Quick Measure Study for iCare ST500 and iCare IC200 | NCT07156630

Studies
Quick Measure Study for iCare ST500 and iCare IC200

NCT07156630

Sponsor

Icare Finland Oy

Status

Completed

Last Update Posted

Dec 11, 2025Actual

Enrollment

122Actual

Phase

Not Applicable

Conditions

Intraocular Pressure

Interventions

iCare ST500
iCare IC200
GAT
Tonovera

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 28, 2025Actual

Primary Completion Date

Dec 3, 2025Actual

Completion Date

Dec 3, 2025Actual

First Submitted Date

Aug 21, 2025

First Submission Date that Met QC Criteria

Sep 1, 2025

First Posted Date

Sep 5, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 10, 2025

Last Update Posted Date

Dec 11, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

122Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
iCare ST500 and iCare IC200 vs GAT and Tonovera	Experimental		Device: iCare ST500 Device: iCare IC200 Device: GAT Device: Tonovera

Interventions

Name	Type	Description	Arm Group Labels	Other Names
iCare ST500	Device	Measurement of IOP	iCare ST500 and iCare IC200 vs GAT and Tonovera

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Demonstrate compliance with ISO 8612:2009-Ophthalmics-Ophthalmic Instruments-Tonometers	Subjects will be distributed into Low IOP, Medium IOP, and High IOP groups based on Goldmann Applanation Tonometer measurements. The iCare ST500 Tonometer and iCare IC200 Tonometer measurements will be within +/-5.0 mmHg of the Goldmann Applanation Tonometer measurements in all groups.	Through study completion, estimated 4 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1. 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
NVision Clinical Research LLC		Torrance	California	90505	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided