Trials / Completed
CompletedNCT07152808
Clinical Study for TONOREF III Tested to ANSI Z80.10-2014
Clinical Pilot Study to Provide Research Data for TONOREF III Tested to ANSI Z80.10-2014
- Status
- Completed
- Phase
- —
- Study type
- Interventional
- Enrollment
- 52 (actual)
- Sponsor
- Nidek Co. LTD. · Industry
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Accepted
Summary
The primary objective of this clinical study was to show that tonometry values for TONOREF III, as the representative device of the NIDEK tonometer series, were comparable to the predicate device. The secondary objective was to demonstrate that the test device was as safe as the predicate device.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| DEVICE | Haag-Streit Goldmann Manual Tonometer | Haag-Streit Goldmann Manual Tonometer measures intraocular pressure to aid in the screening and diagnosis of glaucoma |
Timeline
- Start date
- 2022-09-02
- Primary completion
- 2023-06-19
- Completion
- 2023-06-19
- First posted
- 2025-09-03
- Last updated
- 2026-02-04
- Results posted
- 2026-02-04
Source: ClinicalTrials.gov record NCT07152808. Inclusion in this directory is not an endorsement.