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Completed

NCT Number: NCT03441477

Comparative Study of the NIDEK TONOREF III and the Haag-Streit Goldmann Manual Tonometer and Comparison of Pachymetry Values for NIDEK TONOREF III With the NIDEK CEM-530

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

Primary location

Andover Eye Associates

Andover, Massachusetts, 01810, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • be at least 18 years of age of either sex and any race or ethnicity;
  • be willing and able to provide written informed consent prior to any study procedures being performed;
  • be willing and able to follow all instructions and attend all study visits;

Exclusion criteria

  • have only one functional eye;
  • have poor or eccentric fixation in either eye;
  • have corneal scarring or have had corneal surgery, including corneal laser surgery in either eye;
  • have microphthalmos in either eye;
  • have buphthalmos in either eye;
  • be a contact lens wearer, meaning having worn soft contact lenses within the past 3 months and/or rigid permeable gas lenses within the past 6 months;
  • have dry eyes, meaning having been diagnosed by a physician with dry eyes and currently using a prescribed medication or daily use of artificial tears;
  • be a lid squeezer - blepharospasm;
  • have nystagmus in either eye;
  • have keratoconus in either eye;
  • have any other corneal or conjunctival pathology or infection in either eye;
  • 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

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. Agreement of Intraocular Pressure

    Time frame: 1 day

    Agreement of the measured IOP between the test device and the predicate device for the tonometer function of NIDEK TONOREF III.

    The mean difference and the standard deviation between these two devices are shown in the outcome measures table.

  2. Agreement of Corneal Thickness

    Time frame: 1 day

    Agreement of the measured corneal thickness between the test device and the predicate device for the pachymeter function of the NIDEK TONOREF III.

    The mean difference and the standard deviation between these two devices are shown in the outcome measure table.

Secondary outcomes

  1. Number of Occurrences of Adverse Events

    Time frame: 1day

    Any sight threatening adverse event associated with the test and predicate devices.

Sponsors and collaborators

Lead sponsor

Nidek Co. LTD.

Industry

Registry information

Official study title

Comparative Study of the NIDEK TONOREF III and the Haag-Streit Goldmann Manual Tonometer (Predicate) to Demonstrate Conformance to ANSI Z80.10-2014 Ophthalmic Instruments - Tonometers, to the FDA Guidance for Industry and FDA Staff, Tonometer-Premarket Notification [510(k)] Submissions, and to the Applicable Supplemental Information Sheet and Comparison of Pachymetry Values for NIDEK TONOREF III With the NIDEK CEM-530 (Predicate)

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Feb 22, 2018
Registry last updated
Jul 3, 2023

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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