Intraocular Pressure Data Collection With Tonometers

April 29, 2025 updated by: Icare Finland Oy

The goal of this clinical trial is to collect a comprehensive dataset of intraocular pressure values for developing a measurement algorithm for the new hand-held rebound tonometer device. The measurement algorithm shall fulfill the requirements of ANSI Z80.10:2014 standard. The study population is adults (age ≥ 18 years).

The intraocular pressure of the participants will be measured with four different tonometers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

151

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

  • Slovenia
      • Bled, Slovenia, 4260
        • Optika Mesec d.o.o.
    • Nova Gorica
      • Kromberk, Nova Gorica, Slovenia, 5000
        • Vid d.o.o.

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(s)
  • High corneal astigmatism >3D in the study eye(s)
  • Central corneal scarring
  • History of prior incisional glaucoma surgery or corneal surgery, including corneal refractive laser surgery in the study eye(s)
  • 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
  • Cataract Extraction within last 2 months in the study eye(s)

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: Measurement of IOP Values
Measurement of IOP pressure with four different tonometers.
Device: iCare ST500
Measurement of Intraocular Pressure (IOP)
Device: GAT
Measurement of Intraocular Pressure (IOP)
Device: iCare IC200
Measurement of Intraocular Pressure (IOP)
Device: iCare IC1000
Measurement of Intraocular Pressure (IOP)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Objective
Time Frame: Through study completion, an average of 4 months
The primary objective of this study is to measure wide range of IOP values with the new tonometer and three comparator devices. The IOP value's unit of measure will be mmHg.
Through study completion, an average of 4 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)

May 29, 2024

Primary Completion (Actual)

February 7, 2025

Study Completion (Actual)

February 7, 2025

Study Registration Dates

First Submitted

May 31, 2024

First Submitted That Met QC Criteria

June 7, 2024

First Posted (Actual)

June 10, 2024

Study Record Updates

Last Update Posted (Actual)

April 30, 2025

Last Update Submitted That Met QC Criteria

April 29, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • TA032-082

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 ST500

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Czech Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe