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

Last updated: April 7, 2025
Sponsor: State University of New York at Buffalo
Overall Status: Active - Recruiting

Phase

N/A

Condition

Glaucoma

Treatment

Tono-Vera tonometer

Goldman Applanation Tonometry

Clinical Study ID

NCT05523622
UB Tono-Vera Comparison Trial
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Ability to provide signed and dated informed consent form. Patients willing tocomply 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

Exclusion Criteria:

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

Study Design

Total Participants: 300
Treatment Group(s): 2
Primary Treatment: Tono-Vera tonometer
Phase:
Study Start date:
August 01, 2022
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • Ross Eye Institute

    Buffalo, New York 14209
    United States

    Active - Recruiting

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