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Study Finds Icare HOME Device Offers Glaucoma Patients (Outside of US) Safe and Reliable Option for Self-Monitoring IOP at Home

Posted By Dr. Ari Weitzner On August 27, 2016 @ 10:47 pm In Glaucoma | Comments Disabled

While treatment decisions concerning glaucoma are based on in-office measurements of IOP, it is well-established that glaucoma patients can demonstrate a wide variability in IOP throughout a 24-hour period due to a variety of factors such as physical activity, nocturnal elevation, and body position (supine vs. erect). Accordingly, there is a need for safe and reliable options for 24-hour IOP monitoring, which will allow physicians to better understand the nature of their patient’s disease process and thus improve treatment regimens.

The August 2016 issue of Ophthalmology published the results of a study evaluating glaucoma patients’ use of the Icare HOME (TA022) device for self-monitoring IOP. While not all participants in the study were able to learn how to use the Icare HOME device, for those who were successfully trained, most were able to obtain accurate measurements similar to those obtained by Goldmann applanation tonometry. The study concluded that the Icare HOME device is a safe and reliable option for self-monitoring IOP with the potential to address the need for more frequent IOP measurements in a patient’s day-to-day life.

Click here [1] to access an abstract of the study.

The results of a separate study published in the August 2016 issue of the Journal of Glaucoma [2] concluded that the iCare ONE (a predecessor to the Icare HOME) is a safe, easy to use, and accurate device for identifying higher IOP spikes outside of office hours in patients with normal tension glaucoma with progression that is disproportionate to their clinic IOP measurements.

Finally, an article in the August 2016 issue of Advances in Therapy also offered a positive review of the Icare HOME device for self-monitoring IOP [3]. The article also reviewed two other option for 24-hour IOP monitoring – the Triggerfish (Sensimed AG) contact lens sensor (approved by the FDA for marketing in the US in March 2016 [4]), and EyeMate (an implantable intraocular device that is currently being vetted through human clinical trials [5]).

Unfortunately for glaucoma patients in the United States, in March 2016, Icare Finland Oy – manufacturer of the Icare HOME device – announced that the FDA declined to approve the Icare HOME for sale in the United States [6], though it is available for sale in all Europe, as well as Australia, Japan, South Korea, Brazil, Taiwan, Canada and China.


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URL to article: http://eyedocnews.com/007235-study-finds-icare-home-device-offers-glaucoma-patients-outside-of-us-safe-and-reliable-option-for-self-monitoring-iop-at-home/

URLs in this post:

[1] Click here: http://www.aaojournal.org/article/S0161-6420(16)30236-6/pdf

[2] separate study published in the August 2016 issue of the Journal of Glaucoma: http://journals.lww.com/glaucomajournal/Abstract/publishahead/Self_Monitoring_of_Intraocular_Pressure_Outside_of.98896.aspx

[3] positive review of the Icare HOME device for self-monitoring IOP: http://link.springer.com/article/10.1007/s12325-016-0388-4

[4] approved by the FDA for marketing in the US in March 2016: http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm489308.htm

[5] human clinical trials: https://clinicaltrials.gov/ct2/show/NCT02434692

[6] announced that the FDA declined to approve the Icare HOME for sale in the United States: https://globenewswire.com/news-release/2016/03/17/820684/0/en/Revenio-Group-Corporation-FDA-did-not-grant-sales-permit-for-Icare-HOME-in-the-US.html

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