Welcome new rhexis makers, but don’t trade in your femto

May 25, 2016DrHovanesian No Comments »

In the cover story of this issue of OSN, we discuss new alternate devices that can assist in capsulotomy creation. Femtosecond laser surgery in the U.S. grew to 9.5% of all cataract procedures performed, up from 8.3% in the last quarter of 2014, according to Market Scope, an independent market research firm. Still, these instruments may not be affordable to some lower-volume surgery centers. While these less expensive alternatives may be better suited for some, they lack many of the most appealing features of laser-assisted cataract surgery for cases like these:

 

1. Routine challenges. For very dense cataracts and cases with pseudoexfoliation, many surgeons really rely on their femtosecond laser to soften the nucleus and allow less traumatic, less complicated disassembly because the vast majority of these patients have some degree of astigmatism and they get the added bonus of femto’s incisions. With time and advancing laser platforms, these benefits will only increase.

2. Oddball cases. Increasingly, we are learning how femtosecond surgery can allow safer phaco in cases with corneal scars, intumescent white cataracts and other challenges. Competitive capsulotomy makers may also offer some advantages in these cases, but none are quite as automated as the femtosecond laser.

3. Integration and surgical guidance.Increasingly, systems that measure preoperative corneal curvature and intraoperative aberrometry are directly integrated with each other, so the measurements from one machine auto-populate the settings for the next. This reduces staff time and the risk of data entry errors, and the use of these technologies has already been clearly demonstrated to improve outcomes. Femtosecond surgery is today where phaco was around 1990. We have already seen meaningful improvements through software and hardware upgrades in our existing machinery that have increased both the safety and durability of these instruments, and the next generation of lasers is already being tested in the preclinical setting.

To be sure, there are many facilities where acquiring a femtosecond laser is unrealistic. Simpler, less expensive means of reproducibly creating capsulotomies will have value for many surgeons. The market speaks to every new technology, and it’s likely there will be broad support for these promising, more affordable approaches. Still, the standard by which they will all be measured will continue to be the femtosecond laser.

Disclosure: Hovanesian reports he is a consultant for Alcon, AMO and Bausch + Lomb.


How the ocular surface benefits from sustained drug delivery

May 12, 2016DrHovanesian No Comments »

Delivering drugs slowly to the eye has many benefits, including increased compliance, surgeon control of the type of drug used, and avoidance of pressure spikes in the case of steroid delivery. The ocular surface, though, may benefit most from a sustained delivery approach.

In my practice, the eye drops we prescribe and the ones patients receive are very often different. Pharmacies, motivated by higher profit margins from generic drugs, often switch our patients to generic “alternatives” that are not always well tolerated on the eye. Preservatives and other inactive ingredients in generic drugs have been shown in a number of studies to deliver variable toxicity to the ocular surface. This is most notable in chronic glaucoma therapy, in which generic prostaglandins and their preservatives cause slow destruction of limbal stem cells. In the shorter-term therapy after cataract surgery, generic ocular surface toxicity can impair visual results for months after the procedure.

It’s amazing to me that with all the drug advances we’ve seen in our careers, we still use eye drops to deliver medication to the eye. The pathway between prescribing and the actual delivery of drug is fraught with many pitfalls, and when any eye drop is placed on the eye, it comes at an overwhelmingly high concentration for a very brief time. We can only hope the penetration achieves desired levels. And that’s if the patient takes the drop at all. Sustained-delivery devices, such as the Ocular Therapeutix punctal depot device and the Icon Bioscience steroid depot, have been used in clinical trials in our practice. For the most part, placing them is a non-event for patients, taking a very brief time, and the patients love that they do not have to take drops. After surgery, in general, the eyes look great, with the same control of inflammation you’d expect with topical therapy but none of the side effects.

With steroids, we want a high initial dose followed by a slow taper. Studies of prednisolone acetate suspension have shown that in many cases, even with vigorous bottle shaking, the amount of actual drug delivered in the first drops is one-eighth the concentration of that delivered toward the end of the bottle. This creates an increasing, rather than decreasing, dose of medication. Pressure spikes and toxicity can naturally result.

With glaucoma medication, slow delivery of a therapeutic dose benefits the eye far more than once- or twice-daily dosing, and clinical trials are beginning to show better diurnal pressure curves with sustained delivery.

As more of these technologies become approved, we will have growing options for how we choose to deliver both steroid and glaucoma medications. We will feel more confident that the patient is actually receiving the drug we choose, and the cost to the system will likely decrease rather than increase, as we will see fewer long- and short-term complications that result from patient compliance and ocular surface toxicity.

With better tools we become better doctors, and I am excited to see these technologies become approved in the near future.

Disclosure: Hovanesian reports he is a consultant and clinical investigator for Ocular Therapeutix and Icon Bioscience.


Three essentials for in-office cataract surgery to grow

April 12, 2016DrHovanesian No Comments »

After you first talk to a patient about cataract surgery, what’s the most frequent question you get? For me, it’s, “How soon can we do it?” Wouldn’t it be wonderful if a surgeon could look at his watch and say, “How about 10 minutes?”

 

Just a few years ago, the concept of in-office cataract surgery would have raised many eyebrows, but as we explore in this issue’s cover story, the future of this procedure may be more real than we think. Some basic standards need to change for this to become feasible, though.

1. Equipment companies must support less expensive, reusable supplies. Most of the cataract equipment we use in the U.S. only comes with single-use disposable tubing. These same machines in other countries have approved reusable tubing, and rates of infection and other complications are comparable. Re-sterilizable tubing can be used maybe 20 times and is considerably less expensive. To meet tighter cost controls for any in-office surgeries, companies will need to shift their “standards” back toward sterilizable cassettes and phaco tubing.

2. Payment models need to change. According to reimbursement specialist Kevin Corcoran, Medicare reimbursement for a surgeon performing cataract surgery is the same whether he/she performs the procedure in the hospital, ambulatory surgery center or office. If payers desire to save money, pushing procedures out of the ASC and into the office makes lots of sense, but surgeons will only consider this if the surgeon fee in the office makes up for the cost of added equipment and supplies and the loss of ASC income because so many of us own our surgery centers. There is some precedent for this. In GI, vascular surgery and pain management, CMS has sought to move procedures out of hospitals and into less expensive ASCs. To incentivize this, it increased ASC reimbursement dramatically for certain procedures. Not surprisingly, more surgeons started doing those procedures in ASCs. Indeed, a similar arrangement could be made to increase the surgeon fee for cataract surgery, depending on where the procedure was performed.

3. Malpractice carriers will have to support in-office cataract surgery. Every case of infectious endophthalmitis is a tragedy, yet its likelihood is unlikely to be any greater in the office than a formal operating room, as long as careful sterility standards are followed. Malpractice insurance companies will need to embrace this fact and be prepared to stand behind doctors when a postoperative infection does happen in the office setting.

Time and further study will tell whether shifting cataract surgery to an office setting compromises patient safety/convenience or enhances it. Some with experience, such as a few Kaiser Permanente systems, claim its benefits are clear. As more data accumulates on its safety, it’s likely that in-office surgery will be better supported by our health care system. The system will save costs, and as with ambulatory surgery centers, surgeons who practice with efficiency should continue to be able to earn a living practicing the craft they love so well.


But for the FDA, CXL is already standard of care

March 23, 2016DrHovanesian No Comments »

In many ways, the U.S. leads the world in creating new medical standards. In so many others, we lag terribly. Europe, for example, now largely considersintracameral antibiotics during cataract surgery to be standard of care, while the U.S. still has no FDA-approved antibiotic to inject. Collagen cross-linking for ectatic disorders is another European invention, popularized in Europe by Theo Seiler and others. The procedure, which involves saturating the cornea with riboflavin, then applying ultraviolet-A light to create covalent bonds between collagen layers, still has no FDA-approved products in the U.S. Clinical studies, such as the CXLUSA study of which my practice is a part, mimic the “standards of care” used in Europe and elsewhere. In fact, our group alone, which has been performing cross-linking at 17 U.S. centers since 2009, is now helping set new standards for this procedure internationally.

 

Cross-linking is a very simple concept. Over a period of minutes, the cornea is saturated with riboflavin drops. The eye is then treated with a beam of UVA light, and the patient goes home with recovery instructions similar to PRK or LASIK. Depending on whether the corneal epithelium was removed (so-called epi-off CXL) or left in place (epi-on), the healing period is more or less reasonably comfortable, although most patients in both groups have a fair amount of burning on the night of the procedure.

The concept is simple, and the results are fairly consistent across techniques and studies. Stabilization of keratoconus occurs in at least 95% of eyes, depending on whether full saturation of the cornea with riboflavin was achieved. About 60% of eyes have an improvement in their corneal shape and their uncorrected vision. The biggest gift of the procedure, though, is that the vast majority of these patients will never require a corneal transplant.

So why hasn’t the FDA approved this procedure to make it more widely available? After all, in Europe, it’s considered malpractice not to perform cross-linking on patients with progressive ectasia. Simply because the FDA has yet to see a cohesive set of data that meets its requirements to prove safety and efficacy of this procedure. In other words, the jury of thousands of global doctors has voted, but we are waiting for the judge, the FDA, to issue its verdict. I, for one, am eager to see the procedure approved and become more widely available to our many patients in need of treatment. Meanwhile, it’s worthwhile for every eye doctor to become familiar with centers offering investigational procedures, such as those listed on CXLUSA.com, and refer patients with ectasia for treatment.

Disclosure: Hovanesian is an investigator with the CXLUSA study.


The ‘Costco-ization’ of health care

March 10, 2016DrHovanesian No Comments »

Health care “reform” has brought about some positive, some interesting and some very challenging circumstances for doctors practicing medicine. I have written previously about how the world is beginning to treat doctors as it did pilots a generation ago. But more than just treating us like hourly employees, health care reform is pushing doctors into a role like a returns desk clerk at Costco. Here are four factors that are driving this disturbing change:

 

1. Many patients don’t understand the economics of their own insurance plan. As health insurance premiums rise, patients are shifting more and more into high deductible plans. Clearly, patients win if they don’t need to have care, but when patients do need to see doctors, they can be shocked to be responsible for the entire cost (albeit contracted rate) of their treatment. To them, it seems like little consolation that they signed for a deductible of several thousand dollars toward medical services, diagnostics, surgery, facility fees, anesthesia fees, etc. It’s natural for them to blame the one presenting them the bill. A lab or facility is faceless, but with their doctor they have a personal relationship — one that is newly becoming strained by this dynamic.

2. By and large, patients don’t shop around for doctors based on pricing, and price shopping would hardly make a difference when their insurance contract would call for very similar rates among all doctors. This probably needs to change, with insurance companies being required to tell patients not just the cost of a monthly premium but the health plan’s average out-of-pocket cost paid by the average patient with the average health history.

3. High out-of-pocket costs are blurring the lines between basic and premium services. “Covered” used to mean “paid for,” but now patients who have the least ability to pay, ie, those who choose high deductible plans, must pay the cost of the basic “covered” services in cataract surgery. A few years ago, these same patients might have been able to stretch to afford add-on services like laser astigmatism correction or a premium lens implant. Not any longer. It’s somewhat understandable for them to feel that they’ve paid a premium price for surgery and therefore deserve to see without glasses, even if they opted out of these add-on extras.

4. Patients have been trained by the retail world that if they’re not satisfied, they’re not paying. Most who are not experienced in health care don’t understand that doctors are paid to provide a service rather than an outcome. Facing high out-of-pocket costs, they might mistakenly feel that a doctor is financially responsible when a patient doesn’t react to a procedure in the expected way. No matter their risk status, some can feel that only a perfect result deserves payment.

In response to this, many physicians now have found it necessary to collect any fees that are the patient’s responsibility before surgery rather than after. Moreover, patients feel justified in asking for a refund, or further surgery at no cost, if they are not pleased with their results.

All this is happening while reimbursement to physicians for the same services is declining over time and the cost of employing our staffs and maintaining our offices continues to rise.

How do we address this collision of interests? There’s no simple answer, but educating our patients gently about the realities of health care costs before those costs are incurred will go a long way toward avoiding misunderstanding. With time, I believe the health care system will make more transparent the possible costs to patients of choosing different health care plans, and people will begin to understand that practicing medicine is not the same as selling flat screen TVs. Meanwhile, treating each patient as a friend and doing our level best to help them understand the health care system we work in may be the best that we can do.


Three reasons why MIGS may replace glaucoma drops as first-line therapy

February 23, 2016DrHovanesian No Comments »

1. Preservatives, preservatives, preservatives. We cornea specialists regularly see elderly glaucoma patients with “refractory dry eye.” What most of these patients actually have is irreversible limbal stem cell deficiency caused by chronic use of preservative-containing glaucoma drops. This trend has become especially alarming since latanoprost became available in generic form.

Have you ever looked at the list of “inactive ingredients” in any of the dozen or so available forms of generic latanoprost? You can access that information for any FDA approved drug at http://dailymed.nlm.nih.gov/dailymed/. The type and concentration of preservatives are relatively unregulated by the FDA but can have profound effects, especially with chronic use, on the ocular surface. Benzalkonium chloride (BAK) is a soap that emulsifies bacteria effectively but does the same thing to the cell membranes of the progenitor (but irreplaceable) limbal stem cells. Daily doses of this and other ingredients on the ocular surface can be damaging over the long term.

2. Compliance. If we had a surgical therapy that worked in 50% of patients, it certainly wouldn’t be first-line therapy. Yet we know from multiple studies that only about 50% of patients have adequate compliance to succeed with topical therapy, so why are eye drops the first (and second) line of therapy for glaucoma? Many believe this conservative approach was a byproduct of the risky and failure-prone surgical alternatives in the 1970s and 1980s, when full-thickness drainage procedures were common yet fraught with complications. In Europe today, surgical therapy is emerging as first-line therapy. This approach deserves consideration, especially with the safety of MIGS.

3. MIGS works and is learnable. A number of procedures are available to fit any surgeon’s skill set, from endoscopic cyclophotocoagulation to the iStent (Glaukos), from trabeculotomy with the Trabectome (NeoMedix) to Visco360 viscodilation of Schlemm’s canal (Sight Sciences). Coupled with cataract surgery, all of these procedures provide meaningful and sustained lowering of IOP and relief from the need for drops. They are reimbursed reasonably, FDA approved, and they only add a few minutes to cataract surgery. Generally they don’t increase the risk of hypotony or endophthalmitis. These are truly low-impact surgeries with high-impact results.

One last point: Performing cataract surgery earlier for patients with glaucoma is a trend that most of us agree should grow. It reduces by years the total duration of glaucoma drop therapy and its damaging effects. It eliminates the phacomorphic component of glaucoma and gives us an opportunity to surgically reduce pressure without adding to the patient’s total lifetime surgical risk because we’re simply performing surgery at an earlier stage. It clearly fits into the “what I would do for my sister” category.

The number and growth of companies in the MIGS space speak clearly to the enthusiasm shown by analysts and investors. As doctors, we are always appropriately a shade more conservative in adoption of new techniques, but growth of this promising set of procedures is well supported by their benefits to patients.


Three reasons why Medicare is our best payer

February 10, 2016DrHovanesian No Comments »

If a single policy has kept most ophthalmologists participating in the Medicare system, it was the 2005 CMS ruling that allowed separate private-pay billing of premium lens implants and refractive services performed as part of cataract surgery. For many of us anterior segment surgeons, participation in Medicare gives us access to patients who may elect additional services that are separately reimbursed.

To be sure, there are many legitimate complaints about Medicare, such as increasing hurdles to demonstrate “quality measures” that measure anything but quality and odd restrictions such as reduced payment for the second eye in bilateral cataract surgery, but here are three reasons why Medicare may still be our best third-party payer, and why I, for one, am not opting out of the system.

1. Medicare’s rules are clear and mostly fair. Many private payers sometimes require onerous pre-authorizations and sometimes do not. Some require physicians to bill, only to later find out whether a provided service was covered. Others mandate that their covered lives must have surgery performed in a facility that, although inadequately equipped and staffed, is owned by the payer. While making benefits harder to access, private payers are increasing their premiums to patients at an alarming rate. Not so with Medicare.

2. Medicare pays, generally on time. We regularly have to push back against private payers who down-code capriciously or pay less than the contracted amount for the accepted code. Private insurers sometimes change their billing address without sending notice (just a small address change in the fine print on the back of the patient’s new insurance card). This permits them to sit on claims for months until we protest. In short, working with some private payers feels like having a dishonest business partner where we feel the need constantly to watch for bad behavior.

3. Medicare gives patients the benefits they have already paid for. Whatever you can say about Medicare’s future, the majority of today’s beneficiaries did indeed pay into the system. Whether current actual costs exceed what they paid in is really not relevant. For good or bad, it’s our country’s national health care system, and most seniors would prefer to take advantage of what it provides. We at least owe our elders our best effort in working with the system, flawed as it is, designed to repay them for their hard work.

In medicine, one party sells increasingly expensive services, another receives them, and a third pays the bill. These economics are riddled with conflict, and the rules of conduct will forever become more complicated as costs rise. While Medicare’s flaws are numerous, it deserves a lot of credit for being motivated by patient well-being rather than profit.


Ophthalmology’s failing dry eye report card

January 26, 2016DrHovanesian No Comments »

In my practice, we spend a lot of effort following up with electronic patient questionnaires after office visits or surgery. We want to make sure our treatment or procedure has adequately addressed the problems we were entrusted to solve. To do this, we use a cloud-based follow-up care system called MDbackline. It has given us valuable (and often humbling) insights on conditions such as dry eye, in which we recommend remedies but don’t necessarily schedule a follow-up appointment.

How happy are most of our dry eye patients with their recommended treatment? We do fairly well, with about 70% “very satisfied” or “somewhat satisfied,” but that leaves another 30% who are either neutral or overall somewhat dissatisfied with their treatment. Worse yet, about 45% of dry eye patients questioned 2 weeks later tell us their condition is “about the same” or “worse” than before their office visit.

If there were a professor grading us, we’d be repeating this dry eye class next semester. If we scored like this in cataract surgery (we do much better actually), our practice would lose most referrals.

So how can we be so bad at treating dry eye, and what can we do about it? Our data suggest we are challenged with the same obstacles as every other practice. The issue lies somewhere between compliance and needing better treatments. Of patients who report compliance with the treatments we’ve prescribed, about two-thirds are satisfied, while that same portion is dissatisfied among non-compliers. The treatment perceived to be most effective is artificial tears (60% say they help), followed by warm compresses (35%). Patients taking omega-3 supplements are, not surprisingly, more likely to tell us they’re effective if they take more than 3 g per day. Among patients prescribed more advanced treatments, it’s not entirely fair to judge satisfaction because these patients have, by selection, more advanced, recalcitrant disease.

These sobering data tell me our specialty needs far more tools to combat this complex, multidimensional disease, which only gets worse with age. Restasis (cyclosporine ophthalmic emulsion 0.05%, Allergan) continues to be a valuable tool, and we’re optimistic about Shire’s lifitegrast once it is approved. We’re trying to figure out who are ideal candidates for treatments such as BlephEx, LipiFlow (TearScience) and intense pulsed light. And diagnostics such as MMP-9, osmolarity and Sjögren markers are slowly helping us understand patients and their problems better.

Our effectiveness in treating dry eye is akin to the way we treated cataracts in the early 1980s (before my time, mind you), when IOLs were implanted under air because viscoelastics hadn’t yet been invented and foldable IOLs were not yet even an idea. The future is exciting for this disease because we know so little and have so much to gain for our patients by expanding our offerings.

Disclosure: Hovanesian reports he is a consultant to Shire, Allergan, BlephEx and TearScience and has an equity interest in MDbackline.


The ‘glaucomatization’ of dry eye

January 11, 2016DrHovanesian No Comments »

Dry eye has a well-demonstrated course of disease, from mild visual disturbance with minimal symptoms during stress periods (wind, fatigue, dehydration) at a young age to greater symptoms and intolerance of ocular surface stress in middle age. This leads to more advanced visual impact with dropout and irreversible atrophy of tear producing glands in older age. Counterintuitively, many older patients actually have fewer discomfort symptoms when the disease is at its worst because of slow, progressive denervation of the ocular surface.

Maybe we pay less attention to the older patient with painless dry eye because we believe it needs no treatment. But let’s think about what got the patient to that point: years of inadequately treated ocular surface disease. If we are to be honest with ourselves, maybe we should treat dry eye like glaucoma. As more studies help us define the natural progression of dry eye in its various forms, and as new diagnostics help us objectively measure this progression, I believe our thinking about dry eye will become more proactive and glaucoma-like. Today, although the standard of care is still reacting to patients’ symptoms, maybe we should seek earlier intervention with asymptomatic or minimally symptomatic patients, prescribing treatment that is “one notch” more advanced than we would prescribe based on symptoms alone.

We all know how debilitating moderate to severe dry eye can be. If more aggressive early intervention can prevent that eventuality, don’t all of our patients deserve that?

Disclosure: Hovanesian reports that he consults for a number of companies that have products and services to treat dry eye.


Here’s to the corneal innovators

December 26, 2015DrHovanesian No Comments »

In this issue of Ocular Surgery News, our cover story focuses on the evolving understanding of the cornea as it relates to endothelial replacement surgery. I’d like to reflect on the incredible innovation that has led to these procedures.

About 10 years ago, I remember attending the very earliest meetings of the “Endothelial Keratoplasty Group” at the AAO and ASCRS meetings. This group, organized by the very young Mark Terry, would gather to discuss best methods for performing deep lamellar endothelial keratoplasty. Gerrit Melles had first described this technique in which surgeons use specialized scissors and dissectors to create a total corneal pocket and then remove the posterior one-third of the stroma, replacing it with a similarly dissected posterior disc from a donor cornea that would be tucked into this pocket. In those ugly, early days, we saw frequent cases of primary graft failure and donor dislocation, and we frequently converted to penetrating keratoplasty, the standard procedure of the day for endothelial replacement.

We performed all of these procedures under an IRB protocol to closely watch our results. When eye banks began providing precut donor disc tissue, particularly with laser-assisted cuts, the procedure became entirely more consistent than with hand-dissected donor tissue crafted on an artificial anterior chamber.

A big leap forward occurred when Melles next described Descemet’s stripping endothelial keratoplasty, in which only Descemet’s membrane was removed from the recipient tissue, and we learned that a donor disc of endothelium and thin stroma would stick itself to the inside of the cornea.

Today, we routinely perform Descemet’s membrane endothelial keratoplasty, in which only Descemet’s is transplanted, reducing further the complexity, trauma and tissue alteration of surgery. Frank and Marianne Price, another duo of incredibly devoted innovators, have shown us that this new procedure reduces rejection 10-fold and helped us all understand how to perform these procedures safely.

Although I’ve named a few here, I can’t possibly recognize all of the innovators who deserve credit for the evolution of these amazing procedures. With no industry sponsorship, they have transformed the lives of now hundreds of thousands of patients through the hands of corneal surgeons. It’s an inspiring bit of history that some of us have been lucky enough to observe first hand.

Disclosure: No products or companies that would require financial disclosure are mentioned in this article.