Clinical Validation of iCare IC1000 Tonometer

NCT ID: NCT06748092

Last Updated: 2025-12-26

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

RECRUITING

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-21

Study Completion Date

2026-02-28

Brief Summary

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Clinical validation of iCare IC1000 tonometer per ANSI Z80.10:2014 standard

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

Investigator cannot see the measurement results.

Study Groups

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iCare IC1000 vs GAT, iCare IC200 and Perkins

Group Type EXPERIMENTAL

iCare IC1000

Intervention Type DEVICE

Measurement of Intraocular Pressure (IOP) in sitting and supine position

iCare IC200

Intervention Type DEVICE

Measurement of Intraocular Pressure (IOP) in sitting and supine position

GAT

Intervention Type DEVICE

Measurement of Intraocular Pressure (IOP) in sitting position

Perkins

Intervention Type DEVICE

Measurement of Intraocular Pressure (IOP) in supine position

Interventions

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iCare IC1000

Measurement of Intraocular Pressure (IOP) in sitting and supine position

Intervention Type DEVICE

iCare IC200

Measurement of Intraocular Pressure (IOP) in sitting and supine position

Intervention Type DEVICE

GAT

Measurement of Intraocular Pressure (IOP) in sitting position

Intervention Type DEVICE

Perkins

Measurement of Intraocular Pressure (IOP) in supine position

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
* 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
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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Nova Scotia Health/Dalhousie University

Halifax, Nova Scotia, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Balwantray Chauhan, Prof.

Role: CONTACT

Phone: 902-473-3202

Email: [email protected]

Facility Contacts

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Balwantray Chauhan, Prof.

Role: primary

Other Identifiers

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TA032-135

Identifier Type: -

Identifier Source: org_study_id