Icare HOME Instruction Manual - page 22
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Icare HOME
• Medivac vehicles or similar where vibration or noise levels are so high that
theuser cannot hear error signals.
Environmental restrictions for lay operators (patients):
• Environments where noise is so high that the user cannot hear the error signals.
Mode of operation: continuous
18.1 CLINICAL PERFORMANCE DATA
Summary: A prospective, observational, multi-center clinical trial was conducted to assess the
safety of the Icare HOME tonometer and to determine the measurement agreement between
self-measured IOP with the Icare HOME tonometer and clinic-measured IOP by Goldmann
applanation tonometry (GAT) and by the Icare TA01i tonometer, as well as repeatability
(variability between measurements taken by the same operator and the same device) of the
Icare HOME tonometer compared to that of the other two methods. Performance goals for
agreement as found in ANSI Z80.10-2009 were used. 460 participants age 40 or older were
enrolled across five US sites and 385 eyes of 385 participants found to be eligible. Data from
376 eyes were included in the effectiveness analyses. All participants must have had a pre-
existing diagnosis of glaucoma or ‘glaucoma suspect.’ Participants were trained by study staff
as part of the certification procedure on how to use the Icare HOME tonometer. After a 10-
minute break, the participants were asked to make three self-measurements without any
direct supervision or interaction. Study staff then acquired three measurements on the Icare
TA01i tonometer, then an eye care professional took two GAT measurements (a third if the
first two were not within 2 mm Hg of each other). Other testing procedures included auto-
refraction, auto-keratometry, discomfort assessment using the Visual Analog Scale (VAS)
questionnaire, assessment of fluorescein staining of the cornea and Oxford scheme grading
of any corneal epithelial defects, and corneal pachymetry.
The mean difference and standard deviation (Icare HOME - GAT) were -0.53 mmHg and 2.43
mmHg, respectively. All ANSI performance goals were met as less than 5% of measurements
fell outside ± 5 mmHg at each pressure range and less than 1% fell outside ± 7.5 mmHg at
each pressure range. The HOME CV% was comparable for the low and medium IOP range
The serial number is located on the inside of the battery compartment cover.
The lot number of the probes is on the side of the probe box and the blister packing.
There are no electrical connections from the tonometer to the patient.
The tonometer has BF-type electric shock protection.
Operation environment:
Temperature: +10 °C to +35 °C
Relative humidity: 30% to 90%
Atmospheric pressure: 800hPa – 1060hPa
Storage environment:
Temperature: -10 °C to +55 °C
Relative humidity: 10% to 95%
Atmospheric pressure: 700hPa – 1060hPa
Transport environment:
Temperature: -40 °C to +70 °C
Relative humidity: 10% to 95%
Atmospheric pressure: 500hPa – 1060hPa
Environmental restrictions for professional use include:
Icare HOME tonometer Instruction manual for health care professionals
English
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Icare HOME
Icare HOME tonometer Instruction manual for health care professionals
English
(~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
Icare HOME tonometer Instruction manual for health care professionals
ENGLISH
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