Intraocular PressureNCT06363045
Comparative Study of the NIDEK TONOREF III with Predicate Devices
A study testing NIDEK TONOREF III, Haag-Streit, PERKINS HAND-HELD APPLANATION TONOMETER and NIDEK CEM-530 in people with Intraocular Pressure, run by Nidek Co. LTD. at 1 site in United Kingdom.
Trial summary
The primary objective of this clinical study is to prove that tonometry values for NIDEK TONOREF III are comparable to the predicate device and to prove that the pachymeter function of NIDEK TONOREF III is equivalent to the predicate device. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intraocular Pressure
- What is being tested?
- NIDEK TONOREF III, Haag-Streit, PERKINS HAND-HELD APPLANATION TONOMETER and NIDEK CEM-530
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 183 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 Jun 2024to 13 Dec 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Subjects with only one functional eye;
- Those with one eye having poor or eccentric fixation;
- Those with corneal scarring or who have had corneal surgery including corneal laser surgery;
- Microphthalmos;
- Buphthalmos;
- Contact lens wearers;
Show all 12Show fewer
- Dry eyes;
- Lid squeezers - blepharospasm;
- Nystagmus;
- Keratoconus;
- Any other corneal or conjunctival pathology or infection.
- central corneal thickness greater than 0,600 mm or less than 0,500 mm (2 standard deviations about the human mean)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Aston University
Birmingham, Birmingham, B4 7ET, UK
About this study
Official title: Comparative Study of the NIDEK TONOREF III with the Haag-Streit, Perkins Hand-held Applanation Tonometer for Tonometry Function and NIDEK TONOREF III with the NIDEK CEM-530 for Pachymetry Function
The primary objective of this clinical study is to prove that tonometry values for NIDEK TONOREF III are comparable to the predicate device and to prove that the pachymeter function of NIDEK TONOREF III is equivalent to the predicate device. The secondary objective is to demonstrate that the test device is as safe as the predicate devices.
- Conditions
- Intraocular Pressure
- Being tested
- NIDEK TONOREF III, Haag-Streit, PERKINS HAND-HELD APPLANATION TONOMETER, NIDEK CEM-530
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, PERKINS HAND-HELD APPLANATION TONOMETERDevice
Haag-Streit Goldmann Manual Tonometer measures intraocular pressure to aid in the screening and diagnosis of glaucoma
NIDEK CEM-530Device
Nidek CEM-530 is a non-contact ophthalmic microscope, optical pachymeter, and camera used for examination of the corneal endothelium and for measurement of the thickness of the cornea.
| Study group | Role | What they receive |
|---|---|---|
| Adults 18 years old or older | Experimental | NIDEK TONOREFIII Receives: Device: NIDEK TONOREF III; Device: Haag-Streit, PERKINS HAND-HELD APPLANATION TONOMETER; Device: NIDEK CEM-530 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Equivalent to legally-marketed devices
Agreement of intraocular pressure (mmHg) measurement for TONOREFIII and PAT
Measured: One or two study visits per subject. One visit is less than two hours.
Equivalent to the pachymeter function
Agreement of central corneal thickness (µm) measurement for TONOREF III and CEM-530
Measured: One or two study visits per subject. One visit is less than two hours.
Secondary outcomes (1)
The numbers of adverse events
To demonstrate that the test device is as safe as the predicate devices.
Measured: One or two study visits per subject. One visit is less than two hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start27 Jun 2024
- Primary completion13 Dec 2024
- Study completion13 Dec 2024
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nidek Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tadakazu Ichimura, Study director, Nidek Co. LTD.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06363045
- Sponsor's protocol ID
- NIDEK-TONOREF-UK-0001
- Status last verified
- Mar 2025
- First submitted
- 24 Mar 2024
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of the NIDEK TONOREF III with the Haag-Streit, Perkins Hand-held Applanation Tonometer for Tonometry Function and NIDEK TONOREF III with the NIDEK CEM-530 for Pachymetry Function
- ClinicalTrials.gov ID
- NCT06363045
- Acronym / sponsor ID
- NIDEK-TONOREF-UK-0001
- Conditions
- Intraocular Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- Nidek Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 27 Jun 2024 (actual)
- Primary completion
- 13 Dec 2024 (actual)
- Study completion
- 13 Dec 2024 (actual)
- First posted
- 12 Apr 2024 (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.
The primary objective of this clinical study is to prove that tonometry values for NIDEK TONOREF III are comparable to the predicate device and to prove that the pachymeter function of NIDEK TONOREF III is equivalent to the predicate device. The secondary objective is to demonstrate that the test device is as safe as the predicate devices.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults 18 years old or older | Experimental | Device: NIDEK TONOREF III, Device: Haag-Streit, PERKINS HAND-HELD APPLANATION TONOMETER, Device: NIDEK CEM-530NIDEK TONOREFIII |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (12 listed)
- Subjects with only one functional eye;
- Those with one eye having poor or eccentric fixation;
- Those with corneal scarring or who have had corneal surgery including corneal laser surgery;
- Microphthalmos;
- Buphthalmos;
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 | Adults 18 years old or older |
| Haag-Streit, PERKINS HAND-HELD APPLANATION TONOMETERHaag-Streit Goldmann Manual Tonometer measures intraocular pressure to aid in the screening and diagnosis of glaucoma | Device | Adults 18 years old or older |
| NIDEK CEM-530Nidek CEM-530 is a non-contact ophthalmic microscope, optical pachymeter, and camera used for examination of the corneal endothelium and for measurement of the thickness of the cornea. | Device | Adults 18 years old or older |
Primary outcome
Equivalent to legally-marketed devices
Time frame: One or two study visits per subject. One visit is less than two hours.
Agreement of intraocular pressure (mmHg) measurement for TONOREFIII and PAT
Equivalent to the pachymeter function
Time frame: One or two study visits per subject. One visit is less than two hours.
Agreement of central corneal thickness (µm) measurement for TONOREF III and CEM-530
1 secondary outcome
The numbers of adverse events
Time frame: One or two study visits per subject. One visit is less than two hours.
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 7 Mar 2025.
- 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.
Tadakazu Ichimura study director
Nidek Co. LTD.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NIDEK TONOREF III, Haag-Streit, PERKINS HAND-HELD APPLANATION TONOMETER and NIDEK CEM-530 in people with Intraocular Pressure, run by Nidek Co. LTD. at 1 site in United Kingdom.
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 0 inclusion and 12 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 7 Mar 2025. 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 Kingdom. 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?
Equivalent to legally-marketed devices (time frame: One or two study visits per subject. One visit is less than two hours.). The study lists 2 primary outcomes in all. 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 7 Mar 2025.