N/A
N=225
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
Bottom Line
View on ClinicalTrials.gov: NCT03441477 ↗Enrolled (actual)
225
Serious AEs
0.0%
Results posted
Feb 2022
Primary outcome: Primary: Agreement of Intraocular Pressure — 0.3 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Nidek Tonoref III (Device); Haag-Streit Goldmann Manual Tonometer (Device); NIDEK CEM-530 (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Nidek Co. LTD.
- Primary completion
- Jan 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Agreement of Intraocular Pressure |
0.3 | — |
| PRIMARY Agreement of Corneal Thickness |
-7.1 | — |
| SECONDARY Number of Occurrences of Adverse Events |
1 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03441477). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.