This article is more than 5 years old. Information may no longer be current.
Stifling off-label discussions not conducive to patient care
It used to be a lot of fun to be a speaker at industry-supported dinner talks. Having the opportunity to travel the country, spread a little knowledge and break bread with my colleagues was a great experience. I left each meeting a smarter, better doctor, ready to bring back the clinical pearls that the audience shared with each other and with me. I would like to think that most of them felt the same way about whatever information I shared with them that evening.
While my partners and I continue to provide consulting services to companies that support our specialty, for which I am often compensated, I do not get out on the speaker circuit that much anymore. It is not that I no longer enjoy communing with colleagues outside of my hometown or even that I am having trouble watching my waistline with all that fine dining. It is just not as much fun anymore, for the speakers or the audiences, because the information that we are sharing is so much less functional (to steal a phrase from my CrossFit buddies). All that the U.S. Food and Drug Administration-approved, lawyer-vetted slide decks do is give us pretty pictures to go along with the package insert for whatever drug or device happens to be on the menu — like an illustrated PDA. Unless you are talking about a brand-new drug or device, everyone in the room already knows everything in the deck.
We used to talk about useful stuff, whether it was on-label or off-label. The best speakers told their audience exactly how they used a sponsor’s product, and if another company’s product was involved, that got mentioned, too. Some of the coolest stuff we do, the things that have a profound impact on our patients, their vision and their ocular health, comes from so-called off-label usage of medications that are FDA approved for something else. This is especially so in our dry eye syndrome/ocular surface disease (DES/OSD) world.
Off-label dinner conversation
Let’s pretend we are all sitting around a table, indulging in dinner at Le Steak and picking up our own tabs. We are free to discuss anything we would like. If you are reading this, you not only take care of DES/OSD patients, but you most likely also do anterior segment surgery, perhaps even refractive laser and cataract surgery. We have all had the unfortunate experience of performing stellar surgery, only to have a disappointed patient face us in the office postop because of an issue on the ocular surface. What can be done before surgery to maximize the chances that our visual outcomes will be as stellar as our surgeries were technically brilliant?
I think Bill Trattler, MD, deserves the lion’s share of credit for raising our collective consciousness about the importance of recognizing and treating DES preoperatively in both LASIK and refractive cataract patients. Using slides of preop corneal topography, Bill demonstrated the effects of dryness on our accuracy in preop measurements, especially in measuring corneal cylinder. Eric Donnenfeld, MD, and his associates presented data at the European Society of Cataract and Refractive Surgeons meeting in 2011 that showed an equally dramatic effect when evaluating higher-order aberrations before custom LASIK. Retaking the measurements after treating the eye with Blink Tears (Abbott Medical Optics) produced more accurate measurements and better postop vision. At SkyVision, we participated in a multicenter study looking at the effect of cataract surgery on tear osmolarity. In that study, we showed that regular, uncomplicated cataract surgery produced a significant increase in tear osmolarity in patients whether or not they were previously diagnosed with DES. It is obvious that we should all be looking at the ocular surface and trying to figure out how to optimize it before, as well as after, anterior segment surgeries.
There is not a single treatment that is FDA approved for the perioperative treatment of the ocular surface to improve visual outcomes, which is why you came to our “dinner.” Because I am not getting paid for this gig, I can share precisely what my group is doing to maximize visual results in LASIK, PRK and refractive cataract surgery, all off-label.
One practice’s protocols
Essentially, every surgical consult at SkyVision is also a DES consultation. Every laser refractive and refractive cataract patient undergoes a full ocular surface evaluation, including tear osmolarity. All patients with diagnosable dry eye begin aggressive therapy, according to our internal protocols. If a patient has a tear film abnormality associated with an elevated tear osmolarity, we begin treatment with Restasis (cyclosporine ophthalmic emulsion 0.05%, Allergan), continuing for a minimum of 6 months postop. Patients with OSD associated with meibomian gland dysfunction, especially those with a low tear osmolarity, are treated preoperatively, and often for a period postop, with AzaSite (azithromycin ophthalmic solution 1%, Akorn). Both groups of patients are strongly encouraged to take relatively high doses of marine omega-3 fatty acids (fish oil) and to continue doing so indefinitely.
Certain groups of patients begin treatment even if their preop evaluations are not particularly striking for dry eye because of what we know about the increase in dryness and the presumed decrease in tear effectiveness after anterior segment surgeries. We have found a meaningful improvement in the comfort and time to epithelial healing in PRK patients when they are treated with Restasis as well as the standard steroid/antibiotic/NSAID postop regimen. Likewise, we have noted a trend toward better Snellen vision and fewer complaints about vision quality when we do the same thing with patients who receive a multifocal IOL. Indeed, when we discontinue Restasis at the 6-month postop visit, we quite often have patients return with a measurable decrease in vision that is reversed by once again treating the ocular surface. Don’t forget: The bar is high when we are discussing visual outcomes in these patients, many of whom have invested a considerable sum in order to achieve high-quality uncorrected vision. Evaluating and treating the ocular surface is part of our perioperative protocols.
None of this will show up on-label in a talk, with or without pictures. The most important take-home from this is to remember the pre-corneal tear film when you are doing surgery. Consider treating not only those patients in whom you have a firm diagnosis of DES or OSD, but also those who may not achieve their hoped-for results as quickly if they develop symptomatic DES postoperatively. This is a good, solid, truly patient-centered approach to getting the best possible vision after laser refractive and cataract procedures. Plus, no one is going to have to file a “Sunshine report” if I pick up the tab.