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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
22 Years and older
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares two devices that measure pressure inside the eye: the Tomey FT-1000 and the Goldmann applanation tonometer (GAT). It is for adults age 22 or older who meet the study's eye health rules. Both devices will be used during one study visit.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 22 or older and legally able to choose to join the study.
  • Be able to understand and follow the study steps and staff instructions.
  • Choose to join and sign a written consent form.
  • Meet all study rules and be able to have eye pressure measured with both devices during the visit.

Who can't join

  • Have only one working eye, or have trouble keeping either eye focused on a target.
  • Have had surgery on the cornea, the clear front of the eye, including laser surgery such as LASIK.
  • Have corneal scars, keratoconus (a cone-shaped cornea), another major cornea problem, or abnormal thickness in the center of the cornea.
  • Have an active infection or swelling in the cornea or the thin tissue covering the white of either eye.
  • Have an unusually small or enlarged eyeball.
  • Cannot or will not remove contact lenses before testing.
  • Have dry eye disease, eyelid squeezing, or uncontrolled eye movements that may affect the measurements.
  • Have any other condition or situation that the study doctor thinks could make joining unsafe, interfere with taking part, or make results hard to understand.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

FL