Optometric Physician



Vol. 23, #13  •   Monday, April 4, 2022


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

Want to share your perspective?
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.




Topical Review of the Relationship Between Contact Lens Wear and Meibomian Gland Dysfunction

Contact lens (CL) wearers often suffer from ocular discomfort, which leads to cessation of CL wear. About 30% to 50% of CL wearers complain of dry eye (DE) symptoms. Meibomian gland dysfunction (MGD) is considered the most common cause of evaporative DE. Numerous studies have investigated whether CL wear might affect the meibomian glands. This manuscript reviewed studies examining the relationship between CL use and MGD. A PubMed database search was conducted for studies published between 1980 and 2021, with one or a combination of search terms related to "meibomian gland," "meibomian gland dysfunction," "contact lens," and/or "dry eye."

Of the 115 papers reviewed, 22 articles were identified that examined the association between CL and MGD. Fifteen showed that CL wear affects the morphology and function of meibomian glands (MGs), while seven reported no significant impact of CL wear on MGs.

This review provided an overview of the studies, emphasizing diagnostic tests for MGD and conclusions. The review highlighted the need for longitudinal prospective large cohort studies with control non- CL wearers to clarify the ambiguous relationship between MGD and CL wear, with special attention to varying CL material and wear times in order to identify the long-term impact of CLs on MG.

SOURCE: Ifrah R, Quevedo L, Gantz L. Topical review of the relationship between contact lens wear and meibomian gland dysfunction. J Optom. 2022; Mar 26. [Epub ahead of print].




Automated vs. Human Evaluation of Corneal Staining

Researchers wrote that corneal fluorescein staining is one of the most important diagnostic tests in dry eye disease (DED), although the results depend on the grader. So far, they wrote, no commercially available method exists for automated quantification of corneal staining. The aim of this study was to develop a software-assisted grading algorithm and compare it with a group of human graders with variable clinical experience in patients with DED. Fifty images of eyes stained with 2µl of 2% fluorescein presenting with different severities of superficial punctate keratopathy in patients with DED were taken under standardized conditions. An algorithm for detecting and counting superficial punctate keratitis was developed using ImageJ with a training dataset of 20 randomly picked images. Then, the test dataset of 30 images was analyzed: 1) by the ImageJ algorithm; and 2) by 22 graders, all ophthalmologists with different levels of experience. All graders evaluated the images using the Oxford grading scheme for corneal staining at baseline and after 6 to 8 weeks. Intrarater agreement was also evaluated by adding a mirrored version of all original images into the set of images during the second grading.

The count of particles detected by the algorithm correlated significantly (n=30; p<0.01) with the estimated true Oxford grade (Sr=0,91). Overall human graders showed only moderate intra-rater agreement (K=0,426), while software-assisted grading was always the same (K=1,0). Little difference was found between specialists and non-specialists in terms of intra-rater agreement (K=0,436 specialists; K=0,417 non-specialists). The highest interrater agreement was seen with 75,6% in the most experienced grader, a cornea specialist with 29 years of experience; and the lowest was seen in a resident with 25,6% who had only two years of experience.

Researchers wrote that the variance in human grading of corneal staining, even if small, was likely to have only little impact on clinical management and thus seems to be acceptable. They added that, while human graders gave sufficient results for clinical application, software-assisted grading of corneal staining ensured higher consistency and was preferable for re-evaluating patients, e.g., in clinical trials.

SOURCE: Kourukmas R, Roth M, Geerling G. Automated vs. human evaluation of corneal staining. Graefes Arch Clin Exp Ophthalmol. 2022; Mar 31. [Epub ahead of print].



Corneal Epithelial Thickness Mapping in the Diagnosis of Ocular Surface Disorders Involving the Corneal Epithelium: A Comparative Study

The purpose of this study was to analyze the role of corneal epithelial thickness (ET) mapping provided by spectral-domain optical coherence tomography in the diagnosis of ocular surface disorders (OSDs) involving the corneal epithelium. This was a retrospective comparative study. The study population included 303 eyes with an OSD and 55 normal eyes (controls). Observation procedures included spectral-domain optical coherence tomography with epithelial mapping in the central 6 mm. Main outcome measures included ET map classification (normal, doughnut, spoke-wheel, localized/diffuse, and thinning/thickening patterns) and ET data and statistics (minimum, maximum, and SD). A quantitative threshold was determined with receiver operating curves to distinguish pathological from normal corneas. Sensitivity and specificity of classification and quantitative data were calculated using all eyes to assess the ability to distinguish corneas with a given corneal disorder from other conditions.

Classification of full agreement between three readers was obtained in 75.4% to 99.4% of cases. Main OSD features were keratoconus (135 eyes), doughnut pattern (sensitivity/specificity=56/94%), and max-min ET≥13μm (84/43%); limbal deficiency (56 eyes), spoke-wheel pattern (66/98%), and max-min ET≥14μm (91/59%); epithelial basement membrane dystrophy (55 eyes), inferior thickening pattern (55/92%), and central ET>56μm (53/81%); dry eye (21 eyes), superior thinning pattern (67/88%), and minimal ET≤44μm (86/48%); pterygium (10 eyes), nasal thickening pattern (100/86%), and nasal ET>56μm (80/71%); and in situ carcinoma (11 eyes), max ET>60μm (91/60%), and ET SD>5 μm (100/58%).

The epithelial map pattern recognition combined with quantitative analysis of ET was relevant for the diagnosis of OSDs and for distinguishing various OSDs from each other. Investigators wrote that deep learning analysis of big data could lead to the fully automated diagnosis of these disorders.

SOURCE: Levy A, Georgeon C, Knoeri J, et al. Corneal epithelial thickness mapping in the diagnosis of ocular surface disorders involving the corneal epithelium: a comparative study. Cornea 2022; Mar 31. [Epub ahead of print].






Industry News

New Dry-eye Treatment Approved

Olympic Ophthalmics announced the FDA granted 510(K) approval for the company’s second-generation iTEAR100 device, a prescription neuromodulation therapy to acutely increase tear production in adult patients over a 30-day period. Read more.






Luneau Launches as “Visionix”

Luneau Technology Group recently announced it will take on “Visionix” as its official global name beginning March 31, and unveiled a combined booth at Vision Expo East. “Optovue” will transition to a product brand for Visionix’s OCT and OCTA line. Read more.

Icare USA Introduces iCare HOME2

Icare USA announced FDA 510(k) clearance for its next-generation self-tonometer, the iCare HOME2, designed to provide additional ease of use in measuring patients’ real-world intraocular pressure outside normal clinic hours. A smart light guide and interactive display screen means most patients can utilize the iCare HOME2 on their own. iCare HOME2’s new design enables IOP measurements to be taken while the patient is supine, reclined and sitting. Learn more.

STAAR Announces FDA Nod of EVO Visian ICL Lens

STAAR Surgical Company announced FDA approval of the EVO/EVO+ Visian Implantable Collamer Lens for the correction of myopia and myopia with astigmatism. Earlier versions of the Visian ICL lens required a preoperative peripheral iridotomy, while EVO offers a lens-based alternative for the correction/reduction of refractive error in people who currently use glasses and/or contact lenses for distance vision correction. A U.S. multicenter, prospective clinical investigation confirmed the safety of the EVO family of myopia lenses. Read more.

Prevent Blindness Declares April as Women’s Eye Health and Safety Awareness Month, Elects Gunner to National Board of Director

Prevent Blindness declared April as Women’s Eye Health and Safety Awareness Month. A recent report, “The Lancet Global Health Commission on Global Eye Health: vision beyond 2020,” found a gender imbalance in which women are at higher risk of vision impairment and blindness than men can be attributed to demographic and social factors. Read more.
The group also announced Alan J. Gunner, vice president, Revenue Cycle Management, AEG Vision, was named to the Prevent Blindness board of directors. Read more.


















Journal Reviews Editor:
Shannon Steinhauser, OD, MS, FAAO

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