommodating IOL outperforms the diffractive multifocal IOL across a range of distances Dual-optic patients had significantly better contrast sensitivity in mesopic and photopic conditions

Quality of Life with Diffractive IOLs Jay L Schwartz MD The open-label study of 50 patients (25 in each group) evaluated the visual outcomes and patient satisfaction in patients bilaterally implanted with the three-piece Tecnis Multifocal versus patients bilaterally implanted with ReSTOR (+3). Outcomes, including UCVA, best corrected visual acuity (BCVA), near visual acuity, intermediate visual acuity, spherical equivalent, enhancement rates, and patient satisfaction, were measured. Follow-up visits were at three and six months. For UCVA, at three months 84 per cent of Tecnis eyes were 20/25 or better compared to 76 per cent of ReSTOR eyes. At six months, 92 per cent of Tecnis eyes reached 20/25 UCVA compared to 76 per cent of ReSTOR eyes. Tecnis eyes also experienced improved BSCVA. At three months best corrected visual acuity, 100 per cent of Tecnis eyes reached 20/25, while 92 per cent of ReSTOR did. Then at six months, 100 per cent of both groups reached 20/25, while 96 per cent of each reached 20/20. We also looked at near and intermediate visual acuity. For near acuity at six months, 96 per cent of Tecnis eyes saw J2 or better, and 76 per cent saw J1 or better, compared to 68 per cent and 44 per cent of the ReSTOR eyes respectively. At six months Tecnis eyes also had improved intermediate vision versus ReSTOR and more Tecnis patients were satisfied with their vision compared to ReSTOR patients. This study demonstrates that patients are getting good quality vision with the Tecnis and ReSTOR lenses. The goal of cataract surgery is to achieve better vision and improve patients’ quality of life. The Tecnis lens proved to do both. It is important to note that patients were not randomised to either lens. The patients were heavily counselled prior to their lens selection and the lens that seemed to best fit that patient’s expectations was used. Given a best fit scenario, the Tecnis did seem to fit the patients’ expectations better. Dr Schwartz is in practice in Scottsdale, Arizona. He can be reached at: drschwartzlaser.com. Improving Visual Performance Outcomes Clinical study shows that diffractive lenses provide high spectacle independence 9Driving the Future of Refractive Surgery and Presbyopia Correction Peter Szurman MD M y colleagues, Drs Altpeter and Petermeier, and I compared the new Tecnis Multifocal 1-piece IOL with the monofocal Tecnis 1-piece IOL – in a prospective, double-masked multicenter study either the multifocal IOL (35 patients) or the monofocal IOL (35 patients) were bilaterally implanted in patients with no other ocular disease than cataract and corneal astigmatism less than 1 D. The study was approved by the local ethics committee and all patients signed informed consent. Masked follow-up examinations were performed one day, one week, one month, and six months after surgery and comprised of refraction, monocular and binocular visual acuity, including uncorrected distance visual acuity (UCDVA), best corrected distance visual acuity (BCDVA), uncorrected near visual acuity (UCNVA), and distance corrected near visual acuity (DCNVA), the defocus curve, pupil size, keratometry, and slit-lamp biomicroscopy. All medical and lens related complications were recorded. The preliminary results are of patients who received treatment at the Centre of Ophthalmology, University Eye Hospital Tuebingen. Thirteen eyes were implanted with the multifocal, four eyes with a monofocal. After one week all eyes with a multifocal (13 eyes) achieved UCDVA of 20/25 or better, the residual refractive error was –0.2 D (± 0.2), the four eyes with the monofocal achieved UCDVA of 20/25 or better, the residual refractive error was –0.5 D (± 0.4). Five patients (nine eyes) with the multifocal and one patient (two eyes) with the monofocal finished the four weeks’ follow-up. In the multifocal group, the mean UCDVA was 20/19, BCDVA was 20/17 with a residual refractive error of -0.22. The mean UCNVA and DCNVA were 20/28 and 20/25, respectively. The patient (two eyes) with the monofocal achieved mean UCDVA and BCDVA of 20/32 and 20/16, respectively, the residual refractive error was -0.56 D. The UCNVA (20/50) and DCNVA (20/80) were worse than in eyes with the multifocal. All patients with the multifocal reported high satisfaction and comfort due to spectacle-free near and distance vision. Four patients reported mild or no haloes without disturbance, one patient reported on severe haloes. All multifocal patients were spectacle free. Enhanced vision Overall, this next-generation multifocal lens has demonstrated that patients achieve excellent visual quality and depth of focus across a full range of vision at all distances, as well as experience high patient satisfaction and spectacle independence compared to a monofocal lens. This new lens provides surgeons with the Tecnis Multifocal optic on a one-piece lens design while offering patients another option for helping them achieve the most optimal vision possible. Dr Szurman is with the Centre of Ophthalmology, University Eye Clinic, Eberhard-Karls University, Tübingen, Germany. He can be reached at: Peter.szurman@med.uni-tuebingen.de. Tecnis MF patients reported statistically greater levels of satisfaction than ReSTOR patients “All patients with the multifocal reported high satisfaction and comfort due to spectacle-free near and distance vision”

Comparing the Presbyopia IOL Options Registry demonstrates that diffractive multifocal IOLs provide widest range of functional vision 10 I n a recent study, Guy Kezirian MD, and I analysed outcomes for 3,177 eyes implanted with presbyopia-correcting IOLs, using data collected through DataLink Inc., a registry for premium IOL outcomes entered by surgeons around the world. The registry, which is funded by Bausch + Lomb and administered by SurgiVision Consultants, Inc., represents real-world outcomes rather than those achieved in tightly controlled clinical trials. Our criteria for inclusion was no prior surgery, mean Ks between 41.00 and 46.50 D, mean preoperative astigmatism ≤ 1.0 D, and an axial length of 22 to 26.5mm. To be sure that we were comparing the best outcomes with each lens, we also limited the analysis to eyes with a refractive outcome in which the mean spherical equivalent was ± 0.50 D and astigmatism was no more than 0.75 D. In all, there were 2,641 eyes implanted with Crystalens HD, 391 eyes with ReSTOR +3D and 145 eyes with the Tecnis Multifocal. Good results were achieved with all of these latest-generation presbyopic IOLs. However, the Tecnis Multifocal patients had the best functional range of vision, with superior performance at intermediate and near, and excellent acuity at all distances. At distance, 91 per cent of Tecnis patients, 90 per cent of Crystalens patients, and 86 per cent of the ReStOR patients could see 20/30 or better. For intermediate distances, 87 per cent of Tecnis patients, 84 per cent of Crystalens patients, and 68 per cent of the ReSTOR patients could see 20/30 or better. The biggest difference was seen at near, where 99 per cent of Tecnis patients achieved 20/30 or better, compared to 91 per cent of ReSTOR and only 65 per cent of Crystalens patients (Figs 1-3). The results of this analysis mirrors what I have experienced in clinical practice. I have implanted all three of these lenses. As a diffractive multifocal, the Tecnis Multifocal is relatively pupil- independent, so it offers patients very good quality of vision, even in dim lighting conditions. The Crystalens also offers very high quality of vision, but the spherical outcome and the amount of near correction achieved are much less predictable. Dr Davis is adjunct clinical assistant professor at the University of Minnesota and director of the Minnesota Eye Laser and Surgery Center at Minnesota Eye Consultants. Contact her at: eadavis@mneye.com. Elizabeth A Davis MD, FACS Driving the Future of Refractive Surgery and Presbyopia Correction “The biggest difference was seen at near, where 99 per cent of Tecnis patients achieved 20/30 or better, compared to 91 per cent of ReSTOR and only 65 per cent of Crystalens patients” Figs 1-3: Of the three presbyopic IOLs compared in this analysis, the Tecnis Multifocal IOL offered excellent acuity at all distances. It was superior to the other lenses at near, as shown here, and intermediate. All three lenses are essentially equivalent for distance vision 1 2 3

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