Comparative Study of the NIDEK TONOREF III with Predicate Devices

Comparative Study of the NIDEK TONOREF III with the Haag-Streit, Perkins Hand-held Applanation Tonometer for Tonometry Function and NIDEK TONOREF III with the NIDEK CEM-530 for Pachymetry Function

The primary objective of this clinical study is to prove that tonometry values for NIDEK TONOREF III are comparable to the predicate device and to prove that the pachymeter function of NIDEK TONOREF III is equivalent to the predicate device. The secondary objective is to demonstrate that the test device is as safe as the predicate devices.

Study Overview

• Status: Completed
• Conditions: Intraocular Pressure
• Intervention / Treatment: Device: NIDEK CEM-530; Device: NIDEK TONOREF III; Device: Haag-Streit, PERKINS HAND-HELD APPLANATION TONOMETER

• Study Type: Interventional
• Enrollment (Actual): 183
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Birmingham, United Kingdom, B4 7ET, UK
    • Aston University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Exclusion criteria

1. Subjects with only one functional eye;
2. Those with one eye having poor or eccentric fixation;
3. Those with corneal scarring or who have had corneal surgery including corneal laser surgery;
4. Microphthalmos;
5. Buphthalmos;
6. Contact lens wearers;
7. Dry eyes;
8. Lid squeezers - blepharospasm;
9. Nystagmus;
10. Keratoconus;
11. Any other corneal or conjunctival pathology or infection.
12. central corneal thickness greater than 0,600 mm or less than 0,500 mm (2 standard deviations about the human mean)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Adults 18 years old or older; NIDEK TONOREFIII

Device: NIDEK CEM-530; Nidek CEM-530 is a non-contact ophthalmic microscope, optical pachymeter, and camera used for examination of the corneal endothelium and for measurement of the thickness of the cornea.; Device: NIDEK TONOREF III; 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.; Device: Haag-Streit, PERKINS HAND-HELD APPLANATION TONOMETER; Haag-Streit Goldmann Manual Tonometer measures intraocular pressure to aid in the screening and diagnosis of glaucoma

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Equivalent to legally-marketed devices	Agreement of intraocular pressure (mmHg) measurement for TONOREFIII and PAT	One or two study visits per subject. One visit is less than two hours.
Equivalent to the pachymeter function	Agreement of central corneal thickness (µm) measurement for TONOREF III and CEM-530	One or two study visits per subject. One visit is less than two hours.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The numbers of adverse events	To demonstrate that the test device is as safe as the predicate devices.	One or two study visits per subject. One visit is less than two hours.

Collaborators and Investigators

• Sponsor: Nidek Co. LTD.
• Investigators: Study Director: Tadakazu Ichimura, Nidek Co. LTD.

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2024
• Primary Completion (Actual): December 13, 2024
• Study Completion (Actual): December 13, 2024

Study Registration Dates

• First Submitted: March 24, 2024
• First Submitted That Met QC Criteria: April 9, 2024
• First Posted (Actual): April 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 6, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: NIDEK-TONOREF-UK-0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No