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

NCT04360369 | Completed FDA Device

• 1 other identifier: 16305-TPR-28
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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).

Conditions

Intraocular Pressure; Glaucoma

Keywords

Tonometry, Ocular

Outcome Measures

Primary Outcomes (1)

• 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.

  Through study completion, approximately 4 months.

Secondary Outcomes (2)

• Data collection for two measurement modes.

  Through study completion, approximately 4 months.

• Data collection for device calibration.

  Through study completion, approximately 4 months.

Study Arms (3)

Goldmann Applanation Tonometer

ACTIVE COMPARATOR

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

Device: IOP with Goldmann Applanation Tonometer

ORA G3 and ic100

ACTIVE COMPARATOR

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

Device: IOP with comparator ORA G3 and ic100 tonometers

Tono-Vera Tonometer

EXPERIMENTAL

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

Device: IOP with Tono-Vera Tonometer

Interventions

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).

Goldmann Applanation Tonometer

IOP with comparator ORA G3 and ic100 tonometers DEVICE

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

ORA G3 and ic100

IOP with Tono-Vera Tonometer DEVICE

Measurement of IOP with Tono-Vera Tonometer

Tono-Vera Tonometer

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Reichert, Inc.: lead

Study Sites (1)

Department of Ophthalmology, Duke University

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Henry Tseng, MD, PhD

  Department of Opthalmology, Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: March 16, 2020
• First Posted: April 24, 2020
• Study Start: October 19, 2020
• Primary Completion: April 28, 2021
• Study Completion: April 28, 2021
• Last Updated: January 3, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)