Glaucoma, Intraocular Pressure
Conditions
Keywords
Tonometry, Ocular
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.
Interventions
DEVICEIOP with Goldmann Applanation Tonometer
Measurement of intraocular pressure (IOP) with Goldmann Applanation Tonometer. Measurement will be used to categorize each subject as having Low IOP (7 to 16 mmHg), Medium IOP (\>16 to \<23 mmHg), or High IOP (\>23 mmHg).
DEVICEIOP with comparator ORA G3 and ic100 tonometers
Measurement of IOP with Ocular Response Analyzer G3 and ic100 tonometers.
DEVICEIOP with Tono-Vera Tonometer
Measurement of IOP with Tono-Vera Tonometer
Sponsors
Reichert, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
All study-related tests will be conducted in a single stage, with one clinical visit, to a single clinical center.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Demonstrate compliance with ANSI Z80.10-2014-Ophthalmics-Ophthalmic Instruments-Tonometers. | 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
| Measure | Time frame | Description |
|---|---|---|
| Data collection for two measurement modes. | Through study completion, approximately 4 months. | Tono-Vera has two measurement modes: A 6-measurement mode & Quick measurement mode. The 6-measurement mode will be used during this study. It will be possible to post-process the results to determine the IOP value that would have been obtained using Quick mode. As such the sponsor will be able to ensure the accuracy of both measurement modes compared to Goldmann Tonometry. |
| Data collection for device calibration. | Through study completion, approximately 4 months. | The study will collect data on a large number of patients over a wide range of IOP values. The sponsor may use the collected data in a post-hoc analysis to verify that the Tono-Vera Tonometer factory calibration is optimal. |
Countries
United States
Outcome results
None listed