Icare HOME Instruction Manual page 23

Icare HOME tonometer Instruction manual for health care professionals
Icare HOME tonometer Instruction manual for health care professionals
(~10% for each bin) and smaller for the high IOP range (~7.5%). No adverse events
(including corneal abrasions) were recorded in this study population of 383 eyes. Only
certified users were able to proceed to self-testing. A failure rate of 10.7% of the training/
certification was found in a large clinical study. Self-testing was limited to a single session
10 minutes after certification.
Methods: This study aimed to determine the agreement between the self-measured IOP
(full simulated home use by the patient) using the Icare HOME tonometer and the clinic-
measured IOP using GAT, as well as between the Icare HOME and the FDA-cleared Icare
TA01i tonometer. The study further aimed to assess the precision of the Icare Home
device compared to GAT and the Icare TA01i tonometer, and to record and analyze
individual patient complaints as well as clinical observations of corneal epithelial defects
or other adverse events (AEs) when using the Icare HOME self-tonometer. The study was
designed according to ANSI Z80.10 "Ophthalmic Instruments – Tonometers". Only one eye
from each subject was enrolled into the study. Where both eyes were eligible, the eye with
higher pressure on the last two clinic visits was used. If the pressure was equal in both
eyes, then a random assignment of the right or left eye was used.
Results: Subjects were recruited at five study sites. 10.7% (49/460) of subjects were
unable to demonstrate proficiency with the Icare Home tonometer after training and
failed to complete the certification procedures described in the protocol. The reasons for
failing certification were: three Home readings differed by > 7mmHg (0.7%), the first
Home reading and the GAT measurement differed by > 5mmHg (6.3%), subject requested
to stop, (0.7%), and subject unable to use the device (3.0%). As a result, the Icare HOME
labeling includes the same training and certification procedures described in the protocol
for the patient to be eligible for home-use of the tonometer. Among the 383 subjects who
completed the series of validation measurements, 376 (98.2%) were included in the
effectiveness analyses. Seven subjects were excluded from the effectiveness analysis per
the pre-specified reasons in the study protocol (i.e. less than three Home IOP
measurements being acquired and the series of GAT measurements demonstrated too
much variability).
Inclusion criteria were as follows:
Patients with pre-existing diagnosis of "glaucoma" or "glaucoma suspect" in the study
eye(s):
• Glaucoma suspects will include patients being followed for elevated IOP, for risk
factors for developing glaucoma, or for possible optic nerve damage.
• Glaucoma patients will have confirmed optic nerve damage with visual field loss
consistent with glaucomatous optic neuropathy.
Exclusion criteria were as follows:
• Age < 40 years
• Uncorrected Near Visual Acuity (UCNVA) of 20/200 (binocular)
• Subjects with only one functional eye
• Subjects having poor or eccentric fixation in the study eye
• Hearing impaired to the extent that the individual cannot hear and converse with others
without an assistive aid and/or sign language
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