Comparison of Intraocular Pressure Measurements Between Reichert Tono-Vera Tonometer and Goldmann Tonometry

Glaucoma Clinical Trial

Official title:

Comparison of Intraocular Pressure Measurements Between Reichert Tono-Vera Tonometer and Goldmann Tonometry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04360369
• Other study ID #: 16305-TPR-28
• Status: Completed
• Phase: N/A
• Start date: October 19, 2020
• Est. completion date: April 28, 2021

Study information

• Verified date: December 2021
• Source: Reichert, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: April 28, 2021
• Est. primary completion date: April 28, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma
• Intraocular Pressure

Intervention

Device:
• IOP 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).
• IOP with comparator ORA G3 and ic100 tonometers
Measurement of IOP with Ocular Response Analyzer G3 and ic100 tonometers.
• IOP with Tono-Vera Tonometer
Measurement of IOP with Tono-Vera Tonometer

Locations

Country	Name	City	State
United States	Department of Ophthalmology, Duke University	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Reichert, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Demonstrate compliance with ANSI Z80.10-2014-Ophthalmics-Ophthalmic Instruments-Tonometers.	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.	Through study completion, approximately 4 months.
Secondary	Data collection for two measurement modes.	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.	Through study completion, approximately 4 months.
Secondary	Data collection for device calibration.	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.	Through study completion, approximately 4 months.