Comparing two eye pressure measuring devices in people with glaucoma
Compares a no-touch eye pressure device with the standard tonometer in glaucoma.
Plain-language title generated from the registry record
Registry title: Comparative Study of the Tomey FT-1000, and Goldmann Applanation Tonometer (GAT)
Key facts
- Where
- Jacksonville, United StatesSee the site
Where in United States
- Rovia East Coast Institute for Research Jacksonville - Eye CenterJacksonville, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Tomey Corporation
- Trial code
- NCT07804277
- Record updated
- 6 October 2026
- Original description
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.Read full original descriptionShow less
Comparative Study of the Tomey FT-1000, and Goldmann Applanation Tonometer (GAT)
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.
Inclusion: 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.
Exclusion: Subjects with a history of corneal surgery, including corneal laser or refractive surgery (e.g., LASIK); Subjects with an active corneal or conjunctival infection or inflammation in either eye; Subjects with clinically significant dry eye disease that, in the investigator's opinion, may affect tonometry measurements; 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; Subjects with only one functional eye; Subjects with poor or eccentric fixation in either eye; Subjects with corneal scarring, keratoconus, or any other clinically significant corneal pathology; Subjects with microphthalmos or buphthalmos; Subjects who are unable or unwilling to remove contact lenses before study measurements; Subjects with blepharospasm (lid squeezing) or nystagmus that may interfere with accurate measurements; Subjects with abnormal central corneal thickness (CCT).