An observational study in Glaucoma, sponsored by Tomey Corporation. Not yet recruiting. Open to participants aged 22 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Tomey Corporation · Observational
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.
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)
Exclusion Criteria:
Group with IOP of 7-16 mmHg; 10 subjects.
Device: Non Contact Tonometer and Applanation Tonometer
Group with IOP of \>16 to \<23 mmHg; 10 subjects.
Device: Non Contact Tonometer and Applanation Tonometer
Group with IOP of ≥23 mmHg; 10 subjects.
Device: Non Contact Tonometer and Applanation Tonometer
Intraocular pressure measurement by non-contact tonometer and applanation tonometer.
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.
Time frame: 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.
Time frame: Through study completion, approximately 3 days
No study locations are listed for this record.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Tomey Corporation