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

Primary Purpose

Intraocular Pressure, Glaucoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
IOP with Goldmann Applanation Tonometer
IOP with comparator ORA G3 and ic100 tonometers
IOP with Tono-Vera Tonometer
Sponsored by
Reichert, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Intraocular Pressure focused on measuring Tonometry, Ocular

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Department of Ophthalmology, Duke University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Experimental

Arm Label

Goldmann Applanation Tonometer

ORA G3 and ic100

Tono-Vera Tonometer

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Data collection for two measurement modes.
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.
Data collection for device calibration.
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.

Full Information

First Posted
March 16, 2020
Last Updated
December 30, 2021
Sponsor
Reichert, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04360369
Brief Title
Comparison of Intraocular Pressure Measurements Between Reichert Tono-Vera Tonometer and Goldmann Tonometry
Official Title
Comparison of Intraocular Pressure Measurements Between Reichert Tono-Vera Tonometer and Goldmann Tonometry
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
October 19, 2020 (Actual)
Primary Completion Date
April 28, 2021 (Actual)
Study Completion Date
April 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Reichert, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intraocular Pressure, Glaucoma
Keywords
Tonometry, Ocular

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
All study-related tests will be conducted in a single stage, with one clinical visit, to a single clinical center.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Goldmann Applanation Tonometer
Arm Type
Active Comparator
Arm Description
Measurement of IOP with Goldmann Applanation Tonometer. All subjects will participate in this arm.
Arm Title
ORA G3 and ic100
Arm Type
Active Comparator
Arm Description
Measurement of IOP with Ocular Response Analyzer G3 and ic100 tonometers. All subjects will participate in this arm.
Arm Title
Tono-Vera Tonometer
Arm Type
Experimental
Arm Description
Measurement of IOP with Tono-Vera Tonometer. All subjects will participate in this arm.
Intervention Type
Device
Intervention Name(s)
IOP with Goldmann Applanation Tonometer
Intervention Description
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
Intervention Name(s)
IOP with comparator ORA G3 and ic100 tonometers
Intervention Description
Measurement of IOP with Ocular Response Analyzer G3 and ic100 tonometers.
Intervention Type
Device
Intervention Name(s)
IOP with Tono-Vera Tonometer
Intervention Description
Measurement of IOP with Tono-Vera Tonometer
Primary Outcome Measure Information:
Title
Demonstrate compliance with ANSI Z80.10-2014-Ophthalmics-Ophthalmic Instruments-Tonometers.
Description
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.
Time Frame
Through study completion, approximately 4 months.
Secondary Outcome Measure Information:
Title
Data collection for two measurement modes.
Description
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.
Time Frame
Through study completion, approximately 4 months.
Title
Data collection for device calibration.
Description
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.
Time Frame
Through study completion, approximately 4 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henry Tseng, MD, PhD
Organizational Affiliation
Department of Opthalmology, Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Ophthalmology, Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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