Comparative Study of the NIDEK TONOREF III With Predicate Devices

Intraocular Pressure Clinical Trial

Official title:

Comparative Study of the NIDEK TONOREF III With the Haag-Streit, Perkins Hand-held Applanation Tonometer for Tonometry Function and NIDEK TONOREF III With the NIDEK CEM-530 for Pachymetry Function

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06363045
• Other study ID #: NIDEK-TONOREF-UK-0001
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: November 2024

Study information

• Verified date: April 2024
• Source: Nidek Co. LTD.
• Contact: Tadakazu Ichimura
• Phone: 0533678904
• Email: tadakazu_ichimura[@]nidek.co.jp
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 220
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Intraocular Pressure

Intervention

Device:
• 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.
• Haag-Streit, PERKINS HAND-HELD APPLANATION TONOMETER
Haag-Streit Goldmann Manual Tonometer measures intraocular pressure to aid in the screening and diagnosis of glaucoma
• 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.

Locations

Country	Name	City	State
United Kingdom	Aston University	Birmingham

Sponsors (1)

Lead Sponsor	Collaborator
Nidek Co. LTD.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Equivalent to legally-marketed devices	Agreement of intraocular pressure (mmHg) measurement for TONOREFIII and PAT	One or two study visits per subject. One visit is less than two hours.
Primary	Equivalent to the pachymeter function	Agreement of central corneal thickness (µm) measurement for TONOREF III and CEM-530	One or two study visits per subject. One visit is less than two hours.
Secondary	The numbers of adverse events	To demonstrate that the test device is as safe as the predicate devices.	One or two study visits per subject. One visit is less than two hours.