iCare IC1000 Alignment Study | NCT07022054

Studies
iCare IC1000 Alignment Study

NCT07022054

Sponsor

Icare Finland Oy

Status

Completed

Last Update Posted

Aug 12, 2025Actual

Enrollment

100Actual

Phase

Not Applicable

Conditions

Intraocular Pressure

Interventions

iCare IC1000 measurement

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

Aug 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

May 22, 2025Actual

Primary Completion Date

Aug 5, 2025Actual

Completion Date

Aug 5, 2025Actual

First Submitted Date

May 22, 2025

First Submission Date that Met QC Criteria

Jun 13, 2025

First Posted Date

Jun 15, 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

Aug 7, 2025

Last Update Posted Date

Aug 12, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The primary objective of this study is to evaluate the performance of the alignment feature of iCare IC1000 tonometer.

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

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Measurement of IOP Values	Experimental		Device: iCare IC1000 measurement

Interventions

Name	Type	Description	Arm Group Labels	Other Names
iCare IC1000 measurement	Device	Measurement of intraocular pressure with iCare IC1000	Measurement of IOP Values

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Primary Objective	Number of participants with successful intraocular pressure (IOP) measurements using the alignment feature of the iCare IC1000 tonometer during a single clinic visit.	Through study completion, an average of 2 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
Central corneal scarring
Microphthalmos
Buphthalmos
Contact lens use during measurement or hard lenses 24h prior to measurement
Dry eyes (clinically significant)
Nystagmus
Keratoconus
Any other corneal or conjunctival pathology or infection relevant to this study
Coloboma or other pupil deformation

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
Clear Vue Laser Eye Center		Lake Worth	Florida	33467	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