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

NCT07804277 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2026-09-04

No results posted yet for this study

Summary

This study is intended to evaluate the agreement between 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.

Conditions

Interventions

DEVICE

Non Contact Tonometer and Applanation Tonometer

Intraocular pressure measurement by non-contact tonometer and applanation tonometer.

Sponsors & Collaborators

  • Tomey Corporation

    lead INDUSTRY

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-24
Primary Completion
2026-09-28
Completion
2026-09-28
FDA Device
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07804277 on ClinicalTrials.gov