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



Status:Recruiting
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:2/23/2018
Start Date:December 17, 2017
End Date:April 2018
Contact:Toshio Murata
Email:toshio_murata@nidek.com
Phone:800-223-9044

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Trial Summary
Trial Overview
Inclusion Criteria

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)

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.


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.
We found this trial at
1
site
Andover Eye Associates
Andover, Massachusetts 01810
Phone: 978-685-8900
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from
Andover, MA
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