Comparative Study of the NIDEK TONOREF III with Predicate Devices

NCT06363045 | Completed

• 1 other identifier: NIDEK-TONOREF-UK-0001
• Study Type: interventional
• Target: 183
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intraocular Pressure

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• The numbers of adverse events

  One or two study visits per subject. One visit is less than two hours.

Study Arms (1)

Adults 18 years old or older

EXPERIMENTAL

NIDEK TONOREFIII

Device: NIDEK TONOREF III; Device: Haag-Streit, PERKINS HAND-HELD APPLANATION TONOMETER; Device: NIDEK CEM-530

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.

Adults 18 years old or older

Haag-Streit, PERKINS HAND-HELD APPLANATION TONOMETER DEVICE

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

Adults 18 years old or older

NIDEK CEM-530 DEVICE

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.

Adults 18 years old or older

Eligibility Criteria

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

You may not qualify if:

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

Sponsors & Collaborators

• Nidek Co. LTD.: lead

Study Sites (1)

Aston University

Birmingham, Birmingham, B4 7ET, UK, United Kingdom

Location

Study Officials

• Tadakazu Ichimura

  Nidek Co. LTD.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2024
• First Posted: April 12, 2024
• Study Start: June 27, 2024
• Primary Completion: December 13, 2024
• Study Completion: December 13, 2024
• Last Updated: March 7, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)