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New system offers practical method for treatment of meibomian gland disease
Meibomian gland disease, referred to synonymously as evaporative dry eye, is one of the most common causes of dry eye throughout the world. In fact, it is believed that while between 50% and 70% of older patients in our medical practices have at least some degree of dry eye, approximately 70% of dry eye involves at least some degree of meibomian gland disease.
Despite these numbers, the problem remains that the most effective treatment we know of — the use of warm compresses on the eyelids — is a practice many patients do not follow. Most doctors and patients agree that this method is successful because it applies heat to the meibomian glands, which are not flowing. The difficulty, however, is that patients do not stick with it, and that because we are applying heat from the outside of the eyelid, which is insulated from the glands themselves by the anterior lamella, the heat is dissipated by the time it reaches the gland.
Another method to make blocked glands flow again is to massage and squeeze them. Unfortunately, this is difficult for a patient to do on his or her own because of the amount of pressure needed, the lack of knowledge regarding the anatomy of the gland, and the potential damage to the external structure of the eye that could result from such applied pressure.
New forms of treatment
There are now several technologies being used in the field for the treatment of meibomian gland disease. They include the Maskin Meibomian Gland Intraductal Probe (Rhein Medical) and an off-label use of intense pulsed light, both of which probe the oil glands blocked in meibomian gland disease to help resume normal flow.
Our focus in this segment of State of the Art, however, is the U.S. Food and Drug Administration-approved LipiFlow Thermal Pulsation System (TearScience) and the accompanying LipiView Ocular Surface Interferometer. Unlike the other options, the LipiFlow system has been rigorously tested by the FDA for its efficacy and safety.
How it works
LipiView is the diagnostic portion of this pair of devices, designed to objectively look at the production of tears and how robust they are. It is designed to not only give doctors a view of who has genuine meibomian dysfunction, but also to give the patient an objective measure of how serious the problem is. The test, which takes less than 5 minutes, also gives the doctor a chance to follow therapy over time and measure its effectiveness.
The LipiFlow pulsation system is the therapeutic arm of the pair, used in a 12-minute in-office procedure under topical anesthetic. The device applies localized heat from the inside of the eyelid and then compresses the glands through programmed, pulsed pressure without putting pressure on the globe itself.
Because a premium practice largely centers itself on surgical procedures to enhance vision, there are several reasons these devices will be useful. It is well documented that even a mild degree of tear film instability, particularly in the meibomian gland, is disruptive to vision. Patients judge their surgical result based on their vision, regardless of whether the vision is affected by the lens implant, the refractive outcome or a dry ocular surface. So, we have to treat the whole patient, and these tools will allow us to do just that.
Payment
At this stage, there is no mechanism or coding system for these procedures to be billed to insurance, and they are likely to be considered non-covered benefits by commercial insurance and Medicare.
The out-of-pocket cost for treatment in both eyes will be nearly $1,000. This is a significant upfront investment from patients; however, when taking into account other factors, such as the amount of money patients invest in not just over-the-counter lubricant drops, but also in medications such as Restasis (cyclosporine ophthalmic emulsion 0.05%, Allergan) and AzaSite (azithromycin ophthalmic solution 1%, Inspire Pharmaceuticals), this is not as overwhelming a financial burden. The cost for these devices is not much higher, particularly if we can obtain at least several months of benefit.
In premium practices, the LipiFlow Thermal Pulsation System will likely be another welcome tool.
Conclusion
No treatment in the complex world of dry eye is going to be a panacea that relieves all symptoms completely. But we welcome to our armamentarium a treatment that has been shown to provide some long-lasting benefits in well-selected patients.
It remains to be seen how prolific the adoption of this technology will be, and as usual, that will depend upon how well it works. We have respectable but early-stage data at this point, and further studies are under way to help us understand the clinical application of these devices.
The implications for LipiFlow, if it works well and we can determine the best application of it, are large because of the looming public health problem that is meibomian gland disease, as well as the fact that there are few treatments for it. These devices are a welcome addition even as financial aspects and efficacy are fine-tuned.
John A. Hovanesian, MD, FACS, can be reached at Harvard Eye Associates, 24401 Calle De La Louisa, Suite 300, Laguna Hills, CA 92653; 949-951-2020; fax: 949-380-7856; e-mail: drhovanesian@harvardeye.com.
Disclosure: Dr. Hovanesian is a consultant and member of the medical advisory board to TearScience, the maker of LipiFlow.