NCT05523622

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: State University of New York at Buffalo · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• Glaucoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-08-01
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2022-08-31
• Last updated: 2025-04-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study