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

NCT04360369 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2022-01-03

No results posted yet for this study

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

Interventions

DEVICE

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).

DEVICE

IOP with comparator ORA G3 and ic100 tonometers

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

DEVICE

IOP with Tono-Vera Tonometer

Measurement of IOP with Tono-Vera Tonometer

Sponsors & Collaborators

  • Reichert, Inc.

    lead INDUSTRY

Principal Investigators

  • Henry Tseng, MD, PhD · Department of Opthalmology, Duke University

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-19
Primary Completion
2021-04-28
Completion
2021-04-28
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04360369 on ClinicalTrials.gov