Quick Measure Study for iCare ST500 and iCare IC200

NCT07156630 | Completed FDA Device

• 1 other identifier: TA04-310
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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).

Conditions

Intraocular Pressure

Outcome Measures

Primary Outcomes (1)

• Demonstrate compliance with ISO 8612:2009-Ophthalmics-Ophthalmic Instruments-Tonometers

  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.

  Through study completion, estimated 4 months

Study Arms (1)

iCare ST500 and iCare IC200 vs GAT and Tonovera

EXPERIMENTAL

Device: iCare ST500; Device: iCare IC200; Device: GAT; Device: Tonovera

Interventions

iCare ST500 DEVICE

Measurement of IOP

iCare ST500 and iCare IC200 vs GAT and Tonovera

iCare IC200 DEVICE

Measurement of IOP

iCare ST500 and iCare IC200 vs GAT and Tonovera

GAT DEVICE

Measurement of IOP

iCare ST500 and iCare IC200 vs GAT and Tonovera

Tonovera DEVICE

Measurement of IOP

iCare ST500 and iCare IC200 vs GAT and Tonovera

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Age ≥ 18 years

You may not qualify if:

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

Sponsors & Collaborators

• Icare Finland Oy: lead

Study Sites (1)

NVision Clinical Research LLC

Torrance, California, 90505, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2025
• First Posted: September 5, 2025
• Study Start: August 28, 2025
• Primary Completion: December 3, 2025
• Study Completion: December 3, 2025
• Last Updated: December 11, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)