Intraocular Pressure
Conditions
Brief 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.
Interventions
DEVICENIDEK 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.
DEVICEHaag-Streit, PERKINS HAND-HELD APPLANATION TONOMETER
Haag-Streit Goldmann Manual Tonometer measures intraocular pressure to aid in the screening and diagnosis of glaucoma
DEVICENIDEK 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.
Sponsors
Nidek Co. LTD.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Equivalent to legally-marketed devices | One or two study visits per subject. One visit is less than two hours. | Agreement of intraocular pressure (mmHg) measurement for TONOREFIII and PAT |
| Equivalent to the pachymeter function | One or two study visits per subject. One visit is less than two hours. | Agreement of central corneal thickness (µm) measurement for TONOREF III and CEM-530 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The numbers of adverse events | One or two study visits per subject. One visit is less than two hours. | To demonstrate that the test device is as safe as the predicate devices. |
Countries
United Kingdom
Outcome results
None listed