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

Completed

• Conditions: Intraocular Pressure

• Registration Number: NCT03441477
• Lead Sponsor: Nidek Co. LTD.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-12-17
• Study First Submitted: 2018-01-17
• Study First Submitted QC: 2018-02-14
• Study First Posted: 2018-02-22
• Primary Completion: 2019-01-16
• Study Completion: 2019-01-16
• Disposition First Submitted: 2020-08-05
• Results First Submitted: 2021-12-13
• Status Verified: 2022-01
• Results First Submitted QC: 2022-01-18
• Disposition First Submitted QC: 2022-01-18
• Results First Posted: 2022-02-11
• Disposition First Posted: 2022-02-11
• Last Update Submitted: 2023-06-29
• Last Update Posted: 2023-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 225

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Agreement of Intraocular Pressure	1 day	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.
Agreement of Corneal Thickness	1 day	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.

Secondary Outcome Measures

Name	Time	Method
Number of Occurrences of Adverse Events	1day	Any sight threatening adverse event associated with the test and predicate devices.

Trial Locations

Locations (1)

Andover Eye Associates; 🇺🇸 Andover, Massachusetts, United States