iCare ST500 Clinical Trial

NCT ID: NCT05742009

Last Updated: 2023-11-30

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

165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-05

Study Completion Date

2023-11-14

Brief Summary

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Clinical validation of iCare ST500 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 ST500 vs GAT and iCare IC200

Measurement of intraocular pressure (IOP) with iCare ST500 compared to GAT and iCare IC200. Measurements will be performed in three categories: Low IOP (7 to 16 mmHg), Medium IOP (\>16 to \<23 mmHg), or High IOP (≥23 mmHg).

Group Type EXPERIMENTAL

iCare ST500

Intervention Type DEVICE

Measurement of Intraocular Pressure (IOP)

GAT

Intervention Type DEVICE

Measurement of Intraocular Pressure (IOP)

iCare IC200

Intervention Type DEVICE

Measurement of Intraocular Pressure (IOP)

Interventions

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iCare ST500

Measurement of Intraocular Pressure (IOP)

Intervention Type DEVICE

GAT

Measurement of Intraocular Pressure (IOP)

Intervention Type DEVICE

iCare IC200

Measurement of Intraocular Pressure (IOP)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients at least 18 years old

Exclusion Criteria

1. Subjects with only one functional eye
2. Subjects having poor or eccentric fixation in the study eye(s)
3. High corneal astigmatism \>3D in the study eye(s)
4. Central corneal scarring
5. History of prior incisional glaucoma surgery or corneal surgery, including corneal refractive laser surgery in the study eye(s)
6. Microphthalmos
7. Buphthalmos
8. Contact lens use within one week of continuous wear and within one hour if lens is worn occasionally
9. Dry eyes (clinically significant)
10. Lid squeezers - blepharospasm
11. Nystagmus
12. Keratoconus
13. Any other corneal or conjunctival pathology or infection relevant to this study
14. Central corneal thickness greater than 600 μm or less than 500 μm in the study eye(s)
15. 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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Nova Scotia Health/Dalhousie University

Halifax, Nova Scotia, Canada

Site Status

Countries

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Canada

Other Identifiers

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TA04-185

Identifier Type: -

Identifier Source: org_study_id