An observational study in Glaucoma, sponsored by Tomey Corporation. Recruiting at 1 site in United States. Open to participants aged 22 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-06.
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.
1,419 studies on the registry are indexed under Glaucoma; 223 are open to participants now.
This study's planned enrollment of 30 is below the median of 101 across 385 observational studies indexed under Glaucoma.
Browse Glaucoma studies →Tomey Corporation is the lead sponsor of 6 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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)
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Tomey Corporation