Comparison of Intraocular Pressure Measurement With the Novel TonoVera Device With Other Commonly Used Devices

We are testing the accuracy of Reichert's Tono-Vera tonometer by comparing measurements of IOP with this device and measurements with other commonly-used tonometers, including Goldmann Applanation and iCare.

Study Overview

• Status: Recruiting
• Conditions: Glaucoma
• Intervention / Treatment: Device: Tono-Vera tonometer; Device: Goldman Applanation Tonometry

Detailed Description

This is a comparative study between the TonoVera, the gold standard Goldmann Applanation Tonometry (GAT) and an established rebound tonometry device, iCare. IOP measurements will be obtained using the following devices: Reichert's prototype Tono-Vera Rebound tonometer (a rebound tonometer in development), iCare's iC100 rebound tonometer (a device commonly used in clinical practice), GAT (a device commonly used in clinical practice). Reichert's iPac Handheld Pachymeter (a device commonly used in clinical practice) will be used to measure the test subject's Central Corneal Thickness (CCT), measured in µm if CCT is not already on file. An Autorefractor Keratometer (ARK) (a device commonly used in clinical practice) will be used to measure necessary vision correction and corneal curvature. The Ocular Response Analyzer (a device commonly used in clinical practice) will be used to measure corneal hysteresis. Multiple IOP measurements will be taken with each device on each eye for all subjects: 3 along the central cornea, 3 along the peripheral cornea, and 3 along the sclera.

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sandra Sieminski, MD; Phone Number: 716-408-6909; Email: smfernando17@gmail.com
• Study Contact Backup: Name: Catherine Seeger, MD; Phone Number: 5859443719; Email: cseeger2@buffalo.edu

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14209
      • Recruiting
      • Ross Eye Institute
      • Contact: Sandra Sieminski, MD; Phone Number: 716-881-7900

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Ability to provide signed and dated informed consent form. Patients willing to comply with all study procedures and be available for the duration of the study.

Male or female patients aged 18 to 99 Patients in good general health as evidenced by ability to come to their appointment on day of study.

Exclusion Criteria:

• Patients age less than 18 years Patients unable or unwilling to provide informed consent to participate in the study Patients for which an accurate tonometry reading cannot be performed. This may include those with blepharospasm (lid squeezers), nystagmus, extensive corneal pathology, or contact lens wearers who cannot remove their contact lens.Patients with significant scleral thinning Patients with a known allergy to proparacaine or fluorescein as these are used to anesthetize and allow measurement respectively of the eye when used with the Goldmann tonometer.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: IOP Measurement; These are the measurements of the intraocular pressure.	Device: Tono-Vera tonometer; The tonometer measures intraocular pressure with a small rebound probe, similar to those used with other tonometers currently on the market, such as the iCare.; Device: Goldman Applanation Tonometry; This is the current gold standard for measuring eye pressure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraocular Pressure	pressure inside the eye	Baseline only

Collaborators and Investigators

• Sponsor: State University of New York at Buffalo
• Collaborators: Reichert, Inc.

Publications and helpful links

General Publications

• Chen M, Zhang L, Xu J, Chen X, Gu Y, Ren Y, Wang K. Comparability of three intraocular pressure measurement: iCare pro rebound, non-contact and Goldmann applanation tonometry in different IOP group. BMC Ophthalmol. 2019 Nov 14;19(1):225. doi: 10.1186/s12886-019-1236-5.
• Kaushik S, Pandav SS, Banger A, Aggarwal K, Gupta A. Relationship between corneal biomechanical properties, central corneal thickness, and intraocular pressure across the spectrum of glaucoma. Am J Ophthalmol. 2012 May;153(5):840-849.e2. doi: 10.1016/j.ajo.2011.10.032. Epub 2012 Feb 4.
• Hager A, Loge K, Schroeder B, Fullhas MO, Wiegand W. Effect of central corneal thickness and corneal hysteresis on tonometry as measured by dynamic contour tonometry, ocular response analyzer, and Goldmann tonometry in glaucomatous eyes. J Glaucoma. 2008 Aug;17(5):361-5. doi: 10.1097/IJG.0b013e31815c3ad3.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: August 22, 2022
• First Submitted That Met QC Criteria: August 29, 2022
• First Posted (Actual): August 31, 2022

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: UB Tono-Vera Comparison Trial

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes