Eye AbnormalitiesNCT06733428
Agreement and Precision Study
An observational study of Eye Abnormalities and Normal Eyes, run by Topcon Corporation at 1 site in United States.
Trial summary
To evaluate the performance of pachymetry function Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Eye Abnormalities, Normal Eyes
- What is being tested?
- Pachymeter
- Type of treatment
- Medical device
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2025to 28 Jan 2025
- 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 seeing an eye doctor that have normal cornea, cornea abnormality, or glaucoma
Who may be able to join
- Provide voluntary written consent
- Age at least 22 years old
- For glaucoma group only, visual field defect and optic nerve damage consistent with glaucoma
- For cornea group only, cornea abnormality
Who cannot join
- Ocular condition that may affect ability to perform cornea measurements
- Have or is suspected to have ocular infection
- Unable to tolerate eye testing
Trial locations and contacts
1 site in 1 country.
United States1 site
Illinois College of Optometry
Chicago, Illinois, 60616
About this study
Official title: TRK-3 Agreement and Precision of Pachymetry Function
To evaluate the performance of pachymetry function
- Conditions
- Eye Abnormalities, Normal Eyes
- Being tested
- Pachymeter
- Medical subject headings
- Eye Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PachymeterDevice
Also called TRK-3 auto kerato-refracto tonometer
Measure the thickness of the cornea
| Study group | Role | What they receive |
|---|---|---|
| Normal | Subjects with healthy cornea Receives: Device: Pachymeter | |
| Cornea | Subjects with abnormal cornea Receives: Device: Pachymeter | |
| Glaucoma | Subjects with glaucoma Receives: Device: Pachymeter |
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 posted13 Dec 2024
- Study start9 Jan 2025
- Primary completion28 Jan 2025
- Study completion28 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eye AbnormalitiesStudies 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
- 108 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
- NCT06733428
- Sponsor's protocol ID
- THQ-THINC-2024-01
- Status last verified
- Jan 2025
- First submitted
- 10 Dec 2024
- Last updated
- 4 Feb 2025
- 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 4 Feb 2025. 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
- NCT06733428
- Acronym / sponsor ID
- THQ-THINC-2024-01
- Conditions
- Eye Abnormalities, Normal Eyes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Topcon CorporationIndustry (pharma, biotech, devices)
- Study start
- 9 Jan 2025 (actual)
- Primary completion
- 28 Jan 2025 (actual)
- Study completion
- 28 Jan 2025 (actual)
- First posted
- 13 Dec 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 pachymetry function
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal | – | Device: PachymeterSubjects with healthy cornea |
| Cornea | – | Device: PachymeterSubjects with abnormal cornea |
| Glaucoma | – | Device: PachymeterSubjects with glaucoma |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects seeing an eye doctor that have normal cornea, cornea abnormality, or glaucoma
Key inclusion criteria (4 listed)
- Provide voluntary written consent
- Age at least 22 years old
- For glaucoma group only, visual field defect and optic nerve damage consistent with glaucoma
- For cornea group only, cornea abnormality
Key exclusion criteria (3 listed)
- Ocular condition that may affect ability to perform cornea measurements
- Have or is suspected to have ocular infection
- Unable to tolerate eye 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 |
|---|---|---|
| PachymeterAlso: TRK-3 auto kerato-refracto tonometerMeasure the thickness of the cornea | Device | Cornea, Glaucoma, Normal |
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 4 Feb 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.
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 Eye Abnormalities and Normal Eyes, 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 4 inclusion and 3 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 4 Feb 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 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 4 Feb 2025.