EyeWorld India December 2018 Issue

EWAP FEATURE 15 Neurostimulation device helps patients produce their own tears by Vanessa Caceres EyeWorld Contributing Writer AT A GLANCE • TrueTear helps dry eye patients by providing neurostimulation. • Ophthalmologists have found that it can be used in a variety of dry eye patients, provided that they still have tear production. • Patients can adjust how often they will use the device to their own needs and to their dry eye severity. • Cost has been a barrier in the ability of TrueTear to reach more patients. Dry eye specialists adjust to the addition of TrueTear to their treatment toolbox D ry eye patients can have trouble find- ing treatments that alleviate their signs and symptoms. TrueTear (Allergan, Dublin, Ireland), which received marketing authorization from the U.S. Food and Drug Administration in April of last year, offers a unique option to help this patient group. Ophthalmologists are getting a handle on which patients are best suited for TrueTear, how to explain it, and how often they should use the device. How it works The TrueTear device provides low level neurostimulation via the nose. This sends an afferent signal via the ethmoidal branch of the ophthalmic division of cranial nerve V to the brain, said William Faulkner, MD, director, Scott E. Burk Urgent Eye Clinic, Cincin- nati Eye Institute, and voluntary assistant clinical professor, Depart- ment of Ophthalmology, University of Cincinnati. An efferent signal via cranial nerve VII results in stimula- tion of the lacrimal glands. “The re- sult is the production of physiologic tears with the delicate normal bal- ance of lipid, aqueous, and mucous components,” he said. This is all done by inserting the device in the nose for up to 3 min- utes at a time. The user can adjust the low-level voltage from 1 to 5. Instructions from the manufacturer recommend starting at 2. The concept of neurostimula- tion may be a new one for dry eye, but it’s not new in medicine, Dr. Faulkner said. Neurostimulation has been used for decades with chronic pain, post-herpetic neuralgia, com- plex migraines, peripheral vascular disease, obstructive sleep apnea, and other conditions, he said. John Sheppard, MD, presi- dent, Virginia Eye Consultants, Norfolk, Virginia, thinks that Tru- eTear will appeal the most to those who want a natural, homeopathic alternative. At the same time, they can use it synergistically as they continue other dry eye treatments, including artificial tears, punctal plugs, nutritionals, lid hygiene, thermal pulsation, and prescription medications. Patients who don’t want to use drops or who have trouble admin- istering drops—such as those with arthritis in the neck or hands—are potential candidates for TrueTear, Dr. Sheppard said. Patients with post-surgical corneal nerve injury, neurotrophic viral disease, or toxic exposure to preservatives may also lean on TrueTear for help, he added. Stephen Pflugfelder, MD, Baylor College of Medicine, Hou- ston, sees TrueTear as ideal for dry eye patients with episodic pain, particularly office workers who may find their eyes get more irritated as the day goes on. “It also can be for people traveling a lot or going into dry environments. It’s good for any aqueous tear patient who has the capability of responding to it,” he said. The device is not suited for patients with a cardiac pacemaker, a defibrillator, or another metal device in the head and neck, ac- cording to device instructions. 1 It is also contraindicated in those with chronic nosebleeds or a bleeding disorder. Is it effective? Before it entered the market, TrueTear efficacy was proven with two studies that showed how it increased tear production as meas- ured by Schirmer score compared with a control group. 2 Patient tear production was tracked for up to 180 days. There were only mild adverse events. A randomized, double-masked, placebo-controlled study that Dr. Pflugfelder helped lead found that the device helped to stimulate degranulation of goblet cells in the conjunctiva among 15 subjects. 3 In an unpublished study, Dr. Faulkner found that 71% of 28 pa- tients with moderate to severe dry eye had a favorable impression of TrueTear and rated it 6.92 on a scale of 1 to 10. Among the 28 patients, 25% bought the device immedi- ately; everyone in the study said they would consider purchasing it later. The patients in his study were not satisfied with their current dry eye treatments; 18% of the patients had been diagnosed with Sjögren’s syndrome. “Patient acceptance has been generally good for the moderate to Patient using TrueTear Source: William Faulkner, MD continued on page 16 December 2018