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Recruiting

NCT Number: NCT05523622

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.

Recruiting

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ross Eye Institute

Buffalo, New York, 14209, United States

Location status: Recruiting

Location contact

Sandra Sieminski, MD

CONTACT

716-881-7900

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Goldman Applanation Tonometry

Device

This is the current gold standard for measuring eye pressure.

Primary outcomes

  1. Intraocular Pressure

    Time frame: Baseline only

    pressure inside the eye

Study contacts

Contact information is provided by the study sponsor or research team.

Catherine Seeger, MD

CONTACT

[email protected]

5859443719

Sandra Sieminski, MD

CONTACT

[email protected]

716-408-6909

Sponsors and collaborators

Lead sponsor

State University of New York at Buffalo

Other

Collaborators

  • Reichert, Inc.

Registry information

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Aug 31, 2022
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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