Status:
COMPLETED
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
Lead Sponsor:
Nidek Co. LTD.
Conditions:
Intraocular Pressure
Eligibility:
All Genders
18+ years
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 I...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 17 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 16 2019
Estimated Enrollment :
225 Patients enrolled
Trial Details
Trial ID
NCT03441477
Start Date
December 17 2017
End Date
January 16 2019
Last Update
July 3 2023
Active Locations (1)
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1
Andover Eye Associates
Andover, Massachusetts, United States, 01810