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Quick Measure Study for iCare ST500 and iCare IC200

NCT07156630 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2025-12-11

No results posted yet for this study

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

Interventions

DEVICE

iCare ST500

Measurement of IOP

DEVICE

iCare IC200

Measurement of IOP

DEVICE

GAT

Measurement of IOP

DEVICE

Tonovera

Measurement of IOP

Sponsors & Collaborators

  • Icare Finland Oy

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-08-28
Primary Completion
2025-12-03
Completion
2025-12-03
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07156630 on ClinicalTrials.gov