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

Intraocular Pressure Clinical Trial

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03441477
• Other study ID #: NIDEK-TONOREF-US-0001
• Status: Completed
• Start date: December 17, 2017
• Est. completion date: January 16, 2019

Study information

• Verified date: January 2022
• Source: Nidek Co. LTD.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 225
• Est. completion date: January 16, 2019
• Est. primary completion date: January 16, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. be at least 18 years of age of either sex and any race or ethnicity;

2. be willing and able to provide written informed consent prior to any study procedures being performed;

3. be willing and able to follow all instructions and attend all study visits;

Exclusion Criteria:

1. have only one functional eye;

2. have poor or eccentric fixation in either eye;

3. have corneal scarring or have had corneal surgery, including corneal laser surgery in either eye;

4. have microphthalmos in either eye;

5. have buphthalmos in either eye;

6. 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;

7. 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;

8. be a lid squeezer - blepharospasm;

9. have nystagmus in either eye;

10. have keratoconus in either eye;

11. have any other corneal or conjunctival pathology or infection in either eye;

12. 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.

Related Conditions & MeSH terms

• Intraocular Pressure

Intervention

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

Locations

Country	Name	City	State
United States	Andover Eye Associates	Andover	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Nidek Co. LTD.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Number of Occurrences of Adverse Events	Any sight threatening adverse event associated with the test and predicate devices.	1day