Trials / Completed
CompletedNCT07156630
Quick Measure Study for iCare ST500 and iCare IC200
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 122 (actual)
- Sponsor
- Icare Finland Oy · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
The aim of this clinical study is to compare the agreement and precision of the intraocular pressure (IOP) results measured with the Quick Measure feature of iCare ST500 and iCare IC200 tonometers with results obtained with reference tonometers (Goldmann applanation tonometry and Tono-Vera tonometer). The data will be collected and evaluated in accordance with ISO 8612:2009 "Ophthalmic Instruments - Tonometers" (at least 120 eyes divided in three IOP groups with a minimum of 40 eyes per group, 95% of the paired differences between the reference tonometer and the test tonometer must fall within the tolerance of ±5 mmHg).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | iCare ST500 | Measurement of IOP |
| DEVICE | iCare IC200 | Measurement of IOP |
| DEVICE | GAT | Measurement of IOP |
| DEVICE | Tonovera | Measurement of IOP |
Timeline
- Start date
- 2025-08-28
- Primary completion
- 2025-12-03
- Completion
- 2025-12-03
- First posted
- 2025-09-05
- Last updated
- 2025-12-11
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07156630. Inclusion in this directory is not an endorsement.