Comparative Study of the Tomey FT-1000, and Goldmann Applanation Tonometer (GAT)
ConditionGlaucoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age22+
SponsorTomey Corporation
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Subjects with only one functional eye.
Subjects with poor or eccentric fixation in either eye.
Subjects with a history of corneal surgery, including corneal laser or refractive surgery (e.g., LASIK).
Subjects with corneal scarring, keratoconus, or any other clinically significant corneal pathology.
Trial population
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)
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Non Contact Tonometer and Applanation Tonometer
DeviceIntraocular pressure measurement by non-contact tonometer and applanation tonometer.
Treatment groups
30 Participants
are divided into 3 treatment groupsGroup A: Low Intraocular pressure(IOP) Group: 7-16 mmHg1 intervention
Group B: Middle Intraocular pressure(IOP) Group: >16 to <23 mmHg1 intervention
Group C: High Intraocular pressure(IOP)Group: ≥23 mmHg1 intervention
Trial outcomes
Primary outcomes
1
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 days2
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 daysSponsors and contacts
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Source ClinicalTrials.gov