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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06363045
Other study ID # NIDEK-TONOREF-UK-0001
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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.
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