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

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).

Study Overview

• Status: Completed
• Conditions: Glaucoma; Intraocular Pressure
• Intervention / Treatment: Device: IOP with Goldmann Applanation Tonometer; Device: IOP with comparator ORA G3 and ic100 tonometers; Device: IOP with Tono-Vera Tonometer

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 Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Department of Ophthalmology, Duke University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 86 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Goldmann Applanation Tonometer; Measurement of IOP with Goldmann Applanation Tonometer. All subjects will participate in this arm.	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).
Active Comparator: ORA G3 and ic100; Measurement of IOP with Ocular Response Analyzer G3 and ic100 tonometers. All subjects will participate in this arm.	Device: IOP with comparator ORA G3 and ic100 tonometers; Measurement of IOP with Ocular Response Analyzer G3 and ic100 tonometers.
Experimental: Tono-Vera Tonometer; Measurement of IOP with Tono-Vera Tonometer. All subjects will participate in this arm.	Device: IOP with Tono-Vera Tonometer; Measurement of IOP with Tono-Vera Tonometer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.

Collaborators and Investigators

• Sponsor: Reichert, Inc.
• Investigators: Principal Investigator: Henry Tseng, MD, PhD, Department of Opthalmology, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2020
• Primary Completion (Actual): April 28, 2021
• Study Completion (Actual): April 28, 2021

Study Registration Dates

• First Submitted: March 16, 2020
• First Submitted That Met QC Criteria: April 21, 2020
• First Posted (Actual): April 24, 2020

Study Record Updates

• Last Update Posted (Actual): January 3, 2022
• Last Update Submitted That Met QC Criteria: December 30, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Tonometry, Ocular
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: 16305-TPR-28

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No