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Completed

NCT Number: NCT07152808

Clinical Study for TONOREF III Tested to ANSI Z80.10-2014

The primary objective of this clinical study was to show that tonometry values for TONOREF III, as the representative device of the NIDEK tonometer series, were comparable to the predicate device.

The secondary objective was to demonstrate that the test device was as safe as the predicate device.

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Key information

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Each subject had to have:

  • been at least 22 years of age of either sex and any race or ethnicity;
  • been willing and able to provide written informed consent prior to any study procedures being performed;
  • been willing and able to follow all instructions and attend all study visits;
  • corneal astigmatism of ≤3D and corneal thickness of 500-600 μm in at least one eye.

Exclusion criteria

Each subject had to not to :

  • have only one functional eye;
  • have poor or eccentric fixation in the study eye;
  • have corneal scarring or have had corneal surgery, including corneal laser surgery in the study eye
  • have microphthalmos in the study eye;
  • have buphthalmos in the study eye;
  • be a contact lens wearer in the study eye;
  • have dry eyes;
  • be a lid squeezer - blepharospasm;
  • have nystagmus in the study eye;
  • have keratoconus in the study eye;
  • have any other corneal or conjunctival pathology or infection in the study eye;
  • use medication that affect IOP;
  • current participation in other clinical trials;
  • have a condition or a situation, which in the Investigator's opinion, may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation.

Treatment and study plan

Nidek Tonoref III

Device

The auto ref/kerato/tono/pachymeter TONOREF III is a medical device which measures objective refractive errors, corneal curvature radius, intraocular pressure and corneal thickness of the patient's eye.

Haag-Streit Goldmann Manual Tonometer

Device

Haag-Streit Goldmann Manual Tonometer measures intraocular pressure to aid in the screening and diagnosis of glaucoma

Primary outcomes

  1. Agreement of Intraocular Pressure

    Time frame: 1-2 study visits per subject over the course of 8 days

    Agreement of the measured IOP between the test device and the predicate device (GAT) for the tonometer function of the TONOREF III. (Agreement means the similarity of results when measurements from the test device and the predicate device are compared against each other.)

Secondary outcomes

  1. The Numbers of Adverse Events

    Time frame: 1-2 study visits per subject over the course of 8 days

    To demonstrate that the test device is as safe as GAT

Sponsors and collaborators

Lead sponsor

Nidek Co. LTD.

Industry

Registry information

Official study title

Clinical Pilot Study to Provide Research Data for TONOREF III Tested to ANSI Z80.10-2014

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 3, 2025
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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