Clinical Validation of iCare IC1000 Tonometer

April 1, 2026 updated by: Icare Finland Oy
Clinical validation of iCare IC1000 tonometer per ANSI Z80.10:2014 standard

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

168

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Nova Scotia Health/Dalhousie University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age ≥ 18 years

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: iCare IC1000 vs GAT, iCare IC200 and Perkins
Device: iCare IC1000
Measurement of Intraocular Pressure (IOP) in sitting and supine position
Device: iCare IC200
Measurement of Intraocular Pressure (IOP) in sitting and supine position
Device: GAT
Measurement of Intraocular Pressure (IOP) in sitting position
Device: Perkins
Measurement of Intraocular Pressure (IOP) in supine position

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demonstrate compliance with ANSI Z80.10:2014-Ophthalmics-Ophthalmic Instruments-Tonometers
Time Frame: Through study completion, an average of 6 months
Subjects will be distributed into Low IOP, Medium IOP, and High IOP groups based on the reference tonometer measurements. The iCare IC1000 Tonometer measurements shall be within +/-5.0 mmHg of the reference tonometer measurements in all groups.
Through study completion, an average of 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retrospective analysis of "Quick Measure" mode
Time Frame: Through study completion, an average of 6 months
The secondary objective of this study is to do a retrospective analysis of "Quick Measure" mode. Instead of 6 shots that are taken in Default Measure, Quick Measure takes only 2 shots (or 3 shots if the difference between the first two shots is greater than 2 mmHg). The Quick Measure results are calculated retrospectively from the raw data of the Default Measure results. Quick Measure comparison to reference measurements is done similarly as with Default Measure.
Through study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Icare Finland Oy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 21, 2025

Primary Completion (Actual)

March 24, 2026

Study Completion (Actual)

March 24, 2026

Study Registration Dates

First Submitted

December 19, 2024

First Submitted That Met QC Criteria

December 19, 2024

First Posted (Actual)

December 27, 2024

Study Record Updates

Last Update Posted (Actual)

April 7, 2026

Last Update Submitted That Met QC Criteria

April 1, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • TA032-135

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Intraocular Pressure

Clinical Trials on iCare IC1000

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malawi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe