Comparison of Intraocular Pressure Measurements Between Reichert Tono-Vera Tonometer and Goldmann Tonometry
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Reichert, Inc.
- Enrollment
- 61
- Locations
- 1
- Primary Endpoint
- Demonstrate compliance with ANSI Z80.10-2014-Ophthalmics-Ophthalmic Instruments-Tonometers.
Study Overview
Brief Summary
Determine if the Tono-Vera Tonometer accurately measures intraocular pressure (IOP). The hypothesis of this test is to confirm the Tono-Vera Tonometer is equivalent to the Goldmann Applanation Tonometer (within +/- 5.0 mmHg).
Detailed Description
The Tono-Vera Tonometer (Reichert, Inc.) is a portable rebound tonometer intended to measure IOP. Subjects will undergo a standard ophthalmologic examination. Subjects will then be measured with four tonometers: Goldmann Applanation Tonometer (C.S.O. SRL), Ocular Response Analyzer G3 (Reichert, Inc.), iCare ic100 tonometer (iCare Finland Oy), and Tono-Vera Tonometer.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Subjects must be male or female, between the ages of 18 and 90 years old;
- •Be able and willing to provide signed informed consent
- •Be able to follow study instructions
Exclusion Criteria
- •Subjects with only one functional eye;
- •Subjects with one eye having poor or eccentric fixation;
- •Subjects with central corneal thickness greater than 600 µm or less than 500 µm (about 2 standard deviations the human mean);
- •Subjects with corneal scarring or who have had corneal surgery, including corneal laser surgery;
- •Subjects with concomitant ocular diseases such as: microphthalmos, buphthalmos, nystagmus, keratoconus, severe dry eye syndrome, blepharospasm, any other corneal or conjunctival pathology or infection;
- •Contact lens wearers;
- •Known allergy to proparacaine or fluorescein as these are used to anesthetize the eye and allow IOP measurement, respectively, when used with the GAT.
Arms & Interventions
Goldmann Applanation Tonometer
Measurement of IOP with Goldmann Applanation Tonometer. All subjects will participate in this arm.
Intervention: IOP with Goldmann Applanation Tonometer (Device)
ORA G3 and ic100
Measurement of IOP with Ocular Response Analyzer G3 and ic100 tonometers. All subjects will participate in this arm.
Intervention: IOP with comparator ORA G3 and ic100 tonometers (Device)
Tono-Vera Tonometer
Measurement of IOP with Tono-Vera Tonometer. All subjects will participate in this arm.
Intervention: IOP with Tono-Vera Tonometer (Device)
Outcomes
Primary Outcomes
Demonstrate compliance with ANSI Z80.10-2014-Ophthalmics-Ophthalmic Instruments-Tonometers.
Time Frame: Through study completion, approximately 4 months.
Subjects will be distributed into Low IOP, Medium IOP, and High IOP groups based on Goldmann Applanation Tonometer measurements. The Tono-Vera Tonometer measurements will be within +/-5.0 mmHg of the Goldmann Applanation Tonometer measurements in all groups.
Secondary Outcomes
- Data collection for two measurement modes.(Through study completion, approximately 4 months.)
- Data collection for device calibration.(Through study completion, approximately 4 months.)