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Completed

NCT Number: NCT06363045

Comparative Study of the NIDEK TONOREF III with Predicate Devices

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.

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Key information

Conditions

Intraocular Pressure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aston University

Birmingham, B4 7ET, UK, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

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

Exclusion criteria

  • 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)

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, PERKINS HAND-HELD APPLANATION TONOMETER

Device

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

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.

Primary outcomes

  1. Equivalent to legally-marketed devices

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

    Agreement of intraocular pressure (mmHg) measurement for TONOREFIII and PAT

  2. Equivalent to the pachymeter function

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

    Agreement of central corneal thickness (µm) measurement for TONOREF III and CEM-530

Secondary outcomes

  1. The numbers of adverse events

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

    To demonstrate that the test device is as safe as the predicate devices.

Sponsors and collaborators

Lead sponsor

Nidek Co. LTD.

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 12, 2024
Registry last updated
Mar 7, 2025

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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