Off the Cuff: RF Treatment for Dry Eye: Don’t Get Burned

About a year ago, a very persistent rep finally got his chance to pitch his company’s latest RF device for dry eye. He explained that they had identified me as a leading dry eye expert and they very much wanted me to be part of their team. My interest piqued, I asked him to tell me more.

He explained that his device was originally introduced for esthetic treatments using radio frequency to generate controlled levels of penetrating heat to tighten skin and stimulate production of collagen and elastin. He added that they had found that it was extremely effective at treating MGD and offered a basic overview of how it worked. As it turns out, I have a reasonably strong background in physics and specifically in RF. I’ve held the highest-class FCC radio license for over 40 years and was headed for a degree in electrical engineering. My experience with RF has been up close and personal, designing, building and repairing RF devices. I still have burn scars to remind me of several close encounters. Different implementations of technology, but the sting remains.

I asked the rep to explain how his unit worked for MGD and why I should consider adding it to my therapeutic armamentarium. He vacillated between sharing glowing reports from colleagues and the esthetic benefits of his unit. I asked how it was better than the devices that I already had, all of which were FDA-cleared or -approved, but all he could do was redirect to the esthetic benefits. Realizing our meeting was quickly coming to an end, curiosity got the better of me, and I asked what his device would cost. When he told me that my “special price” was over $100,000 I laughed out loud. That was the last I saw of him. Since then, what continues to perplex me is how enamored many of my colleagues are by RF devices.

Even though modern RF units are generally safe, safety still remains a consideration. Incorrect settings, operator error and variable patent treatment response make an eventual adverse outcome likely if not inevitable. The medicolegal consequences are made worse as RF devices are cleared for esthetic, not ophthalmic, use. Unless your state board either explicitly or by intentional omission allows esthetic treatments, RF use is likely outside your scope of practice. Not only could this prompt optometry board action against you, but it could trigger medical board action for practicing medicine without a license. Worse yet, many malpractice policies specifically exclude procedures or treatments outside of practice scope, potentially voiding coverage.

Taking it a step further, if this ends up in litigation, the availability of FDA-cleared devices specifically designed for MGD treatment by heating and expression and the more recent FDA approval of Lumenis’ OptiLight for the management of dry eye would not play well with a judge or a jury and would make off-label use of a device cleared for skin tightening even more difficult to justify. I have also been unable to locate a single refereed scientific article that examines the role of RF treatment of MGD.

The bottom line is that there are cleared and approved devices with strong scientific support for managing MGD and related dry eye. Use of off-label devices may create significant and unnecessary risk. So, if you are considering or using RF for MGD treatment, be careful you don’t get burned.

Editor’s Note: It is with great sadness I note the passing of my friend and colleague William Joe Benjamin. Joe was one of the quiet giants in our profession. An academic by nature with an especially keen mind, he didn’t seek accolades, he sought to make the profession, our patients and our world better. I recall a conversation when we first met years ago. He had just accepted the editorship of the 2nd edition of the seminal Borish’s Clinical Refraction text. I was contemplating writing a book on corneal and anterior segment disease at the time. Joe, who I just met, immediately offered encouragement and advice. The man had no façade, just a gentle kind nature that came through every time you met him. It is often said that we stand on the shoulders of giants. William Joe Benjamin was such a giant. Our sincere condolences to his wife, Pat, his son, Daniel, and his family.

 

 

Arthur B. Epstein, OD, FAAO Chief Medical Editor artepstein@optometricphysician.com

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Write to Dr. Epstein at artepstein@optometricphysician.com. The views expressed in this editorial are solely those of the author and do not necessarily represent the opinions of Jobson Medical Information LLC (JMI), or any other entities or individuals.