Intraocular PressureNCT07152808

Clinical Study for TONOREF III Tested to ANSI Z80.10-2014

A study testing NIDEK TONOREF III and Haag-Streit Goldmann Manual Tonometer in people with Intraocular Pressure, run by Nidek Co. LTD..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The primary objective of this clinical study was to show that tonometry values for TONOREF III, as the representative device of the NIDEK tonometer series, were comparable to the predicate device. The secondary objective was to demonstrate that the test device was as safe as the predicate device. Read more about this study

Who is it for?: Ages 22 years and olderHealthy volunteers can take part
Conditions the study is for: Intraocular Pressure
What is being tested?: NIDEK TONOREF III and Haag-Streit Goldmann Manual Tonometer
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 52 participants
Where: No sites listed yet
Study dates: 2 Sep 2022to 19 Jun 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 22 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Each subject had to have:
been at least 22 years of age of either sex and any race or ethnicity;
been willing and able to provide written informed consent prior to any study procedures being performed;
been willing and able to follow all instructions and attend all study visits;
corneal astigmatism of ≤3D and corneal thickness of 500-600 μm in at least one eye.

Who cannot join

Each subject had to not to :
have only one functional eye;
have poor or eccentric fixation in the study eye;
have corneal scarring or have had corneal surgery, including corneal laser surgery in the study eye
have microphthalmos in the study eye;
have buphthalmos in the study eye;

Show all 15Show fewer

be a contact lens wearer in the study eye;
have dry eyes;
be a lid squeezer - blepharospasm;
have nystagmus in the study eye;
have keratoconus in the study eye;
have any other corneal or conjunctival pathology or infection in the study eye;
use medication that affect IOP;
current participation in other clinical trials;
have a condition or a situation, which in the Investigator's opinion, may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation.

About this study

Official title: Clinical Pilot Study to Provide Research Data for TONOREF III Tested to ANSI Z80.10-2014

The primary objective of this clinical study was to show that tonometry values for TONOREF III, as the representative device of the NIDEK tonometer series, were comparable to the predicate device.

The secondary objective was to demonstrate that the test device was as safe as the predicate device.

Conditions: Intraocular Pressure
Being tested: NIDEK TONOREF III, Haag-Streit Goldmann Manual Tonometer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NIDEK TONOREF IIIDevice
The auto ref/kerato/tono/pachymeter TONOREF III is a medical device which measures objective refractive errors, corneal curvature radius, intraocular pressure and corneal thickness of the patient's eye.
Haag-Streit Goldmann Manual TonometerDevice
Haag-Streit Goldmann Manual Tonometer measures intraocular pressure to aid in the screening and diagnosis of glaucoma

Study groups in NCT07152808
Study group	Role	What they receive
TONOREF III and Goldmann Tonometer Measurements	Experimental	Subjects will undergo IOP measurements using both the investigational device (TONOREF III) and the predicate device (Goldmann Applanation Tonometer). Receives: Device: NIDEK TONOREF III; Device: Haag-Streit Goldmann Manual Tonometer

What is being measured

The primary outcome is the main question the study is designed to answer.

Agreement of Intraocular Pressure
Agreement of the measured IOP between the test device and the predicate device (GAT) for the tonometer function of the TONOREF III. (Agreement means the similarity of results when measurements from the test device and the predicate device are compared against each other.)
Measured: 1-2 study visits per subject over the course of 8 days

Secondary outcomes (1)

The Numbers of Adverse Events
To demonstrate that the test device is as safe as GAT
Measured: 1-2 study visits per subject over the course of 8 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Sep 202219 Jun 2023

First posted3 Sep 2025
Study start2 Sep 2022
Primary completion19 Jun 2023
Study completion19 Jun 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 52 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07152808
Sponsor's protocol ID: NIDEK-TONOREF-PILOT-0002
Status last verified: Apr 2026
First submitted: 26 Aug 2025
Last updated: 24 Apr 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Active, not recruiting
Effect of IOP Lowering on Progressive HM
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Glaucoma Drop Aids Part 2
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Active, not recruiting
Clinical Investigation of Eye C Better's Photobionic Intraocular Pressure Biomonitor Tonometer
Elevated Intraocular Pressure (IOP)
Recruiting
Impact of Home Intraocular Pressure Telemonitoring on Intraocular Pressure Control and Glaucoma Progression
Glaucoma, Intraocular Pressure
Not yet recruitingPhase 1
Eplerenone and IOP in Healthy Adults
Intraocular Pressure (IOP), Healthy Adult

All Intraocular Pressure trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Pilot Study to Provide Research Data for TONOREF III Tested to ANSI Z80.10-2014
ClinicalTrials.gov ID: NCT07152808
Acronym / sponsor ID: NIDEK-TONOREF-PILOT-0002
Conditions: Intraocular Pressure
Study type: Interventional
Recruitment status: Completed
Enrolment: 52 participants (actual)
Lead sponsor: Nidek Co. LTD.Industry (pharma, biotech, devices)
Study start: 2 Sep 2022 (actual)
Primary completion: 19 Jun 2023 (actual)
Study completion: 19 Jun 2023 (actual)
First posted: 3 Sep 2025 (actual)
Results: Posted 4 Feb 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The primary objective of this clinical study was to show that tonometry values for TONOREF III, as the representative device of the NIDEK tonometer series, were comparable to the predicate device.

The secondary objective was to demonstrate that the test device was as safe as the predicate device.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
TONOREF III and Goldmann Tonometer Measurements	Experimental	Device: NIDEK TONOREF III, Device: Haag-Streit Goldmann Manual TonometerSubjects will undergo IOP measurements using both the investigational device (TONOREF III) and the predicate device (Goldmann Applanation Tonometer).

Who may qualify

Ages: 22 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

been at least 22 years of age of either sex and any race or ethnicity;
been willing and able to provide written informed consent prior to any study procedures being performed;
been willing and able to follow all instructions and attend all study visits;
corneal astigmatism of ≤3D and corneal thickness of 500-600 μm in at least one eye.

Key exclusion criteria (15 listed)

have only one functional eye;
have poor or eccentric fixation in the study eye;
have corneal scarring or have had corneal surgery, including corneal laser surgery in the study eye
have microphthalmos in the study eye;
have buphthalmos in the study eye;

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
NIDEK TONOREF IIIThe auto ref/kerato/tono/pachymeter TONOREF III is a medical device which measures objective refractive errors, corneal curvature radius, intraocular pressure and corneal thickness of the patient's eye.	Device	TONOREF III and Goldmann Tonometer Measurements
Haag-Streit Goldmann Manual TonometerHaag-Streit Goldmann Manual Tonometer measures intraocular pressure to aid in the screening and diagnosis of glaucoma	Device	TONOREF III and Goldmann Tonometer Measurements

Primary outcome

Agreement of Intraocular Pressure
Time frame: 1-2 study visits per subject over the course of 8 days
Agreement of the measured IOP between the test device and the predicate device (GAT) for the tonometer function of the TONOREF III. (Agreement means the similarity of results when measurements from the test device and the predicate device are compared against each other.)

1 secondary outcome

The Numbers of Adverse Events
Time frame: 1-2 study visits per subject over the course of 8 days

Results and safety

Results posted to the registry on 4 Feb 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TONOREF III and Goldmann Tonometer Measurements	52	42

Primary outcome: Agreement of Intraocular Pressure

Time frame: 1-2 study visits per subject over the course of 8 days. Mean (Standard Deviation). Unit: mmHg

Measure	TONOREF III and Goldmann Tonometer Measurements n = 42
NIDEK TONOREF III	18.4 (4.50)
Haag-Streit GAT	18.3 (5.11)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 1 to 8 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TONOREF III and Goldmann Tonometer Measurements	0 of 52 (0%)	0 of 52 (0%)	0 of 52

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Intraocular Pressure

Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Not yet recruiting
Glaucoma Drop Aids Part 2
Glaucoma, Intraocular Pressure
Active, not recruiting
Clinical Investigation of Eye C Better's Photobionic Intraocular Pressure Biomonitor Tonometer
Elevated Intraocular Pressure (IOP)
Recruiting
Impact of Home Intraocular Pressure Telemonitoring on Intraocular Pressure Control and Glaucoma Progression
Glaucoma, Intraocular Pressure
Not yet recruitingPhase 1
Eplerenone and IOP in Healthy Adults
Intraocular Pressure (IOP), Healthy Adult

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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A study testing NIDEK TONOREF III and Haag-Streit Goldmann Manual Tonometer in people with Intraocular Pressure, run by Nidek Co. LTD..

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 5 inclusion and 15 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 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

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?

Yes. Results are posted in the registry (first posted 4 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Agreement of Intraocular Pressure (time frame: 1-2 study visits per subject over the course of 8 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07152808.

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 24 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.