GlaucomaNCT07804277
Comparative Study of the Tomey FT-1000, and Goldmann Applanation Tonometer (GAT)
An observational study of Glaucoma, run by Tomey Corporation at 1 site in United States.
Trial summary
This study is intended to evaluate the agreement between Intraocular pressure(IOP) measurements obtained with the FT-1000 non-contact tonometer and a GAT to confirm the feasibility of the measurement procedures. This is a prospective comparative study that will be conducted at one clinical site in the United States. 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?
- Non Contact Tonometer and Applanation Tonometer
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2026to 28 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Low Intraocular pressure(IOP) (22 years old or older) Middle Intraocular pressure(IOP)(22 years old or older) High Intraocular pressure(IOP)(22 years old or older)
Who may be able to join
- Male or female subjects 22 years of age or older who have full legal capacity to volunteer on the date the informed consent is signed.
- Subjects who are able to understand and follow the study procedures and instructions provided by the clinical staff.
- Subjects who voluntarily provide written informed consent.
- Subjects who satisfy all study eligibility requirements and are able to undergo both FT-1000 and Goldmann applanation tonometry measurements during the study visit.
Who cannot join
- Subjects with only one functional eye.
- Subjects with poor or eccentric fixation in either eye.
- Subjects with a history of corneal surgery, including corneal laser or refractive surgery (e.g., LASIK).
- Subjects with corneal scarring, keratoconus, or any other clinically significant corneal pathology.
- Subjects with an active corneal or conjunctival infection or inflammation in either eye.
- Subjects with microphthalmos or buphthalmos.
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- Subjects who are unable or unwilling to remove contact lenses before study measurements.
- Subjects with clinically significant dry eye disease that, in the investigator's opinion, may affect tonometry measurements.
- Subjects with blepharospasm (lid squeezing) or nystagmus that may interfere with accurate measurements.
- Subjects with abnormal central corneal thickness (CCT).
- Subjects with any condition or circumstance that, in the opinion of the investigator, could place the subject at significant risk, interfere with study participation, or confound interpretation of the study results.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Rovia East Coast Institute for Research Jacksonville - Eye Center
Jacksonville, Florida, 32256
Chief Scientific Officer & Head of Partnerships, 813-220-5217, rg@roviaclinical.com
About this study
This study is intended to evaluate the agreement between Intraocular pressure(IOP) measurements obtained with the FT-1000 non-contact tonometer and a GAT to confirm the feasibility of the measurement procedures.
This is a prospective comparative study that will be conducted at one clinical site in the United States. Subjects who sign an informed consent form and fulfill all inclusion and exclusion criteria will undergo FT-1000 measurements followed by Goldmann applanation tonometry during a single study visit.
Read more
The primary analysis will be performed using one preselected study eye from each subject. Measurements from the fellow eye, when available, may be summarized as exploratory analyses but will not contribute to the primary effectiveness analysis.
In general, descriptive statistics (n, mean, standard deviation, median, minimum and maximum) will be used to summarize continuous variables. Frequencies and percentages will be used to summarize categorical variables. The number of accepted scans and the total number of scans evaluated will be summarized by scan type, device, and subject population.
Agreement between the FT-1000 and the Goldmann applanation tonometer will be evaluated using the study eye measurements by calculating the mean difference, standard deviation (SD), 95% limits of agreement (LOA), Bland-Altman plots, Deming regression, and Pearson correlation coefficient.
Exploratory analyses may also be performed using fellow-eye measurements.
- Conditions
- Glaucoma
- Being tested
- Non Contact Tonometer and Applanation Tonometer
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non Contact Tonometer and Applanation TonometerDevice
Intraocular pressure measurement by non-contact tonometer and applanation tonometer.
| Study group | Role | What they receive |
|---|---|---|
| Low Intraocular pressure(IOP) Group: 7-16 mmHg | Group with IOP of 7-16 mmHg; 10 subjects. Receives: Device: Non Contact Tonometer and Applanation Tonometer | |
| Middle Intraocular pressure(IOP) Group: >16 to <23 mmHg | Group with IOP of >16 to <23 mmHg; 10 subjects. Receives: Device: Non Contact Tonometer and Applanation Tonometer | |
| High Intraocular pressure(IOP)Group: ≥23 mmHg | Group with IOP of ≥23 mmHg; 10 subjects. Receives: Device: Non Contact Tonometer and Applanation Tonometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement of the Intraocular pressure (IOP) mmHg between the test devices and predicate device
Agreement of the Intraocular pressure (IOP) mmHg between the FT-1000 and the Goldmann Applanation Tonometer(GAT) will be evaluated using the study eye measurements by calculating the mean difference, standard deviation (SD), 95% limits of agreement (LOA), Bland-Altman plots, Deming regression, and Pearson correlation coefficient.
Exploratory analyses may also be performed using fellow-eye measurements.
Measured: Through study completion, approximately 3 days
Safety of the test devices
Any adverse events observed or reported during the study visit will be assessed and documented.
Measured: Through study completion, approximately 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study start23 Sep 2026
- Primary completion28 Sep 2026 (estimated)
- Study completion28 Sep 2026 (estimated)
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
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tomey Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07804277
- Sponsor's protocol ID
- TomeyFT-1000-001
- Status last verified
- Oct 2026
- First submitted
- 31 Aug 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of the Tomey FT-1000, and Goldmann Applanation Tonometer (GAT)
- ClinicalTrials.gov ID
- NCT07804277
- Acronym / sponsor ID
- TomeyFT-1000-001
- Conditions
- Glaucoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tomey CorporationIndustry (pharma, biotech, devices)
- Study start
- 23 Sep 2026 (actual)
- Primary completion
- 28 Sep 2026 (estimated)
- Study completion
- 28 Sep 2026 (estimated)
- First posted
- 4 Sep 2026 (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.
This study is intended to evaluate the agreement between Intraocular pressure(IOP) measurements obtained with the FT-1000 non-contact tonometer and a GAT to confirm the feasibility of the measurement procedures.
This is a prospective comparative study that will be conducted at one clinical site in the United States. Subjects who sign an informed consent form and fulfill all inclusion and exclusion criteria will undergo FT-1000 measurements followed by Goldmann applanation tonometry during a single study visit.
The primary analysis will be performed using one preselected study eye from each subject. Measurements from the fellow eye, when available, may be summarized as exploratory analyses but will not contribute to the primary effectiveness analysis.
In general, descriptive statistics (n, mean, standard deviation, median, minimum and maximum) will be used to summarize continuous variables. Frequencies and percentages will be used to summarize categorical variables. The number of accepted scans and the total number of scans evaluated will be summarized by scan type, device, and subject population.
Agreement between the FT-1000 and the Goldmann applanation tonometer will be evaluated using the study eye measurements by calculating the mean difference, standard deviation (SD), 95% limits of agreement (LOA), Bland-Altman plots, Deming regression, and Pearson correlation coefficient.
Exploratory analyses may also be performed using fellow-eye measurements.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low Intraocular pressure(IOP) Group: 7-16 mmHg | – | Device: Non Contact Tonometer and Applanation TonometerGroup with IOP of 7-16 mmHg; 10 subjects. |
| Middle Intraocular pressure(IOP) Group: >16 to <23 mmHg | – | Device: Non Contact Tonometer and Applanation TonometerGroup with IOP of >16 to <23 mmHg; 10 subjects. |
| High Intraocular pressure(IOP)Group: ≥23 mmHg | – | Device: Non Contact Tonometer and Applanation TonometerGroup with IOP of ≥23 mmHg; 10 subjects. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Low Intraocular pressure(IOP) (22 years old or older) Middle Intraocular pressure(IOP)(22 years old or older) High Intraocular pressure(IOP)(22 years old or older)
Key inclusion criteria (4 listed)
- Male or female subjects 22 years of age or older who have full legal capacity to volunteer on the date the informed consent is signed.
- Subjects who are able to understand and follow the study procedures and instructions provided by the clinical staff.
- Subjects who voluntarily provide written informed consent.
- Subjects who satisfy all study eligibility requirements and are able to undergo both FT-1000 and Goldmann applanation tonometry measurements during the study visit.
Key exclusion criteria (11 listed)
- Subjects with only one functional eye.
- Subjects with poor or eccentric fixation in either eye.
- Subjects with a history of corneal surgery, including corneal laser or refractive surgery (e.g., LASIK).
- Subjects with corneal scarring, keratoconus, or any other clinically significant corneal pathology.
- Subjects with an active corneal or conjunctival infection or inflammation 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 |
|---|---|---|
| Non Contact Tonometer and Applanation TonometerIntraocular pressure measurement by non-contact tonometer and applanation tonometer. | Device | High Intraocular pressure(IOP)Group: ≥23 mmHg, Low Intraocular pressure(IOP) Group: 7-16 mmHg, Middle Intraocular pressure(IOP) Group: >16 to <23 mmHg |
Primary outcome
Agreement of the Intraocular pressure (IOP) mmHg between the test devices and predicate device
Time frame: Through study completion, approximately 3 days
Agreement of the Intraocular pressure (IOP) mmHg between the FT-1000 and the Goldmann Applanation Tonometer(GAT) will be evaluated using the study eye measurements by calculating the mean difference, standard deviation (SD), 95% limits of agreement (LOA), Bland-Altman plots, Deming regression, and Pearson correlation coefficient. Exploratory analyses may also be performed using fellow-eye measurements.
Safety of the test devices
Time frame: Through study completion, approximately 3 days
Any adverse events observed or reported during the study visit will be assessed and documented.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
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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.
Rovia East Coast Institute for Research Jacksonville - Eye Center
Jacksonville, United States
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 Glaucoma, run by Tomey 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 11 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: looking for participants now, as of the sponsor's last update on 6 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement of the Intraocular pressure (IOP) mmHg between the test devices and predicate device (time frame: Through study completion, approximately 3 days). 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 6 Oct 2026.