NormalNCT06250868
TRK-3 Performance of Pachymetry
An observational study of Normal, run by Topcon Corporation at 1 site in United States.
Trial summary
To evaluate the performance of a new tonometer. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Normal
- What is being tested?
- Kerato-Refracto Tonometer
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2024to 26 Feb 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: Subjects who have healthy cornea
Who may be able to join
- Provide voluntary written consent for participation in the study.
- Age at least 22 years old at the time of informed consent.
Who cannot join
- Ocular condition that may affect the ability to perform corneal measurement (e.g., corneal perforation, bullous keratopathy, nystagmus)
- Have or is suspected to have an ocular infection in either eye.
- Otherwise considered unsuitable for the study by the investigator
- Unable to tolerate ophthalmic testing.
Trial locations and contacts
1 site in 1 country.
United States1 site
Topcon Healthcare Innovation Center
La Jolla, California, 92037
About this study
Official title: TRK-3 Agreement and Precision of Pachymetry Function
To evaluate the performance of a new tonometer.
- Conditions
- Normal
- Being tested
- Kerato-Refracto Tonometer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kerato-Refracto TonometerDevice
measures pressure inside the eye and thickness of the cornea.
| Study group | Role | What they receive |
|---|---|---|
| Normal cornea | Not described Receives: Device: Kerato-Refracto Tonometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cornea thickness
Thickness of the cornea
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 posted9 Feb 2024
- Study start20 Feb 2024
- Primary completion26 Feb 2024
- Study completion26 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NormalStudies 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
- 30 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
- NCT06250868
- Sponsor's protocol ID
- THQ-THINC-2023-03
- Status last verified
- Feb 2024
- First submitted
- 1 Feb 2024
- Last updated
- 1 Mar 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 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRK-3 Agreement and Precision of Pachymetry Function
- ClinicalTrials.gov ID
- NCT06250868
- Acronym / sponsor ID
- THQ-THINC-2023-03
- Conditions
- Normal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Topcon CorporationIndustry (pharma, biotech, devices)
- Study start
- 20 Feb 2024 (actual)
- Primary completion
- 26 Feb 2024 (actual)
- Study completion
- 26 Feb 2024 (actual)
- First posted
- 9 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 evaluate the performance of a new tonometer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Normal cornea | – | Device: Kerato-Refracto Tonometer |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who have healthy cornea
Key inclusion criteria (2 listed)
- Provide voluntary written consent for participation in the study.
- Age at least 22 years old at the time of informed consent.
Key exclusion criteria (4 listed)
- Ocular condition that may affect the ability to perform corneal measurement (e.g., corneal perforation, bullous keratopathy, nystagmus)
- Have or is suspected to have an ocular infection in either eye.
- Otherwise considered unsuitable for the study by the investigator
- Unable to tolerate ophthalmic testing.
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 |
|---|---|---|
| Kerato-Refracto Tonometermeasures pressure inside the eye and thickness of the cornea. | Device | Normal cornea |
Primary outcome
Cornea thickness
Time frame: 1 day
Thickness of the cornea
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 1 Mar 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Normal, run by Topcon Corporation 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 2 inclusion and 4 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 1 Mar 2024. 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?
Cornea thickness (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 1 Mar 2024.