Intraocular Pressure
Conditions
Brief summary
Clinical validation of iCare IC1000 tonometer per ANSI Z80.10:2014 standard
Interventions
DEVICEiCare IC1000
Measurement of Intraocular Pressure (IOP) in sitting and supine position
DEVICEiCare IC200
Measurement of Intraocular Pressure (IOP) in sitting and supine position
DEVICEGAT
Measurement of Intraocular Pressure (IOP) in sitting position
DEVICEPerkins
Measurement of Intraocular Pressure (IOP) in supine position
Sponsors
Icare Finland Oy
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
Investigator cannot see the measurement results.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age ≥ 18 years
Exclusion criteria
* Subjects with only one functional eye * Subjects having poor or eccentric fixation in the study eye * High corneal astigmatism \>3D in the study eye * Central corneal scarring * History of prior incisional glaucoma surgery or corneal surgery, including corneal refractive laser surgery in the study eye * Microphthalmos * Buphthalmos * Contact lens use within one week of continuous wear and within one hour if lens is worn occasionally * Dry eyes (clinically significant) * Lid squeezers - blepharospasm * Nystagmus * Keratoconus * Any other corneal or conjunctival pathology or infection relevant to this study * Central corneal thickness greater than 600 µm or less than 500 µm in the study eye * Cataract Extraction within last 2 months in the study eye
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Demonstrate compliance with ANSI Z80.10:2014-Ophthalmics-Ophthalmic Instruments-Tonometers | Through study completion, an average of 6 months | Subjects will be distributed into Low IOP, Medium IOP, and High IOP groups based on the reference tonometer measurements. The iCare IC1000 Tonometer measurements shall be within +/-5.0 mmHg of the reference tonometer measurements in all groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Retrospective analysis of "Quick Measure" mode | Through study completion, an average of 6 months | The secondary objective of this study is to do a retrospective analysis of "Quick Measure" mode. Instead of 6 shots that are taken in Default Measure, Quick Measure takes only 2 shots (or 3 shots if the difference between the first two shots is greater than 2 mmHg). The Quick Measure results are calculated retrospectively from the raw data of the Default Measure results. Quick Measure comparison to reference measurements is done similarly as with Default Measure. |
Countries
Canada
Outcome results
None listed