The explosion of interest and research around dry eye disease and its root causes has led to a proliferation of device-based treatments.
Patients are increasingly interested in nondrug therapies for conditions in general, and eye care is no exception. Industry, patients and providers are always on the lookout for the next “paradigm shift.”
In July 2017, the Tear Film & Ocular Surface Society (TFOS) Dry Eye Workshop II (DEWS II) report was published. This extensive 2-year literature review resulted in a several-hundred-page report updating various aspects of the group’s landmark 2007 report.
In the classification of dry eye disease (DED), the report states that pathophysiology is a continuum in which both aqueous-deficient dry eye (ADDE) and evaporative dry eye (EDE) exist, and patients will have elements of both. Epidemiological and clinical evidence suggest that the preponderance of DED is evaporative in nature (EDE). ADDE affects lacrimal gland function, and EDE is recognized to include both lid- and blink-related causes (meibomian gland dysfunction) and ocular surface-related causes.
Our patients have ever-expanding choices for their cataract surgery, whether it be advanced IOL technology or the option of a laser procedure. The more they pay, the higher their expectations rise. This makes proactive ocular surface disease treatment vital. It cannot be overstated how important a healthy tear film is to accurate corneal measurements and preoperative biometry. When it comes to OSD, you must do your best to identify it and you must do your best to treat it so that patients receive the outcomes they demand.
Here’s an overview of some of the latest technology we have currently available to our practices. Pick your favorite game-changer and get started on your path to a more aggressive DED treatment strategy.
TrueTear (Allergan) is the first-of-its-kind neurostimulation device to increase the production of real tears. Used intranasally, the FDA-cleared product is indicated to provide a temporary increase of tear production in adult patients. It works by stimulating the trigeminal nerve, which, in turn, activates the entire lacrimal functional unit. The resulting tears contain meibum from the meibomian glands, aqueous from the lacrimal glands and mucin from goblet cell degranulation. The device’s efficacy was demonstrated in two clinical trials.
I have had success with the device in patients with moderate to severe DED who are taking anti-inflammatories or immunoregulators, as well as in those who are frequent users of artificial tears yet have some lacrimal function. The device consists of a rechargeable base and a disposable hydrogel tip. TrueTear launched at this year’s American Society for Cataract and Refractive Surgery meeting in Washington.
LipiFlow (Johnson & Johnson Vision) is an FDA-approved thermal pulsation system approved for the treatment of DED caused by meibomian gland dysfunction (MGD). LipiFlow applies localized heat to the meibomian glands to improve meibum mobility. The device uses adaptive pressure that cleans the glands without putting pressure on the globe. The procedure is done bilaterally in the office and takes about 12 minutes to elicit expression.
In multiple clinical studies, LipiFlow has been shown to significantly improve mean meibomian gland secretions and reduce mean dry eye symptoms to approximately half of the preprocedure level (Blackie et al., Greiner, Satjawatcharaphong et al.). LipiFlow has been used in 80,000 procedures since its launch. A study showed that one treatment of LipiFlow was as effective as 3 months of twice-daily lid warming and massage (Finis et al.). LipiFlow is a great option.
The FDA 510(k)-cleared iLux system (Tear Film Innovations) treats MGD using the application of light-based heat and compression under direct visualization. The eye care provider can view the eyelid margin through the magnifier, warm the eyelid tissue within a therapeutic range to melt meibum, then apply compression to the eyelid to express the meibum through the orifices. It can treat both upper and lower eyelids.
The rechargeable device is handheld and portable, so it is easily worked into the practice flow. It consists of sterile, single-patient-use disposable iLux Smart Tip with an inner and outer pad, a magnifying lens and one-button control of heating and compression. The precision temperature sensors continually monitor the temperature to maintain safe, therapeutic heat levels during treatment. The procedure is quick and efficient, with most patients being treated in 8 minutes or less. It is gentle, comfortable and, according to Tear Film Innovations, a great value for the practice and for patients.
The iLux clearance was based on a pivotal study of 142 patients at eight U.S. clinical sites. Patients had similar outcomes with the iLux compared to LipiFlow. The price, however, is reportedly one-third lower for iLux.
Intense pulsed light therapy (IPL) has been FDA-approved for more than 15 years to treat rosacea and remove superficial skin lesions, and it is commonly used in dermatology practice. Ophthalmologist Rolando Toyos, MD, originated the idea of using IPL in eye care after a series of DED patients presented in his office demonstrating improved tear film characteristics without any change in their treatment regimen; all had been treated for rosacea with IPL (Toyos et al.). Increasingly, IPL has been shown to have a positive effect on patients with MGD (Gupta et al., Craig et al.).
IPL is contraindicated in patients with darker pigmentation, it is a 10-minute procedure, and patients generally have four treatments separated by 4 weeks.
MiBo Thermoflo (MiBo Medical Group) is another technology for treating MGD as the root cause of DED. The device uses sustained thermoelectric heat delivered via a handheld probe, through the lid, to the meibomian glands. Heat at a temperature of 108 degrees is emitted from the probe, and a technician massages the patients’ lids to generate better meibum flow.
Users report good results in MGD and lipid-deficient DED patients and consider it an adjunct treatment option combined with traditional approaches. It is easy for staff to perform, economical and may be a practice builder. More frequent treatments may be necessary when compared to other strategies.
BlephEx addresses biofilms as a cause of DED. Biofilms are extracellular debris created by bacteria that accumulate on the lid margins and eyelashes. Once the bacteria multiples it becomes inflammatory, resulting in blepharitis. It has been suggested that some dry eye starts with lid colonization by bacteria and that biofilms have an important and under-recognized role.
Microblepharoexfoliation with BlephEx involves a rotary device with a soft sponge tip used together with a gentle eyelid cleanser to remove biofilms from the lid margins and lashes. The procedure only takes minutes in the office and can be performed by an optometrist or a technician. It may be complementary to LipiFlow, which has been shown successful in the patients with significant MGD.
No matter which of today’s new innovative strategies spark your interest, make sure you develop a consistent process to identify patients with ocular surface disease, use the appropriate diagnostics to categorize disease and then treat promptly. Identifying the root cause or causes of DED directs proper therapy selection.
Blackie CA, et al. Clin Ophthalmol. 2016;doi:10.2147/OPTH.S109663.
Craig JP, et al. Invest Ophthalmol Vis Sci. 2015;doi:10.1167/iovs.14-15764.
Finis D, et al. Ocular Surface. 2014;doi:10.1016/j.jtos.2013.12.001.
Greiner JV. Eye Contact Lens. 2016; doi:10.1097/ICL.0000000000000166.
Gupta PK, et al. Can J Ophthalmol. 2016;doi:10.1016/j.jcjo.2016.01.005.
Nelson JD, et al. Ocular Surface. 2017;doi.org/10.1016/j.jtos.2017.05.005.
Satjawatcharaphong P, et al. Optom Vis Sci. 2015;doi:10.1097/OPX.0000000000000670.
Toyos R, et al. Photomed Laser Surg. 2015;doi:10.1089/pho.2014.3819.