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OpenTrials
Completed

NCT Number: NCT04360369

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

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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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Ophthalmology, Duke University

Durham, North Carolina, 27705, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

IOP with Goldmann Applanation Tonometer

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).

IOP with comparator ORA G3 and ic100 tonometers

Device

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

IOP with Tono-Vera Tonometer

Device

Measurement of IOP with Tono-Vera Tonometer

Primary outcomes

  1. Demonstrate compliance with ANSI Z80.10-2014-Ophthalmics-Ophthalmic Instruments-Tonometers.

    Time frame: Through study completion, approximately 4 months.

    Subjects will be distributed into Low IOP, Medium IOP, and High IOP groups based on Goldmann Applanation Tonometer measurements. The Tono-Vera Tonometer measurements will be within +/-5.0 mmHg of the Goldmann Applanation Tonometer measurements in all groups.

Secondary outcomes

  1. Data collection for two measurement modes.

    Time frame: Through study completion, approximately 4 months.

    Tono-Vera has two measurement modes: A 6-measurement mode & "Quick" measurement mode. The 6-measurement mode will be used during this study. It will be possible to post-process the results to determine the IOP value that would have been obtained using Quick mode. As such the sponsor will be able to ensure the accuracy of both measurement modes compared to Goldmann Tonometry.

  2. Data collection for device calibration.

    Time frame: Through study completion, approximately 4 months.

    The study will collect data on a large number of patients over a wide range of IOP values. The sponsor may use the collected data in a post-hoc analysis to verify that the Tono-Vera Tonometer factory calibration is optimal.

Sponsors and collaborators

Lead sponsor

Reichert, Inc.

Industry

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 24, 2020
Registry last updated
Jan 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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