EyeWorld India June 2013 Issue

57 EWAP DEVICES June 2013 inflammatory dry eye. “The InflammaDry test is a single- use disposable test that can be performed by a technician or a medical assistant,” he said. Since the patient does not need to leave the exam room to be tested with an external device or wait for an electronic device to be brought into the workup room, it can easily be administered before the physician comes in to see a patient. It also offers a quick turnaround for results, taking less than 30 seconds to perform and only about 10 minutes to produce results. “It’s a proven technique that’s easy to use to collect a small tear sample, and in a dry eye patient, it can be difficult to collect more than a small sample,” Dr. Sambursky said. “Since it’s looking for an inflammatory protein produced throughout the lacrimal system, there’s no risk of result variability problems associated with reflex tearing.” The InflammaDry test checks for the presence of MMP- 9, which is a “biomarker that is specifically elevated in patients who have dry eye,” Dr. Sambursky said. Elevated levels of MMP-9 have been shown to correlate with symptoms of dry eye and may be a more sensitive diagnostic marker for dry eye than clinical signs. Dr. Lane highlighted the importance of TearScience’s LipiView and LipiFlow technology. LipiView is the diagnostic device, while LipiFlow is the treatment device. He said the LipiView provides a great deal of information so doctors can see what a patient’s tear film looks like. “We have a new modality to look at the true function of the tears by measuring lipid layer thickness. But even more than just looking at the thickness of the lipid layer on the cornea, we can actually see how the patient blinks and what the response is in terms of coverage of the cornea.” Treatment and how the devices can help doctors manage dry eye These types of tests, Dr. de Luise said, “give the ophthalmologist a quantitative parameter to measure,” which he said can help to diagnose and treat dry eye. Treatment depends on the severity of the dry eye. For patients with mild dry eye, non-preserved artificial tears and ointment or dietary changes may be part of the remedy. Meanwhile, moderate dry eye may call for the use of topical Restasis (cyclosporine, Allergan, Irvine, Calif., USA) or “the reduction of the inflammatory component of dry eye with short courses of ‘soft’ topical corticosteroids, pulses of topical azithromycin, and consideration of punctal plugs,” he said. Finally, severe cases of dry eye may require a combination of all possible treatments. Dr. Sambursky said that the InflammaDry test guides therapy and treatment options. “It’s a true point in the management plan where you can decide which direction to move from a therapeutic regimen,” he said. Dr. Sambursky said if symptoms are consistent with dry eye and inflammation, then treatment may include anti-inflammatory agents. Or if there is dry eye with no inflammation, options may be artificial tears or punctal plugs. Meanwhile, the LipiFlow provides a treatment option that is very proactive, Dr. Lane said. “I think the LipiFlow offers, for the first time, a true device for the treatment of meibomian gland dysfunction.” MGD is thought to be one of the leading causes of dry eye disease, and Dr. Lane said LipiFlow provides a way to reset the meibomian glands. To do this, the LipiFlow device uses heat that helps to melt the secretions within the meibomian glands while at the same time providing gentle pulsating pressure. This effectively evacuates the secretions that have built up. Availability and who pays for these devices Dr. Lemp said the TearLab Osmolarity System is reimbursable through Medicare. Private companies also offer reimbursement for it, although they would have to come to their own agreements. He described the test as having a “razor/razorblade relationship” with doctors being able to buy one or more machines and disposable testing cards. He said the TearLab product is currently available in the U.S. and Europe, with an FDA clearance and a CE mark. Dr. Sambursky said that the InflammaDry test is approved for use in Canada, as it has Health Canada approval. It also has the CE mark in Europe. The device is not currently available in the United States, but it is undergoing FDA 510(k) trials, Dr. Sambursky said. “We have successfully, at this point in time, enrolled two thirds of the patients required for completion of the study, and we find the data extremely optimistic.” Dr. Sambursky said that he could not presently talk about what the cost and reimbursement for the product will be until InflammaDry becomes FDA approved. However, he said the clinician or end user would buy a box of disposable test kits, which would come with 10 individual tests and do not require a separate machine. “They would use the tests and submit that for reimbursement,” he said. Dr. Lane said that there is an out-of-pocket cost for LipiView and LipiFlow. “Payment for the LipiFlow and the LipiView is not covered by insurance,” he said. For this reason, he said it’s very important to make it clear to the patient in the discussion of treatment that this is not something that will be covered. However, Dr. Lane said this treatment option provides an efficacious and safe way of treating dry eye. “When patients have suffered from this for years and years, they’re more than happy to pay for the treatment.” The TearScience LipiView and LipiFlow are approved for use in the United States, as well as many other locations worldwide. Other necessities for dry eye care “Dry eye care requires the ophthalmologist to take a good history from the patient,” Dr. de Luise said. In addition to patient history, “doing a good eye exam, including evaluation of visual acuity, tear film breakup time, tear meniscus height and quality, conjunctival and corneal vital dye staining with lissamine green and fluorescein” is important, Dr. de Luise said. He said that doing quantitative tests combined with newer technologies can be very beneficial for dry eye treatment. EWAP Editors’ note: Dr. de Luise has no financial interests related to this article. Dr. Sambursky has financial interests with RPS. Dr. Lane has financial interests with TearScience. Dr. Lemp has financial interests with TearLab. Contact information De Luise : vdeluisemd@gmail.com Lane : sslane@associatedeyecare.com Lemp : malemp@lempdc.com Sambursky : robsambo@yahoo.com