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ACOS Newsletter Year-End 2011 Dear ACOS Members, We can all be proud of the quality and success of the first ACOS Summit that was held on October 21st in Orlando. True to the ACOSs mission of providing education on the clinical, business, and medicolegal aspects of ophthalmology, the Summits program featured sessions on the renaissance of cataract surgery, product development and financing, and regulatory affairs. We look forward to bringing you the post-Summit materials soon. In fact, a few presenters videos are already available online at Eyetube.net. In the meantime, this newsletter features a few items of interest from our meetings this year in Deer Valley and Orlando. First, we have a unique perspective on the current state of affairs in this country between the FDA and the medical field from Daya Sharma, MD, one of our members who trained in the UK and practices in Australia. Additionally, we summarize presentations from both meetings that were exceptionally well received. Finally, remember to register now for the ACOS-Dulaney Winter Meeting, held at the beautiful St. Regis Aspen, February 26-29, 2012. This meeting is always very popular and fills up quickly! Best, Stephen G. Slade, MD ACOS President

The Intersection of Regulation, Innovation, and Medicine

By Daya Sharma, MBBS, FRANZCO
The ACOS Summer Symposium in beautiful Deer Valley, Utah, brought together an incredible array of leaders, including ophthalmic experts and industry heavyweights. As an outsider to the US healthcare system, it was a privilege to attend and learn about the challenges that innovators and companies face in developing new technology and translating that research into clinical practice. A recurring theme of the meeting was that the FDA obstructs access to medical treatments that may be widely available elsewhere. Although the agency cites reasons of safety and efficacy, its process blocks patient access to important treatment options. One example is the Visian toric ICL (STAAR Surgical Company, Monrovia, CA), which would allow effective astigmatic correction with the same operation
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and essentially the same risk profile as the Visian spherical ICL (STAAR Surgical Company), yet only the latter is FDA approved. There are a number of treatments available outside the United States that domestic patients do not have access to. To name just a few: corneal cross-linking toric and multifocal secondary sulcus IOLs topography-guided PRK the Synchrony IOL (Abbott Medical Optics Inc., Santa Ana, CA) (although trials were conducted in the US that demonstrated safety and efficacy) the Oculentis M-plus lens (Oculentis GmbH, Berlin, Germany) REGULATION AND ACCESS TO CARE Delays in FDA approval slow the pace of innovation and development. In Europe, some perceive this behavior as the FDA protecting US economic interests by blocking foreign companies from accessing the US market. However, it is clear that US companies, large and small, are being severely hampered by the FDA as well. George Waring IV, MD, introduced a useful acronym, OUS, meaning outside the US, because of the frequent need to refer to treatments only available OUS. In addition to the FDA, the Centers for Medicare and Medicaid Services also obstruct patient choice. Regarding access to treatment options such as femtocataract surgery, the rallying call from Richard Lindstrom, MD, was that patients have the right to want it, the right to ask for it, and the right to pay for it. American cultural ideals of freedom, liberty, reward for hard work, and autonomy are, ironically, not well integrated in the US healthcare system, particularly with regard to patients ability to choose treatments. There is an inconsistency: patients can pay extra for a private room in a hospital, but they do not have the right to choose to have a more expensive surgical option for something that is considered a covered service. To an outsider, this certainly seems un-American. Patients can pay extra for a private room in a hospital, but they do not have the right to choose to have a more expensive surgical option for something that is considered a covered service. To an outsider, this certainly seems un-American. This arrangement has apparently developed because of the fear in some quarters of having a twotiered health system. In the UK, which has a socialized healthcare system, many well-off people choose treatments within the National Health Service, while some choose private treatment. A two-tier system exists, yet, there is no sense of unfairness in a person choosing private treatment and paying for it. Likewise, in Australia, having two tiers is seen as a benefit: moving people from the public health system into private, elective day surgery takes pressure off the public system. Indeed, the taxation system penalizes people for not taking up private insurance if they can afford it, and encourages people to take it up early. Former US Congressman Christopher Cox elaborated on reasons why the FDA is slow to approve new treatments. First, it has become populated with former staffers of politicians, and hence is an overly politicized organization. Second, there is no incentive or reward to approve new treatments, only fear of being criticized later if an approved treatment causes harm. Junior staff members are afraid of being rebuked by their seniors, and senior staff members are afraid of rebuke by politicians. The FDA needs some protection against blame for approving treatments. It is inevitable that there will always be a risk that a product will need to be removed from the market, and the only real guarantee against this is to block all new treatments from reaching the market.
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The FDA needs some protection against blame for approving treatments. The most likely motivating factor to get faster approvals appears to be shame. In my opinion, the FDA should be embarrassed that US citizens are travelling abroad for safe and effective treatments that are not available to them domestically. It is a fundamental principle in all of medicine, and life, that risk must be balanced against benefit. If a treatment option is delayed too long, patients can suffer. The most topical example is corneal cross-linking (CXL) for treating keratoconus. Denying widespread access to this treatment at a time when it is widely available elsewhere undoubtedly means that some patients will undergo a corneal transplant with all of the attendant risks and costs that potentially could have been avoided. Although there is much more to be learned about CXL, how much more information is required before patients have it as an option? It is important to recognize that there is definite harm in not approving a technology or drug, just as there is potential for harm in a patient delaying a decision to have surgery. Seemingly arbitrary requests from the FDA for additional (and often redundant) data foster concerns that the regulatory body causes deliberate delay. There must be some means to make the FDA accountable to patients for their lost opportunities. There must be some means to make the FDA accountable to patients for their lost opportunities. THE ROLE OF VENTURE CAPITAL The European model of CE Marking was discussed as a system that works well and promotes jobs and development. It is funded by companies, is focused on safety rather than efficacy, and it has less red tape. Although it seems doubtful that a similar system has a chance of being approved in the US, one suggestion is that the FDA should focus primarily on safety rather than efficacy. Then, let the clinicians make a judgment on efficacy based on their experience and available data, and let the patients decide if they think it is worthwhile. J. Andy Corley of Yelroc Consulting, Inc., in California, and Tony Natale, MD, of Prism Venture Management in Massachusetts, explained how venture capitalists help foster innovations and bring new treatments to the clinic that larger companies cannot. Large companies may be hampered because they cannot focus on running their business while developing multiple new ideas. Venture capitalists have the advantage of being smaller and can choose projects after researching the potential of the market. There are, however, multiple challenges that venture capitalists face. Dr. Natale emphasized a critical point: that the US has great innovators and entrepreneurs, but they are hampered by over-regulation. This means that great innovations must be developed OUS, with clinical trials often conducted in Europe prior to seeking FDA approval. This creates extra travel costs, and it means that collaborators and investigators, who work in a different system, need to be identified. There are more unknowns, and businesses would much prefer to be able to continue development within the United States. There is also a risk that US companies conducting trials abroad can be perceived as experimenting on poorer populations, with ensuing reputational damage. Overseas R&D can wrongly promote the perception that Americans are prepared to experiment on others with unknown treatments that they would consider unsafe for themselves. More to the point, would American patients be happier if treatments developed in the US had been tested overseas first? Many patients simply want access to the latest options, and would be prepared to accept the risks. ECONOMIC PRESSURES An important point made by Bill Link, PhD, of Versant Venture Management in California, is that it is
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difficult to innovate in a very tight market, where there are small margins. A high return on the initial investment produces capital for further research and development. Unfortunately, the current economic reality means that many brilliant and clinically useful innovations will never be developed at all, either because of exorbitant development costs or because the market is too small to recoup the initial investment. While innovations in other sectors are becoming cheaper, drug and device development costs appear to be increasing massively. Is there any way to make drug development cheaper? A new balance must be reached. Mr. Corely stressed that we need to understand the issues the FDA is facing. As he said, firing letters between one another will not create an effective relationship. Negotiating a better position requires a good understanding of what the FDAs internal issues are. Mr. Corely is optimistic that the relationship with the FDA can be improved to facilitate moving the translational phase of research back to the US. INNOVATION Individual surgeons should not be afraid to be part of the innovation cycle. They are in the fantastic position of talking to patients every day about their needs, and hence can identify unmet needs and develop ideas to fulfill those needs. The next steps are to identify the scope of the market and liaise with companies and entrepreneurs to develop the idea into a marketable opportunity. By bringing surgeons and industry together, ACOS meetings will certainly facilitate this type of innovation to improve patient care. Daya Sharma, MBBS, MSc, FRANZCO, is an ophthalmologist based in Sydney, Australia. He was a Corneal, Cataract, and Refractive Surgery Fellow at Moorfields Eye Hospital in London, England, and a Refractive Surgery Fellow in Heraklion, Crete. Dr. Sharma may be reached at dr.daya.sharma@gmail.com.

Dealing With Unwanted Images in Patients with Pseudophakia

By Samuel Masket, MD

In the July issue of the Journal of Cataract and Refractive Surgery, Nicole Fram, MD, and I published a new theory on the etiology of negative dysphotopsia and our method for managing it surgically.1 This is a summary of what is known about the condition to date.

BACKGROUND Negative dysphotopsia, a dark crescent in the patients temporal visual field, is a frustrating phenomenon in that it occurs after anatomically perfect cataract surgery and it appears to have no correlation with either the type of IOL implanted or the location of the main incision.2,3 However, there have been no reports in the literature of negative dysphtopsia occurring with lenses implanted in the sulcus or the anterior chamber, nor has it been reported with malpositioned IOLs. The condition is not associated with LASIK flaps, penetrating keratoplasty, astigmatic corneal incisions, radial corneal incisions, or pre- or postoperative ametropia. HYPOTHESIS A review of the literature led us to conclude that negative dysphotopsia is induced at the interface of the
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anterior capsulotomy and the anterior surface of the PC-IOL, perhaps due to the edge of the anterior capsulotomy being reflected onto the nasal peripheral retina. Pharmacotherapy does not work; surgical treatments of negative dysphotopsia seem most effective. The surgical strategies most commonly tested for this purpose have been IOL exchange with sulcus placement of the new IOL, secondary piggyback IOL implantation, and reverse optic capture. Our study showed the most reliable results using the reverse optic capture and piggyback IOL techniques.1 TECHNIQUE To perform reverse optic capture at the time of cataract surgery, I clean the anterior lens epithelial cells to reduce postoperative fibrotic changes in the capsule. I place the three-piece IOL in the bag, and then use a spatula to pop the optic anterior to the edge of the capsulorhexis. To succeed with this maneuver, it is crucial that the capsulorhexis is properly sized. Alternatively, I can simply place the lens in the sulcus, but the optic-capture technique provides better centration and fixation for long-term stability. For highly symptomatic patients, I can perform a secondary reverse optic capture or exchange the IOL for one placed in the ciliary sulcus. Samuel Masket, MD, is a clinical professor at the David Geffen School of Medicine, UCLA, and is in private practice in Los Angeles. Dr. Masket may be reached at (310) 229-1220; avcmasket@aol.com. Nicole Fram, MD, is a clinical instructor at the David Geffen School of Medicine, UCLA, and is in private practice in Los Angeles. Dr. Fram may be reached at (310) 229-1220. 1. Masket S, Fram NR. Pseudophakic negative dysphotopsia: Surgical management and new theory of etiology. J Cataract Refract Surg. 2011;37(7)1199-1207. 2. Narvez J, Banning CS, Stulting RD. Negative dysphotopsia associated with the implantation of the Z9000 intraocular lens. J Cataract Refract Surg. 2005;31(4):846847. 3. Trattler WB, Whitsett JC, Simone PA. Negative dysphotopsia after intraocular lens implantation irrespective of design and material. J Cataract Refract Surg. 2005;31(4):841845.

The Way We Evaluate Eyes with Thin Corneas for LASIK May Need to Change
By William B. Trattler, MD
Evaluating eyes with thin corneas for potential LASIK surgery is an inexact science, and some of our common assumptions about these patients may actually be based on flawed logic. Although several studies have demonstrated that abnormal preoperative topographic readings are a risk factor for postLASIK ectasia, there is no consensus on what constitutes an abnormal reading. Moreover, some patients with normal preoperative topography still develop ectasia, and we do not have good guidance for identifying these individuals in our presurgical planning. DIFFICULTY GRADING TOPOGRAPHY The scoring system developed by Randelman and Stulting1 has been helpful for understanding some of the potential risk factors for developing post-LASIK ectasia. This system assigns points for variables such as age, planned residual stromal bed, preoperative corneal thickness, and manifest refraction. Topographic readings are an important element of the Randelman scoring system, but recent research presented at the AAO in Orlando suggests that there can be significant variability in how these scores are graded. Renato Ambrosio, MD, PhD, reported on his study wherein 10 different experienced topography experts evaluated preoperative topographic maps, and some of the eyes ended up
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developing post-LASIK ectasia.2 There was marked disagreement by the graders in the interpretation of the preoperative topography. For most of the cases that developed ectasia, the final Randleman risk score varied based on the interpretation of the preoperative topography. As a result, the study found that the patients candidacy for LASIK varied according to which doctor was interpreting the preoperative topography. Thin Corneas and LASIK Keratoconus results in corneal thinning and irregular astigmatism. It has been suggested that if a patients corneal findings, such as corneal thickness, are two standard deviations outside of normal, then this may be a clue that the patient is developing early keratoconus, and therefore he or she may be at greater risk for post-LASIK ectasia. However, it is interesting that the same thinking is not used to exclude eyes that are two standard deviations or more outside the norm with regard to astigmatism (Figure). One of the underlying assumptions is that the corneas thickness is a direct measure of its rigidity/strength. This thinking would suggest that thin corneas have less corneal strength and are thus more susceptible to developing ectasia. Contrary to this hypothesis, however, are various findings that demonstrate that the actual thickness of the cornea is not a direct measure of corneal strength. A few examples: (1) our corneas naturally become stiffer as we age, even though their thickness changes very little; (2) after corneal cross-linking, the cornea becomes thinner yet stronger; and (3) African and African-American populations have thinner corneas compared with other ethnicities, but do not show any greater incidence of keratoconus or postLASIK ectasia. So, the central corneal thickness does not appear to be a direct measure of corneal strength. ECTASIA RISK FACTORS With these thoughts in mind, it seems that the current thinking about excluding patients with thin corneas from LASIK may be overly cautious. In a retrospective review of 1,702 eyes that underwent myopic LASIK with normal preoperative topography, Perry S. Binder, MS, MD, noted that 12% of the eyes had a Randelman score of 3 or higher, yet none developed ectasia.3 Interestingly, the original paper by Randelman and Stulting included a control group of 133 eyes, and 12% of eyes in the control group had a score of 3 or higher, yet none developed ectasia. Other studies in the literature have also noted a low risk of post-LASIK ectasia in patients with thin corneas after operations performed with microkeratomes.4-7 It is notable that in these studies, with populations ranging from as small as 39 eyes to as large as 400 eyesand including studies specifically in patients with moderate-to-high myopia and thin corneasthat no cases of ectasia were reported through the follow-up of these studies. What I take away from the limited data on thin corneas as it pertains to the risk for post-LASIK ectasia is that it is crucial to evaluate the corneal shape in both eyes. There are many available technologies that can provide valuable information in assessing the candidacy of patients, including the Orbscan (Bausch + Lomb, Rochester, NY), Pentacam Comprehensive Eye Scanner (Oculus, Inc., Lynnwood, WA), or the Galilei (Ziemer Ophthalmic Systems AG, Port, Switzerland). Measuring corneal biomechanical strength with the Ocular Response Analyzer (Reichert, Inc., Depew, NY) may provide additional information. Additionally, flap creation with femtosecond lasers and more advanced microkeratomes may be safer compared with older microkeratome technology, because flap thickness is more predictable. Lastly, to ensure that the flap is not cut too deep, it may be prudent to perform
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intraoperative pachymetry whenever possible. William B. Trattler, MD, is the director of cornea at the Center for Excellence in Eye Care in Miami and the chief medical editor of Eyetube.net. Dr. Trattler may be reached at (305) 598-2020; wtrattler@earthlink.net. 1. Randleman JB, Woodward M, Lynn MJ, Stulting RD. Risk assessment for ectasia after corneal refractive surgery. Ophthalmology 2008;115:37-50. 2. Ramos I, Ambrosio R Jr, Guerra FP, et al. Impact of the subjective variability of corneal topography classification on the ectasia risk score system. Poster presented at: The AAO annual meeting; October 22-25; Orlando, FL. 3. Binder PS, Trattler WB. Evaluation of a risk factor scoring system for corneal ectasia after LASIK. J Refract Surg. 2010;26(4):241-250. 4. Kremer I, Bahar I, Hirsh A, Levinger S. Clinical outcome of wavefront-guided laser in situ keratomileusis in eyes with moderate to high myopia with thin corneas; J Cataract Refract Surg. 2005 2005;31(7):1366-1371. 5. Kymionis GD, Bouzoukis D, Diakonis V, et al. Long-term results of thin corneas after refractive laser surgery. Am J Ophthalmol. 2007;144(2):181-185. 6. He TG, Shi XR. Clinical study of ultrathin flap LASIK and LASEK for the treatment of high myopia with thin cornea. Zhonghua Yan Ke Za Zhi. 2006;42(6):517-521. 7. Caster AI, Friess DW, Potvin RS. Absence of keratectasia after LASIK in eyes with preoperative central corneal thickness of 450 to 500 microns. J Refract Surg. 2007;23(8):782788.

Achieving Efficiency with Femtosecond Laser Refractive Cataract Surgery

By Eric D. Donnenfeld, MD
Femtosecond laser refractive cataract surgery is a new technology, and therefore it will take careful thinking and planning to figure out how best to use it. In the long term, though, I think surgery can ultimately become more efficient with this new technology. In fact, consumer demand may force us to figure out how to effectively use a femtosecond laser in a high-volume cataract practice. The early response to laser refractive cataract surgery from the patients in my surgical center has been enthusiasticand, in fact, overwhelming. I had initially planned on a 15% to 20% penetration of patients wanting this procedure. So far, we have achieved a 60% conversion rate. Given the high demand, we have had little choice but to learn and adapt to the technology so that we can better serve our patients wishes. "Given the high demand, we have had little choice but to learn and adapt to the technology so that we can better serve our patients wishes." SURGICAL PEARLS The use of the femtosecond laser in cataract surgery has been studied in controlled settings, and the results are positive. Because the technology is so new, however, there is still a dearth of information about how it may be used in the clinic. To that end, my staff and I have learned a few surgical pearls in our early experience that may be beneficial to share. 1. Patients must be able to comply with the suction element of the femtosecond laser. This may
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mean selecting out patients with medical conditions (ie, tremors) that would prevent them from lying perfectly still. The laser we use, the LenSx (Alcon Laboratories, Inc., Fort Worth, TX), requires only a modicum of interpalpebral exposure, but redundant conjunctiva may prevent suction, as may the use of gels or ointments. One technique my staff and I have found very useful is to retropulse the globe. We use a speculum to press down on the globe, which causes the eye to move forward and results in better applanation. 2. Achieving good dilation and staying about 0.5 mm away from the iris during the femtosecond ablation are essential to a safe surgery. 3. The use of a novel device requires increased chair time with patients preoperatively to explain all the parameters. Although greater chair time may dampen overall efficiency, it is time well spent if the patient ultimately walks away happy. 4. Laser refractive cataract surgery is a premium procedure, and my staff and I want to make sure that patients experience a premium service as well. We keep them on the same stretcher from start to finish so they move seamlessly through our center. PRACTICE PEARLS One of the important considerations that will affect patient flow and dynamics is the placement of the laser in the surgical center. Maintaining or improving patient throughput is best achieved by having the laser as close to the OR as possible. Optimally, the laser would be just outside the OR, because sacrificing an OR exclusively for the lasers use forfeits the revenue potential of that room. The trick is to find a placement that works for you and then maximize how the device is used. For example, we had to place our femtosecond laser in one of our ORs, simply because we do not have the space to place it anywhere else. We have three ORs in use on surgical days. When using one room for laser refractive cataract surgery, I am approximately 50% slower with my surgical time compared with standard cataract surgery; with two rooms I am 35% slower; and with all three in service, I am still about 20% slower. Once I realized how inefficient I had become, I decided to have our surgical fellow perform all of the laser procedures so that I could concentrate on the surgical portion. This change has increased our centers efficiency by 10% to 20%. I believe that surgeons should strongly consider performing their first 200 or so cases, but after that point, splitting duties is very beneficial. This might even be a good role for a senior associateperhaps someone contemplating retirement and/or scaling back his or her responsibilities. Eric D. Donnenfeld, MD, is a professor of ophthalmology at NYU and a trustee of Dartmouth Medical School in Hanover, New Hampshire. Dr. Donnenfeld is in private practice with Ophthalmic Consultants of Long Island in Rockville Centre, New York. He acknowledged no financial interest in the products or company mentioned herein. Dr. Donnenfeld may be reached at (516) 766-2519; eddoph@aol.com.

Emphasize Education and Patient Choice to Improve Conversion Rates

By James D. Dawes, MHA, CMPE, COE
Patients want the best improving vision possible after cataract surgery. Unfortunately, we often do a poor job of making the decision to spend discretionary dollars on improving vision an easy one. Getting patients to commit extra, out-of-pocket dollars to a premium lens choice requires a practice-wide commitment to simplifying the overall educational process. In general, patients come to the practice unaware of what their vision might be after surgery and unfamiliar with modern technological advancements in lens replacement surgery. Many practices want to improve their conversion rates to
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premium lenses; and, while our practice has been successful in the premium channel, our focus is really on allowing the patient to make the decision instead of trying to sell something that they may not want and probably dont quite understand. We truly believe that informing our patients about all the parameters involved in cataract surgery represents our best chance for helping them achieve their desired outcome and to be comfortable and happy with that decision. Although a lot is involved in educating individuals about these implants, for the purposes of this article, I will review the points we emphasize in our practice during the patient-counselor encounter. EDUCATION I emphasize that patients ought to be educated about their IOL options before consulting with the surgeon. My staff and I believe that patients really seek a lens recommendation from their surgeon, and we want them to be well informed of their options so that the discussion with the operating surgeon can be fruitful. Our commitment to education is all-inclusive and involves the referring physician, the frontoffice staff, the technicians, the patient counselors, and the surgeon. The encounter between the counselor and the patient usually lasts 10 to 15 minutes, and we attempt to personalize the experience as much as possible. We ask patients about their hobbies, how they use their vision, and what their visual needs might be after cataract surgery. That knowledge can be a powerful reference point as the discussion continues. Visual cues help many patients assimilate the information we are providing. We have equipped our counseling rooms with large, flat-screen televisions so that patients can easily see visual aids that demonstrate how normal vision is perceived as well as how it degrades due to presbyopia and cataracts. We spend a good amount of time reviewing the anatomy of the eye and the pathophysiology of a cataract. We follow with a discussion about astigmatism and how a cataract and lens replacement procedure alone does not address near vision or any pre-existing astigmatism. We discuss our approach to treating and managing astigmatism, which is imperative to achieving the patients best visual outcome. Then, we generally describe IOL options for the patient, being careful to identify the advantages and disadvantages of both standard and premium lenses. Any discussion about cataracts and lens options must account for potential complications, and time should be spent explaining why some expected follow-up issues are not, in fact, failures of the procedure. For instance, we explain that some patients may experience halos and glare after implantation with premium lenses, and others require an Nd:YAG capsulotomy. We emphasize that these occurrences are not a failure by the operating surgeon, but instead expected and very common postoperative conditions. SIMPLIFY THE PAYMENT PROCESS One of the trickiest aspects of cataract surgery for our patients to understand is the insurance and payment process. In the interest of simplification, we perform a preregistration process to identify the individual patients responsibilities for copay, coinsurance, deductible, and out-of-pocket expenses. We then let the patient see a side-by-side comparison of the costs associated with premium and standard
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lenses. At this time, a reminder that he or she may be responsible for a copay, deductibles, and/or coinsurance payment for a needed Nd:YAG capsulotomy is certainly warranted. Before wrapping the conversation, we also introduce the various financing options we have available. We want to assure our cataract surgery candidates that we will continue to work with them to navigate this process and help them achieve their visual goals. At that point, we emphasize that the next step in the process is for the surgeon to determine if the patient is a candidate for a premium lens, and that he or she will make a recommendation as to the best technology to meet the patients desired visual outcome. CONCLUSION An informed consumer is our best customer, and in most cases is a happier patient. Asking a patient to pay thousands of dollars for an IOL is a tricky proposition, but one that can be greatly aided by personalizing the decision so the focus is on the patient. My staff and I believe in helping patients achieve their visual goals and in making sure that they understand all the options and ramifications of the final lens choice. James D. Dawes, MHA, CMPE, COE, is the chief administrative officer at Center For Sight in Sarasota, Florida. Mr. Dawes may be reached at (941) 480-2105; jdawes@centerforsight.net.

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