Comparative Study of the NIDEK TONOREF III with Predicate Devices

Nidek

Status: Completed

Conditions: Intraocular Pressure

Treatments: Device: NIDEK TONOREF III; Device: Haag-Streit, PERKINS HAND-HELD APPLANATION TONOMETER; Device: NIDEK CEM-530

Study type: Interventional

Funder types: Industry

Identifiers

NCT06363045

NIDEK-TONOREF-UK-0001

Details and patient eligibility

About

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.

Enrollment: 183 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Exclusion criteria

1. Subjects with only one functional eye;
2. Those with one eye having poor or eccentric fixation;
3. Those with corneal scarring or who have had corneal surgery including corneal laser surgery;
4. Microphthalmos;
5. Buphthalmos;
6. Contact lens wearers;
7. Dry eyes;
8. Lid squeezers - blepharospasm;
9. Nystagmus;
10. Keratoconus;
11. Any other corneal or conjunctival pathology or infection.
12. central corneal thickness greater than 0,600 mm or less than 0,500 mm (2 standard deviations about the human mean)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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183 participants in 1 patient group

Adults 18 years old or older

Experimental group

Description:

NIDEK TONOREFIII

Treatment:

Device: NIDEK CEM-530

Device: Haag-Streit, PERKINS HAND-HELD APPLANATION TONOMETER

Device: NIDEK TONOREF III