NCT04360369

Comparison of Intraocular Pressure Measurements Between Reichert Tono-Vera Tonometer and Goldmann Tonometry

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Reichert, Inc. · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

Summary

Determine if the Tono-Vera Tonometer accurately measures intraocular pressure (IOP). The hypothesis of this test is to confirm the Tono-Vera Tonometer is equivalent to the Goldmann Applanation Tonometer (within +/- 5.0 mmHg).

Detailed description

The Tono-Vera Tonometer (Reichert, Inc.) is a portable rebound tonometer intended to measure IOP. Subjects will undergo a standard ophthalmologic examination. Subjects will then be measured with four tonometers: Goldmann Applanation Tonometer (C.S.O. SRL), Ocular Response Analyzer G3 (Reichert, Inc.), iCare ic100 tonometer (iCare Finland Oy), and Tono-Vera Tonometer.

Conditions

• Intraocular Pressure
• Glaucoma

Interventions

Type	Name	Description
DEVICE	IOP with Goldmann Applanation Tonometer	Measurement of intraocular pressure (IOP) with Goldmann Applanation Tonometer. Measurement will be used to categorize each subject as having Low IOP (7 to 16 mmHg), Medium IOP (\>16 to \<23 mmHg), or High IOP (\>23 mmHg).
DEVICE	IOP with comparator ORA G3 and ic100 tonometers	Measurement of IOP with Ocular Response Analyzer G3 and ic100 tonometers.
DEVICE	IOP with Tono-Vera Tonometer	Measurement of IOP with Tono-Vera Tonometer

Timeline

• Start date: 2020-10-19
• Primary completion: 2021-04-28
• Completion: 2021-04-28
• First posted: 2020-04-24
• Last updated: 2022-01-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study