Comparative Study of the Tomey FT-1000, and Goldmann Applanation Tonometer (GAT)

Conditions

• Glaucoma

Eligibility Criteria

Sex

ALL

Age

22 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Non Contact Tonometer and Applanation Tonometer — DEVICE
  Intraocular pressure measurement by non-contact tonometer and applanation tonometer.

Study Details

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.

Key Dates

First listed

Sep 4, 2026

Start date

Sep 23, 2026

Status verified

Oct 2026

Primary completion

Sep 28, 2026

Completion

Sep 28, 2026

Study Design

Enrollment

30 participants (estimated)

Arms

• Arm: Low Intraocular pressure(IOP) Group: 7-16 mmHg
  Group with IOP of 7-16 mmHg; 10 subjects.
• Arm: Middle Intraocular pressure(IOP) Group: >16 to <23 mmHg
  Group with IOP of \>16 to \<23 mmHg; 10 subjects.
• Arm: High Intraocular pressure(IOP)Group: ≥23 mmHg
  Group with IOP of ≥23 mmHg; 10 subjects.

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 ]

Locations (1)

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