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

Reichert, Inc.

Status: Completed

Conditions: Glaucoma; Intraocular Pressure

Treatments: Device: IOP with Tono-Vera Tonometer; Device: IOP with comparator ORA G3 and ic100 tonometers; Device: IOP with Goldmann Applanation Tonometer

Study type: Interventional

Funder types: Industry

Identifiers

NCT04360369

16305-TPR-28

Details and patient eligibility

About

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).

Full 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.

Enrollment: 61 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects must be male or female, between the ages of 18 and 90 years old;
• Be able and willing to provide signed informed consent
• Be able to follow study instructions

Exclusion criteria

• Subjects with only one functional eye;
• Subjects with one eye having poor or eccentric fixation;
• Subjects with central corneal thickness greater than 600 µm or less than 500 µm (about 2 standard deviations the human mean);
• Subjects with corneal scarring or who have had corneal surgery, including corneal laser surgery;
• Subjects with concomitant ocular diseases such as: microphthalmos, buphthalmos, nystagmus, keratoconus, severe dry eye syndrome, blepharospasm, any other corneal or conjunctival pathology or infection;
• Contact lens wearers;
• Known allergy to proparacaine or fluorescein as these are used to anesthetize the eye and allow IOP measurement, respectively, when used with the GAT.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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61 participants in 3 patient groups

Goldmann Applanation Tonometer

Active Comparator group

Description:

Measurement of IOP with Goldmann Applanation Tonometer. All subjects will participate in this arm.

Treatment:

Device: IOP with Goldmann Applanation Tonometer

ORA G3 and ic100

Active Comparator group

Description:

Measurement of IOP with Ocular Response Analyzer G3 and ic100 tonometers. All subjects will participate in this arm.

Treatment:

Device: IOP with comparator ORA G3 and ic100 tonometers

Tono-Vera Tonometer

Experimental group

Description:

Measurement of IOP with Tono-Vera Tonometer. All subjects will participate in this arm.

Treatment:

Device: IOP with Tono-Vera Tonometer