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Quick Measure Study for iCare ST500 and iCare IC200

Quick Measure Study for iCare ST500 and iCare IC200

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07156630
Enrollment
122
Registered
2025-09-05
Start date
2025-08-28
Completion date
2025-12-03
Last updated
2025-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intraocular Pressure

Brief 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).

Interventions

DEVICEiCare ST500

Measurement of IOP

DEVICEiCare IC200

Measurement of IOP

DEVICEGAT

Measurement of IOP

DEVICETonovera

Measurement of IOP

Sponsors

Icare Finland Oy
Lead SponsorINDUSTRY

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

Inclusion criteria

1\. Age ≥ 18 years

Exclusion criteria

1. Subjects with only one functional eye 2. Subjects having poor or eccentric fixation in the study eye 3. High corneal astigmatism \>3D in the study eye 4. Central corneal scarring 5. History of prior incisional glaucoma surgery or corneal surgery, including corneal refractive laser surgery in the study eye 6. Microphthalmos 7. Buphthalmos 8. Contact lens use within one week of continuous wear and within one hour if lens is worn occasionally 9. Dry eyes (clinically significant) 10. Lid squeezers - blepharospasm 11. Nystagmus 12. Keratoconus 13. Any other corneal or conjunctival pathology or infection relevant to this study 14. Central corneal thickness greater than 600 μm or less than 500 μm in the study eye 15. Cataract Extraction within last 2 months in the study eye

Design outcomes

Primary

MeasureTime frameDescription
Demonstrate compliance with ISO 8612:2009-Ophthalmics-Ophthalmic Instruments-TonometersThrough study completion, estimated 4 monthsSubjects will be distributed into Low IOP, Medium IOP, and High IOP groups based on Goldmann Applanation Tonometer measurements. The iCare ST500 Tonometer and iCare IC200 Tonometer measurements will be within +/-5.0 mmHg of the Goldmann Applanation Tonometer measurements in all groups.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026