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

NCT07152808 | Completed Results

• 1 other identifier: NIDEK-TONOREF-PILOT-0002
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Intraocular Pressure

Outcome Measures

Primary Outcomes (1)

• Agreement of Intraocular Pressure

  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.)

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

Secondary Outcomes (1)

• The Numbers of Adverse Events

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

Study Arms (1)

TONOREF III and Goldmann Tonometer Measurements

EXPERIMENTAL

Subjects will undergo IOP measurements using both the investigational device (TONOREF III) and the predicate device (Goldmann Applanation Tonometer).

Device: NIDEK TONOREF III; Device: Haag-Streit Goldmann Manual Tonometer

Interventions

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.

TONOREF III and Goldmann Tonometer Measurements

Haag-Streit Goldmann Manual Tonometer DEVICE

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

TONOREF III and Goldmann Tonometer Measurements

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nidek Co. LTD.: lead

Results Point of Contact

• Title: Tadakazu Ichimura
• Organization: NIDEK CO., LTD.

tadakazu_ichimura@nidek.co.jp

+81-533-67-8904

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 3, 2025
• Study Start: September 2, 2022
• Primary Completion: June 19, 2023
• Study Completion: June 19, 2023
• Last Updated: April 24, 2026
• Results First Posted: February 4, 2026

Record last verified: 2026-04