GlaucomaNCT06247072
TRK-3 Conformance to Standards for Tonometers
An observational study of Glaucoma, run by Topcon Corporation at 2 sites in United States.
Trial summary
To collect measurements of a new tonometer and show conformance to standards for tonometers. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma
- What is being tested?
- Tonometer
- Type of treatment
- Medical device
- How many people
- 125 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Feb 2024to 4 Apr 2024
- 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 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Eyes with different range of IOP
Who may be able to join
- Age at least 22 years at the time of the informed consent
- Provide voluntary written consent for participation in the study
Who cannot join
- Have only one functional eye
- Have difficulty in ocular fixation or eccentric fixation in either eye
- Have corneal scar or have a history of corneal surgery such as corneal laser surgery (cataract surgery is acceptable)
- Have microphthalmia
- Have buphthalmos
- Wear contact lens (have used soft contact lenses within the last 3 months and/or hard contact lenses within the last 6 months)
Show all 15Show fewer
- Have dry eyes and taking prescription medication or using artificial tears daily
- Have blepharospasm
- Have nystagmus
- Have keratoconus
- Have corneal or conjunctival lesions or infections
- Have a central corneal thickness of <500μm or >600μm
- Have corneal astigmatism >3D
- Have known allergy to ophthalmic anesthetics
- Have known allergy to sodium fluorescein
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Illinois College of Optometry
Chicago, Illinois, 60616
New View Optometric Center
La Mesa, California, 91942
About this study
To collect measurements of a new tonometer and show conformance to standards for tonometers.
- Conditions
- Glaucoma
- Being tested
- Tonometer
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TonometerDevice
measures IOP
| Study group | Role | What they receive |
|---|---|---|
| low IOP | having low IOP in one eye Receives: Device: Tonometer | |
| intermediate IOP | having intermediate IOP in one eye Receives: Device: Tonometer | |
| high IOP | having high IOP in one eye Receives: Device: Tonometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
IOP
pressure inside the eye
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 posted7 Feb 2024
- Study start2 Feb 2024
- Primary completion4 Apr 2024
- Study completion4 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 125 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
- NCT06247072
- Sponsor's protocol ID
- THQ-THINC-2023-02
- Status last verified
- Apr 2024
- First submitted
- 30 Jan 2024
- Last updated
- 8 Apr 2024
- 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 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRK-3 Conformance to Standards for Tonometers
- ClinicalTrials.gov ID
- NCT06247072
- Acronym / sponsor ID
- THQ-THINC-2023-02
- Conditions
- Glaucoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Topcon CorporationIndustry (pharma, biotech, devices)
- Study start
- 2 Feb 2024 (actual)
- Primary completion
- 4 Apr 2024 (actual)
- Study completion
- 4 Apr 2024 (actual)
- First posted
- 7 Feb 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.
To collect measurements of a new tonometer and show conformance to standards for tonometers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| low IOP | – | Device: Tonometerhaving low IOP in one eye |
| intermediate IOP | – | Device: Tonometerhaving intermediate IOP in one eye |
| high IOP | – | Device: Tonometerhaving high IOP in one eye |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Eyes with different range of IOP
Key inclusion criteria (2 listed)
- Age at least 22 years at the time of the informed consent
- Provide voluntary written consent for participation in the study
Key exclusion criteria (15 listed)
- Have only one functional eye
- Have difficulty in ocular fixation or eccentric fixation in either eye
- Have corneal scar or have a history of corneal surgery such as corneal laser surgery (cataract surgery is acceptable)
- Have microphthalmia
- Have 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 |
|---|---|---|
| Tonometermeasures IOP | Device | high IOP, intermediate IOP, low IOP |
Primary outcome
IOP
Time frame: 1 day
pressure inside the eye
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 8 Apr 2024.
- 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 Glaucoma, run by Topcon Corporation at 2 sites 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 2 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 8 Apr 2024. 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 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?
IOP (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 8 Apr 2024.