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

NCT03441477 | Completed Results

• 1 other identifier: NIDEK-TONOREF-US-0001
• Study Type: interventional
• Target: 225
• 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)

• Agreement of Intraocular Pressure

  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.

  1 day

• Agreement of Corneal Thickness

  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.

  1 day

Secondary Outcomes (1)

• Number of Occurrences of Adverse Events

  1day

Study Arms (1)

Adults 18 years old or older

EXPERIMENTAL

Nidek Tonoref III

Device: Nidek Tonoref III; Device: Haag-Streit Goldmann Manual 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 Goldmann Manual 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 qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nidek Co. LTD.: lead

Study Sites (1)

Andover Eye Associates

Andover, Massachusetts, 01810, United States

Location

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: January 17, 2018
• First Posted: February 22, 2018
• Study Start: December 17, 2017
• Primary Completion: January 16, 2019
• Study Completion: January 16, 2019
• Last Updated: July 3, 2023
• Results First Posted: February 11, 2022

Record last verified: 2022-01

Locations

US (1)