Quick Measure Study for iCare ST500 and iCare IC200

NCT ID: NCT07156630

Last Updated: 2025-12-11

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

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-28

Study Completion Date

2025-12-03

Brief Summary

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The aim of this clinical study is to compare the agreement and precision of the intraocular pressure (IOP) results measured with the Quick Measure feature of iCare ST500 and iCare IC200 tonometers with results obtained with reference tonometers (Goldmann applanation tonometry and Tono-Vera tonometer). The data will be collected and evaluated in accordance with ISO 8612:2009 "Ophthalmic Instruments - Tonometers" (at least 120 eyes divided in three IOP groups with a minimum of 40 eyes per group, 95% of the paired differences between the reference tonometer and the test tonometer must fall within the tolerance of ±5 mmHg).

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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iCare ST500 and iCare IC200 vs GAT and Tonovera

Group Type EXPERIMENTAL

iCare ST500

Intervention Type DEVICE

Measurement of IOP

iCare IC200

Intervention Type DEVICE

Measurement of IOP

GAT

Intervention Type DEVICE

Measurement of IOP

Tonovera

Intervention Type DEVICE

Measurement of IOP

Interventions

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iCare ST500

Measurement of IOP

Intervention Type DEVICE

iCare IC200

Measurement of IOP

Intervention Type DEVICE

GAT

Measurement of IOP

Intervention Type DEVICE

Tonovera

Measurement of IOP

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1\. Age ≥ 18 years

Exclusion Criteria

1. Subjects with only one functional eye
2. Subjects having poor or eccentric fixation in the study eye
3. High corneal astigmatism \>3D in the study eye
4. Central corneal scarring
5. History of prior incisional glaucoma surgery or corneal surgery, including corneal refractive laser surgery in the study eye
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
15. 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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NVision Clinical Research LLC

Torrance, California, United States

Site Status

Countries

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United States

Other Identifiers

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TA04-310

Identifier Type: -

Identifier Source: org_study_id

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