Supplement September 2012

EUROTIMESESC

RS ™

Providing Broad Spectrum Presbyopia Correction

by Damien Gatinel MD

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As the world population ages, the demand for a reliable presbyopia correction solution will also increase. In 2005, 1.04 billion people were affected by presbyopia worldwide1. In 2010

that number increased to 1.6 billion people, and in 2020, the number is estimated to grow to 2.1 billion. An underserved, untapped market for vision correction exists in the ageing populations of countries worldwide. For example, according to a 2009 United Nations report2, the median population age for Europe is 40, and in some countries like Italy and Germany, the median age is even higher, 44 and 43 respectively.

With the number of adults affected by presbyopia growing every day, understanding and treating the presbyope has become more daunting. Presbyopia by itself is a challenging condition to address, however, most patients present with additional factors to consider, such as the age of onset, refractive error and prior refractive and/or cataract surgery. As a result, each presbyopic patient is unique and, until recently, as practitioners we have not had a solution that would address such a broad spectrum of patients.

In 2010, the KAMRA inlay was launched commercially after years of clinical research. The inlay extends a patient’s depth of focus as a result of its unique small aperture design. Patients experience an improvement in near and intermediate vision while maintaining good distance vision in the inlay-implanted eye.

While originally intended for emmetropic presbyopes, today the inlay is being used in combination with a laser vision correction treatment to simultaneously address ametropia and presbyopia. Further, surgeons globally are evaluating more advanced techniques to insert the inlay in Post-LASIK and pseudophakic patients.

In the following pages, the contributing authors to this publication will share their perspectives on working with the KAMRA inlay in commercial practices, surgical application, visual performance, patient satisfaction and strategies for growing your practice.

I have personally found the KAMRA corneal inlay to be a safe and effective treatment for correcting presbyopia. It employs well-established visual principles to improve near vision with minimal effect on distant vision. With its broad indication range, the KAMRA inlay is able to benefit a wide range of presbyopic patients.

With over 14,000 inlays implanted worldwide and commercial availability in over 20 countries, I look forward to seeing the procedure establish itself as the leading presbyopia-correcting procedure.

Damien Gatinel MD, is assistant professor and head of the Anterior Segment & Refractive Surgery Department, Rothschild Ophthalmology Foundation, Paris, France.

References 1. Holden BA, Fricke TR, Ho SM, et al. Global vision impairment

due to uncorrected presbyopia. Arch Ophthalmol. 2008;126(12):1731-39.

2. United Nations, “World Population Aging 2009”. Dec 2009.

Treating the Growing Presbyopia MarketAs the population ages, having a reliable presbyopia correction solution will be even more important

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table of contentsGlobal Experience Using a Corneal Inlay for Presbyopia Correction 2–6John A Vukich MD, Robert E T Ang MD, Francesco Carones MD,Robert Paul MBBS, FRANZCO, Khaled Sharif MD, FRCOphth

Simulated and Real-World Visual Acuity with a Small Aperture 3Pablo Artal PhD

Maximising Reading Speed and Acuity through Small Aperture Optics 4Günther Grabner MD

Small Aperture Inlay: A Personal Perspective 5Robert P Rivera MD

Implanting an Inlay in Combination with or after a Prior LASIK Correction 7Minoru Tomita MD, PhD

Long-term Outcomes Show a Stable Result 8Günther Grabner MD

Multicentre International Study Results Show Substantial Acuity Gains 9Daniel S Durrie MD

One Practice’s Roadmap for Success 10David Allamby MD, FRCSC, FRCOphth

I have been involved with the KAMRA inlay as a clinical investigator for over three years now, and am continually impressed with the results my patients are experiencing. Since starting with this technology,

I have seen first-hand the significant improvement in near and intermediate acuity that this simple device provides. What is even more striking is the maintenance of distance acuity these patients experience in their implanted eye; which is traditionally compromised when treating presbyopia. The inlay has been refined over the past 10 years to maximise depth-of-focus, minimise compromise, optimise visual quality and ensure biocompatibility.

In this roundtable discussion, I have invited surgeons from regions around the globe to describe what their experience has been with the KAMRA inlay. by John A Vukich MD

Dr Vukich: Welcome gentlemen. To start, please share with the group how long you have been implanting the inlay and what your results look like?

Dr Paul: I began working with the inlay in October of 2011. On average my patients achieve J1 to J2 for near vision after surgery, some of my patients have even reached J1+. Additionally, my patients are able to see 20/20 on average for distance, which isn’t the case with other monocular procedures such as monovision. Most importantly, patients have been very impressed with the inlay.

Dr Ang: I have been implanting the inlay for the past three years, and what I like the most is that the distance vision is not sacrificed. Patients rarely complain of any decrease in distance vision, while their near and intermediate vision is significantly improved. A very minor percentage, less than five per cent, say that the gain in near vision is not quite enough and they still use reading glasses some of the time.

Dr Sharif: While I have only been implanting the KAMRA inlay since 2011, I am also impressed with the results. Most of my patients can read J2-J3 at near with good distance and intermediate vision.

Dr Carones: I may have the least experience here - I’ve only been using the KAMRA inlay since December 2011, however, I think this is a perfect solution for patients between 45 and 70 years old. I’ve found that vision at all distances is quite good once patients adapt to their new vision, usually between one and three months.

Small aperture optics Dr Vukich: The KAMRA inlay is the only implant that uses a small aperture to restore near and intermediate vision. What is your perspective on the performance of a small aperture versus other refractive approaches to presbyopia correction?

Dr Ang: The idea of increased depth-of-focus via a small aperture is simple and yet ingenious. Multifocality has to rely on splitting of light, while accommodation is dependent on some effort, motion or aberration change to work. The inlay works without any participation from any structure in the eye or any complicated optical principles. As a result, as the patient’s lens continues to dysfunction over time, the results provided by the inlay remain unaffected. (See Long-term Outcomes, page 8).

Dr Sharif: The inlay’s small aperture provides patients with approximately 2.5 D of depth-of-focus. Although the inlay is implanted unilaterally, it does not create a monovision state. The eye with the implant maintains good distance so both eyes work together, and the lack of image magnification prevents aniseikonia.

Dr Paul: Patients who had monovision used to bitterly complain about differential vision because one eye could see well for distance and the other eye could not. That’s the beauty of a small aperture inlay; you just don’t get that. Patients maintain stereoscopic vision. (Figure 1.)

John A Vukich

Robert E T Ang

Robert Paul

FrancescoCarones

Khaled Sharif

Global Experience Using a Corneal Inlay for Presbyopia CorrectionIn this roundtable discussion, surgeons from Europe, the Middle East, Southeast Asia and Australia share their personal experiences, impressions and learnings from working with the KAMRA inlay

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Figure 1: In a poster presented at the 2012 ARVO meeting in Fort Lauderdale, Florida, Dr Steve Linn of Hoopes Vision, USA shared results of a prospective assessment of stereoacuity scores measured at pre-op and six months post-op in a series of 60 emmetropic presbyopes. Dr Linn found that there is no change in mean distance stereoacuity scores between pre-op and six months post-inlay implantation.

Stereopsis after Monocular Inlay Implantation

Moderator John A Vukich MD, is a partner at the Davis Duehr Dean Center for Refractive Surgery in Madison, Wisconsin. He is a consultant and clinical investigator for AcuFocus.

Participants Robert E T Ang MD, is a refractive surgeon at the Asian Eye Institute in Manilla, Philippines and is a clinical investigator for AcuFocus.

Francesco Carones MD, is the founder and medical director of Centro Oftalmo Chirurgico Carones in Milan, Italy.

Robert Paul MBBS, FRANZCO, is the medical director and principal surgeon at WA Laser Eye Centre in Perth, Australia.

Khaled Sharif MD, FRCOphth is the medical director of Sharif Eye Center in Dubai, Amman, and Doha.

MODeRAtOR

Surgical strategies Dr Vukich: What types of surgical procedures are you performing with the inlay?

Dr Sharif: I started implanting the inlay under a 200-micron flap, then after 20 cases I started using the pocket technique for all emmetropic cases; which don’t require a refractive correction to be performed first. I advise surgeons to start with the flap technique, as it is an easier starting point. As you become more confident with inlay handling and placement, move to the pocket technique.

Since starting we have been implanting the inlay in a variety of patients including hyperopic, myopic and emmetropic presbyopes. To qualify for a combined LASIK procedure (CLK), we limit the refractive correction in the inlay eye to between +3.00 D to -5.00 D, with no more than 3 D of astigmatism. Like LASIK, we exclude patients with severe dry eyes, keratoconus, cataract, glaucoma or macular degeneration.

Dr Paul: I have performed both pocket and flap procedures. The thing I like about CLK is the fact that you’ve got greater scope for placement of the inlay. If you’ve got a pocket, you can really only move the inlay along the horizontal axis. Moving it superiorly or inferiorly to manipulate it for correct positioning is more difficult because you are working in a tighter space.

As for the type of patients, I use the inlay for, hyperopic presbyopes up to +3 D, emmetropes and moderate myopes up to -4 D. I think high myopes are better served by lensectomies if they’re in that age group, or phakic IOLs.

Dr Ang: All of my inlays are implanted under a 200-micron flap as my femtosecond laser is not currently able to create pockets. The nice thing about working under a flap is that you have full access to the stromal bed for inlay placement. Some surgeons have expressed concern about ectasia risk with cutting a thicker flap, however, in over 100 patients, with some out to three years, I have not had one case of ectasia. Additionally, there have been no reported cases of ectasia with the KAMRA inlay in over 14,000 patients.

Performing ophthalmic assessments Dr Vukich: There have been some questions about the ability to see intraocular structures with the inlay in place. What has your experience been?

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There are both surgical and non-surgical options for the correction of presbyopia. Presbyopia-correcting potential of the KAMRA

corneal inlay lies in its ability to extend depth of focus through use of a small aperture. This approach is unique, as all other methodologies attempt to correct near vision through adjustments in refraction or corneal shape.

To better understand the potential visual benefits and limitations, we undertook both simulated and real-world comparisons of visual performance with and without a small aperture.

Simulated and real results In the study published in IOVS1 last year, we compared visual acuity monocularly and binocularly, using our binocular adaptive optics vision analyzer (AOVA). Three subjects were tested under three different conditions: 1) monocularly with a 4.0mm pupil size, 2) monocularly with a 1.5mm pupil size (to reproduce the inlay) and 3) binocularly with one eye set at a 4.0mm pupil and the fellow eye set at a 1.5mm pupil. In all cases, the subject’s dominant eye was tested with the 4.0mm pupil and the non-dominant eye was tested with the 1.5mm pupil.

Results of this comparative study showed that even under mesopic conditions, the simulated inlay extended depth of focus compared to the 4.0mm pupil. In mesopic conditions, depth of focus with the simulated inlay was approximately 1.5 D, while under photopic testing conditions, the simulated inlay achieved approximately 2.5 D of depth of focus. On average binocular acuity of the three subjects was 0.3 LogMAR (better than J3) from 0.0 to 3.0 D.

We also compared the monocular and binocular results using the AOVA with a real KAMRA inlay patient. Depth of focus with the real inlay and the aperture produced by the system were very similar. The subjective visual experience of the subject with the replicated and real aperture was similar as well. This pilot study was a confirmation that the use of the AOVA successfully reproduced the optical conditions of the real KAMRA inlay.

In short, predicted visual results with the AOVA and real-life clinical results with the small aperture inlay are very similar. The KAMRA corneal inlay’s approach to increasing depth of focus is a simple but attractive solution for people with presbyopia.

Pablo Artal PhD is professor at the Laboratorio de Optica, Universidad de Murcia, Murcia, Spain, and a consultant to AcuFocus.

Reference 1. Tabernero J, Schwarz C, Fernandez EJ, Artal P.

Binocular visual simulation of a corneal inlay to increase depth of focus. Invest Ophthalmol Vis Sci. 2011;52:5273–5277

Simulated and Real-World Visual Acuity with a Small Aperture

Figure 2: Results of a contralateral comparison of nine patients, conducted by Dr Francesco Sanchez Leon presented at the 2012 ARVO meeting, show that the presence of the KAMRA inlay did not appear to impact reliability on standard automated perimetry. the poster also reported that no localised constrictions, or scotomas, were identified, as demonstrated by the lack of difference in PSD scores between implanted and non-implanted (fellow) eyes; and GHt calculations were not impacted.

Visual Field Assessment Unaffected by Presence of Corneal Inlay

by Pablo Artal PhD

Dr Sharif: I have found that the inlay does not interfere with examination and imaging of the ocular structures. Visual field testing (Figure 2) as well as OCT exams of patients with the inlay implanted show thresholds remaining within preoperative values.

Dr Ang: After having implanted the inlay myself, I have found that it is very easy to view and assess intraocular structures. The central 1.6mm aperture of the inlay is clear and allows for good visualisation of the lens and retina (Figure 3). There may be a slight learning curve for practitioners who aren’t used to performing retinal exams, however, practice makes perfect, so the more you do, the easier it becomes.

Ocular surface management Dr Vukich: We know presbyopes, especially women, tend to have more naturally occurring dry eye. How do you counsel your patients about management?

Dr Ang: What is most important is to appropriately assess patients for dry eye before surgery and aggressively treat after surgery. The presence of moderate to severe dry eye before surgery should serve as a warning that this particular patient may not do as well after the inlay has been placed. We can pre-treat the patient before the surgery. However, if this is not handled well, dry eye can affect patient satisfaction in terms of poor vision and increased discomfort. While it may be a burden in the short term, if the rationale for prolonged eyedrop use is explained well, I’ve found patients to be motivated to instill dry eye medications. Use of plugs, drops and cyclosporine post-op are all highly recommended.

Dr Sharif: We evaluate the ocular surface and tear function on all potential refractive surgery candidates. For a potential KAMRA patient with mild to moderate dry eyes, we insert extended wear punctal plugs and give the patient plenty of artificial tears as well as Restasis eye drops. We also educate the patients about the importance of keeping the eye hydrated for optimal visual results. We have found that a proactive approach

to optimising the ocular surface and tear film results in happier patients postoperatively.

Dr Paul: I live in a dry environment, so most of my patients are already aware of dry eye, and tend to be compliant with drops. If patients are producing less than 5mm on Schirmer’s, I recommend against moving forward with either a KAMRA inlay or LASIK until their dry eye is under control with punctal plugs.

I’ve also found that patients are thrilled on day one, but by week two some start to complain about blurry vision, which is also the peak time for dryness induced by a LASIK flap. This is the same for our regular LASIK patients. However, by two months, the eye has healed quite well and the dry eye complaints are minimal. Ultimately, the need to use drops is greatly outweighed by the benefits of not having to carry around reading glasses.

Cosmesis Dr Vukich: As the inlay is opaque, it can be seen in some very light coloured eyes. Has this been an issue with patients you have talked to about getting an inlay?

Dr Paul: I’ve yet to have a patient complain about being able to see the inlay. I tell all my patients this is the safest method we have for surgically correcting presbyopia at this time. I ensure that they are informed about the removability of this device because I think that reassures them as well. More than 90 per cent of the patients who have a KAMRA inlay implanted no longer require glasses for reading. That’s why patients have it done.

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Maximising Reading Speed and Acuity through Small Aperture Opticsby Günther Grabner MD

One of the evaluations performed on the series of 32 patients who had the KAMRA corneal inlay implanted as part of the international clinical

trial at University Eye Clinic in Salzburg, Austria, involved assessing changes in reading performance parameters pre-op to post-op.1 For this study, we evaluated only naturally emmetropic presbyopes. Major outcomes analysed included bilateral reading acuity, reading distance and reading speed. We used the Salzburg Reading Desk to standardise our testing procedure. Follow-up was 24 months.

Reading results In this analysis, we found significant improvement for each tested parameter. At a mean follow-up of 24.2 months ± 0.8 (SD), the mean reading distance reduced from a preoperative value of 48.1 ± 5.5cm to 38.9 ± 6.3cm (P < .0001). Mean reading acuity for best distance also showed an improvement – from 0.3 ± 0.14 logRAD to 0.24 ± 0.11 logRAD (P <.0001).

Mean reading speed increased from 142 ± 13 words per minute (wpm) to 149 ± 17 wpm (P = 0.29) while mean reading improved by 2.7 ± 1.6 lines in 30 patients (mean gain was up to six lines). One patient lost one line and one patient had no change.

Importance of reading When a patient comes to your practice seeking a solution for presbyopia they are really looking for a treatment that helps them read and see objects up close without the need for reading glasses. In our experience with the inlay, patients are able to read faster, at shorter distances, and with better reading acuity independent of reading glasses.

Günther Grabner MD practices at the University Eye Clinic, Paracelsus Medical University, Salzburg, Austria. AcuFocus supports the clinical research of the Fuchs Foundation for the Promotion of Ophthalmology, Salzburg.

Reference 1. Dexl AK, Seyeddain O, Riha W, Hohensinn M, Hitzl W,

Grabner G. Reading performance after implantation of a small-aperture corneal inlay for the surgical correction of presbyopia: Two-year follow-up. J Cataract Refract Surg. 2011;37:525-531.

“In our experience with the inlay, patients are able to read faster, at shorter distances, and with better reading acuity independent of reading glasses”

Günther Grabner MD

Dr Carones: For very light eyes, there is a chance that the inlay may be visible in very bright light conditions. I do explain this to all patients as they need to be aware of the possibility. I also remind patients that spectacles are more easily seen than the inlay, this usually puts the patients at ease.

Dr Ang: Fortunately, for Asian eyes, it is not a big issue because we have dark irises. I do still warn them about it; but so far, over the past three years, none of my patients have told me they, or anyone else, have noticed that they have an inlay.

Secondary surgical procedures Dr Vukich: Have you had to perform any inlay recentrations or removals?

Dr Ang: One of the most important advantages that resonates well with patients is that the inlay is removable. I have offered to remove the inlay if a patient is not satisfied, but in over three years of working with the inlay, no one has opted to have it removed.

Dr Sharif: I haven’t had to remove any of the inlays I’ve implanted to date; however, two inlays were recentred successfully after three months due to insufficient increase in near and intermediate visual acuity. The procedure was simple and both patients experienced an immediate improvement in visual acuity.

Dr Carones: I have only removed one inlay and it was a result of my personal learning curve with patient selection. This patient was one of my first inlay patients; a 44-year-old hyperopic man. I implanted the inlay in

his non-dominant eye after performing a hyperopic LASIK correction. Since he was a very early presbyope, he still had a good amount of natural accommodation in his dominant eye. As a result, he wasn’t ready to fully appreciate the benefits of the inlay and I ended up removing it. That has been my only patient who wanted it removed; his vision after removal was not impacted at all.

Dr Vukich: Have any of your patients gone on to develop a cataract, and if so what has been your treatment with regards to the KAMRA inlay? Did you leave it in?

Dr Ang: Cataract surgery with the inlay in place does require some small modifications to your surgical technique in order to see around the device. However, it is a skill that can be easily learned (Figure 4). However, if preferred, the inlay can be removed and a new inlay placed after the cataract surgery has healed. It is also possible to perform a YAG through the central opening of the inlay.

Dr Paul: Performing a cataract surgical procedure is absolutely doable with the inlay in place. The inlay diameter is 3.8mm so it can actually be a nice guide for creating a capsulorhexis.

The more appropriate question is, in the age of femto-phaco, do you leave the inlay in and perform a traditional cataract procedure or do you remove the inlay and use your femtosecond laser to debulk the nucleus? Ultimately, either option will work as the beauty of the inlay is that you can remove or replace it depending on your preference.

Dr Vukich: Prior inlay generations have been linked to corneal thinning. What are your thoughts on the potential risks today with this small aperture inlay?

Dr Ang: We have learned a lot over the years about how to successfully implant inlays. Prior generations were implanted shallower in the cornea, which didn’t allow for proper nutritional flow and the postoperative medication regimen wasn’t as aggressive as it needed to be in order to support corneal healing. Today, all of these issues have been addressed with refinements in

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Put simply, I’m your most difficult patient – the emmetropic presbyope. I had been a fully functioning emmetrope (even with mixed astigmatism of -0.5 +1.00 in both eyes) and

now I couldn’t trust my 50-year-old eyes. The only spectacles I’d ever worn were sunglasses. Now I had to have readers everywhere - on my head, in my pocket, in my briefcase, in my car, essentially any strategic location I could think of. And if I couldn’t find them, life was just plain miserable. I just couldn’t see without glasses. Professionally, the worst of it all for me was to evaluate patients in consultation for refractive surgery to rid them of their eyeglasses, only to have to slip on a pair myself in order to read their chart.

As a surgeon, the aspect of the KAMRA corneal inlay that intrigued me the most was its ability to maintain good distance vision while correcting my presbyopia. I simply could not tolerate any loss of distance vision, especially in the operating room, and I was not willing to compromise one type of vision for another. In addition, the removability of the inlay procedure gave

me somewhat of an “exit strategy” in case I didn’t like the vision it provided. Lastly, using a small aperture to treat my presbyopia would mean I would not require any enhancements as the years continue, since the inlay has the same effect in a 45-year-old as in a 65-year-old and beyond.

I’ve had the KAMRA in my own eye for over a year now. Even from my day one post-op exam, I was able to read my iPad® without readers, and my reading vision has continued to improve from there. I’ve even been able to go back to fly-fishing without relying on my readers to tie the smallest trout flies to the end of my line – and that was a major goal of mine. I don’t even own a pair of reading glasses anymore; that is how pleased I’ve been with my vision.

If I was forced to find a complaint, I’d be hard-pressed, but I do notice in lower light that the KAMRA eye has mild glare, but that has yet to impact any aspect of my life. From one who’s been there, I can unequivocally tell you I wouldn’t hesitate to have this done again. My only real regret? That I didn’t jump on the bandwagon the moment I heard about this technology.

Robert P Rivera MD is the director of clinical research at Hoopes Vision in Sandy, Utah, USA.

iPad is a registered trademark of Apple, Inc.

Small Aperture Inlay: A Personal Perspectiveby Robert P Rivera MD

“Inlay implantation is far less invasive than an IOL as it doesn’t carry the inherent risk of endophthalmitis that a lens-based procedure does”

Robert Paul MBBS

the surgical procedure, KAMRA inlay design and post-op regimen. As a result, with the final KAMRA inlay design, there have been no flap thinnings due to the inlay.

Dr Carones: With the femtosecond laser, we can make more predictable flap thickness, and as long as surgeons are creating 200-220 depths for the inlay, I think it’s unlikely we’ll run into thinning issues. Flap construction is more the issue than the physiology of the inlay in the pocket or in the interface between the flap and the bed.

Comparing presbyopia correction options Dr Vukich: What are your impressions of how the KAMRA inlay compares to other corneal-based procedures for correcting presbyopia?

Dr Sharif: We were intrigued with the visual results with the KAMRA inlay at various distances compared to our previous results with monovision LASIK. In our group of patients, by a few weeks post-implantation their near vision had an improvement to J2 on average. Our patients also achieved excellent intermediate vision, but most importantly, we also saw a nice preservation of distance vision that is not achievable with other methods.

Dr Carones: The blended vision patient is almost always unhappy. They don’t see clearly for near or distance, and they’re not spectacle independent. In my experience, there is much more spectacle independence with the KAMRA inlay than with blended vision.

Dr Paul: In the inlay eye, patients are getting 20/20 to 20/30 unaided distance vision, which is not the case with monovision. We also know monovision patients lose stereopsis once there’s a differential of more than 1.5 D, so night driving vision is worse. Some inlay patients do get mild glare and haloes, but not to the same degree as monovision.

With ‘mini-monovision,’ patients are usually 20/40 or worse, and, in my experience, the quality of reading vision with mini-monovision just isn’t as good as it is with the inlay.

Dr Carones: You can’t really compare KAMRA vision with monovision. I also don’t think you can label it ‘advanced monovision’ as some have, because the KAMRA patient still has great distance vision. Our patients are seeing 20/20 for distance with the inlay – those results are just not possible with monovision.

Dr Vukich: What about presbyopia correcting lenses, how does their performance compare to the inlay?

Dr Ang: Multifocal IOLs may give more near vision than the inlay, but are plagued by decreased contrast, and more glare and haloes. Accommodating IOLs provide good distance vision and good contrast vision but may not give enough near vision compared to the inlay. The other challenge with accommodating lenses is the power of the lens can be strong in some people and weak in others. We also don’t know what factors within the eye impact the efficacy of the accommodating lens. With the KAMRA inlay, there is no need for any part of the eye to participate. You put it there, and you see through the pinhole. It’s that easy; patients don’t have to work for it.

Dr Carones: In my experience, I also find that accommodating IOLs are not as predictable as I’d like. They work great for some people, but not in others. That hasn’t been an issue with the inlay.

Dr Paul: For someone whose only vision issue is presbyopia, the KAMRA inlay is a perfect solution. Inlay implantation is far less invasive than an IOL as it doesn’t carry the inherent risk of endophthalmitis that a lens-based procedure does.

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Figure 4a (top left): the inlay provides a guide for manual capsulorhexis; Figure 4b (top right): Phacoemulsification is performed with minimal change to surgical technique; Figure 4c (bottom left): A monofocal IOL is inserted into the eye after successful cataract extraction; Figure 4d (bottom right): View of the completed cataract surgery with the IOL visible behind the inlay.

Implantation of an IOL with Inlay In-vivo

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“Our patients are seeing 20/20 for distance with the inlay – those results are just not possible with monovision”

Francesco Carones MD

Figure 3: Dr Casas-Llera et al published in the Sept 2011 JCRS on their experience with retinal imaging and assessment subsequent to implantation of a small aperture corneal inlay in two patients. For both patients, the inlay allowed normal visualisation of the central and peripheral fundus, as well as good-quality central and peripheral imaging and OCt scans. Images of central and peripheral fundus taken through the central aperture of a KAMRA inlay provided courtesy of Günther Grabner MD.

Assessing the Retina

by Minoru Tomita MD, PhD

At Shinagawa LASIK Center, we have performed more than one million LASIK cases since opening in 2004. As a primary LASIK centre, we were looking for a reliable corneal-based solution for presbyopia

correction that had a broad spectrum of application.Based on the clinical results first reported in emmetropes,

we became interested in the KAMRA inlay as a possible solution for our presbyopic patients. We began working with the inlay in 2009 and since then have performed more than 8,000 inlay procedures. In that time, I also began to explore possible applications of the inlay in ametropic patients and patients previously treated with LASIK.

Ametropic presbyopes We recently undertook a study to evaluate the outcomes of a simultaneous LASIK procedure and inlay implantation (CLK) for treatment of presbyopia in patients with refractive errors.

Between August 2009 and February 2012, 2,941 patients underwent CLK in their non-dominant eye. This group of patients had a mean preoperative spherical equivalent refraction of -2.90 D (range +2.88 to -9.00). For each patient a stromal flap was created at 200 microns and a LASIK procedure performed. The target refraction was –0.75 D in the inlay eye. After the LASIK portion was performed, the inlay was placed on the stromal bed and the flap replaced. This surgery takes approximately six to seven minutes. The fellow eye was treated with a traditional LASIK procedure and a target refraction of plano.

For this generally myopic group (78 per cent), mean uncorrected distance visual acuity (UDVA) in the inlay eye improved eight lines from preoperative 20/125 to 20/20 at one year, and 72 per cent achieved 20/20 or better at one year. Mean uncorrected near visual acuity (UNVA) improved three lines from pre-op J6 to J2 at one year. A total of 56 per cent of patients achieved J1 or better and 77 per cent achieved J2 or better.

At one year, 91 per cent of patients were satisfied with their vision without reading glasses. Preoperatively, about 65 per cent needed reading glasses, by year one that number decreased to eight per cent.

Post-LASIK presbyopes A second study we are conducting evaluates inlay implantation in presbyopic patients previously treated with LASIK surgery.

Between November 2010 and February 2012, 2,193 prior LASIK patients were implanted with a KAMRA inlay. Inlays were again implanted in the non-dominant eye. This group of patients had a mean preoperative spherical equivalent refraction of -0.11 D (range +2.38 to -2.00 D).

Using the Ziemer Adjustable Femto LDV pocket software (Ziemer LDV) a lamellar pocket was created 100 μm below the prior LASIK flap interface. In some cases, the previous LASIK flap was lifted and a laser enhancement performed to achieve a target refraction of plano. In all cases, the inlay was implanted at least one month post-LASIK.

At six months (n=484), the mean UDVA reduced by one line from 20/16 to 20/20; 84 per cent were 20/25 or better and 74 per cent were 20/20 or better. UNVA improved four lines, from J8 to J2. At six months, 82 per cent achieved J3 or better.

Six-month follow-up also showed excellent satisfaction in this group with 94 per cent reporting satisfaction with their vision without reading glasses.

Overall, I have been very impressed with the results for the KAMRA inlay. Like previously reported results for emmetropic presbyopes, our patients experienced gains in near acuity while gaining or maintaining good uncorrected distance acuity. The surgical technique is easy to perform and patients are pleased with their visual outcomes. As a result, we have made the inlay our only corneal-based solution choice for presbyopia correction.

Minoru Tomita MD, PhD, is executive medical director at the Shinagawa LASIK Center, Tokyo, Japan. Dr Tomita is a member of the AcuFocus International Medical Advisory Board.

Implanting an Inlay in Combination with or aftera Prior LASIK Correction

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Combining the KAMRA corneal inlay with LASIK provides excellent visual outcomes

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Figure 2: At one year after CLK, mean UNVA in the inlay eye improved three lines from J6 to J2.

Figure 3: At one year, 91 per cent of CLK patients are satisfied with their vision without reading glasses.

Figure 1: Mean UDVA improved eight lines from 20/125 to 20/20 at one year in the inlay eye after CLK.

UDVA: Implanted Eyes (Snellen)

UNVA: Implanted Eyes (Jaeger)

Patient Satisfaction and Necessityfor Reading Glasses

by Günther Grabner MD

My colleagues and I have patients with the inlay now out to five-and-a-half years postoperative. The majority of these patients report excellent vision with the corneal inlay.

The long-term results presented here are for the generation immediately prior to the commercially available KAMRA inlay. Both generations are made of polyvinyledene fluoride (PVDF), measure 3.8mm in total diameter and have a 1.6mm central opening. As a result, the visual acuity results with both generations of inlay are similar as the aperture size is what drives the improvement in depth of focus.

The changes between generations were made to support a natural corneal metabolic process, refine visual quality and minimise corneal curvature influence. The prior generation inlay only had 1,600 micro-perforations (measuring 25µm in size); the commercially available design has increased the number of micro-perforations to 8,400 (sizes range from 5 to 11µm) and they are arranged in a pseudo-random pattern. The inlay profile has been reduced from 10 µm to 5 µm. Further, light transmission rate is now five per cent, versus 7.5 per cent, which contributes to a reduction in photic phenomenon.

Long-term study results A total of 32 patients were enrolled and 100 per cent completed their three-year follow-up. Patient inclusion criteria included: age between 45 and 55, pre-op spherical equivalent of + 0.5 D, uncorrected near visual acuity (UNVA) ≥ 20/100 and ≤ 20/40, and best corrected distance visual acuity (BCDVA) ≥ 20/20 in both eyes.

Pre-op UNVA was J6, uncorrected intermediate vision (UIVA) was 20/40, and UDVA was 20/16 in the non-dominant eye as well as bilaterally. In this study, patients were tested to 20/12.5 on an ETDRS chart.

At three years’ post-op, mean monocular UNVA improved to J1, a four-line gain, and 97 per cent achieved J3 or better. Mean UIVA improved to 20/25 with 91 per cent achieving 20/32 or better in the inlay eye. Improvements in UNVA and UIVA were statistically significant. When comparing results in the inlay eye versus the fellow, untreated eye, we found a significant difference in acuity. When viewed over the three-year time period, the progression of presbyopia is apparent in the fellow eye where, in the inlay eye, there is no change (Figures 1 and 2). This comparison demonstrates how independent the inlay is to the progressive nature of presbyopia.

For distance acuity, mean monocular UDVA dropped slightly to 20/20 as expected. Binocular UDVA remained stable at 20/16 throughout the post-op period. No patient lost a line of binocular BCDVA. When asked about their dependence on reading glasses, at three years’ post-op only 6.3 per cent (two patients) reported dependence on reading glasses versus 87.5 per cent (28 patients) at pre-op. Further analysis on the five-year results is currently under way.

Overall, I believe the KAMRA corneal inlay is a great addition to our surgical armamentarium - it increases our ability to help a growing population eager for an effective treatment for their presbyopia.

Günther Grabner MD, practices at the University Eye Clinic of the Paracelsus Medical University Salzburg, Austria. AcuFocus supports the clinical research of the Fuchs Foundation for the Promotion of Ophthalmology, Salzburg.

Long-term Outcomes Show a Stable Result

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Three-year follow-up finds patients have consistent distance vision, with excellent near and intermediate vision improvement

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Figures 1–2: Contralateral comparison of mean uncorrected near and intermediate acuities for the inlay implanted eye (Ie), fellow eye (Oe) and both eyes (Be).

Uncorrected Near Visual Acuity

Uncorrected Intermediate Visual Acuity

1

2

In the July 2011 issue of JCRS, Yilmaz et al reported on their results with a small aperture inlay in emmetropic and post-LASIK presbyopes. At four years (N=22), mean uncorrected near visual acuity

(UNVA) was 20/20 and all patients gained two or more lines of UNVA in the inlay eye. Further, 96 per cent of patients could read J3 or better at the last follow-up visit. Mean uncorrected distance visual acuity (UDVA) was 20/25 with 100 per cent of eyes achieving 20/40 or better. There was no difference in mean pre-op and four-year post-op best corrected distance visual acuity.

Four-Year Results of a Small Aperture Inlay

Near and Distance Visual Acuity

by Daniel S Durrie MD

Results from the international multicentre clinical trial of the KAMRA inlay show that eyes implanted with this inlay gain near and intermediate vision with minimal affect on distance vision.

The inlay used in this study measures 3.8mm in total diameter, is 5 microns thick and has a 1.6mm central aperture. The inlay is made from polyvinyledene fluoride (PVDF), and nano-particles of carbon. In addition, there are 8,400 micro-perforations ranging in size from 5-11 microns, arranged pseudo-randomly throughout the inlay annulus. This unique inlay design is the same as the commercially available inlay.

Study design This prospective, non-randomised clinical trial is evaluating safety and efficacy of the inlay for correction of emmetropic presbyopia. A total of 507 patients were enrolled and implanted at 24 sites. Inclusion criteria

included ages between 45 and 60, manifest spherical equivalent between +0.50 D to –0.75 D, uncorrected near visual acuity (UNVA) worse than 20/40 and better than 20/100, with best corrected distance visual acuity (BCDVA) of 20/20 or better in both eyes.

The inlay was inserted into a femtosecond laser-created lamellar incision in the patient’s non-dominant eye. Inlays were implanted at a depth of 200 microns and centred on the 1st Purkinje reflex.

24-month results At 24 months, 429 patients of the total 507 enrolled were available for analysis. Mean UNVA in the inlay eye improved to J2 from J8 at pre-op. This change represents an average gain of 3.2 lines. Mean uncorrected intermediate visual acuity (UIVA) also improved one line from 20/32 to 20/25 in the inlay. Mean uncorrected distance visual acuity (UDVA) remained virtually unchanged in the inlay, at 20/20. (Figures 1–3.)

Mean BCDVA in the implanted eye remained at 20/16 from pre-op through the 24-month follow-up. Binocular UDVA was unchanged, remaining constant at 20/16 throughout the study.

Optimising outcomes Additional sub-analysis of results identified refraction and femtosecond laser settings as key contributors to inlay outcomes. When results were analysed based on refraction, we found that patients who were slightly myopic (plano to -0.75D) in the inlay eye, tended to have better reading, acuity, higher satisfaction scores, and experienced no change in distance acuity. Those patients who were more hyperopic tended to be less satisfied and experienced a mean loss of half a line of UDVA (20/16 to 20/20). This learning has been further supported by commercial results.

Results were also analysed by femtosecond laser spot/line setting, or equivalent. Investigators in this study were instructed to use the same femtosecond laser settings as their regular LASIK procedures. In this post-hoc analysis, we found that using smaller spot/line settings resulted in improved visual acuity and satisfaction. While more analysis is under way, there is a clear trend that the smoothness of the lamellar resection does play a role in outcomes.

Summary Over the last couple of decades, a tremendous amount of research and development has been put into creating a corneal implant for the treatment for presbyopia. To be a success, this type of technology needs to be simple to implant, must treat a wide range of presbyopes, provide reliable, long-lasting results, and minimise compromise. I am encouraged by the results of the clinical trial presented here along with the commercial outcomes from around the world. This data is currently being prepared for submission to FDA for approval and I look forward to the availability of this technology in the US.

Dan Durrie MD, is chief medical officer for AcuFocus and is in clinical practice at Durrie Vision in Overland Park, Kansas, USA.

Multicentre International Study Results Show Substantial Acuity Gains

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At 24 months, patients gained, on average, 3.2 lines of near acuity and one line of intermediate acuity

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Figure 1: Mean monocular UNVA improved 3.2 lines from J8 to J2 at 24 months in the inlay eye.

Figure 2: Mean UIVA in the inlay eye at 24 months was 20/25, an improvement of one line from pre-op.

Figure 3: Mean UDVA remained relatively unchanged at 20/20.

Uncorrected Near Visual Acuity

Uncorrected Intermediate Visual Acuity

Uncorrected Distance Visual Acuity

by David Allamby MD, FRCSC, FRCOphth

Since implanting my first KAMRA inlay in the UK in July 2011, it has become my primary surgical correction for presbyopia. I have found that patient satisfaction is so high that patients are

referring spouses, friends and colleagues – and faster than with any other presbyopia treatments we offer.

From my first implant, the KAMRA inlay has impressed me, especially in terms of improved near vision and reading lines. It also maintains binocularity of patients’ natural distance vision, which is a considerable advantage over monovision. And, ultimately it is removable, which means neither the patient nor myself are restricted from pursuing other future surgical procedures if and when they are warranted.

The market potential for presbyopia correction is only going to increase over time. In Western Europe alone, Market Scope® calculates that about 39.3 per cent of the population is in the presbyopic age range; and those numbers are projected to grow to 42.4 per cent by 2020. With numbers like those, it is clear that there is a real opportunity for refractive practices to specialise in presbyopia correction. Presbyopia is a condition that will affect all patients at some point in their life. So focusing on surgical presbyopia correction represents a new opportunity for practice differentiation.

Getting started with any new technology can seem daunting, as there are so many options to choose from for marketing and education. Following are a few of the most important first steps I took to raise overall awareness of presbyopia as a condition and of the KAMRA inlay as the solution.

KAMRA-ready First of all, we are marketing the KAMRA inlay as our primary choice for presbyopia correction for patients aged 45 years to 65 years, assuming there are no significant lenticular changes.

We also start the conversation about presbyopia and options with patients who are 40 to 45 years old to make them ‘KAMRA-ready’. We explain to everyone in this age group that they are in a pre-presbyopic age range. If they just let me treat them with LASIK, we explain that they will still need glasses in the next few years. Instead we propose making a surgical plan that will ensure that they do not become dependent upon reading glasses in the future. Surgically speaking, we’ll target the non-dominant eye in these patients to -0.5 D or -0.25 D. We also create a thin flap at the time of the initial LASIK surgery; when

the patient is ready to address their presbyopia, we’ve already done the corneal prep work, and simply need to insert the inlay deeper down within a corneal pocket. Patients appreciate this approach to their vision care and seriously consider it.

Website More and more patients are looking to the Internet to learn about treatment options and to seek recommendations for a surgeon. Early on in my KAMRA adoption, I developed a website dedicated to marketing the inlay specifically to potential patients – www.kamravision.com (Figure 1). A simple web search should bring up our site first. It contains information about the inlay itself via animations, charts and videos of patient testimonials. Potential patients also have a chance to see me speaking on video about how the procedure works.

I have invested a lot of hours into developing this website because I believe it is a good way to reach potential patients and educate people about the KAMRA corneal inlay. Recently, I added a physician link to the website, so prospective patients from around the world can find a certified KAMRA physician in their area. I have found this tool to be an extremely helpful resource both for education and patient marketing. I encourage all KAMRA surgeons to visit this site and welcome you to use it as an educational tool for your practices.

Patient seminars Finally, I highly recommend patient seminars on the overall topic of presbyopia and the KAMRA inlay. We’ve found the attendees to these sessions are highly motivated individuals, who have read or heard about KAMRA and want more information. We have found that 100 per cent of people sign-up for a consultation with us to discuss individual candidacy after the seminars. I cannot emphasise how much that has increased patient awareness in our community, not only about our practice, but about the inlay.

I believe the KAMRA inlay is the best solution for presbyopia on the market today for the 45-65 age range. By targeting the right patient group, clearly explaining what the inlay can do for the correction of presbyopia, and being a ‘go-to’ source of information, we’ve grown our presbyopic refractive practice markedly since we began using the KAMRA inlay last year. I can only imagine how much busier we’ll be as word of this treatment continues to expand.

David Allamby MD, FRCSC, FRCOphth is managing director of Focus Laser Vision in London, England, UK. His website for the KAMRA corneal inlay can be found at: www.kamravision.com.

“I believe the KAMRA inlay is the best solution for presbyopia on the market today for the 45-65 age range”

One practice’s roadmap for success

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Excellent results, patient education and a web presence drive interest in presbyopia correcting technology

10Figure 1. Landing page at KAMRAVision.com

Supplement September 2012

EUROTIMESESC

RS ™

Supported by an educational grant from AcuFocus, Inc

The KAMRA™ inlay is an investigational device, limited by federal (U.S.) law to investigational use and not available for sale in the United States.

RP-0912