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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-19

Study Completion Date

2021-04-28

Brief Summary

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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).

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Detailed Description

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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

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Intraocular Pressure Glaucoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

All study-related tests will be conducted in a single stage, with one clinical visit, to a single clinical center.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Goldmann Applanation Tonometer

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

Group Type ACTIVE_COMPARATOR

IOP with Goldmann Applanation Tonometer

Intervention Type DEVICE

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).

ORA G3 and ic100

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

Group Type ACTIVE_COMPARATOR

IOP with comparator ORA G3 and ic100 tonometers

Intervention Type DEVICE

Measurement of IOP with Ocular Response Analyzer G3 and ic100 tonometers.

Tono-Vera Tonometer

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

Group Type EXPERIMENTAL

IOP with Tono-Vera Tonometer

Intervention Type DEVICE

Measurement of IOP with Tono-Vera Tonometer

Interventions

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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).

Intervention Type DEVICE

IOP with comparator ORA G3 and ic100 tonometers

Measurement of IOP with Ocular Response Analyzer G3 and ic100 tonometers.

Intervention Type DEVICE

IOP with Tono-Vera Tonometer

Measurement of IOP with Tono-Vera Tonometer

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes