Comparative Study of the NIDEK TONOREF III with Predicate Devices

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

183 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-27

Study Completion Date

2024-12-13

Brief Summary

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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.

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Detailed Description

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Conditions

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Intraocular Pressure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Adults 18 years old or older

NIDEK TONOREFIII

Group Type EXPERIMENTAL

NIDEK TONOREF III

Intervention Type DEVICE

The auto ref/kerato/tono/pachymeter TONOREF III is a medical device which measures objective refractive errors, corneal curvature radius, intraocular pressure and corneal thickness of the patient's eye.

Haag-Streit, PERKINS HAND-HELD APPLANATION TONOMETER

Intervention Type DEVICE

Haag-Streit Goldmann Manual Tonometer measures intraocular pressure to aid in the screening and diagnosis of glaucoma

NIDEK CEM-530

Intervention Type DEVICE

Nidek CEM-530 is a non-contact ophthalmic microscope, optical pachymeter, and camera used for examination of the corneal endothelium and for measurement of the thickness of the cornea.

Interventions

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NIDEK TONOREF III

The auto ref/kerato/tono/pachymeter TONOREF III is a medical device which measures objective refractive errors, corneal curvature radius, intraocular pressure and corneal thickness of the patient's eye.

Intervention Type DEVICE

Haag-Streit, PERKINS HAND-HELD APPLANATION TONOMETER

Haag-Streit Goldmann Manual Tonometer measures intraocular pressure to aid in the screening and diagnosis of glaucoma

Intervention Type DEVICE

NIDEK CEM-530

Nidek CEM-530 is a non-contact ophthalmic microscope, optical pachymeter, and camera used for examination of the corneal endothelium and for measurement of the thickness of the cornea.

Intervention Type DEVICE

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes