Intraocular Pressure Data Collection With Tonometers | NCT06450587

Studies
Intraocular Pressure Data Collection With Tonometers

NCT06450587

Sponsor

Icare Finland Oy

Status

Completed

Last Update Posted

Apr 30, 2025Actual

Enrollment

151Actual

Phase

Not Applicable

Conditions

Intraocular Pressure

Interventions

iCare IC1000
iCare ST500
iCare IC200
GAT

Countries

Slovenia

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

Apr 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 29, 2024Actual

Primary Completion Date

Feb 7, 2025Actual

Completion Date

Feb 7, 2025Actual

First Submitted Date

May 31, 2024

First Submission Date that Met QC Criteria

Jun 7, 2024

First Posted Date

Jun 10, 2024Actual

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

Apr 29, 2025

Last Update Posted Date

Apr 30, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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 goal of this clinical trial is to collect a comprehensive dataset of intraocular pressure values for developing a measurement algorithm for the new hand-held rebound tonometer device. The measurement algorithm shall fulfill the requirements of ANSI Z80.10:2014 standard. The study population is adults (age ≥ 18 years).

The intraocular pressure of the participants will be measured with four different tonometers.

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

151Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Measurement of IOP Values	Experimental	Measurement of IOP pressure with four different tonometers.	Device: iCare IC1000 Device: iCare ST500 Device: iCare IC200 Device: GAT

Interventions

Name	Type	Description	Arm Group Labels	Other Names
iCare IC1000	Device	Measurement of Intraocular Pressure (IOP)	Measurement of IOP Values

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Primary Objective	The primary objective of this study is to measure wide range of IOP values with the new tonometer and three comparator devices. The IOP value's unit of measure will be mmHg.	Through study completion, an average of 4 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ≥ 18 years

Exclusion Criteria:

Subjects with only one functional eye
Subjects having poor or eccentric fixation in the study eye(s)
High corneal astigmatism >3D in the study eye(s)
Central corneal scarring
History of prior incisional glaucoma surgery or corneal surgery, including corneal refractive laser surgery in the study eye(s)
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
Cataract Extraction within last 2 months in the study eye(s)

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
Optika Mesec d.o.o.		Bled	Municipality of Bled	4260	Slovenia
Vid d.o.o.

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