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

NCT05523622 | Recruiting FDA Device

• 1 other identifier: UB Tono-Vera Comparison Trial
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (1)

• Intraocular Pressure

  pressure inside the eye

  Baseline only

Study Arms (1)

IOP Measurement

OTHER

These are the measurements of the intraocular pressure.

Device: Tono-Vera tonometer; Device: Goldman Applanation Tonometry

Interventions

Tono-Vera tonometer DEVICE

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.

IOP Measurement

Goldman Applanation Tonometry DEVICE

This is the current gold standard for measuring eye pressure.

IOP Measurement

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Reichert, Inc.: collaborator
• State University of New York at Buffalo: lead

Study Sites (1)

Ross Eye Institute

Buffalo, New York, 14209, United States

RECRUITING

Related Publications (3)

• 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.

  PMID: 31726999 BACKGROUND

• 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.

  PMID: 18703945 BACKGROUND

• 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.

  PMID: 22310080 BACKGROUND

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Central Study Contacts

Sandra Sieminski, MD

CONTACT

716-408-6909; smfernando17@gmail.com

Catherine Seeger, MD

CONTACT

5859443719; cseeger2@buffalo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: We are comparing the accuracy of eye pressure measurements with a Tono-Vera device compared to the current gold standard, Goldmann Applanation Tonometry.

Study Record Dates

• First Submitted: August 22, 2022
• First Posted: August 31, 2022
• Study Start: August 1, 2022
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-05

Locations

US (1)