Intraocular PressureNCT04360369
Comparison of Intraocular Pressure Measurements Between Reichert Tono-Vera Tonometer and Goldmann Tonometry
A study testing IOP with Goldmann Applanation Tonometer, IOP with comparator ORA G3 and ic100 tonometers and IOP with Tono-Vera Tonometer in people with Intraocular Pressure and Glaucoma, run by Reichert, Inc. at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Intraocular Pressure, Glaucoma
- What is being tested?
- IOP with Goldmann Applanation Tonometer, IOP with comparator ORA G3 and ic100 tonometers and IOP with Tono-Vera Tonometer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Oct 2020to 28 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Ophthalmology, Duke University
Durham, North Carolina, 27705
About this study
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).
Read the 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.
- Conditions
- Intraocular Pressure, Glaucoma
- Being tested
- IOP with Goldmann Applanation Tonometer, IOP with comparator ORA G3 and ic100 tonometers, IOP with Tono-Vera Tonometer
- Keywords
- Tonometry, Ocular
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IOP with Goldmann Applanation TonometerDevice
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 tonometersDevice
Measurement of IOP with Ocular Response Analyzer G3 and ic100 tonometers.
IOP with Tono-Vera TonometerDevice
Measurement of IOP with Tono-Vera Tonometer
| Study group | Role | What they receive |
|---|---|---|
| Goldmann Applanation Tonometer | Active comparator | Measurement of IOP with Goldmann Applanation Tonometer. All subjects will participate in this arm. Receives: 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. Receives: 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. Receives: Device: IOP with Tono-Vera Tonometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, approximately 4 months.
Secondary outcomes (2)
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.
Measured: Through study completion, approximately 4 months.
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.
Measured: Through study completion, approximately 4 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start19 Oct 2020
- Primary completion28 Apr 2021
- Study completion28 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraocular PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reichert, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Henry Tseng, MD, PhD, Principal investigator, Department of Opthalmology, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04360369
- Sponsor's protocol ID
- 16305-TPR-28
- Status last verified
- Dec 2021
- First submitted
- 16 Mar 2020
- Last updated
- 3 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intraocular Pressure Measurements Between Reichert Tono-Vera Tonometer and Goldmann Tonometry
- ClinicalTrials.gov ID
- NCT04360369
- Acronym / sponsor ID
- 16305-TPR-28
- Conditions
- Intraocular Pressure, Glaucoma
- Keywords
- Tonometry, Ocular
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Reichert, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Oct 2020 (actual)
- Primary completion
- 28 Apr 2021 (actual)
- Study completion
- 28 Apr 2021 (actual)
- First posted
- 24 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- All study-related tests will be conducted in a single stage, with one clinical visit, to a single clinical center.
| Arm | Type | Receives |
|---|---|---|
| Goldmann Applanation Tonometer | Active comparator | Device: IOP with Goldmann Applanation TonometerMeasurement of IOP with Goldmann Applanation Tonometer. All subjects will participate in this arm. |
| ORA G3 and ic100 | Active comparator | Device: IOP with comparator ORA G3 and ic100 tonometersMeasurement of IOP with Ocular Response Analyzer G3 and ic100 tonometers. All subjects will participate in this arm. |
| Tono-Vera Tonometer | Experimental | Device: IOP with Tono-Vera TonometerMeasurement of IOP with Tono-Vera Tonometer. All subjects will participate in this arm. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IOP with Goldmann Applanation TonometerMeasurement 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 | Goldmann Applanation Tonometer |
| IOP with comparator ORA G3 and ic100 tonometersMeasurement of IOP with Ocular Response Analyzer G3 and ic100 tonometers. | Device | ORA G3 and ic100 |
| IOP with Tono-Vera TonometerMeasurement of IOP with Tono-Vera Tonometer | Device | Tono-Vera Tonometer |
Primary outcome
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.
2 secondary outcomes
Data collection for two measurement modes.
Time frame: Through study completion, approximately 4 months.
Data collection for device calibration.
Time frame: Through study completion, approximately 4 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henry Tseng, MD, PhD principal investigator
Department of Opthalmology, Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IOP with Goldmann Applanation Tonometer, IOP with comparator ORA G3 and ic100 tonometers and IOP with Tono-Vera Tonometer in people with Intraocular Pressure and Glaucoma, run by Reichert, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demonstrate compliance with ANSI Z80.10-2014-Ophthalmics-Ophthalmic Instruments-Tonometers. (time frame: Through study completion, approximately 4 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2022.