Icare HOME Instruction Manual page 24

Icare HOME tonometer Instruction manual for health care professionals
Icare HOME tonometer Instruction manual for health care professionals
• High corneal astigmatism >3D in the study eye(s) based on their current refractive
prescription if available. Those without a prescription will undergo auto-refraction to
obtain Keratometry readings.
• Disabling arthritis or limited motor coordination limiting self-handling of the Icare
Home tonometer
• Lack of comprehension or willingness to use the tonometer as instructed
• Corneal scarring
• History of prior incisional glaucoma surgery or corneal surgery, including corneal laser
surgery in the study eye
• Microphthalmos
• Buphthalmos
• Contact Lens Use
• Symptoms of Dry Eye Syndrome and signs of dry eye on examination of cornea
• Known history of difficulty in obtaining Goldmann IOP measurements or any factors
that might contribute to inaccurate Goldmann IOP measurements (e.g. lid squeezing or
tremor)
• Nystagmus
• Keratoconus
• Any other corneal or conjunctival pathology or infection
• Central corneal thickness greater than 0.60 mm or less than 0.50 mm in the study eye
• Inability to demonstrate proficiency with Icare Home tonometer after training and
failure to complete certification procedures described in the attachment to this
protocol
• Cataract Extraction within last 2 months in study eye
Table 1 provides demographics of the completed eligible subjects and distribution of
intraocular pressures.
Table 1. Demographics of the completed eligible subjects and distribution of IOP.
Demographics
Age N
Mean (SD)
Min, Max
Gender Male
Female
Race Asian Indian
Black/African
American
Black/African
American,
American Indian
or Alaska Native
Black/African
American, White
Chinese
Chinese, Korean
Filipino
Filipino, Japanese
Japanese
Korean
Native Hawaiian
Other Asian
Vietnamese
White
Refused
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ENGLISH
Overall
383
66.1 (12.6)
35, 95
171 (44.6%)
212 (55.4%)
2 (0.5%)
70 (18.3%)
1 (0.3%)
1 (0.3%)
15 (3.9%)
1 (0.3%)
8 (2.1%)
1 (0.3%)
157 (41.0%)
9 (2.3%)
1 (0.3%)
5 (1.3%)
1 (0.3%)
108 (28.2%)
3 (0.8%)
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