Quick Measure Study for iCare ST500 and iCare IC200

Not Applicable

Recruiting

• Conditions: Intraocular Pressure

• Registration Number: NCT07156630
• Lead Sponsor: Icare Finland Oy

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-08-21
• Study Start: 2025-08-28
• Study First Submitted QC: 2025-09-01
• Study First Posted: 2025-09-05
• Status Verified: 2025-10
• Last Update Submitted: 2025-10-02
• Last Update Posted: 2025-10-07
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Demonstrate compliance with ISO 8612:2009-Ophthalmics-Ophthalmic Instruments-Tonometers	Through study completion, estimated 4 months	Subjects 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.

Trial Locations

Locations (1)

NVision Clinical Research LLC; 🇺🇸 Torrance, California, United States