Eyeworld

EW NEWS & OPINION 27 July 2017 " We think that [patients who will benefit from this device] are glaucoma patients who doctors are losing sleep over because they're not sure what's going on. " —Holly Swain, OD this is just a piece of the puzzle, and we don't want the patients to be making any changes. We want the doctor to be making the changes." A pilot study evaluating the ease of use and accuracy of this device found that it seemed to record lower IOP levels, compared to GAT. 1 In the study, 39.5% of patients found Icare HOME "easy to use," 46.5% described its ease as "normal," and 13.9% said it was "difficult to use." A study of 60 patients that also com- pared GAT and Icare HOME found the latter device presented measure- ments within 3 mm Hg of GAT. 2 In this study, 10–16% of eyes revealed an IOP spike outside of what would be considered office hours, and 62% showed different IOP patterns from day to day. In a separate study, 18 normal tension glaucoma (NTG) patients had IOP measured with GAT and Icare ONE (an earlier iteration with the same technology as Icare HOME) at 2-hour intervals for a 24-hour period. 3 The researchers found that IOP spikes were more common during nighttime hours vs. daytime, and noted strong correlations in IOP measurements between the GAT and Icare ONE devices. "This study sug- gests that in patients with NTG with progression that is disproportionate to their clinic IOP measurements, 24-hour phasing can reveal higher IOP spikes than those identified during typical office hours." Icare ONE, the study authors wrote, could be a useful self-monitoring tool for these purposes. In pediatric glaucoma, a small study of patients who'd had pro- cedures to improve outflow found that the procedure did lower IOP and average IOP fluctuations. It also identified that there was a nearly 93% chance in catching a pressure spike in the study participants over a 14-day monitoring period. 4 Triggerfish (Sensimed, Lausanne, Switzerland), a wearable contact lens device with a receiver system for data, was approved in March 2016 by the FDA for 24-hour monitoring of glaucoma patients. Unlike Icare HOME, Triggerfish does not measure IOP in mm Hg directly; it measures changes in corneal-scleral shape, which correlates with tonometry. 5 Though FDA-approved, Sensimed CEO David Baily said in a state- ment last year that the company was developing and conducting a study that would establish the use of Triggerfish to predict IOP progres- sion and to establish ocular volume change as a biomarker for the treat- ment of glaucoma. Some of the recently published research involving Triggerfish includes a study that detailed how sleep position could affect IOP; research that showed nocturnal IOP peak patterns after medical washout in primary open-angle glaucoma patients, which did not change after selective laser trabec- uloplasty; and a study comparing IOP fluctuation in normal tension glaucoma patients and healthy subjects that suggested 24-hour IOP monitoring could help distinguish NTG glaucoma suspects. 5–7 Dr. Swain said that Triggerfish is a good option if the physician is looking for a continuous, 24-hour timespan of information. In con- trast, Icare HOME can take several days' worth of information—though not continuous—and is meant to be minimally disruptive to the patient's everyday life. Triggerfish is worn as a contact lens, a transmitter around the face, and a receiver around the neck, while Icare HOME can be car- ried around and takes 1 to 2 minutes to use, Dr. Swain explained. "I think [Icare HOME] would be less disruptive throughout [a pa- tient's] day, especially if they were to take it to work," Dr. Swain said. Other at-home IOP monitoring devices are currently in develop- ment, including an implantable sensor by Implandata Ophthalmic Products (Hannover, Germany), which received the CE mark in June, and another implantable device by AcuMEMS (Menlo Park, California). A recent systematic review of at- home IOP monitoring devices also mentioned the Tono-Pen (Reichert Technologies, Depew, New York), which requires a topical anesthetic and thus, Ittoop et al. wrote, is not typically suggested for at-home use, and the Proview Eye Pressure Monitor (Bausch + Lomb, Bridge- water, New Jersey), which the study authors wrote has shown poor correlation in studies with GAT and compared to Tono-Pen measure- ments. 8 Ittoop et al. concluded that with all of these new technologies—from implantable devices still in develop- ment to the at-home measurement devices recently gaining approval— a focus on bioinformatics and customized patient treatment "will become the standard of care for glaucoma." The authors acknowl- edged the challenges each new method of monitoring has but wrote that "with time, these challenges will be addressed and our patients will be offered a variety of options for 24-hour IOP monitoring." EW References 1. Noguchi A, et al. A pilot evaluation assessing the ease of use and accuracy of the new self/ home-tonometer Icare HOME in healthy young subjects. J Glaucoma. 2016;25:835–41. 2. Quérat L, et al. Monitoring daily intraocular pressure fluctuations with self-tonometry in healthy subjects. Acta Ophthalmol. 2017 Mar 14. Epub ahead of print. 3. Sood V, et al. Self-monitoring of intraocular pressure outside of normal office hours using rebound tonometry: Initial clinical experience in patients with normal tension glaucoma. J Glaucoma. 2016;25:807–11. 4. Bitner DP, et al. Long-term home monitoring of intraocular pressure in pediatric glaucoma. J AAPOS. 2016;20:515–18. 5. Mansouri K, et al. Efficacy of a contact lens sensor for monitoring 24-h intraoc- ular pressure related patterns. PLoS One. 2015;10:e0125530. 6. Beltran-Agulió L, et al. Twenty-four hour in- traocular pressure monitoring with SENSIMED Triggerfish contact lens: Effect of body posture during sleep. Br J Ophthalmol. 2017 Mar 7. Epub ahead of print. 7. Aptel F, et al. 24-hour intraocular pressure rhythm in patients with untreated primary open angle glaucoma and effects of se- lective laser trabeculoplasty. J Glaucoma. 2017;26:272–277. 8. Ittoop SM, et al. Systematic review of current devices for 24-h intraocular pressure monitoring. Adv Ther. 2016;33:1679–90. Editors' note: Dr. Swain has financial interests with Icare USA. Contact information Swain: holly.swain@icare-usa.com

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