The Icare HOME (TA022) Study: Performance of an Intraocular Pressure Measuring Device for Self-Tonometry by Glaucoma Patients.

PURPOSE

To evaluate the Icare HOME (TA022) device (Icare Oy, Vanda, Finland) for use by glaucoma patients for self-tonometry.

DESIGN

Prospective performance evaluation of a medical device.

PARTICIPANTS

One hundred eighty-nine participants with glaucoma or suspected glaucoma were recruited from the Wilmer Eye Institute, Baltimore, Maryland, between July 2014 and April 2015.

METHODS

Participants had standardized training and had to be able use the Icare HOME device independently. Subjects also had to be able to obtain the first intraocular pressure (IOP) measurement within 5 mmHg of Goldmann applanation tonometry (GAT). Those certified obtained 3 IOP measures using the HOME device, and these were compared with Icare TA01i and GAT IOP measurements.

MAIN OUTCOME MEASURES

The agreement between Icare HOME and reference tonometers was used to assess precision. The intraclass correlation coefficient was used to assess within-patient reliability for the HOME device.

RESULTS

Eighteen of 189 recruited patients were ineligible to take part in the study. Forty-four of 171 patients (25.7%) started but failed to complete the study: 7 stopped because of time concerns, 10 of 171 patients (6%) stopped because of difficulty using the device during certification, and 27 of 171 patients (16%) failed to be certified based on IOP. The HOME and GAT measurements agreed within 5 mmHg in 116 of 127 participants (91.3%); 2 participants (1.6%) had a difference of more than 7 mmHg. The mean difference between the Icare HOME and GAT measurements was -0.33 mmHg (standard deviation, 3.11 mmHg). The overall intraclass correlation coefficient for the HOME device was 0.92 (95% confidence interval, 0.89-0.95).

CONCLUSIONS

Not all participants could learn how to use the Icare HOME device, but for those who could, most were able to obtain measurements similar to those obtained by GAT. The Icare HOME device is safe and reliable for self-tonometry, but nearly 1 in 6 individuals may fail to certify in use of the device based on large differences in IOP when comparing GAT with the Icare HOME measurements. The device has the potential to address an unmet need by providing more frequent IOP measurements in a patient's day to day life.