Is there a standard of care for dry eye?
The field of DED is young and therefore still developing rapidly.
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Man, there has been some really weird stuff coming across my “desk” of late. Same with you?
It does not matter if we are talking about email, text or social media — the eye care world is tracking the craziness of the world at large, thank you very much. I am not sure about you, but legislation before both houses of Congress meant to bring liability relief to physicians of all kinds when it comes to care provided during the strict lockdowns sure seems like an important idea after seeing some of the madness that is fermenting out there.
The weirdest of the weird was a series of emails and social media posts declaring that a particular dry eye disease treatment was the standard of care (SOC). These posts directed you to a website set up by a law firm. There you found rather disturbing declarations that patients who have not been given this treatment were on the receiving end of care that might be medical malpractice. These sad souls were instructed to contact the law firm so that they might receive relief for the harm that had been done unto them due to the failure of their eye doctors to provide this SOC treatment. (I am purposely not sharing the URL or the product; the company that makes it has no association with the law firm and was appalled to learn about the website.)
Of course, this brings up the obvious question: What is the SOC in treating patients with DED? Let me take a stab at that, beginning with a declaration that I will then explain and support. There is no discrete SOC in the diagnosis and treatment of DED. Indeed, in some ways there are as many ways of treating the many varieties of DED as there are doctors doing the treating. To understand this, one must review what is (and what is not) SOC in the general sense and then briefly discuss the many acceptable pathways that doctors with experience follow when diagnosing and then treating DED.
A standard of care is generally defined as care that would be provided by reasonable physicians with comparable training when confronted with a particular disease state and similar circumstances. While there exists an implied “in the same general geographic region” sense when this comes up, there is not a consensus about the existence of “local” norms. SOC does not imply a single care pathway for a particular disease state. Rather, all care pathways that may be considered by the mythical “reasonable physician” would be SOC. For example, in my opinion, there are arguably three discrete tactics to prevent post-cataract surgery endophthalmitis that would all be considered within the SOC. As long as you apply Betadine to the eye preop, you can then use either topical, intracameral or intravitreal antibiotics and still be within the SOC.
Evidence-based medicine (EBM) is an interesting little offshoot of the SOC conversation. When we think of EBM, we think of science that has settled on a single way to handle a particular disease state. However, our recent experience with evidence regarding how to treat COVID-19 demonstrates the challenge of coming to an agreement on the evidence, let alone how we should interpret that evidence. Making matters worse, sometimes the best, most current evidence gets a bit out in front of the SOC for a particular disease state. Practicing on the cutting edge (“no drops ever” cataract surgery, for example) can land you in hot water if you get an established complication following surgery. This is even more problematic in jurisdictions where EBM may not be allowed as evidence in court (ironic, eh?).
Confusing the conversation about SOC even further is the concept of best practices, those things that would constitute ideal care for a particular disease state. The definition of SOC is specific in that it is the care that would be provided by a majority of “similar reasonable” physicians. A great example of this confounder is the brouhaha created when an American Academy of Ophthalmology publication quoted an academic retina specialist on the SOC when examining a patient with new floaters. This eminent physician naturally described the “best practices” of an examination in an academic retina practice, one that is vastly different from that performed more than 90% of the time by the general ophthalmologists and optometrists who see these patients first. Confusing or conflating SOC with “best practices” makes the conversation even harder.
So, what about DED? Why is there no SOC for the diagnosis and treatment of DED? The (sub)-subspecialty of DED care is simply too young, the research into the underlying pathophysiology still too sparse for us to be able to declare a single approach that we could call SOC. We have little consensus about basic diagnostic tests. Two of our most important prescription medications for DED were approved based on improving Schirmer test results in afflicted patients, yet few eye doctors do a regular Schirmer in the clinic. When we do, we do not even agree on how to do it. With or without anesthetic?
Corneal and conjunctival staining is a standard metric, yet we do not agree on the universal use of dyes beyond fluorescein. Lissamine green, yes or no? Do you use point-of-care testing, and if so, how frequently? Some very thoughtful doctors say POC testing is unnecessary. There is broad-based criticism of both tear osmolarity and MMP-9 testing. Do results in either constitute a driver for care? Again, even people who routinely do them cannot always state what one should do with the results (note: we are big POC testers at SkyVision).
Treating DED is equally controversial, perhaps more so. Does cyclosporine A work? Editorialists from both Dartmouth and University of California say no (the latter in a sensational opinion piece declaring all DED treatment regression to the mean). Most experienced DED doctors disagree and prescribe both available versions (Restasis from Allergan and Cequa from Sun). Likewise, the other immunomodulator, Xiidra (Novartis). There is strong sentiment in pockets of the dry eye world that it has too many side effects, while a majority of DED doctors feel that it is effective in most cases. And may I just say: steroids? There is a vigorous “yes or no” debate you have to work through before you ever get to “which one.”
When you move into device-driven treatments such as LipiFlow (Johnson & Johnson Vision), iLux (Alcon) and TearCare (Sight Sciences), or more hands-on treatments such as intense pulsed light and BlephEx (BlephEx LLC), the issue becomes further complicated by the fact that none are covered by health insurance; all are cash pay. Can you declare a treatment that carries a patient-borne cost as a mandatory part of the SOC?
For good reasons, there is no clear standard of care when it comes to diagnosing and treating DED in the U.S. The field is young and is therefore still developing rapidly. More practitioners are entering the arena and bringing with them new and novel ideas. Industry is continually bringing more and better diagnostic and treatment options. As time goes on, the science will doubtless coalesce around more tightly bound care experiences. Until then, the only SOC that now exists is this:
DED is real, and you cannot ignore it.
- For more information:
- Darrell E. White, MD, can be reached at SkyVision Centers, 2237 Crocker Road, Suite 100, Westlake, OH 44145; email: dwhite@healio.com.
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