Comparative Study of the NIDEK TONOREF III with Predicate Devices
Not Applicable
Completed
- Conditions
- Intraocular Pressure
- Interventions
- Device: NIDEK TONOREF IIIDevice: Haag-Streit, PERKINS HAND-HELD APPLANATION TONOMETERDevice: NIDEK CEM-530
- Registration Number
- NCT06363045
- Lead Sponsor
- Nidek Co. LTD.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 183
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Adults 18 years old or older NIDEK TONOREF III NIDEK TONOREFIII Adults 18 years old or older Haag-Streit, PERKINS HAND-HELD APPLANATION TONOMETER NIDEK TONOREFIII Adults 18 years old or older NIDEK CEM-530 NIDEK TONOREFIII
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Aston University
🇬🇧Birmingham, United Kingdom