Intraocular PressureNCT05167773
Clinical Study of the Topcon Tonometer TRK-3
An observational study of Intraocular Pressure, run by Topcon Corporation at 2 sites in Japan.
Trial summary
The study will assess the TRK-3 for conformity to ISO 8612:2009, JIS T7312:2015, and ANSI Z80.10-2014 Ophthalmic Instruments - Tonometers, to the FDA Guidance for Industry and FDA Staff, Tonometer-Premarket Notification [510(k)] Submissions, and the applicable Supplemental Information Sheet. 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?
- tonometer
- Type of treatment
- Medical device
- How many people
- 139 participants
- Where
- 2 sitesJapan
- Study dates
- 11 Oct 2021to 14 Jan 2022
- Phase
- Observational
- 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
Study population: Subjects undergoing routine eye exam at eye care clinic
Who may be able to join
- Be 18 years of age or older at the time of informed consent
- Irrespective of sex
- Irrespective of race or ethnicity
- Be willing and able to provide written informed consent by subject or legally designated representative prior to any study procedures
Who cannot join
- Have only one functional eye
- Have one eye with poor or eccentric fixation
- Have corneal scarring or have had corneal surgery, including corneal laser surgery in either eye
- Have microphthalmos in either eye
- Have buphthalmos in either eye
- Be a contact lens wearer (persons wearing soft contact lenses within the past 3 months and/or hard contact lenses within the past 6 months)
Show all 14Show fewer
- Have dry eyes (persons who have been diagnosed by a physician and are currently using prescription drugs or routinely using artificial tears)
- Uncontrollably blink, squint, wink, twitch or squeeze eye(s) - blepharospasm
- Have nystagmus in either eye
- Have keratoconus in either eye
- Have any other corneal or conjunctival pathology or infection in either eye
- Have central corneal thickness is less than 500μm or more than 600μm
- Be allergic to eye drop anesthetics
- Be allergic to sodium fluorescein
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Clinical Study of the Topcon Tonometer TRK-3 to Demonstrate Conformance to ISO 8612, JIS T7312, and ANSI Z80.10-2014 Ophthalmic Instruments - Tonometers
The study will assess the TRK-3 for conformity to ISO 8612:2009, JIS T7312:2015, and ANSI Z80.10-2014 Ophthalmic Instruments - Tonometers, to the FDA Guidance for Industry and FDA Staff, Tonometer-Premarket Notification [510(k)] Submissions, and the applicable Supplemental Information Sheet.
- Conditions
- Intraocular Pressure
- Being tested
- tonometer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tonometerDevice
A subject undergoes intraocular pressure measurement with tonometer
What is being measured
The primary outcome is the main question the study is designed to answer.
fluid pressure inside the eye (intraocular pressure) measured in millimeters of mercury (mm Hg)
Intraocular Pressure (IOP) measurements acquired with the study tonometer are compared to the reference tonometer IOP measurements to demonstrate that they meet the requirement specified in the tonometer standards (ISO 8612:2009, JIS T7312:2015 and ANSI Z80.10-2014)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2021
- Study start11 Oct 2021
- Primary completion14 Jan 2022
- Study completion14 Jan 2022
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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Topcon Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05167773
- Sponsor's protocol ID
- THQ-2021-04
- Status last verified
- Jul 2022
- First submitted
- 8 Nov 2021
- Last updated
- 20 Jul 2022
- 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 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of the Topcon Tonometer TRK-3 to Demonstrate Conformance to ISO 8612, JIS T7312, and ANSI Z80.10-2014 Ophthalmic Instruments - Tonometers
- ClinicalTrials.gov ID
- NCT05167773
- Acronym / sponsor ID
- THQ-2021-04
- Conditions
- Intraocular Pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Topcon CorporationIndustry (pharma, biotech, devices)
- Study start
- 11 Oct 2021 (actual)
- Primary completion
- 14 Jan 2022 (actual)
- Study completion
- 14 Jan 2022 (actual)
- First posted
- 22 Dec 2021 (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 study will assess the TRK-3 for conformity to ISO 8612:2009, JIS T7312:2015, and ANSI Z80.10-2014 Ophthalmic Instruments - Tonometers, to the FDA Guidance for Industry and FDA Staff, Tonometer-Premarket Notification [510(k)] Submissions, and the applicable Supplemental Information Sheet.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects undergoing routine eye exam at eye care clinic
Key inclusion criteria (4 listed)
- Be 18 years of age or older at the time of informed consent
- Irrespective of sex
- Irrespective of race or ethnicity
- Be willing and able to provide written informed consent by subject or legally designated representative prior to any study procedures
Key exclusion criteria (14 listed)
- Have only one functional eye
- Have one eye with poor or eccentric fixation
- Have corneal scarring or have had corneal surgery, including corneal laser surgery in either eye
- Have microphthalmos in either eye
- Have buphthalmos in either 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 |
|---|---|---|
| tonometerA subject undergoes intraocular pressure measurement with tonometer | Device | – |
Primary outcome
fluid pressure inside the eye (intraocular pressure) measured in millimeters of mercury (mm Hg)
Time frame: 1 day
Intraocular Pressure (IOP) measurements acquired with the study tonometer are compared to the reference tonometer IOP measurements to demonstrate that they meet the requirement specified in the tonometer standards (ISO 8612:2009, JIS T7312:2015 and ANSI Z80.10-2014)
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 20 Jul 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intraocular Pressure, run by Topcon Corporation at 2 sites in Japan.
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 4 inclusion and 14 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 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. 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?
fluid pressure inside the eye (intraocular pressure) measured in millimeters of mercury (mm Hg) (time frame: 1 day). 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 20 Jul 2022.