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

Not Applicable

Recruiting

• Conditions: Glaucoma
• Interventions: Device: Tono-Vera tonometer; Device: Goldman Applanation Tonometry

• Registration Number: NCT05523622
• Lead Sponsor: State University of New York at Buffalo

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.

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 Timeline

• Study Start: 2022-08-01
• Study First Submitted: 2022-08-22
• Study First Submitted QC: 2022-08-29
• Study First Posted: 2022-08-31
• Status Verified: 2025-02
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-09
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IOP Measurement	Tono-Vera tonometer	These are the measurements of the intraocular pressure.
IOP Measurement	Goldman Applanation Tonometry	These are the measurements of the intraocular pressure.

Primary Outcome Measures

Name	Time	Method
Intraocular Pressure	Baseline only	pressure inside the eye

Trial Locations

Locations (1)

Ross Eye Institute; 🇺🇸 Buffalo, New York, United States