Intraocular Pressure Data Collection With Tonometers

NCT ID: NCT06450587

Last Updated: 2025-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

151 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-29

Study Completion Date

2025-02-07

Brief Summary

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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.

Detailed Description

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Conditions

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Intraocular Pressure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Measurement of IOP Values

Measurement of IOP pressure with four different tonometers.

Group Type EXPERIMENTAL

iCare IC1000

Intervention Type DEVICE

Measurement of Intraocular Pressure (IOP)

iCare ST500

Intervention Type DEVICE

Measurement of Intraocular Pressure (IOP)

iCare IC200

Intervention Type DEVICE

Measurement of Intraocular Pressure (IOP)

GAT

Intervention Type DEVICE

Measurement of Intraocular Pressure (IOP)

Interventions

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iCare IC1000

Measurement of Intraocular Pressure (IOP)

Intervention Type DEVICE

iCare ST500

Measurement of Intraocular Pressure (IOP)

Intervention Type DEVICE

iCare IC200

Measurement of Intraocular Pressure (IOP)

Intervention Type DEVICE

GAT

Measurement of Intraocular Pressure (IOP)

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Icare Finland Oy

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Vid d.o.o.

Kromberk, Nova Gorica, Slovenia

Site Status

Optika Mesec d.o.o.

Bled, Občina Bled, Slovenia

Site Status

Countries

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Slovenia

Other Identifiers

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TA032-082

Identifier Type: -

Identifier Source: org_study_id

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