Clinical Study for TONOREF III Tested to ANSI Z80.10-2014

Nidek

Status: Completed

Conditions: Intraocular Pressure

Treatments: Device: Haag-Streit Goldmann Manual Tonometer; Device: NIDEK TONOREF III

Study type: Interventional

Funder types: Industry

Identifiers

NCT07152808

NIDEK-TONOREF-PILOT-0002

Details and patient eligibility

About

The primary objective of this clinical study was to show that tonometry values for TONOREF III, as the representative device of the NIDEK tonometer series, were comparable to the predicate device.

The secondary objective was to demonstrate that the test device was as safe as the predicate device.

Enrollment: 52 patients

Sex: All

Ages: 22+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Each subject had to have:

1. been at least 22 years of age of either sex and any race or ethnicity;
2. been willing and able to provide written informed consent prior to any study procedures being performed;
3. been willing and able to follow all instructions and attend all study visits;
4. corneal astigmatism of ≤3D and corneal thickness of 500-600 μm in at least one eye.

Exclusion criteria

Each subject had to not to :

1. have only one functional eye;
2. have poor or eccentric fixation in the study eye;
3. have corneal scarring or have had corneal surgery, including corneal laser surgery in the study eye
4. have microphthalmos in the study eye;
5. have buphthalmos in the study eye;
6. be a contact lens wearer in the study eye;
7. have dry eyes;
8. be a lid squeezer - blepharospasm;
9. have nystagmus in the study eye;
10. have keratoconus in the study eye;
11. have any other corneal or conjunctival pathology or infection in the study eye;
12. use medication that affect IOP;
13. current participation in other clinical trials;
14. 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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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52 participants in 1 patient group

TONOREF III and Goldmann Tonometer Measurements

Experimental group

Description:

Subjects will undergo IOP measurements using both the investigational device (TONOREF III) and the predicate device (Goldmann Applanation Tonometer).

Treatment:

Device: NIDEK TONOREF III

Device: Haag-Streit Goldmann Manual Tonometer