Intraocular Pressure
Conditions
Brief summary
The goal of this clinical trial is to collect a comprehensive dataset of intraocular pressure values for developing a measurement algorithm for the new hand-held rebound tonometer device. The measurement algorithm shall fulfill the requirements of ANSI Z80.10:2014 standard. The study population is adults (age ≥ 18 years). The intraocular pressure of the participants will be measured with four different tonometers.
Interventions
DEVICEiCare IC1000
Measurement of Intraocular Pressure (IOP)
DEVICEiCare ST500
Measurement of Intraocular Pressure (IOP)
DEVICEiCare IC200
Measurement of Intraocular Pressure (IOP)
DEVICEGAT
Measurement of Intraocular Pressure (IOP)
Sponsors
Icare Finland Oy
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
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(s) * High corneal astigmatism >3D in the study eye(s) * Central corneal scarring * History of prior incisional glaucoma surgery or corneal surgery, including corneal refractive laser surgery in the study eye(s) * 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 * Cataract Extraction within last 2 months in the study eye(s)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Objective | Through study completion, an average of 4 months | The primary objective of this study is to measure wide range of IOP values with the new tonometer and three comparator devices. The IOP value's unit of measure will be mmHg. |
Countries
Slovenia
Outcome results
None listed