Recruiting

FT-1000 & GAT

Sponsor:

Tomey Corporation

Code:

NCT07804277

Conditions

Glaucoma

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Accepted

Interventions

Non Contact Tonometer and Applanation Tonometer

Study Details

Brief 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. 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.

Conditions

Glaucoma

Study ID

NCT07804277

Start date

Sep 23, 2026

Status verified date

Oct, 2026

Completion date

Sep 28, 2026

Anticipated

Primary completion date

Sep 28, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. 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.
2. Subjects who are able to understand and follow the study procedures and instructions provided by the clinical staff.
3. Subjects who voluntarily provide written informed consent.
4. Subjects who satisfy all study eligibility requirements and are able to undergo both FT-1000 and Goldmann applanation tonometry measurements during the study visit.

Exclusion Criteria:

1. Subjects with only one functional eye.
2. Subjects with poor or eccentric fixation in either eye.
3. Subjects with a history of corneal surgery, including corneal laser or refractive surgery (e.g., LASIK).
4. Subjects with corneal scarring, keratoconus, or any other clinically significant corneal pathology.
5. Subjects with an active corneal or conjunctival infection or inflammation in either eye.
6. Subjects with microphthalmos or buphthalmos.
7. Subjects who are unable or unwilling to remove contact lenses before study measurements.
8. Subjects with clinically significant dry eye disease that, in the investigator's opinion, may affect tonometry measurements.
9. Subjects with blepharospasm (lid squeezing) or nystagmus that may interfere with accurate measurements.
10. Subjects with abnormal central corneal thickness (CCT).
11. 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.

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

Low Intraocular pressure(IOP) Group: 7-16 mmHg

Group with IOP of 7-16 mmHg; 10 subjects.

Middle Intraocular pressure(IOP) Group: >16 to <23 mmHg

Group with IOP of >16 to <23 mmHg; 10 subjects.

High Intraocular pressure(IOP)Group: ≥23 mmHg

Group with IOP of ≥23 mmHg; 10 subjects.

Interventions

Non Contact Tonometer and Applanation Tonometer

Intraocular pressure measurement by non-contact tonometer and applanation tonometer.

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 ]
  • Safety of the test devices [ Time Frame: Through study completion, approximately 3 days ]

Central Contacts and Locations

Locations

Rovia East Coast Institute for Research Jacksonville - Eye Center

Recruiting

Jacksonville, Florida, United States, 32256

Contacts

Chief Scientific Officer & Head of Partnerships

813-220-5217rg@roviaclinical.com

More Information

Sponsor

Tomey Corporation

Last update posted

Oct 6, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-07. This information was provided to ClinicalTrials.gov by Tomey Corporation on 2026-10-06. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.