Not on the Same Page

The draft FDA guidelines around LASIK are causing concern within ophthalmology circles, so we invited a group of refractive experts to share their reaction to the proposals. Here, Cathleen McCabe, Eric Donnenfeld, and John Hovanesian, explain how the FDA is understating the benefits of LASIK and why the regulators – who share many of the same goals as doctors – should reassess the information they are presenting to patients.

Meet the Experts
 

Cathleen McCabe is a cataract and refractive surgeon practicing in Sarasota, Florida, offering LASIK and refractive correction to patients across the country. Eric Donnenfeld has performed over 100,000 laser vision correction procedures and was an initial investigator of the VISX laser ahead of its FDA approval in 1995. John Hovanesian is an ophthalmologist who has focused on refractive surgery for over 25 years. He is a member of the teaching faculty at UCLA and has a primary practice at Harvard Eye Associates in Southern California.

What are your initial thoughts on the FDA’s draft LASIK guidelines?
 

McCabe: It’s unfortunate how little attention is given in the draft guidelines to how well patients do with LASIK – especially considering the patient reported outcomes in the FDA PROWL-1 study in 2017. That study showed that patients are very happy with the results of LASIK surgery – it has one of the highest satisfaction rates of any elective procedure. Only a small proportion of patients reported any new problems – less than 10 percent – and only around four percent complained of bothersome post-surgery symptoms. That’s a very low side-effect profile for a procedure offered to patients electively.

Donnenfeld: LASIK is both safe and effective for those who are good candidates – a fact the FDA has reaffirmed repeatedly and further substantiated in the 2017 PROWL study.  As a surgeon, I find the guidelines very one-sided. LASIK has a more than 96 percent satisfaction rate and a 25-year track record, but the 25-page FDA document features very little information on the benefits of LASIK. So, though we share the FDA’s goals, we don’t believe the current draft of the guidelines is an appropriate or effective mechanism for educating patients about the LASIK procedure.

Hovanesian: I’d go a little further and say that the guidelines represent a significant overreach that is outside the scope of duty and authority of the FDA. They misrepresent the benefits of the procedure, which are very well documented. Compared with alternatives like contact lenses, LASIK surgery has been proven to be considerably safer and less likely to cause significant complications. Any guidance document should be balanced, with a discussion of the benefits alongside the risks. The reason LASIK is so popular is because the procedure is simple and it works, providing spectacle freedom for the vast majority of patients.

Did you take part in the consultation process for FDA proposed guidelines?
 

McCabe: In one of my roles, I’m Chair of the Refractive Surgery Clinical Committee for the ASCRS. So, in that capacity, I have been monitoring the process and carefully scrutinizing the draft. I was surprised to learn that, after the FDA closed the window for public responses, another 200 responses had been logged!

Donnenfeld: As part of the ASCRS Refractive Surgery Clinical Committee – and as a member of the Refractive Surgery Council – I have made inquiries through these organizations. I have not, however, been in direct contact with the FDA; notably, the agency has not provided information regarding the experts with whom it consulted.

A loaded question: Would you like to see more space given to the positives of LASIK in the draft guidelines?
 

McCabe: Speaking for refractive surgeons – and for ophthalmologists more generally, I’d say that we are extremely committed to clear and accurate communication with patients about the benefits and risks of everything we offer – not just refractive surgery. Part of the responsibility of being a physician is educating our patients so they can be actively involved in deciding on the best course of medical care. Education is fundamental to ensuring that patients are informed, but this doesn’t mean overloading the patient with information that may not be relevant. If a patient wants to be free of glasses, for example, we talk about the different ways this can be achieved, but we make sure to do this with a focused and tailored approach. My major problem with the guidelines is that they paint with a very broad brush that doesn’t actually pertain to the vast majority of patients.

In only mentioning risks, the document doesn’t offer a balanced risk–benefit ratio, which is how I would approach it when talking with a patient. It is also a static document that doesn’t correlate with how I actively deal with patients and absorb information as medicine evolves. For example, if I had a LASIK candidate today, I would counsel that patient very differently to a patient with a similar profile from back in 2000 – when we didn’t know as much about what we needed to look at in terms of corneal topography or optimizing refractive outcomes.

Would you agree that patient expectations are higher in a world where refractive techniques are more sophisticated?
 

McCabe: Absolutely – and this is also true for cataract surgery. As we get more predictable results, patients see and talk about the overwhelmingly positive outcomes. When the vast majority of patients are free from wearing spectacles, it’s no surprise that expectations increase! The good news is that, as more new techniques and innovations come to light, refractive surgeons are able to meet those expectations. When I started, LASIK was relatively new and we had patients with high expectations even back then. Since then, we’ve only gotten better and better.

Donnenfeld: One of the misconceptions about LASIK is that the procedure has not improved over the past 25 years. Thanks to improvements in technology – including prolate ablation patterns, wavefront and topographic ablations, and pupil, cyclotorsion, and centroid shift tracking – the results are dramatically better today. Patient expectations have become higher and technology has risen to the occasion to meet and often exceed expectations. Since the FDA began its post-market study of patients’ quality of life after LASIK in 2008, there have been significant advancements in LASIK – all of which create opportunities to educate patients about the clinical reality of the procedure today.

Patients with high expectations coming into the consult are typically only informed by what their friends and family have told them about their experiences – which may or may not be recent. Ensuring that patients have a clear understanding of what LASIK can and cannot do for them is essential.

How do you manage the side effects when they do occur?
 

McCabe: Let’s be clear, LASIK is a surgical procedure and – as with all other surgical procedures – there are risks as well as benefits. Surgeons don’t want to minimize the risks – even if they do not often occur – because that is the very basis of informed consent. The goal of the FDA is to help ensure there is accurate and clear communication between physicians and patients. And that is exactly what ophthalmologists want too! The goal is the same, but the vehicle for achieving the goal has to be effective.

Halos and dry eyes are the most common side effects of LASIK because they are the biggest risks. But the FDA guidelines include so many things that are so highly unlikely, it makes them confusing and not appropriate for every patient. The document could well harm communication more than helping it. Modern treatment actually improves some of the preoperative phenomena we see. For example, dry eye could occur from contact lens tolerance – getting rid of contact lenses in that case would be a more effective dry eye treatment.

Donnenfeld: The draft guidance appears to be predicated on relatively outdated research and clinical experience. With today’s advanced LASIK technologies, techniques, and diagnostics, the majority of side effects are effectively managed. There are prescribed medications to help the few patients who do experience symptoms in the post-operative recovery and healing process. In very rare circumstances, patients have lingering or severe symptoms that require additional treatments and therapeutics. LASIK has been clinically proven to have a lower risk of infection than contact lenses (1). And a well-designed clinical study found LASIK significantly reduced night driving difficulties in former contact lens wearers (2). In summary, the LASIK risk profile is exceptionally low. That said, both the general and specific risks of LASIK for any given patient should be thoroughly discussed along with the assurance that they will be well supported throughout treatment and recovery to achieve the best outcome possible.

Hovanesian: However successful, any surgical procedure has some risks, but the FDA’s over-representation of the risks of LASIK actually poses a public health hazard – namely, the risk that patients who are contact lens intolerant will continue to wear contact lenses. These patients, who could have a very satisfactory outcome with LASIK, will put their eyes at significant risk of permanent damage from contact lens-induced corneal infections.

How should patient communication about the risks of LASIK change?
 

McCabe: I think this is an individual doctor question. There probably are circumstances where the consent is not complete or as informed as we would like it to be. Not every doctor has the same level of communication skills, so having vehicles that facilitate communication can really level the playing field. I think improvement is always possible; doctors are generally enthusiastic about learning and developing in all areas and this is true for our communication skills. Again, the goal of refractive surgeons and the FDA is the same, but we depart from the FDA guidelines as they are currently written because they do not seem balanced in some ways or accurate in others.

The guidelines want industry to be involved in the patient–doctor conversation, but this is not really the place for industry to be. What is important is the relationship of trust that exists between physicians and patients – we don’t need to have industry or the FDA making that more difficult.

Donnenfeld: Patient education is taken very seriously. Collectively, we invest in creating a variety of channels and formats to support patients in their journey. In addition to visits, calls, and our own websites, the Refractive Surgery Council and the AAO offer patient-facing resources for people doing their own independent research. Can we do better? Sure. But we have to acknowledge the extraordinary work that is already being done by many in refractive surgery to make sure patients have access to the latest information about their vision correction choices. Our hope is to work with the FDA to address the imbalance in the draft guidelines and ensure its final content reflects the current clinical reality of LASIK today so that, perhaps, it can be a useful educational tool for patients in the future.

Hovanesian: Of course, all responsible surgeons are in favor of the public receiving accurate information about surgical procedures. But accurate information must include all the facts about benefits as well as risks. Studies have demonstrated that LASIK surgery has a very high safety profile and a high rate of satisfaction. It has been performed around the world safely for over 25 years. To be blunt, the safety record speaks for itself. In my opinion, no significant changes or regulations are needed to better inform the public about the safety of LASIK surgery – if a patient is not a suitable candidate, we don’t offer them the procedure – no matter how motivated they may be.