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

Not Applicable

Completed

• Conditions: Intraocular Pressure; Glaucoma
• Interventions: Device: IOP with Tono-Vera Tonometer; Device: IOP with comparator ORA G3 and ic100 tonometers; Device: IOP with Goldmann Applanation Tonometer

• Registration Number: NCT04360369
• Lead Sponsor: Reichert, Inc.

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 Timeline

• Study First Submitted: 2020-03-16
• Study First Submitted QC: 2020-04-21
• Study First Posted: 2020-04-24
• Study Start: 2020-10-19
• Primary Completion: 2021-04-28
• Study Completion: 2021-04-28
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-30
• Last Update Posted: 2022-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Tono-Vera Tonometer	IOP with Tono-Vera Tonometer	Measurement of IOP with Tono-Vera Tonometer. All subjects will participate in this arm.
ORA G3 and ic100	IOP with comparator ORA G3 and ic100 tonometers	Measurement of IOP with Ocular Response Analyzer G3 and ic100 tonometers. All subjects will participate in this arm.
Goldmann Applanation Tonometer	IOP with Goldmann Applanation Tonometer	Measurement of IOP with Goldmann Applanation Tonometer. All subjects will participate in this arm.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Department of Ophthalmology, Duke University; 🇺🇸 Durham, North Carolina, United States